Abacavir | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Abacavir with Lamivudine | C3590 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3591 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3592 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3592 |
| C3593 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3593 |
Abacavir with Lamivudine and Zidovudine | C3979 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in a patient over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3980 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection where the patient over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3981 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in a patient over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3981 |
| C3982 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection where the patient over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3982 |
Abatacept | C3996 | P3996 | | Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS-subsidised treatment with abatacept, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with abatacept for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures
|
| | | | Continuation of a course of initial treatment with abatacept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3997 | P3997 | | Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with abatacept, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with abatacept for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with abatacept are not eligible to commence treatment with abatacept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with abatacept and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised abatacept treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised abatacept treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures
|
| | | | Continuation of a course of initial treatment with abatacept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3998 | P3998 | | Rheumatoid arthritis — continuing treatment
Continuing PBS-subsidised treatment with abatacept, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with abatacept; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with abatacept; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with abatacept;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of abatacept therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures
|
| | | | Continuation of a course of continuing treatment with abatacept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
Abciximab | C1716 | | | Patients undergoing percutaneous coronary balloon angioplasty | Compliance with Authority Required procedures - Streamlined Authority Code 1716 |
| C1717 | | | Patients undergoing percutaneous coronary atherectomy | Compliance with Authority Required procedures - Streamlined Authority Code 1717 |
| C1718 | | | Patients undergoing percutaneous coronary stent placement | Compliance with Authority Required procedures - Streamlined Authority Code 1718 |
Acamprosate | C2665 | | | For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence | Compliance with Authority Required procedures - Streamlined Authority Code 2665 |
Aciclovir | C1715 | | | Herpes simplex keratitis. | |
| C3622 | P3622 | | Treatment of patients with herpes zoster within 72 hours of the onset of the rash | Compliance with Authority Required procedures - Streamlined Authority Code 3622 |
| C3630 | P3630 | | Patients with advanced human immunodeficiency virus disease (CD4 cell counts of less than 150 million per L) | Compliance with Authority Required procedures - Streamlined Authority Code 3630 |
| C3631 | P3631 | | Herpes zoster ophthalmicus | Compliance with Authority Required procedures - Streamlined Authority Code 3631 |
| C3632 | P3632 | | Moderate to severe initial genital herpes | Compliance with Authority Required procedures - Streamlined Authority Code 3632 |
| C3633 | P3633 | | Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Compliance with Authority Required procedures - Streamlined Authority Code 3633 |
Acitretin | C1363 | | | Severe forms of disorders of keratinisation | Compliance with Authority Required procedures - Streamlined Authority Code 1363 |
| C1366 | | | Severe intractable psoriasis | Compliance with Authority Required procedures - Streamlined Authority Code 1366 |
Adalimumab | C2986 | P2986 | | Crohn disease — initial treatment 1
(patient assessed by CDAI)
Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has not received any prior PBS-subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS-subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised treatment with adalimumab or infliximab for this condition was approved; and
(c) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) has failed to achieve an adequate response to prior systemic therapy including:
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and
(ii) immunosuppressive therapy including:
— azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
— 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
— methotrexate at a dose of at least 15 mg weekly for 3 or more months; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens mentioned at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
failure to achieve an adequate response is indicated by a severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as assessed, and is demonstrated in the patient at the time of the authority application;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the most recent CDAI assessment is no more than 1 month old at the time of application;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and
(iii) the signed patient acknowledgement;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment | Compliance with Written Authority Required procedures
|
| | | | Continuation of initial treatment in a treatment cycle, by a gastroenterologist or a consultant physician, of a patient with severe refractory Crohn disease who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C2988 | P2988 | | Crohn disease — initial treatment 3
(patient assessed by CDAI)
Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of severe refractory Crohn disease and was receiving treatment with adalimumab prior to 9 November 2007; and
(b) had a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with adalimumab; and
(c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and baseline Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; and
(ii) the signed patient acknowledgment;
the current CDAI assessment is no more than 1 month old at the time of application;
the baseline CDAI assessment is from immediately prior to commencing treatment with adalimumab;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient may qualify for PBS-subsidised treatment under this restriction once only | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C2990 | P2990 | | Crohn disease — initial treatment 1
(patient with short gut syndrome or an ostomy patient)
Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:
(a) has confirmed Crohn disease defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has diagnostic imaging or surgical evidence of short gut syndrome or has an ileostomy or colostomy; and
(c) has evidence of intestinal inflammation; and
(d) has not received any prior PBS-subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS-subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised treatment with adalimumab or infliximab for this condition was approved; and
(e) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(f) has failed to achieve an adequate response to prior systemic drug therapy including:
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and
(ii) immunosuppressive therapy including:
— azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
— 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
— methotrexate at a dose of at least 15 mg weekly for 3 or more months; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (f) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens mentioned at (f) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
failure to achieve an adequate response is indicated by the following and is demonstrated in the patient at the time of the authority application:
(a) have evidence of intestinal inflammation, including:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; and/or
(ii) faeces: higher than normal lactoferrin or calprotectin level; and/or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; and/or
(b) be assessed clinically as being in a high faecal output state; and/or
(c) be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of adalimumab;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and
(ii) reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iii) date of the most recent clinical assessment; and
(iv) the signed patient acknowledgement;
all assessments, pathology tests and diagnostic imaging studies are made within 1 month of the date of application;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment in a treatment cycle, by a gastroenterologist or a consultant physician, of a patient with severe refractory Crohn disease who has short gut syndrome or an ileostomy or colostomy and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C2993 | P2993 | | Crohn disease — initial treatment 1
(patient with extensive small intestine disease)
Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has extensive small intestinal disease with radiological evidence of intestinal inflammation affecting more than 50 cm of the small intestine; and
(c) has not received any prior PBS-subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS-subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised treatment with adalimumab or infliximab for this condition was approved; and
(d) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(e) has failed to achieve an adequate response to prior systemic therapy including:
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and
(ii) immunosuppressive therapy including:
— azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
— 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
— methotrexate at a dose of at least 15 mg weekly for 3 or more months; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (e) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens mentioned at (e) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
failure to achieve an adequate response is indicated by the following and is demonstrated in the patient at the time of the authority application:
(a) have severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and/or
(b) have evidence of active intestinal inflammation, including:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; and/or
(ii) faeces: higher than normal lactoferrin or calprotectin level; and/or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; and/or
(c) be assessed clinically as being in a high faecal output state; and/or
(d) be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of adalimumab;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and
(ii) (1) reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; or
(2) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the dates of assessment of the patient's condition, if relevant; and
(iii) date of the most recent clinical assessment; and
(iv) the signed patient acknowledgement;
all assessments, pathology tests and diagnostic imaging studies are made within 1 month of the date of application;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment in a treatment cycle, by a gastroenterologist or a consultant physician, of a patient with severe refractory Crohn disease who has extensive small intestine disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C2995 | P2995 | | Crohn disease — initial treatment 3
(patient with short gut syndrome or extensive small intestine disease, or an ostomy patient)
Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of severe refractory Crohn disease and was receiving treatment with adalimumab prior to 9 November 2007; and
(b) (1) has a history of extensive small intestinal disease with radiological evidence of intestinal inflammation affecting more than 50 cm of the small intestine; or
(2) has diagnostic imaging or surgical evidence of short gut syndrome or has an ileostomy or colostomy with a documented history of intestinal inflammation; and
(c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) has demonstrated or sustained an adequate response to treatment with adalimumab according to the criteria included in the relevant continuation restriction; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as:
(a) a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150; or
(b) improvement of intestinal inflammation as demonstrated by:
(i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or
(ii) faeces: normalisation of lactoferrin or calprotectin level; and/or
(iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or
(c) reversal of high faecal output state; or
(d) avoidance of the need for surgery or total parenteral nutrition (TPN);
the same criteria used to determine an inadequate response to prior treatment at baseline are used to determine response to treatment and eligibility for continuing therapy, according to the criteria included in the continuing treatment restriction;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) (1) the completed current and baseline Crohn Disease Activity Index (CDAI) Score calculation sheet, where relevant, including the date of the assessment of the patient's condition; or
(2) the reports and dates of the current and baseline pathology or diagnostic imaging test(s) in order to assess response to therapy; or
(3) the date of clinical assessment(s); and
(ii) the signed patient acknowledgement;
the patient's assessment is no more than 1 month old at the time of application;
the baseline assessment is from immediately prior to commencing treatment with adalimumab;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient may qualify for PBS-subsidised treatment under this restriction once only | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with extensive small intestine disease, short gut syndrome or an ileostomy or colostomy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3265 | P3265 | | Chronic plaque psoriasis (whole body) — initial treatment 1
Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the whole body; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrated in the patient at the time of the authority application;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3267 | P3267 | | Chronic plaque psoriasis (face, hand, foot) — initial treatment 1
Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the face, hand or foot; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3486 | P3486 | | Psoriatic arthritis — initial treatment 1
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have severe active psoriatic arthritis; and
(2) have received no prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
(3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) an active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgment;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment with adalimumab in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3502 | P3502 | | Ankylosing spondylitis — initial treatment 1
Initial treatment with adalimumab commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
(a) who has not received any PBS-subsidised treatment with a tumour necrosis factor (TNF)-alfa antagonist, or, where the patient has previously received PBS-subsidised TNF-alfa antagonist treatment for this condition, has received no such treatment for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and
(b) who has at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
(iii) limitation of chest expansion relative to normal values for age and gender; and
(c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised TNF-alfa antagonist therapy of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated by:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;
both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;
if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;
if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form; and
(iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment with adalimumab in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3520 | P3520 | | Juvenile idiopathic arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)
Initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) has received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(c) has failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg per day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means adalimumab or etanercept; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and (b) either:
(i) an active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of adalimumab provided a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in their previous treatment cycle and the date of the first application under the new treatment cycle;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3522 | P3522 | | Juvenile idiopathic arthritis — initial treatment 3
Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) was receiving treatment with adalimumab prior to 1 March 2010; and
(c) has demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and
(d) is receiving treatment with adalimumab at the time of application; and
where the following conditions apply: the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient is eligible for PBS-subsidised treatment under the above criteria once only | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2010 and at the time of the initial application for PBS-subsidised therapy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3695 | P3695 | | Fistulising Crohn disease — initial treatment 1
Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has an externally draining enterocutaneous or rectovaginal fistula; and
(c) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement;
the most recent fistula assessment is no more than 1 month old at the time of application;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment in a treatment cycle, by a gastroenterologist or a consultant physician as specified above, of a patient with complex refractory fistulising Crohn disease who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3697 | P3697 | | Fistulising Crohn disease — initial treatment 3
(previous adalimumab treatment non-PBS-subsidised)
Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who satisfies the following criteria:
(a) has a documented history of complex refractory fistulising Crohn disease and was receiving treatment with adalimumab prior to 4 November 2010; and
(b) had a draining enterocutaneous or rectovaginal fistula(e) prior to commencing treatment with adalimumab; and
(c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) is receiving treatment with adalimumab at the time of application; and
(e) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient;
the application for authorisation is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current and baseline Fistula Assessment form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement;
the current fistula assessment is no more than 1 month old at the time of application;
the baseline fistula assessment is from immediately prior to commencing treatment with adalimumab;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient is eligible for PBS-subsidised treatment under this restriction once only | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of complex refractory fistulising Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3706 | P3706 | | Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS-subsidised treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with adalimumab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3743 | P3743 | | Juvenile idiopathic arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)
Initial PBS-subsidised treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or etanercept for this condition; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with adalimumab in this treatment cycle and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised adalimumab treatment is a 16 week initial treatment course, is made following a minimum of 12 weeks of therapy;
a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3744 | P3744 | | Juvenile idiopathic arthritis — continuing treatment
Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older:
(a) who has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) who has demonstrated an adequate response to treatment with adalimumab; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with adalimumab; and
where bDMARD means adalimumab or etanercept; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) an active joint count of fewer than 10 active (swollen and tender) joints; or
(ii) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(iii) a reduction in the number of the following joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of adalimumab therapy is a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a patient who has failed to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of continuing treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3745 | P3745 | | Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with adalimumab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with adalimumab are not eligible to commence treatment with adalimumab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with adalimumab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised adalimumab treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3746 | P3746 | | Rheumatoid arthritis — continuing treatment
Continuing PBS-subsidised treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with adalimumab; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with adalimumab; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of adalimumab therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of continuing treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3747 | P3747 | | Fistulising Crohn disease — initial treatment 2
(change or recommencement of PBS-subsidised treatment)
Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:
(a) has a documented history of complex refractory fistulising Crohn disease; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or infliximab for a draining enterocutaneous or rectovaginal fistula; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where TNF-alfa antagonist means adalimumab or infliximab; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior TNF-alfa antagonist treatment including details of date and duration of treatment;
the most recent fistula assessment is no more than 1 month old at the time of application;
to demonstrate a response to treatment the application must be accompanied by the results of the patient's most recent course of TNF-alfa antagonist therapy;
the assessment of response to the most recent course of TNF-alfa antagonist therapy must:
(a) be provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased; and
(b) have been made following a minimum of 12 weeks of treatment if the course of therapy was a 16-week initial course of adalimumab, and up to 12 weeks after the first dose (6 weeks following the third dose) if the course of therapy was a 3 dose initial course of infliximab;
if the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of TNF-alfa antagonist;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician as specified above, of a patient who has a documented history of complex refractory fistulising Crohn disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment or recommencement of treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3748 | P3748 | | Fistulising Crohn disease — continuing treatment
Continuing PBS-subsidised treatment with adalimumab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of complex refractory fistulising Crohn disease; and
(b) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient;
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition;
the fistula assessment is no more than 1 month old at the time of application;
the assessment of the patient's response to a course of treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy;
where an assessment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response | Compliance with Written Authority Required procedures |
| | | | Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of complex refractory fistulising Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3749 | P3749 | | Psoriatic arthritis — initial treatment 2
Initial treatment, or recommencement of treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have a documented history of severe active psoriatic arthritis; and
(2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and are eligible to receive further therapy with a biological agent; and
(3) have not failed treatment with adalimumab during the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with adalimumab within this Treatment Cycle and wishes to recommence therapy with this drug within this same cycle, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised adalimumab treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3750 | P3750 | | Psoriatic arthritis — continuing treatment
Continuing treatment with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
(1) who have a documented history of severe active psoriatic arthritis; and
(2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with adalimumab; and
(3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to treatment with adalimumab is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of adalimumab therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of continuing treatment with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3751 | P3751 | | Ankylosing spondylitis — initial treatment 2
Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised tumour necrosis factor (TNF)-alfa antagonist treatment for this condition and is eligible to receive further TNF-alfa antagonist therapy, and has not failed PBS-subsidised therapy with adalimumab in the current treatment cycle; and
where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
a patient is eligible to receive further therapy with a TNF-alfa antagonist within this treatment cycle provided they have not already failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists within this treatment cycle;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form;
an assessment of response to the patient's most recent course of PBS-subsidised TNF-alfa antagonist treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased;
where the most recent course of TNF-antagonist treatment is an initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
if the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3752 | P3752 | | Ankylosing spondylitis — continuing treatment
Continuing treatment with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated an adequate response to treatment with adalimumab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with adalimumab; and
where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
(a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
(b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline;
all measurements provided are no more than 1 month old at the time of application;
where only 1 acute phase reactant measurement is supplied to establish baseline in the first application for PBS-subsidised treatment, that same marker is measured and supplied in all subsequent continuing treatment applications;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of adalimumab therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of continuing treatment with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3753 | P3753 | | Crohn disease — initial treatment 2
(patient assessed by CDAI)
Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient who:
(a) has a documented history of severe refractory Crohn disease; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with infliximab or adalimumab for this condition; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; and
(ii) details of prior adalimumab and infliximab treatment including details of date and duration of treatment; and
to demonstrate a response to treatment the application is accompanied by the results of the patient's most recent course of adalimumab or infliximab therapy where:
(a) the response assessment is provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased; and
(b) (i) if the course of therapy is a 16-week initial course (in the case of adalimumab), the assessment of response is made following a minimum of 12 weeks of treatment; or
(ii) if the course of therapy is a 3 dose initial course (in the case of infliximab), the assessment of response is made up to 12 weeks after the first dose (6 weeks following the third dose);
if the response assessment to the previous course of adalimumab or infliximab treatment is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician, of a patient who has a documented history of severe refractory Crohn disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment or recommencement of treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3754 | P3754 | | Crohn disease — initial treatment 2
(patient with short gut syndrome or extensive small intestine disease, or an ostomy patient)
Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient who:
(a) has a documented history of severe refractory Crohn disease and has short gut syndrome, an ileostomy or colostomy, or extensive small intestine disease; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with infliximab or adalimumab for this condition; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criteria, if relevant; and (ii) details of prior adalimumab and infliximab treatment including details of date and duration of treatment;
to demonstrate a response to treatment the application is accompanied by the results of the patient's most recent course of adalimumab or infliximab therapy where:
(a) the response assessment is provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased; and
(b) (i) if the course of therapy is a 16-week initial course (in the case of adalimumab), the assessment of response is made following a minimum of 12 weeks of treatment; or
(ii) if the course of therapy is a 3 dose initial course (in the case of infliximab), the assessment of response is made up to 12 weeks after the first dose (6 weeks following the third dose);
if the response assessment to the previous course of adalimumab or infliximab treatment is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;
the same baseline criterion used to determine response to an initial course of adalimumab treatment is used to determine response, and thus eligibility for continued PBS-subsidised therapy, to subsequent courses of treatment;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician, of a patient who has a documented history of severe refractory Crohn disease and has short gut syndrome, an ileostomy or colostomy, or extensive small intestine disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment or recommencement of treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3755 | P3755 | | Crohn disease — continuing treatment
(patient assessed by CDAI)
Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of severe refractory Crohn disease; and
(b) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition;
the CDAI assessment is no more than 1 month old at the time of application;
the CDAI assessment of the patient's response to a course of treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy;
where an assessment is not submitted to the Chief Executive Medicare as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response | Compliance with Written Authority Required procedures |
| | | | Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3756 | P3756 | | Crohn disease — continuing treatment
(patient with short gut syndrome or an ostomy patient)
Continuing treatment in an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of severe refractory Crohn disease with intestinal inflammation and with short gut syndrome or with an ileostomy or colostomy; and
(b) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as:
(a) improvement of intestinal inflammation as demonstrated by:
(i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or
(ii) faeces: normalisation of lactoferrin or calprotectin level; and/or
(iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or
(b) reversal of high faecal output state; or
(c) avoidance of the need for surgery or total parenteral nutrition (TPN);
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy or the date of clinical assessment;
the patient's assessment is no more than 1 month old at the time of application;
the assessment of the patient's response to a course of treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy;
where an assessment is not submitted to the Chief Executive Medicare as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above;
the same baseline criterion used to determine response to an initial course of adalimumab treatment is used to determine response, and thus eligibility for continued PBS-subsidised therapy, to subsequent courses of treatment;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response 3757 | Compliance with Written Authority Required procedures |
| | | | Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with short gut syndrome or an ileostomy or colostomy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3757 | P3757 | | Crohn disease — continuing treatment
(patient with extensive small intestine disease)
Continuing treatment in an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of severe refractory Crohn disease with extensive intestinal inflammation affecting more than 50 cm of the small intestine; and
(b) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as:
(a) a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150; or
(b) improvement of intestinal inflammation as demonstrated by:
(i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or
(ii) faeces: normalisation of lactoferrin or calprotectin level; and/or
(iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or
(c) reversal of high faecal output state; or
(d) avoidance of the need for surgery or total parenteral nutrition (TPN);
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy; or
(iii) the date of clinical assessment;
all assessments are no more than 1 month old at the time of application;
the assessment of the patient's response to a course of treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy;
where an assessment is not submitted to the Chief Executive Medicare as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above;
the same baseline criterion used to determine response to an initial course of adalimumab treatment is used to determine response, and thus eligibility for continued PBS-subsidised therapy, to subsequent courses of treatment;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response | Compliance with Written Authority Required procedures |
| | | | Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with extensive small intestine disease, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3758 | P3758 | | Chronic plaque psoriasis (whole body) — initial treatment 2
Initial treatment, or recommencement of treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis; and
(b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and
(c) have not failed PBS-subsidised therapy with adalimumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who have previously demonstrated a response to PBS-subsidised treatment with adalimumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised adalimumab treatment was submitted to the Chief Executive Medicare within 1 month of cessation of that treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment, or of a course which recommences treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3759 | P3759 | | Chronic plaque psoriasis (face, hand, foot) — initial treatment 2
Initial treatment, or recommencement of treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and
(c) have not failed PBS-subsidised therapy with adalimumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who have previously demonstrated a response to PBS-subsidised treatment with adalimumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised adalimumab treatment was submitted to the Chief Executive Medicare within 1 month of cessation of that treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment, or of a course which recommences treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3760 | P3760 | | Chronic plaque psoriasis (whole body) — continuing treatment
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with adalimumab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with adalimumab; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Chief Executive Medicare no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with adalimumab;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3761 | P3761 | | Chronic plaque psoriasis (face, hand, foot) — continuing treatment
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with adalimumab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with adalimumab; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Chief Executive Medicare no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with adalimumab;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
Adapalene with benzoyl peroxide | C3689 | P3689 | | Acute treatment, in combination with an oral antibiotic, of severe acne vulgaris | |
| C3690 | P3690 | | Maintenance treatment of severe acne vulgaris | |
Adefovir | C3971 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient without cirrhosis who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance | Compliance with Written or Telephone Authority Required procedures |
| C3972 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures |
| C3973 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient without cirrhosis who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3973 |
| C3974 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3974 |
Adrenaline | C3434 | | | Initial sole PBS-subsidised supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient who has been assessed to be at significant risk of anaphylaxis by, or in consultation with, a clinical immunologist, allergist, paediatrician or respiratory physician, and where the name of the specialist consulted is included in the authority application | Compliance with Authority Required procedures |
| C3435 | | | Initial sole PBS-subsidised supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient who has been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis | Compliance with Authority Required procedures |
| C3436 | | | Continuing sole PBS-subsidised supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis, where the patient has previously been issued with an authority prescription for this drug | Compliance with Authority Required procedures |
Albendazole | C1388 | P1388 | | Strongyloidiasis | Compliance with Authority Required procedures - Streamlined Authority Code 1388 |
| C1496 | | | For the treatment of hydatid disease in conjunction with surgery or when a surgical cure cannot be achieved or where surgery cannot be used | Compliance with Authority Required procedures - Streamlined Authority Code 1496 |
| C1525 | P1525 | | Treatment of tapeworm infestation | Compliance with Authority Required procedures - Streamlined Authority Code 1525 |
| C2446 | P2446 | | Treatment of whipworm infestation in an Aboriginal or a Torres Strait Islander person | Compliance with Authority Required procedures - Streamlined Authority Code 2446 |
| C3241 | P3241 | | Treatment of hookworm infestation | Compliance with Authority Required procedures - Streamlined Authority Code 3241 |
Alendronic Acid | C2646 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | Compliance with Authority Required procedures - Streamlined Authority Code 2646 |
| C3070 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3070 |
| C3256 | | | Symptomatic Paget disease of bone | Compliance with Authority Required procedures - Streamlined Authority Code 3256 |
| C3933 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -2.5 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3933 |
Alendronic acid with colecalciferol | C2646 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | Compliance with Authority Required procedures - Streamlined Authority Code 2646 |
| C3070 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3070 |
| C3933 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -2.5 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3933 |
Alendronic acid with colecalciferol and calcium | C2646 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | Compliance with Authority Required procedures - Streamlined Authority Code 2646 |
| C3070 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3070 |
| C3933 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -2.5 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3933 |
Alprazolam | C1975 | | | Panic disorder where other treatments have failed or are inappropriate | Compliance with Authority Required procedures |
Amantadine | C1258 | | | Parkinson's disease which is not drug induced | |
Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid | C1314 | | | Pyridoxine non-responsive homocystinuria | |
Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexanoic acid | C1453 | | | Tyrosinaemia | |
Amino acid formula without phenylalanine | C1286 | | | Phenylketonuria | |
Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine | C1286 | | | Phenylketonuria | |
Amino acid formula with vitamins and minerals without lysine and low in tryptophan | C2612 | | | An infant or young child with proven glutaric aciduria type 1 | |
| C3134 | | | A child aged from 6 months up to 10 years with proven glutaric aciduria type 1 | |
| C3550 | | | A child aged less than 9 years with proven glutaric aciduria type 1 | |
| C3678 | | | A patient aged 3 years or older with proven glutaric aciduria type 1 | |
Amino acid formula with vitamins and minerals without methionine | C1314 | | | Pyridoxine non-responsive homocystinuria | |
| C1484 | | | For infants and very young children with pyridoxine non-responsive homocystinuria | |
Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine | C1225 | | | Methylmalonic acidaemia | |
| C1307 | | | Propionic acidaemia | |
Amino acid formula with vitamins and minerals without phenylalanine | C1286 | | | Phenylketonuria | |
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine | C1453 | | | Tyrosinaemia | |
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine | C1220 | | | Maple syrup urine disease | |
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid | C1220 | | | Maple syrup urine disease | |
Amino acids — synthetic, formula | C1687 | P1687 | | Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed | Compliance with Authority Required procedures |
| C1688 | P1688 | | Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition | Compliance with Authority Required procedures |
| C2734 | P2734 | | Initial treatment for up to 3 months, by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who requires an amino acid based formula as a component of a dietary elimination programme, and where:
eosinophilic oesophagitis is demonstrated by the following criteria:
(i) chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and
(ii) a lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and
(iii) eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy specimen had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;
the date of birth of the patient is included in the authority application;
treatment with oral steroids is not commenced during the period of initial treatment | Compliance with Authority Required procedures |
| C2735 | P2735 | | Continuing treatment by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who has responded to an initial course of PBS-subsidised treatment, and where:
response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy specimen has 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;
the response criteria will be deemed to have been not met if the patient commenced oral steroids during initial treatment | Compliance with Authority Required procedures |
| C4033 | P4033 | | Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated colic or reflux) in a child up to the age of 24 months. Combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4034 | P4034 | | Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4035 | P4035 | | Initial treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4036 | P4036 | | Treatment, in consultation with a specialist allergist or clinical immunologist, for a child with cows' milk anaphylaxis, up to the age of 24 months. Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4037 | P4037 | | Continuing treatment for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4038 | P4038 | | Continuing treatment for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed at least once or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. Then name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4039 | P4039 | | Continuing treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist at intervals not greater than 12 months. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids | C1687 | | | Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed | Compliance with Authority Required procedures |
| C1688 | | | Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition | Compliance with Authority Required procedures |
| C4033 | | | Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated colic or reflux) in a child up to the age of 24 months. Combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4034 | | | Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4035 | | | Initial treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4036 | | | Treatment, in consultation with a specialist allergist or clinical immunologist, for a child with cows' milk anaphylaxis, up to the age of 24 months. Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4037 | | | Continuing treatment for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4038 | | | Continuing treatment for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed at least once or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. Then name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4039 | | | Continuing treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist at intervals not greater than 12 months. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides | C1687 | P1687 | | Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed | Compliance with Authority Required procedures |
| C1688 | P1688 | | Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition | Compliance with Authority Required procedures |
| C2734 | P2734 | | Initial treatment for up to 3 months, by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who requires an amino acid based formula as a component of a dietary elimination programme, and where:
eosinophilic oesophagitis is demonstrated by the following criteria:
(i) chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and
(ii) a lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and
(iii) eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy specimen had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;
the date of birth of the patient is included in the authority application;
treatment with oral steroids is not commenced during the period of initial treatment | Compliance with Authority Required procedures |
| C2735 | P2735 | | Continuing treatment by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who has responded to an initial course of PBS-subsidised treatment, and where:
response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy specimen has 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;
the response criteria will be deemed to have been not met if the patient commenced oral steroids during initial treatment | Compliance with Authority Required procedures |
| C4033 | P4033 | | Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated colic or reflux) in a child up to the age of 24 months. Combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4034 | P4034 | | Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4035 | P4035 | | Initial treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4036 | P4036 | | Treatment, in consultation with a specialist allergist or clinical immunologist, for a child with cows' milk anaphylaxis, up to the age of 24 months. Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4037 | P4037 | | Continuing treatment for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4038 | P4038 | | Continuing treatment for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed at least once or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. Then name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4039 | P4039 | | Continuing treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist at intervals not greater than 12 months. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
Amiodarone | C1350 | | | Severe cardiac arrhythmias | |
Amisulpride | C1589 | | | Schizophrenia | Compliance with Authority Required procedures - Streamlined Authority Code 1589 |
Amlodipine with Atorvastatin | C2449 | | | For use in patients who have hypertension and/or angina and who meet the criteria set out in the General Statement for Lipid-Lowering Drugs, and who are currently receiving treatment with a dihydropyridine calcium channel blocker | |
| C2450 | | | For use in patients who have hypertension and/or angina and who meet the criteria set out in the General Statement for Lipid-Lowering Drugs, and whose blood pressure and/or angina is inadequately controlled with other classes of antihypertensive and/or anti-anginal agent, and in whom adjunctive therapy with a dihydropyridine calcium channel blocker would be appropriate | |
| C2451 | | | For use in patients who have hypertension and/or angina and who meet the criteria set out in the General Statement for Lipid-Lowering Drugs, and who are intolerant of the side effects of other classes of antihypertensive and/or anti-anginal agent, and in whom replacement therapy with a dihydropyridine calcium channel blocker would be appropriate | |
Amlodipine with valsartan | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Amlodipine with valsartan and hydrochlorothiazide | C3539 | | | Hypertension in a patient who is not adequately controlled with any two of the drugs in the combination | |
Amoxycillin | C1582 | | | Acute exacerbations of chronic bronchitis | |
Amoxycillin with Clavulanic Acid | C1836 | | | Infections where resistance to amoxycillin trihydrate is suspected | |
| C1837 | | | Infections where resistance to amoxycillin trihydrate is proven | |
Amylopectin, modified long chain | C3081 | | | Glycogen storage disease | |
Anastrozole | C2213 | | | Treatment of hormone-dependent breast cancer in post-menopausal women | |
Apixaban | C3957 | P3957 | | Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy | Compliance with Authority Required procedures |
| C3991 | P3991 | | Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 15 days of therapy | Compliance with Authority Required procedures |
| C4043 | P4043 | | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 10 days supply to complete a course of treatment | Compliance with Authority Required procedures |
| C4044 | P4044 | | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 15 days supply to complete a course of treatment | Compliance with Authority Required procedures |
| C4046 | P4046 | | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days supply to complete a course of treatment | Compliance with Authority Required procedures |
Apomorphine | C1256 | | | Where the patient is receiving treatment at/from a private hospital Parkinson's disease in patients severely disabled by motor fluctuations which do not respond to other therapy | Compliance with Written or Telephone Authority Required procedures |
| C3314 | | | Where the patient is receiving treatment at/from a public hospital Parkinson's disease in patients severely disabled by motor fluctuations which do not respond to other therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3314 |
Apraclonidine | C1374 | | | Short-term reduction of intra-ocular pressure in patients already on maximally tolerated anti-glaucoma therapy | |
Aprepitant | C3619 | | | Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where any 1 of the following chemotherapy agents are to be administered:
(a) altretamine;
(b) carmustine;
(c) cisplatin, when a single dose constitutes a cycle of chemotherapy;
(d) cyclophosphamide, at a dose of 1500 mg per square metre per day or greater;
(e) dacarbazine;
(f) procarbazine, when a single dose constitutes a cycle of chemotherapy;
(g) streptozocin; and
where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy | Compliance with Authority Required procedures - Streamlined Authority Code 3619 |
| C3620 | | | Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer, in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where cyclophosphamide and an anthracycline are to be co-administered, and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy | Compliance with Authority Required procedures - Streamlined Authority Code 3620 |
| C3621 | | | Management of nausea and vomiting associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine type 3 receptor (5HT3) antagonist and dexamethasone on day 1, where the patient has had a prior episode of chemotherapy induced nausea or vomiting where any 1 of the following intravenous chemotherapy agents is to be administered:
(a) arsenic trioxide;
(b) azacitidine;
(c) carboplatin;
(d) cyclophosphamide, at a dose of less than 1500 mg per square metre per day;
(e) cytarabine, at a dose of greater than 1 g per square metre per day;
(f) dactinomycin;
(g) daunorubicin;
(h) doxorubicin;
(i) epirubicin;
(j) fotemustine;
(k) idarubicin;
(l) ifosfamide;
(m) irinotecan;
(n) melphalan;
(o) methotrexate, at a dose of 250 mg to 1 g per square metre;
(p) oxaliplatin;
(q) raltitrexed; and
where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy, and where concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle | Compliance with Authority Required procedures - Streamlined Authority Code 3621 |
Arginine with carbohydrate | C1458 | | | Urea cycle disorders | |
Aripiprazole | C1589 | | | Schizophrenia | Compliance with Authority Required procedures - Streamlined Authority Code 1589 |
Arsenic | C3150 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Induction and consolidation treatment of relapsed acute promyelocytic leukaemia (characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript) in a patient who is arsenic naive at induction | Compliance with Authority Required Procedures |
| C3891 | | | Where the patient is receiving treatment at/from a Public Hospital Induction and consolidation treatment of relapsed acute promyelocytic leukaemia (characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript) in a patient who is arsenic naive at induction | Compliance with Authority Required procedures - Streamlined Authority Code 3891 |
Artemether with lumefantrine | C3210 | | | Treatment of suspected or confirmed malaria due to Plasmodium falciparum | Compliance with Authority Required procedures |
| C3551 | | | Treatment of suspected or confirmed malaria due to Plasmodium falciparum in a patient unable to swallow a solid dosage form of artemether with lumefantrine | Compliance with Authority Required procedures |
Asenapine | C1589 | | | Schizophrenia | Compliance with Authority Required procedures - Streamlined Authority Code 1589 |
| C3935 | | | Treatment, for up to 6 months, of an episode of acute mania or mixed episodes associated with bipolar I disorder | Compliance with Authority Required procedures - Streamlined Authority Code 3935 |
| C3936 | | | Maintenance treatment, as monotherapy, of bipolar I disorder | Compliance with Authority Required procedures - Streamlined Authority Code 3936 |
Atazanavir | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Atomoxetine | C3025 | | | Initial sole PBS-subsidised treatment of attention-deficit hyperactivity disorder (ADHD) diagnosed between the ages of 6 and 18 years inclusive, by a paediatrician or psychiatrist according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, where treatment with dexamphetamine sulfate or methylphenidate hydrochloride poses an unacceptable medical risk due to the following contraindications as specified in the Therapeutic Goods Administration-approved Product Information:
(1) the patient has a history of substance abuse or misuse (other than alcohol); and/or
(2) the patient has comorbid motor tics or Tourette's Syndrome; and/or
(3) the patient has comorbid severe anxiety diagnosed according to the DSM-IV | Compliance with Authority Required procedures |
| C3026 | | | Initial sole PBS-subsidised treatment of attention-deficit hyperactivity disorder (ADHD) diagnosed between the ages of 6 and 18 years inclusive, by a paediatrician or psychiatrist according to the DSM-IV criteria, where treatment with dexamphetamine sulfate or methylphenidate hydrochloride has resulted in the development or worsening of a comorbid mood disorder (that is, anxiety disorder, obsessive compulsive disorder or depressive disorder, diagnosed according to the DSM-IV criteria) of a severity necessitating permanent stimulant treatment withdrawal, or where the combination of stimulant treatment with another agent would pose an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal | Compliance with Authority Required procedures |
| C3027 | | | Initial sole PBS-subsidised treatment of attention-deficit hyperactivity disorder (ADHD) diagnosed between the ages of 6 and 18 years inclusive, by a paediatrician or psychiatrist according to the DSM-IV criteria, where treatment with dexamphetamine sulfate and methylphenidate hydrochloride has resulted in the development of adverse reactions of a severity necessitating permanent treatment withdrawal:
(1) Adverse effects on growth and weight; and/or
(2) Adverse effects on sleep including insomnia; and/or
(3) Adverse effects on appetite including anorexia | Compliance with Authority Required procedures |
| C3028 | | | Continuing sole PBS-subsidised treatment where the patient has previously been issued with an authority prescription for this drug | Compliance with Authority Required procedures |
Atorvastatin | C1540 | P1540 | | For use in patients that meet the criteria set out in the General Statement for Lipid-Lowering Drugs | |
| C3047 | P3047 | | For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Atovaquone | C1433 | | | Treatment of mild to moderate Pneumocystis carinii pneumonia in adult patients who are intolerant of trimethoprim with sulfamethoxazole therapy | Compliance with Authority Required procedures - Streamlined Authority Code 1433 |
Atovaquone with proguanil | C3135 | | | Treatment of suspected or confirmed Plasmodium falciparum malaria in a patient aged 3 years or older where quinine containing regimens are inappropriate | Compliance with Authority Required procedures |
Azithromycin | C1299 | | | Where the patient is receiving treatment at/from a private hospital Prophylaxis against Mycobacterium avium complex infections in human immunodeficiency virus-positive patients with CD4 cell counts of less than 75 per cubic millimetre | Compliance with Written or Telephone Authority Required procedures |
| C1405 | P1405 | | Trachoma | |
| C1838 | P1838 | | Uncomplicated urethritis due to Chlamydia trachomatis | |
| C1839 | P1839 | | Uncomplicated cervicitis due to Chlamydia trachomatis | |
| C3317 | | | Where the patient is receiving treatment at/from a public hospital Prophylaxis against Mycobacterium avium complex infections in human immunodeficiency virus-positive patients with CD4 cell counts of less than 75 per cubic millimetre | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3317 |
Baclofen | C1637 | | | Where the patient is receiving treatment at/from a private hospital Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity of cerebral origin | Compliance with Written or Telephone Authority Required procedures |
| C1638 | | | Where the patient is receiving treatment at/from a private hospital Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity due to multiple sclerosis | Compliance with Written or Telephone Authority Required procedures |
| C1639 | | | Where the patient is receiving treatment at/from a private hospital Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity due to spinal cord injury | Compliance with Written or Telephone Authority Required procedures |
| C1640 | | | Where the patient is receiving treatment at/from a private hospital Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity due to spinal cord disease | Compliance with Written or Telephone Authority Required procedures |
| C3318 | | | Where the patient is receiving treatment at/from a public hospital Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity of cerebral origin | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3318 |
| C3319 | | | Where the patient is receiving treatment at/from a public hospital Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity due to multiple sclerosis | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3319 |
| C3320 | | | Where the patient is receiving treatment at/from a public hospital Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity due to spinal cord injury | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3320 |
| C3321 | | | Where the patient is receiving treatment at/from a public hospital Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity due to spinal cord disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3321 |
Balsalazide | C1708 | | | Ulcerative colitis where hypersensitivity to sulfonamides exists | Compliance with Authority Required procedures - Streamlined Authority Code 1708 |
| C1709 | | | Ulcerative colitis where intolerance to sulfasalazine exists | Compliance with Authority Required procedures - Streamlined Authority Code 1709 |
"BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain) | C1419 | | | Treatment of carcinoma in situ of the urinary bladder | |
"BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain) | C1290 | | | Primary and relapsing superficial urothelial carcinoma of the bladder | |
Beclomethasone | C1266 | | | Patients unable to achieve co-ordinated use of other metered dose inhalers containing this drug | |
Benzydamine | C1669 | P1669 | | Radiation induced mucositis | |
| C3634 | P3634 | | Initial supply, for up to 4 months, for a palliative care patient where a painful mouth is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3634 |
| C3635 | P3635 | | Continuing supply for a palliative care patient where a painful mouth is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3635 |
Betamethasone | C1020 | | | Alopecia areata | |
| C1102 | | | For local intra-articular or peri-articular infiltration | |
| C1146 | | | Granulomata, dermal | |
| C1189 | | | Keloid | |
| C1191 | | | Lichen planus hypertrophic | |
| C1192 | | | Lichen simplex chronicus | |
| C1197 | | | Lupus erythematosus, chronic discoid | |
| C1237 | | | Necrobiosis lipoidica | |
| C1465 | | | Uveitis | |
| C1422 | | | Treatment of corticosteroid-responsive dermatoses | |
Bevacizumab | C3430 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Initial PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with previously untreated metastatic colorectal cancer with a World Health Organisation performance status of 0 or 1, where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks | Compliance with Authority Required Procedures |
| C3431 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Continuing PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with metastatic colorectal cancer who has who has previously been issued with an authority prescription for bevacizumab and who does not have progressive disease and who remains on first-line chemotherapy, where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks | Compliance with Authority Required Procedures |
| C3894 | | | Where the patient is receiving treatment at/from a Public Hospital Initial PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with previously untreated metastatic colorectal cancer with a World Health Organisation performance status of 0 or 1, where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks, and where the patient's WHO performace status and body weight is recorded in the patient's medical records at the time the treatment cycle is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3894
|
| C3896 | | | Where the patient is receiving treatment at/from a Public Hospital Continuing PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with metastatic colorectal cancer who has previously received PBS-subsidised treatment with bevacizumab and who does not have progressive disease and who remains on first-line chemotherapy, where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks, and where the patient's body weight is documented in the patient's medical records at the time the treatment cycle is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3896
|
Bicalutamide | C3674 | | | Metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) analogue therapy | Compliance with Authority Required procedures – Streamlined Authority Code 3674 |
Bimatoprost with timolol | C3426 | | | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy; | |
| C3427 | | | Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy. | |
Bisacodyl | C1025 | P1025 | | Anorectal congenital abnormalities | |
| C1122 | P1122 | | For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult | |
| C1221 | P1221 | | Megacolon | |
| C1254 | P1254 | | Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function | |
| C1263 | P1263 | | Patients receiving palliative care | |
| C1268 | P1268 | | Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities | |
| C1400 | P1400 | | Terminal malignant neoplasia | |
| C3642 | P3642 | | Initial supply, for up to 4 months, for a palliative care patient where constipation is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3642 |
| C3643 | P3643 | | Continuing supply for a palliative care patient where constipation is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3643 |
Bisoprolol | C3234 | | | Moderate to severe heart failure in a patient stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor or angiotensin II antagonist, if tolerated | Compliance with Authority Required procedures - Streamlined Authority Code 3234 |
Bivalirudin | C3075 | | | A patient undergoing percutaneous coronary intervention | Compliance with Authority Required procedures - Streamlined Authority Code 3075 |
Bleomycin | C1139 | | | Germ cell neoplasms | |
| C1198 | | | Lymphoma. | |
Bortezomib | C3762 | P3762 | | Retreatment of a patient who has been previously treated with PBS-subsidised bortezomib
Initial PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of a patient with multiple myeloma who has progressive disease and who has been previously treated with PBS-subsidised bortezomib. The patient must have experienced at least a partial response to the most recent course of PBS-subsidised bortezomib therapy.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause)
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein and less than 200 mg per 24 hour Bence-Jones proteinuria.
If serum M protein and urine Bence-Jones protein levels are measurable, partial response (PR) compared with baseline (prior to re-treatment with bortezomib) is defined as:
(a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or
(b) at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours
If serum M protein and Bence-Jones protein levels are unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as:
(c) the difference between involved and uninvolved serum free light chain (FLC) levels, with at least a 50% reduction in this value
If serum M protein and urine Bence-Jones protein levels and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(d) at least a 50% reduction in bone marrow plasma cells; or
(e) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(f) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan); or
(g) normalization of corrected serum calcium to less than or equal to 2.65 mmol per L.
The same parameters provided for the diagnosis of progressive disease are to be used to demonstrate at least a partial response to treatment.
Bortezomib will only be subsidised for patients with multiple myeloma who are not receiving concomitant PBS-subsidised lenalidomide
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma Authority Application - Supporting Information Form which includes details of the basis of the current diagnosis of progressive disease and nomination of which disease activity parameters will be used to assess response; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response to the most recent course of PBS-subsidised bortezomib, if not previously provided to the Chief Executive Medicare
To enable confirmation by the Chief Executive Medicare, current diagnostic reports of at least one of the following are required:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria — the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. magnetic resonance imaging or computed tomography scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (either previous or current serum M protein less than 10 g per L and urinary Bence-Jones protein undetectable or less than 200 mg per 24 hours) must be provided; and
(4) a signed patient acknowledgment | Compliance with Written Authority Required procedures |
| C3763 | P3763 | | Continuing retreatment of a patient who has been previously treated with PBS-subsidised bortezomib
Continuing PBS-subsidised retreatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of multiple myeloma in a patient who has received 4 treatment cycles of bortezomib in the current treatment course and who, at the time of application, has demonstrated at least a partial response to bortezomib
If serum M protein and urine Bence-Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as:
(a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or
(b) at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours
If serum M protein and urine Bence-Jones protein levels are unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as:
(c) at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(d) at least a 50% reduction in bone marrow plasma cells; or
(e) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(f) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan); or
(g) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
For the purpose of assessing eligibility for continuing the current course of PBS-subsidised bortezomib treatment beyond 4 cycles, the patient must have achieved at least a partial response at the completion of cycle 4. The results of the response assessment must be included in a written application to the Chief Executive Medicare for further treatment. Where a response assessment is not submitted to the Chief Executive Medicare prior to cycle 5, patients will be deemed to have failed to respond to treatment with bortezomib. Continuing PBS-subsidised supply will not be approved if there is a gap of more than 6 months between the initial application and subsequent applications
The same parameters provided for the diagnosis of progressive disease are to be used to demonstrate at least a partial response to treatment
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma Authority Application - Supporting Information Form; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response.
Diagnostic reports must be no more than 1 month old at the time of application
Patients who fail to demonstrate at least a partial response after 8 cycles will not be eligible to receive further PBS-subsidised treatment with bortezomib
No more than 2 cycles of treatment beyond the cycle at which a confirmed complete response was first achieved will be authorised. Confirmation requires 2 determinations a minimum of 6 weeks apart | Compliance with Written Authority Required procedures |
| C3764 | P3764 | | Continuing retreatment of a patient who has been previously treated with PBS-subsidised bortezomib
Continuing PBS-subsidised retreatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of multiple myeloma in a patient who has received 8 treatment cycles with bortezomib in the current treatment course and who, at the time of application, has demonstrated at least a partial response to bortezomib but who has not received 2 treatment cycles after first achieving a confirmed complete response
If serum M protein and urine Bence-Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as:
(a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or
(b) at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours
If serum M protein and urine Bence-Jones protein levels are unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as:
(c) the difference between involved and uninvolved serum free light chain (FLC) levels, with at least a 50% reduction in this value
If serum M protein and urine Bence-Jones protein levels and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(d) at least a 50% reduction in bone marrow plasma cells; or
(e) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(f) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan); or
(g) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
The same parameters provided for the diagnosis of progressive disease are to be used to demonstrate at least a partial response to treatment
Diagnostic reports must be within 1 month of the date of application.
For the purpose of assessing eligibility for continuing PBS-subsidised bortezomib treatment beyond 8 cycles, the patient must have achieved at least a partial response at the completion of cycle 8. The results of the response assessment must be included in a written application to the Chief Executive Medicare for further treatment. Where a response assessment is not submitted to the Chief Executive Medicare prior to cycle 9, patients will be deemed to have failed to respond to treatment with bortezomib. Continuing PBS-subsidised supply will not be approved if there is a gap of more than 10 months between the initial application and an application following completion of 8 treatment cycles
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma Authority Application - Supporting Information Form; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response.
No more than 2 cycles of treatment beyond the cycle at which the complete response was first achieved will be authorised. Confirmation requires 2 determinations a minimum of 6 weeks apart
Applications for PBS-subsidised treatment with bortezomib that extends beyond 11 cycles per treatment course will not be approved | Compliance with Written Authority Required procedures |
| C3765 | P3765 | | Continuing PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of multiple myeloma in a patient who has previously received 4 treatment cycles of bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib; and
where the following conditions apply:
if serum M protein and urine Bence-Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as:
(a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or
(b) at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours;
if serum M protein and urine Bence-Jones protein levels are unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as:
(c) at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels;
if serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(d) at least a 50% reduction in bone marrow plasma cells; or
(e) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(f) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan); or
(g) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L;
the same parameters provided for the diagnosis of progressive disease are used to demonstrate at least a partial response to treatment;
a patient is eligible for continuing PBS-subsidised bortezomib treatment beyond 4 cycles if they have achieved at least a partial response at the completion of cycle 4, and the results of the response assessment are included in the application for authorisation of further treatment;
where a response assessment is not submitted to the Chief Executive Medicare prior to cycle 5, patients will be deemed to have failed to respond to treatment with bortezomib;
the authority application is made in writing not later than 6 months after the application for initial treatment and includes:
(1) a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form; and
(2) diagnostic reports, which are no more than 1 month old at the time of application, demonstrating that the patient has achieved at least a partial response;
patients who fail to demonstrate at least a partial response after 8 cycles are not eligible to receive further PBS-subsidised treatment with bortezomib;
a patient is eligible to receive no more than 2 cycles of treatment beyond the cycle at which a complete response, confirmed by 2 determinations a minimum of 6 weeks apart, was first achieved | Compliance with Written Authority Required procedures |
| C3766 | P3766 | | Initial treatment with PBS-subsidised bortezomib
Initial PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of a patient with a histological diagnosis of multiple myeloma who has progressive disease after at least 1 prior therapy, who has undergone or is ineligible for a primary stem cell transplant and who has experienced treatment failure after a trial of at least 4 weeks of thalidomide at a dose of at least 100 mg daily or who has failed to achieve at least a minimal response after 8 or more weeks of thalidomide-based therapy for progressive disease; and
where progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing, or the development of a new, soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause);
where oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein and less than 200 mg per 24 hour Bence-Jones proteinuria;
where thalidomide treatment failure is defined as:
(1) confirmed disease progression during thalidomide treatment or within 6 months of discontinuing thalidomide treatment; or
(2) severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment;
where severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living;
where toxicity from thalidomide is defined as peripheral neuropathy (Grade 2 or greater, interfering with function), drug-related seizures, serious Grade 3 or Grade 4 drug-related dermatological reactions, such as Stevens-Johnson Syndrome, or other Grade 3 or 4 toxicity;
where failure to achieve at least a minimal response after 8 or more weeks of thalidomide-based therapy for progressive disease is defined as:
(1) less than a 25% reduction in serum or urine M protein; or
(2) in oligo-secretory and non-secretory myeloma patients only, less than a 25% reduction in the difference between involved and uninvolved serum free light chain levels; and
where the following conditions apply:
the patient is not receiving concomitant PBS-subsidised lenalidomide;
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of thalidomide treatment failure; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response; and
(2) duration of thalidomide and daily dose prescribed; and
(3) a signed patient acknowledgment;
if the dosing requirement for thalidomide cannot be met, the authority application states the reasons why this criterion cannot be satisfied;
to enable confirmation of eligibility by the Chief Executive Medicare, current diagnostic reports of at least 1 of the following are required:
(a) the level of serum M protein (monoclonal protein); or
(b) Bence-Jones proteinuria — the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination, i.e. magnetic resonance imaging or computed tomography scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration;
as these parameters will be used to determine response, results of the above diagnostic reports must be provided with the authority application as follows:
(i) for all patients, results for (a) or (b) or (c) must be provided;
(ii) where the patient has oligo-secretory or non-secretory multiple myeloma, (c) or (d) or if relevant (e), (f) or (g) must be provided;
where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (either previous or current serum M protein less than 10 g per L and urinary Bence-Jones protein undetectable or less than 200 mg per 24 hours) must be provided | Compliance with Written Authority Required procedures |
| C3767 | P3767 | | Continuing PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of multiple myeloma in a patient who has previously received 8 treatment cycles with bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib but who has not received 2 treatment cycles after first achieving a confirmed complete response; and
where the following conditions apply:
if serum M protein and urine Bence-Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as:
(a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or
(b) at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours;
if serum M protein and urine Bence-Jones protein levels are unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as:
(c) the difference between involved and uninvolved serum free light chain (FLC) levels, with at least a 50% reduction in this value;
if serum M protein and urine Bence-Jones protein levels and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(d) at least a 50% reduction in bone marrow plasma cells; or
(e) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(f) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan); or
(g) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L;
the same parameters provided for the diagnosis of progressive disease are used to demonstrate at least a partial response to treatment;
a patient is eligible for continuing PBS-subsidised bortezomib treatment beyond 8 cycles if they have achieved at least a partial response at the completion of cycle 8, and the results of the response assessment are included in the application for authorisation of further treatment;
where a response assessment is not submitted to the Chief Executive Medicare prior to cycle 9, patients will be deemed to have failed to respond to treatment with bortezomib;
the authority application is made in writing not later than 10 months after the application for initial treatment and includes:
(1) a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form; and
(2) diagnostic reports, which are no more than 1 month old at the time of application, demonstrating that the patient has achieved at least a partial response;
a patient is eligible to receive no more than 2 cycles of treatment beyond the cycle at which a complete response, confirmed by 2 determinations a minimum of 6 weeks apart, was first achieved;
PBS-subsidised treatment with bortezomib is limited to a maximum of 11 cycles per treatment course | Compliance with Written Authority Required procedures |
| C7003 | | | Treatment, in combination with chemotherapy, of a patient with newly diagnosed symptomatic multiple myeloma who is eligible for high dose chemotherapy and autologous stem cell transplantation The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma Authority Application – Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma; and (3) a signed patient acknowledgement A maximum of 4 cycles of treatment with bortezomib will be authorised under this restriction Bortezomib will only be subsidised for patients with multiple myeloma who are not receiving PBS-subsidised thalidomide or lenalidomide | Compliance with Written Authority Required procedures |
| C7004 | | | Initial PBS-subsidised treatment in combination with a corticosteroid and melphalan or cyclophosphamide, of a patient with newly diagnosed symptomatic multiple myeloma who is ineligible for high dose chemotherapy The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma and ineligibility for high dose chemotherapy; and (3) a signed patient acknowledgment A maximum of 4 cycles of treatment with bortezomib will be authorised under this restriction Bortezomib will only be subsidised for patients with multiple myeloma who are not receiving PBS-subsidised thalidomide or lenalidomide | Compliance with Written Authority Required procedures |
| C7005 | | | Continuing PBS-subsidised treatment in combination with a corticosteroid and melphalan or cyclophosphamide, of a patient with newly diagnosed symptomatic multiple myeloma who is ineligible for high dose chemotherapy and who has received an initial authority prescription for bortezomib and who, at the time of application has demonstrated: (i) no progressive disease; and (ii) has not yet achieved a best confirmed response to bortezomib Authority applications for continuing treatment may be made by telephone Continuing PBS-subsidised supply will not be approved if there is a gap of more than 6 months between the initial application and this application A maximum of 5 cycles of treatment with bortezomib will be authorised under this restriction Bortezomib will only be subsidised for patients with multiple myeloma who are not receiving PBS-subsidised thalidomide or lenalidomide | Compliance with Written or Telephone Authority Required procedures |
| C7006 | | | Initial PBS-subsidised treatment, in combination with a corticosteroid and/or cyclophosphamide, of a patient with newly diagnosed symptomatic multiple myeloma who has severe acute renal failure. Patients must require dialysis or be at high risk of requiring dialysis in the opinion of a nephrologist The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma Authority Application – Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, the name of the nephrologist who has reviewed the patient and the date of review, a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology Authority, and nomination of the disease activity parameter(s) that will be used to assess response; and (3) a signed patient acknowledgement Disease activity parameters include current diagnostic reports of at least one of the following: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) in oligo-secretory and non-secretory myeloma patients only, the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination, i.e. magnetic resonance imaging or computed tomography scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L and urinary Bence-Jones protein undetectable or less than 200 mg per 24 hours) must be provided A maximum of 4 cycles of treatment with bortezomib will be authorised under this restriction Bortezomib will only be subsidised for patients with multiple myeloma who are not receiving PBS-subsidised thalidomide or lenalidomide | Compliance with Written Authority Required procedures |
| C7007 | | | Continuing PBS-subsidised treatment in combination with a corticosteroid and/or cyclophosphamide, of a patient with newly diagnosed symptomatic multiple myeloma who has severe acute renal failure and who has received an initial authority prescription for bortezomib and who, at the time of application has demonstrated at least a partial response at the completion of cycle 4 If serum M protein and urine Bence-Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as: (a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or (b) at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours If serum M protein and urine Bence-Jones protein levels are unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as: (c) at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as: (d) at least a 50% reduction in bone marrow plasma cells; or (e) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or (f) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan); or (g) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma Authority Application – Supporting Information form, which includes a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology authority; and (3) diagnostic reports demonstrating the patient has achieved at least a partial response Authority applications for continuing treatment may be faxed to the Chief Executive Medicare. the Chief Executive Medicare will then contact the prescriber by telephone Continuing PBS-subsidised supply will not be approved if there is a gap of more than 6 months between the initial application and this application A maximum of 5 cycles of treatment with bortezomib will be authorised under this restriction Bortezomib will only be subsidised for patients with multiple myeloma who are not receiving PBS-subsidised thalidomide or lenalidomide | Compliance with Written or Telephone Authority Required procedures |
Brimonidine with Timolol | C3426 | | | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy | |
| C3427 | | | Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy | |
Brinzolamide with timolol | C3426 | | | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy | |
| C3427 | | | Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy | |
Bromocriptine | C1001 | P1001 | | Acromegaly | |
| C1255 | P1255 | | Parkinson's disease | |
| C1289 | P1289 | | Prevention of the onset of lactation in the puerperium for medical reasons | |
| C1841 | P1841 | | Pathological hyperprolactinaemia where surgery is not indicated | |
| C1842 | P1842 | | Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution | |
| C1843 | P1843 | | Pathological hyperprolactinaemia where radiotherapy is not indicated | |
| C1844 | P1844 | | Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution | |
Budesonide | C1351 | | | Severe chronic asthma in patients who require long-term steroid therapy and who are unable to use other forms of inhaled steroid therapy | Compliance with Authority Required procedures - Streamlined Authority Code 1351 |
Budesonide with Eformoterol | C1756 | | | Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide | |
| C1757 | | | Patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide | |
| C2671 | | | For single maintenance and reliever therapy in a patient who experiences frequent asthma symptoms while receiving treatment with oral corticosteroids | |
| C2672 | | | For single maintenance and reliever therapy in a patient who experiences frequent asthma symptoms while receiving treatment with inhaled corticosteroids | |
| C2673 | | | For maintenance and reliever therapy in a patient who experiences frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and a long-acting beta-2 agonist | |
| C2680 | | | Symptomatic treatment of chronic obstructive pulmonary disease (COPD), where the forced expiratory volume in 1 second (FEV1) is less than 50% predicted normal and there is a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy | |
Buprenorphine | C1062 | | | Chronic severe disabling pain not responding to non-narcotic analgesics | |
Bupropion | C2774 | P2774 | | Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who has entered a comprehensive support and counselling program, and where details of the program are specified in the authority application | Compliance with Authority Required procedures |
| C2775 | P2775 | | Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who is entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the authority application | Compliance with Authority Required procedures |
| C2776 | P2776 | | Completion of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has previously been issued with an authority prescription for this drug and who is enrolled in a comprehensive support and counselling program | Compliance with Authority Required procedures |
Cabazitaxel | C7000 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel due to resistance or intolerance and has a World Health Organisation performance status of 2 or less | Compliance with Authority Required procedures |
| C7001 | | | Where the patient is receiving treatment at/from a Public Hospital Treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel due to resistance or intolerance and has a World Health Organisation performance status of 2 or less | Compliance with Authority Required procedures – Streamlined Authority Code 7001 |
Cabergoline | C1255 | | | Parkinson's disease | |
| C1289 | P1289 | | Prevention of the onset of lactation in the puerperium for medical reasons | |
| C2659 | P2659 | | Pathological hyperprolactinaemia where surgery is not indicated | Compliance with Authority Required procedures - Streamlined Authority Code 2659 |
| C2660 | P2660 | | Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution | Compliance with Authority Required procedures - Streamlined Authority Code 2660 |
| C2661 | P2661 | | Pathological hyperprolactinaemia where radiotherapy is not indicated | Compliance with Authority Required procedures - Streamlined Authority Code 2661 |
| C2662 | P2662 | | Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution | Compliance with Authority Required procedures - Streamlined Authority Code 2662 |
Calcipotriol | C1066 | | | Chronic stable plaque type psoriasis vulgaris | |
Calcipotriol with betamethasone | C3209 | | | Chronic stable plaque type psoriasis vulgaris in a patient who is not adequately controlled with either calcipotriol or potent topical corticosteroid monotherapy | |
| C3827 | | | Chronic stable plaque type psoriasis vulgaris of the scalp in a patient who is not adequately controlled with either calcipotriol or potent topical corticosteroid monotherapy | |
Calcitriol | C1165 | | | Hypocalcaemia due to renal disease | Compliance with Authority Required procedures - Streamlined Authority Code 1165 |
| C1166 | | | Hypoparathyroidism | Compliance with Authority Required procedures - Streamlined Authority Code 1166 |
| C1167 | | | Hypophosphataemic rickets | Compliance with Authority Required procedures - Streamlined Authority Code 1167 |
| C1467 | | | Vitamin D-resistant rickets | Compliance with Authority Required procedures - Streamlined Authority Code 1467 |
| C2636 | | | Treatment for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | Compliance with Authority Required procedures - Streamlined Authority Code 2636 |
Calcium | C2212 | | | Hyperphosphataemia associated with chronic renal failure | Compliance with Authority Required procedures - Streamlined Authority Code 2212 |
Candesartan with Hydrochlorothiazide | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Capecitabine | C1522 | | | Treatment of advanced or metastatic colorectal cancer | Compliance with Authority Required procedures |
| C1614 | | | Advanced breast cancer in combination with docetaxel after failure of prior anthracycline-containing chemotherapy | Compliance with Authority Required procedures |
| C1738 | | | Advanced breast cancer after failure of prior therapy which includes a taxane and an anthracycline | Compliance with Authority Required procedures |
| C1739 | | | Advanced breast cancer where therapy with a taxane or an anthracycline is contraindicated | Compliance with Authority Required procedures |
| C3509 | | | Advanced (Stage III or IV) oesophago-gastric cancer, previously untreated, in combination with a cisplatin-based regimen, in a patient with a World Health Organisation performance status of 2 or less | Compliance with Authority Required procedures |
| C3942 | | | Adjuvant treatment of stage III (Dukes C) colon cancer, following complete resection of the primary tumour either as:
(a) monotherapy; or
(b) in combination with oxaliplatin | Compliance with Authority Required procedures |
Captopril | C1998 | | | For patients unable to take a solid dose form of an angiotensin-converting enzyme inhibitor | |
Carbohydrate, fat, vitamins, minerals and trace elements | C1276 | | | Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae | |
Carbomer | C1359 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures - Streamlined Authority Code 1359 |
| C1362 | P1362 | | Severe dry eye syndrome, including Sjogren's syndrome | |
| C2802 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures |
| C3036 | P3036 | | For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements. | |
Carbomer 974 | C1359 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures - Streamlined Authority Code 1359 |
| C2802 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures |
Carbomer with Triglyceride Lipids | C1359 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures - Streamlined Authority Code 1359 |
| C1362 | P1362 | | Severe dry eye syndrome, including Sjogren's syndrome | |
| C2802 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures |
| C3036 | P3036 | | For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | C3036 |
Carmellose | C1359 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures - Streamlined Authority Code 1359 |
| C1362 | P1362 | | Severe dry eye syndrome, including Sjogren's syndrome. | |
| C2802 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures |
| C3036 | P3036 | | For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
| C3636 | P3636 | | Initial supply, for up to 4 months, for a palliative care patient where dry mouth is a symptom | Compliance with Authority Required procedures - Streamlined Authority Code 3636 |
| C3637 | P3637 | | Continuing supply for a palliative care patient where dry mouth is a symptom | Compliance with Authority Required procedures - Streamlined Authority Code 3637 |
Carmellose with glycerin | C1359 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures - Streamlined Authority Code 1359 |
| C1362 | P1362 | | Severe dry eye syndrome, including Sjogren's syndrome | |
| C2802 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures |
| C3036 | P3036 | | For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Carmustine | C2462 | | | Glioblastoma multiforme, suspected or confirmed, at the time of initial surgery | |
Carvedilol | C1735 | | | Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002 | Compliance with Authority Required procedures - Streamlined Authority Code 1735 |
| C3234 | | | Moderate to severe heart failure in a patient stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor or angiotensin II antagonist, if tolerated | Compliance with Authority Required procedures - Streamlined Authority Code 3234 |
Cefepime | C1427 | | | Treatment of febrile neutropenia | Compliance with Authority Required procedures |
Cefotaxime | C1169 | | | Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | |
| C1846 | | | Septicaemia, suspected | |
| C1847 | | | Septicaemia, proven | |
Ceftriaxone | C1143 | P1143 | | Gonorrhoea | |
| C1169 | P1169 | | Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | |
| C1846 | P1846 | | Septicaemia, suspected | |
| C1847 | P1847 | | Septicaemia, proven | |
Celecoxib | C1547 | | | Symptomatic treatment of osteoarthritis | |
| C1848 | | | Symptomatic treatment of rheumatoid arthritis | |
Cephazolin | C1169 | | | Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | |
| C1846 | | | Septicaemia, suspected | |
| C1847 | | | Septicaemia, proven | |
| C3132 | | | Cellulitis | |
Certolizumab pegol | C3714 | | | Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS-subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with certolizumab pegol for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 18 to 20 weeks of treatment, depending on the dosage regimen | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than the maximum allowed based on their dosage regimen, and where approval of the application would enable the patient to complete a course of 18 or 20 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3768 | | | Rheumatoid arthritis — continuing treatment
Continuing PBS-subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with certolizumab pegol; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with certolizumab pegol; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with certolizumab pegol;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of certolizumab pegol therapy is an 18 or 20 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of continuing treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3769 | | | Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with certolizumab pegol for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with certolizumab pegol are not eligible to commence treatment with certolizumab pegol until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with certolizumab pegol and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised certolizumb pegol treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised certolizumab pegol treatment is an 18 or 20 week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 18 to 20 weeks of treatment, depending on the dosage regimen | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than the maximum allowed based on their dosage regimen, and where approval of the application would enable the patient to complete a course of 18 or 20 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
Cetuximab | C2713 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx for the week prior to radiotherapy, where cisplatin is contraindicated according to the Therapeutic Goods Administration-approved Product Information | Compliance with Authority Required procedures |
| C2714 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is not tolerated | Compliance with Authority Required procedures |
| C2715 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated | Compliance with Authority Required procedures |
| C3843 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Initial PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K-RAS wild type metastatic colorectal cancer after failure of first-line chemotherapy | Compliance with Authority Required procedures |
| C3844 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K-RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease | Compliance with Authority Required procedures |
| C3903 | | | Where the patient is receiving treatment at/from a Public Hospital Initial PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K-RAS wild type metastatic colorectal cancer after failure of first-line chemotherapy | Compliance with Authority Required procedures - Streamlined Authority Code 3903 |
| C3904 | | | Where the patient is receiving treatment at/from a Public Hospital Continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K-RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease | Compliance with Authority Required procedures - Streamlined Authority Code 3904 |
| C3919 | | | Where the patient is receiving treatment at/from a Public Hospital Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx for the week prior to radiotherapy, where cisplatin is contraindicated according to the Therapeutic Goods Administration-approved Product Information | Compliance with Authority Required procedures - Streamlined Authority Code 3919 |
| C3920 | | | Where the patient is receiving treatment at/from a Public Hospital Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is not tolerated | Compliance with Authority Required procedures - Streamlined Authority Code 3920 |
| C3921 | | | Where the patient is receiving treatment at/from a Public Hospital Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated | Compliance with Authority Required procedures - Streamlined Authority Code 3921 |
Cholestyramine | | P3035 | | For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Chorionic Gonadotrophin | C1116 | | | For the treatment, for a period not exceeding 6 months, of males over the age of 16 years who show clinical evidence of hypogonadism or delayed puberty | |
| C1117 | | | For the treatment of infertility in males associated with isolated luteinising hormone deficiency | |
| C1118 | | | For the treatment of infertility in males due to hypogonadotrophic hypogonadism | |
| C1120 | | | For the treatment of males who have combined deficiency of human growth hormone and gonadotrophins and in whom the absence of secondary sexual characteristics indicates a lag in maturation | |
| C1878 | | | Anovulatory infertility | |
Cidofovir | C1610 | | | Where the patient is receiving treatment at/from a private hospital Treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome | Compliance with Written or Telephone Authority Required procedures |
| C3322 | | | Where the patient is receiving treatment at/from a public hospital Treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3322 |
Cinacalcet | C2893 | | | Where the patient is receiving treatment at/from a private hospital Management, including initiation and stabilisation, by a nephrologist, of a patient with chronic kidney disease on dialysis who has sustained secondary hyperparathyroidism with intact parathyroid hormone (iPTH) of at least 50 pmol per L, not responding to conventional therapy | Compliance with Written or Telephone Authority Required procedures |
| C2894 | | | Where the patient is receiving treatment at/from a private hospital Management, including initiation and stabilisation, by a nephrologist, of a patient with chronic kidney disease on dialysis who has sustained secondary hyperparathyroidism with intact parathyroid hormone (iPTH) of at least 15 pmol per L and less than 50 pmol per L and an (adjusted) serum calcium concentration at least 2.6 mmol per L, not responding to conventional treatment | Compliance with Written or Telephone Authority Required procedures |
| C3323 | | | Where the patient is receiving treatment at/from a public hospital Management, including initiation and stabilisation, by a nephrologist, of a patient with chronic kidney disease on dialysis who has sustained secondary hyperparathyroidism with intact parathyroid hormone (iPTH) of at least 50 pmol per L, not responding to conventional therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3323 |
| C3324 | | | Where the patient is receiving treatment at/from a public hospital Management, including initiation and stabilisation, by a nephrologist, of a patient with chronic kidney disease on dialysis who has sustained secondary hyperparathyroidism with intact parathyroid hormone (iPTH) of at least 15 pmol per L and less than 50 pmol per L and an (adjusted) serum calcium concentration at least 2.6 mmol per L, not responding to conventional treatment | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3324 |
| C3672 | P3672 | | Maintenance therapy, following initiation and stabilisation of treatment with cinacalcet, of a patient with chronic kidney disease on dialysis who has intact parathyroid hormone (iPTH) greater than 15 pmol per L and an (adjusted) serum calcium concentration of less than 2.6 mmol per L after 6 months treatment | Compliance with Authority Required procedures - Streamlined Authority Code 3672 |
| C3673 | P3673 | | Maintenance therapy, following initiation and stabilisation of treatment with cinacalcet, of a patient with chronic kidney disease on dialysis who has a decrease of at least 30% in intact parathyroid hormone (iPTH) concentrations after 6 months treatment | Compliance with Authority Required procedures - Streamlined Authority Code 3673 |
Ciprofloxacin | C1031 | | | Bacterial keratitis | Compliance with Authority Required procedures |
| C1143 | | | Gonorrhoea | Compliance with Authority Required procedures |
| C1431 | | | Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials | Compliance with Authority Required procedures |
| C1432 | | | Treatment of joint and bone infections, epididymo-orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram-negative bacteria or gram-positive bacteria resistant to all other appropriate antimicrobials | Compliance with Authority Required procedures |
| C1572 | | | Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients | Compliance with Authority Required procedures |
| C1573 | | | Bacterial gastroenteritis in severely immunocompromised patients | Compliance with Authority Required procedures |
| C2615 | | | Treatment of chronic suppurative otitis media in an Aboriginal or a Torres Strait Islander person aged 1 month or older | Compliance with Authority Required procedures |
| C3191 | | | Treatment of chronic suppurative otitis media in a patient less than 18 years of age with perforation of the tympanic membrane | Compliance with Authority Required procedures |
| C3192 | | | Treatment of chronic suppurative otitis media in a patient less than 18 years of age with a grommet in situ | Compliance with Authority Required procedures |
| C3830 | | | Bacterial keratitis under the supervision and direction of an ophthalmologist | Compliance with Authority Required procedures |
Citalopram | C1211 | | | Major depressive disorders | |
Citrulline with carbohydrate | C3679 | | | Urea cycle disorders in order to prevent low plasma arginine or citrulline levels | |
Cladribine | C3180 | | | Hairy cell leukaemia | Compliance with Authority Required procedures - Streamlined Authority Code 3180 |
Clarithromycin | C1434 | | | Where the patient is receiving treatment at/from a private hospital Treatment of Mycobacterium avium complex infections | Compliance with Written or Telephone Authority Required procedures |
| C3016 | | | Bordetella pertussis | |
| C3017 | | | Atypical mycobacterial infections | |
| C3325 | | | Where the patient is receiving treatment at/from a public hospital Treatment of Mycobacterium avium complex infections | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3325 |
Clindamycin | C1145 | | | Gram-positive coccal infections where these cannot be safely and effectively treated with a penicillin | |
Clodronic Acid | C1035 | | | Bone metastases from breast cancer | |
| C1205 | | | Maintenance treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy | |
| C1233 | | | Multiple myeloma | |
Clomiphene | C1026 | | | Anovulatory infertility | |
| C1267 | | | Patients undergoing in-vitro fertilisation | |
Clomipramine | C1041 | | | Cataplexy associated with narcolepsy | |
| C1241 | | | Obsessive-compulsive disorder | |
| C1287 | | | Phobic disorders in adults | |
Clonazepam | C1093 | | | Epilepsy. | |
| C1574 | P1574 | | Neurologically proven epilepsy | Compliance with Authority Required procedures |
| C3657 | P3657 | | Initial supply, for up to 4 months, for a palliative care patient for the prevention of epilepsy | Compliance with Authority Required procedures |
| C3658 | P3658 | | Continuing supply for a palliative care patient for the prevention of epilepsy | Compliance with Authority Required procedures |
Clopidogrel | C1719 | | | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients with a history of symptomatic cerebrovascular ischaemic episodes while on therapy with low-dose aspirin | Compliance with Authority Required procedures - Streamlined Authority Code 1719 |
| C1720 | | | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding | Compliance with Authority Required procedures - Streamlined Authority Code 1720 |
| C1721 | | | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs | Compliance with Authority Required procedures - Streamlined Authority Code 1721 |
| C1722 | | | Prevention of recurrence of myocardial infarction or unstable angina in patients with a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin | Compliance with Authority Required procedures - Streamlined Authority Code 1722 |
| C1723 | | | Prevention of recurrence of myocardial infarction or unstable angina in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding | Compliance with Authority Required procedures - Streamlined Authority Code 1723 |
| C1724 | | | Prevention of recurrence of myocardial infarction or unstable angina in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs | Compliance with Authority Required procedures - Streamlined Authority Code 1724 |
| C3146 | | | Treatment in combination with aspirin following cardiac stent insertion | Compliance with Authority Required procedures - Streamlined Authority Code 3146 |
| C3879 | | | Treatment of acute coronary syndrome (myocardial infarction or unstable angina) in combination with aspirin | Compliance with
Authority Required procedures – Streamlined Authority
Code 3879 |
Clopidogrel with aspirin | C1722 | | | Prevention of recurrence of myocardial infarction or unstable angina in patients with a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin | Compliance with Authority Required procedures - Streamlined Authority Code 1722 |
| C3219 | | | Treatment following cardiac stent insertion | Compliance with Authority Required procedures - Streamlined Authority Code 3219 |
| C3880 | | | Treatment of acute coronary syndrome (myocardial infarction or unstable angina) | Compliance with
Authority Required procedures – Streamlined Authority
Code 3880 |
Clozapine | C1826 | | | Where the patient is receiving treatment at/from a private hospital Schizophrenia in patients who are non-responsive to other neuroleptic agents | Compliance with Written or Telephone Authority Required procedures |
| C1827 | | | Where the patient is receiving treatment at/from a private hospital Schizophrenia in patients who are intolerant of other neuroleptic agents | Compliance with Written or Telephone Authority Required procedures |
| C3326 | | | Where the patient is receiving treatment at/from a public hospital Schizophrenia in patients who are non-responsive to other neuroleptic agents | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3326 |
| C3327 | | | Where the patient is receiving treatment at/from a public hospital Schizophrenia in patients who are intolerant of other neuroleptic agents | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3327 |
Codeine with Paracetamol | | P2064 | CN2064 | Treatment (for up to 6 months) of severe disabling pain not responding to non-narcotic analgesics, at a dose not exceeding 8 tablets per day | Compliance with Authority Required procedures |
Colestipol | | P3035 | | For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Cromoglycic Acid | C1466 | | | Vernal kerato-conjunctivitis. | |
Cyclosporin | C1504 | | | Where the patient is receiving treatment at/from a private hospital For use by organ or tissue transplant recipients | Compliance with Written or Telephone Authority Required procedures |
| C1654 | | | Where the patient is receiving treatment at/from a private hospital Management of rejection in patients following organ or tissue transplantation, under the supervision and direction of a transplant unit, where management includes initiation, stabilisation and review of therapy as required | Compliance with Written or Telephone Authority Required procedures |
| C1655 | | | Where the patient is receiving treatment at/from a private hospital Management (which includes initiation, stabilisation and review of therapy) by dermatologists or clinical immunologists of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate | Compliance with Written or Telephone Authority Required procedures |
| C1656 | | | Where the patient is receiving treatment at/from a private hospital Management (which includes initiation, stabilisation and review of therapy) by dermatologists of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life | Compliance with Written or Telephone Authority Required procedures |
| C1657 | | | Where the patient is receiving treatment at/from a private hospital Management (which includes initiation, stabilisation and review of therapy) by nephrologists of patients with nephrotic syndrome in patients in whom steroids and cytostatic drugs have failed or are not tolerated or are considered inappropriate and in whom renal function is unimpaired | Compliance with Written or Telephone Authority Required procedures |
| C1658 | | | Where the patient is receiving treatment at/from a private hospital Management (which includes initiation, stabilisation and review of therapy) by rheumatologists or clinical immunologists of patients with severe active rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents (including methotrexate) are ineffective or inappropriate | Compliance with Written or Telephone Authority Required procedures |
| C2049 | | | Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with organ or tissue transplants, where therapy remains under the supervision and direction of the transplant unit reviewing the patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | Compliance with Authority Required procedures |
| C2050 | | | Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate, where therapy remains under the supervision and direction of a dermatologist, clinical immunologist or specialised unit reviewing the patient and where the name of the dermatologist, clinical immunologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application | Compliance with Authority Required procedures |
| C2051 | | | Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life, where therapy remains under the supervision and direction of a dermatologist or specialised unit reviewing the patient and where the name of the dermatologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application | Compliance with Authority Required procedures |
| C2052 | | | Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with nephrotic syndrome in whom steroids and cytostatic drugs have failed or are not tolerated or are considered inappropriate and in whom renal function is unimpaired, where therapy remains under the supervision and direction of a nephrologist or specialised unit reviewing the patient and where the name of the nephrologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application | Compliance with Authority Required procedures |
| C2053 | | | Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe active rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents (including methotrexate) are ineffective or inappropriate, where therapy remains under the supervision and direction of a rheumatologist, clinical immunologist or specialised unit reviewing the patient and where the name of the rheumatologist, clinical immunologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application | Compliance with Authority Required procedures |
| C3328 | | | Where the patient is receiving treatment at/from a public hospital Management of rejection in patients following organ or tissue transplantation, under the supervision and direction of a transplant unit, where management includes initiation, stabilisation and review of therapy as required | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3328 |
| C3329 | | | Where the patient is receiving treatment at/from a public hospital Management (which includes initiation, stabilisation and review of therapy) by dermatologists or clinical immunologists of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3329 |
| C3330 | | | Where the patient is receiving treatment at/from a public hospital Management (which includes initiation, stabilisation and review of therapy) by dermatologists of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3330 |
| C3331 | | | Where the patient is receiving treatment at/from a public hospital Management (which includes initiation, stabilisation and review of therapy) by nephrologists of patients with nephrotic syndrome in patients in whom steroids and cytostatic drugs have failed or are not tolerated or are considered inappropriate and in whom renal function is unimpaired | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3331 |
| C3332 | | | Where the patient is receiving treatment at/from a public hospital Management (which includes initiation, stabilisation and review of therapy) by rheumatologists or clinical immunologists of patients with severe active rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents (including methotrexate) are ineffective or inappropriate | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3332 |
| C3333 | | | Where the patient is receiving treatment at/from a public hospital For use by organ or tissue transplant recipients | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3333 |
Cyproheptadine | C1288 | | | Prevention of migraine | |
Cyproterone | C1014 | P1014 | | Advanced carcinoma of the prostate | Compliance with Authority Required procedures - Streamlined Authority Code 1014 |
| C1230 | P1230 | | Moderate to severe androgenisation, of which acne alone is not a sufficient indication, in non-pregnant women | Compliance with Authority Required procedures - Streamlined Authority Code 1230 |
| C1404 | P1404 | | To reduce drive in sexual deviations in males | Compliance with Authority Required procedures - Streamlined Authority Code 1404 |
Cystine with carbohydrate | C1314 | | | Pyridoxine non-responsive homocystinuria | |
Dabigatran etexilate | C3957 | P3957 | | Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy | Compliance with Authority Required procedures |
| C4047 | P4047 | | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 20 days supply to complete a course of treatment | Compliance with Authority Required procedures |
| C4048 | P4048 | | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days supply to complete a course of treatment | Compliance with Authority Required procedures |
Dalteparin | | P1148 | | Haemodialysis | |
| C3688 | P3688 | | Management of symptomatic venous thromboembolism in a patient with a solid tumour(s) | |
Danazol | C1090 | | | Endometriosis, visually proven | Compliance with Authority Required procedures - Streamlined Authority Code 1090 |
| C1151 | | | Hereditary angio-oedema | Compliance with Authority Required procedures - Streamlined Authority Code 1151 |
| C2639 | | | Treatment, for up to 6 months, of intractable primary menorrhagia | Compliance with Authority Required procedures - Streamlined Authority Code 2639 |
| C2640 | | | Treatment, for up to 6 months, of severe benign (fibrocystic) breast disease or mastalgia associated with severe symptomatic benign breast disease in patients refractory to other treatments | Compliance with Authority Required procedures - Streamlined Authority Code 2640 |
Dantrolene | C1421 | | | Treatment of chronic spasticity | |
Darbepoetin Alfa | C1957 | | | Where the patient is receiving treatment at/from a private hospital Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia. | Compliance with Written or Telephone Authority Required procedures |
| C3334 | | | Where the patient is receiving treatment at/from a public hospital Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3334 |
Darunavir | C3594 | | | Where the patient is receiving treatment at/from a private hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir twice daily in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity | Compliance with Written or Telephone Authority Required procedures |
| C3595 | | | Where the patient is receiving treatment at/from a public hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir twice daily in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3595 |
| C3940 | | | Where the patient is receiving treatment at/from a Private Hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance, and who has not demonstrated darunavir resistance associated mutations detected on resistance testing
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity | Compliance with Written or Telephone Authority Required procedures |
| C3941 | | | Where the patient is receiving treatment at/from a Public Hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance, and who has not demonstrated darunavir resistance associated mutations detected on resistance testing
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3941 |
Dasatinib | C2769 | P2769 | | Acute lymphoblastic leukaemia
Initial treatment, as monotherapy, of a patient with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR-ABL, who has failed treatment with chemotherapy and imatinib, and, where appropriate, allogeneic haemopoietic stem cell transplantation; and
where failure of treatment is defined as either:
(i) failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months of treatment with intensive chemotherapy and imatinib;
(ii) morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy and imatinib;
(iii) morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation; and
where the following conditions apply:
the patient has active leukaemia, as defined by the presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; or the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission;
the authority application includes:
(a) a completed copy of the appropriate Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; and
(b) a signed patient acknowledgement; and
(c) a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript, along with the date of the relevant report or reports | Compliance with Written Authority Required procedures |
| C2770 | P2770 | | Acute lymphoblastic leukaemia
Initial treatment, as monotherapy, of a patient with acute lymphoblastic leukaemia bearing the Philadelphia chromosome or expressing the transcript, BCR-ABL, who has been treated prior to 1 December 2007 and has failed treatment with chemotherapy and, where appropriate, allogeneic haemopoietic stem cell transplantation; and
where the following conditions apply:
the patient has active leukaemia, as defined by the presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; or the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission;
the authority application includes:
(a) a completed copy of the appropriate Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; and
(b) a signed patient acknowledgement; and
(c) a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript, along with the date of the relevant report or reports | Compliance with Written Authority Required procedures |
| C2771 | P2771 | | Acute lymphoblastic leukaemia
Continuing treatment, as monotherapy, of a patient with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR-ABL, where the patient has previously been issued with an authority prescription for dasatinib for ALL and does not have progressive disease | Compliance with Written or Telephone Authority Required procedures |
| C3999 | P3999 | | Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase who has failed an adequate trial of imatinib or nilotinib as first-line treatment
Failure of an adequate trial of imatinib or nilotinib is defined as:
(i) Lack of response to initial imatinib or nilotinib therapy, defined as either:
— failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or nilotinib for patients initially treated in chronic phase; or
— failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or nilotinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or
— failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or nilotinib; OR
(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or nilotinib therapy; OR
(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or nilotinib therapy; OR
(iv) Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or nilotinib for any phase of chronic myeloid leukaemia
Accelerated phase is defined by the presence of 1 or more of the following:
(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or
(3) Peripheral basophils greater than or equal to 20%; or
(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR
Blast crisis is defined as either:
(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or
(2) Extramedullary involvement other than spleen and liver; OR
(v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia
Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to dasatinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals
Applications for authorisation must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Chronic Myeloid Leukaemia - Second and Third Line - Supporting Information Form; and
(c) a signed patient acknowledgement; and
(d) a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale. (The date of the relevant pathology report needs to be provided); and
(e) where there has been a loss of response to imatinib or nilotinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement | Compliance with Written Authority Required procedures
|
| C4000 | P4000 | | Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial PBS-subsidised treatment with dasatinib for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response, or less than 1% BCR-ABL level in the blood, to dasatinib in the preceding 18 months and thereafter at 12 monthly intervals
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Chronic Myeloid Leukaemia - Second and Third Line - Application Form for continuing treatment; and
(3) demonstration of continued response to treatment as evidenced by either:
(a) major cytogenetic response. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided
Definitions of response
A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells
A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response | Compliance with Written Authority Required procedures
|
| C4003 | P4003 | | Initial treatment, as the sole PBS-subsidised therapy, of a patient in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, BCR-ABL tyrosine kinase, and who has a primary diagnosis of chronic myeloid leukaemia
Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved
Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and
(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and
(4) a signed patient acknowledgement form | Compliance with Written Authority Required procedures
|
| C4004 | P4004 | | Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial PBS-subsidised treatment with dasatinib for the chronic phase of chronic myeloid leukaemia and who has demonstrated either a major cytogenetic response or less than 1% BCR-ABL level in the blood
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) demonstration of continued response to treatment as evidenced by either:
(a) major cytogenetic response. Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale. Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided
Definitions of response
A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells
A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response | Compliance with Written Authority Required procedures
|
Deferasirox | C3828 | | | Where the patient is receiving treatment at/from a public hospital Chronic iron overload in patients with disorders of erythropoiesis | Compliance with
Written or Telephone
Authority Required procedures – Streamlined Authority
Code 3828 |
| C3829 | | | Where the patient is receiving treatment at/from a private hospital Chronic iron overload in patients with disorders of erythropoiesis | Compliance with Written or Telephone Authority Required procedures |
Deferiprone | C1911 | | | Where the patient is receiving treatment at/from a private hospital Iron overload in patients with thalassaemia major who are unable to take desferrioxamine therapy | Compliance with Written or Telephone Authority Required procedures |
| C1912 | | | Where the patient is receiving treatment at/from a private hospital Iron overload in patients with thalassaemia major in whom desferrioxamine therapy has proven ineffective | Compliance with Written or Telephone Authority Required procedures |
| C3338 | | | Where the patient is receiving treatment at/from a public hospital Iron overload in patients with thalassaemia major who are unable to take desferrioxamine therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3338 |
| C3339 | | | Where the patient is receiving treatment at/from a public hospital Iron overload in patients with thalassaemia major in whom desferrioxamine therapy has proven ineffective | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3339 |
Degarelix | C3229 | | | Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate | Compliance with Authority Required procedures - Streamlined Authority Code 3229 |
Denosumab | C1035 | | | Bone metastases from breast cancer | Compliance with Authority Required procedures |
| C3987 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for established post-menopausal osteoporosis in a woman with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | Compliance with Authority Required procedures - Streamlined Authority Code 3987 |
| C4051 | | | Bone metastases from castration-resistant prostate cancer | Compliance with Authority Required procedures |
| C4054 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a woman aged 70 years of age or older with a bone mineral density T-score of -2.5 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures – Streamlined Authority Code 4054 |
Desferrioxamine | C1085 | | | Where the patient is receiving treatment at/from a private hospital Disorders of erythropoiesis associated with treatment-related chronic iron overload | Compliance with Written or Telephone Authority Required procedures |
| C3340 | | | Where the patient is receiving treatment at/from a public hospital Disorders of erythropoiesis associated with treatment-related chronic iron overload | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3340 |
Desmopressin | C1678 | P1678 | | Cranial diabetes insipidus | Compliance with Authority Required procedures - Streamlined Authority Code 1678 |
| C2641 | P2641 | | Primary nocturnal enuresis in patients aged 6 years or older who are refractory to an enuresis alarm | Compliance with Authority Required procedures - Streamlined Authority Code 2641 |
| C2642 | P2642 | | Primary nocturnal enuresis in patients aged 6 years or older for whom an enuresis alarm is contraindicated, and where the reason for the contraindication is documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 2642 |
Desvenlafaxine | C1211 | | | Major depressive disorders | |
Dexamphetamine | C1236 | | | Narcolepsy | Compliance with Authority Required procedures |
| C1461 | | | Use in attention deficit hyperactivity disorder, in accordance with State/Territory law | Compliance with Authority Required procedures |
Diazepam | | P3655 | CN3655 | Initial supply, for up to 4 months, for a palliative care patient where anxiety is a problem | Compliance with Authority Required procedures |
| | P3656 | CN3656 | Continuing supply for a palliative care patient where anxiety is a problem | Compliance with Authority Required procedures |
Diclofenac | C1036 | P1036 | | Bone pain due to malignant disease | |
| C1054 | P1054 | | Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
| C3645 | P3645 | | Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3645 |
| C3646 | P3646 | | Continuing supply for a palliative care patient where severe pain is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3646 |
| | P3665 | CN3665 | Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem | Compliance with Authority Required procedures |
| | P3666 | CN3666 | Continuing supply for a palliative care patient where severe pain is a problem | Compliance with Authority Required procedures |
Dicloxacillin | C1345 | | | Serious staphylococcal infections | |
Didanosine | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Dipyridamole | C1725 | | | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients receiving therapy with low-dose aspirin | |
| C1726 | | | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding | |
| C1727 | | | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs | |
Dipyridamole with Aspirin | C1728 | | | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events | |
Docetaxel | C3186 | | | Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound | Compliance with Authority Required procedures - Streamlined Authority Code 3186 |
| C3888 | | | Neoadjuvant treatment of a patient with a World Health Organisation performance status of 1 or less, with inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx, in combination with cisplatin and fluorouracil | Compliance with Authority Required procedures - Streamlined Authority Code 3888 |
| C3890 | | | Locally advanced or metastatic non-small cell lung cancer | Compliance with Authority Required procedures - Streamlined Authority Code 3890 |
| C3892 | | | Adjuvant treatment of operable breast cancer in combination with cyclophosphamide | Compliance with Authority Required procedures - Streamlined Authority Code 3892 |
| C3916 | | | Adjuvant treatment of node-positive breast cancer in combination with an anthracycline and cyclophosphamide | Compliance with Authority Required procedures - Streamlined Authority Code 3916 |
| C3955 | | | Metastatic breast cancer | Compliance with Authority Required procedures - Streamlined Authority Code 3955 |
| C3956 | | | Treatment of HER2 positive breast cancer in combination with trastuzumab | Compliance with Authority Required procedures - Streamlined Authority Code 3956 |
| C7002 | | | Treatment of androgen independent (castration resistant) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles | Compliance with Authority Required procedures – Streamlined Authority Code 7002 |
Donepezil | C2934 | | | Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more who demonstrate improvement in cognitive function following initial PBS-subsidised therapy, and where:
(1) improvement in cognitive function is demonstrated by:
(a) in the case of patients with a baseline MMSE or SMMSE score of 10 or more and less than 25 — an increase of at least 2 points from baseline on the MMSE or SMMSE; or
(b) in the case of patients with a baseline MMSE or SMMSE score of at least 25 points — an increase of at least 2 points from baseline on the MMSE or SMMSE, or, if a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) was submitted with the application for initial treatment, a decrease of at least 4 points from baseline on the ADAS-Cog; and
(2) the relevant result from the MMSE, SMMSE or ADAS-Cog is included in the authority application for continuing treatment | Compliance with Written Authority Required procedures |
| | | | Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more and with demonstrated improvement in cognitive function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment | Compliance with Written Authority Required procedures |
| C2938 | | | Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease and who demonstrate improvement in function following initial PBS-subsidised therapy, based on a rating of "very much improved" or "much improved" on the Clinicians Interview Based Impression of Change scale, as assessed by the same clinician who initiated treatment, and where the improvement rating achieved on the Clinicians Interview Based Impression of Change scale is stated in the authority application for continuing treatment | Compliance with Written Authority Required procedures |
| | | | Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less and with demonstrated improvement in function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment | Compliance with Written Authority Required procedures |
| C3875 | | | Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application | Compliance with Authority Required procedures |
| | | | Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the baseline scores submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total | Compliance with Written Authority Required procedures |
| | | | Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application | Compliance with Written Authority Required procedures |
| C3876 | | | Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment | Compliance with Authority Required procedures |
| | | | Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the information submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total | Compliance with Written Authority Required procedures
|
| | | | Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment | Compliance with Written Authority Required procedures
|
Dornase Alfa | C1507 | | | Where the patient is receiving treatment at/from a private hospital Patient 5 years of age or older
Use by cystic fibrosis patients who satisfy all of the following criteria:
(1) are 5 years of age or older;
(2) have a FVC greater than 40% predicted for age, gender and height;
(3) have evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);
(4) are participating in a 4 week trial as detailed below or have achieved a 10% or greater improvement in FEV1 (compared to baseline established prior to dornase alfa treatment) after a 4 week trial.
In order for patients to be eligible for participation in the highly specialised drugs (HSD) program, the following conditions must be met:
(1) Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of dornase alfa under the HSD program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;
(2) The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at established lung function testing laboratories, unless this is not possible because of geographical isolation;
(3) Prior to dornase alfa therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease;
(4) Initial therapy is limited to 4 weeks' treatment with dornase alfa at a dose of 2.5 mg daily;
(5) At or towards the end of the initial 4 weeks' trial, patients must be reassessed and a further FEV1 measurement be undertaken (single test under conditions as above). Patients who achieve a 10% or greater improvement in FEV1 (compared to baseline established prior to dornase alfa treatment) are eligible for continued subsidy under the HSD program at a dose of 2.5 mg daily;
(6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 2.5 mg daily, may have 1 further trial in the next 12 months but not before 3 months after the initial trial;
(7) Following an initial 6 months' therapy, a global assessment must be undertaken involving the patient, the patient's family (in the case of paediatric patients) and the treating physician(s) to establish that all agree that dornase alfa treatment is continuing to produce worthwhile benefits. (Dornase alfa therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.) Further reassessments are to be undertaken at six-monthly intervals;
(8) Other aspects of treatment, such as physiotherapy, must be continued;
(9) Where there is documented evidence that a patient already receiving dornase alfa therapy would have met the criteria for subsidy (i.e. satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period) | Compliance with Written or Telephone Authority Required procedures |
| C3200 | | | Where the patient is receiving treatment at/from a private hospital Patient less than 5 years of age
Treatment of cystic fibrosis in a patient less than 5 years of age who has:
(1) A severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring frequent hospital admissions more frequently than 3 times per year; or
(2) Significant bronchiectasis on chest high resolution computed tomography scan; or
(3) Severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; or
(4) Severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy
In order for the patient to be eligible for participation in the highly specialised drugs (HSD) program, the following conditions must be met:
(1) The patient must be assessed at a cystic fibrosis clinic/centre which is under the supervision of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis, and the prescribing of dornase alfa under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;
(2) Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented involving the patient, the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team to establish agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use. Further reassessments are to be undertaken and documented yearly | Compliance with Written or Telephone Authority Required procedures |
| C3201 | | | Where the patient is receiving treatment at/from a private hospital Patient 5 years of age or older (commenced treatment at age of less than 5 years)
Continuation of treatment of cystic fibrosis in a patient 5 years of age or older, who initiated treatment with dornase alfa at an age of less than 5 years and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team, documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use | Compliance with Written or Telephone Authority Required procedures |
| C3202 | | | Where the patient is receiving treatment at/from a private hospital Patient less than 5 years of age (treatment initiated prior to 1 November 2009)
Treatment of cystic fibrosis in a patient less than 5 years of age who initiated treatment with dornase alfa prior to 1 November 2009 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team, documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use | Compliance with Written or Telephone Authority Required procedures |
| C3344 | | | Where the patient is receiving treatment at/from a public hospital Patient 5 years of age or older
Use by cystic fibrosis patients who satisfy all of the following criteria:
(1) are 5 years of age or older;
(2) have a FVC greater than 40% predicted for age, gender and height;
(3) have evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);
(4) are participating in a 4 week trial as detailed below or have achieved a 10% or greater improvement in FEV1 (compared to baseline established prior to dornase alfa treatment) after a 4 week trial
In order for patients to be eligible for participation in the highly specialised drugs (HSD) program, the following conditions must be met:
(1) Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of dornase alfa under the HSD program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;
(2) The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at established lung function testing laboratories, unless this is not possible because of geographical isolation;
(3) Prior to dornase alfa therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease;
(4) Initial therapy is limited to 4 weeks' treatment with dornase alfa at a dose of 2.5 mg daily;
(5) At or towards the end of the initial 4 weeks' trial, patients must be reassessed and a further FEV1 measurement be undertaken (single test under conditions as above). Patients who achieve a 10% or greater improvement in FEV1 (compared to baseline established prior to dornase alfa treatment) are eligible for continued subsidy under the HSD program at a dose of 2.5 mg daily;
(6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 2.5 mg daily, may have 1 further trial in the next 12 months but not before 3 months after the initial trial;
(7) Following an initial 6 months' therapy, a global assessment must be undertaken involving the patient, the patient's family (in the case of paediatric patients) and the treating physician(s) to establish that all agree that dornase alfa treatment is continuing to produce worthwhile benefits. (Dornase alfa therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.) Further reassessments are to be undertaken at six-monthly intervals;
(8) Other aspects of treatment, such as physiotherapy, must be continued;
(9) Where there is documented evidence that a patient already receiving dornase alfa therapy would have met the criteria for subsidy (i.e. satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period) | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3344 |
| C3345 | | | Where the patient is receiving treatment at/from a public hospital Patient less than 5 years of age
Treatment of cystic fibrosis in a patient less than 5 years of age who has:
(1) A severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring frequent hospital admissions more frequently than 3 times per year; or
(2) Significant bronchiectasis on chest high resolution computed tomography scan; or
(3) Severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; or
(4) Severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy
In order for the patient to be eligible for participation in the highly specialised drugs (HSD) program, the following conditions must be met:
(1) The patient must be assessed at a cystic fibrosis clinic/centre which is under the supervision of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis, and the prescribing of dornase alfa under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;
(2) Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented involving the patient, the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team to establish agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use. Further reassessments are to be undertaken and documented yearly | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3345 |
| C3346 | | | Where the patient is receiving treatment at/from a public hospital Patient 5 years of age or older (commenced treatment at age of less than 5 years)
Continuation of treatment of cystic fibrosis in a patient 5 years of age or older, who initiated treatment with dornase alfa at an age of less than 5 years and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team, documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3346 |
| C3347 | | | Where the patient is receiving treatment at/from a public hospital Patient less than 5 years of age (treatment initiated prior to 1 November 2009)
Treatment of cystic fibrosis in a patient less than 5 years of age who initiated treatment with dornase alfa prior to 1 November 2009 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team, documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3347 |
Dorzolamide with Timolol | C3426 | | | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy | |
| C3427 | | | Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy | |
Doxorubicin - Pegylated Liposomal | C1568 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen | Compliance with Authority Required procedures |
| C1795 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane | Compliance with Authority Required procedures |
| C1796 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated | Compliance with Authority Required procedures |
| C1828 | | | Where the patient is receiving treatment at/from a private hospital Treatment of acquired immunodeficiency syndrome-related Kaposi's sarcoma in patients with CD4 cell counts of less than 200 per cubic millimetre and extensive mucocutaneous involvement | Compliance with Written or Telephone Authority Required procedures |
| C1829 | | | Where the patient is receiving treatment at/from a private hospital Treatment of acquired immunodeficiency syndrome-related Kaposi's sarcoma in patients with CD4 cell counts of less than 200 per cubic millimetre and extensive visceral involvement | Compliance with Written or Telephone Authority Required procedures |
| C3348 | | | Where the patient is receiving treatment at/from a public hospital Treatment of acquired immunodeficiency syndrome-related Kaposi's sarcoma in patients with CD4 cell counts of less than 200 per cubic millimetre and extensive mucocutaneous involvement | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3348 |
| C3349 | | | Where the patient is receiving treatment at/from a public hospital Treatment of acquired immunodeficiency syndrome-related Kaposi's sarcoma in patients with CD4 cell counts of less than 200 per cubic millimetre and extensive visceral involvement | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3349 |
| C3905 | | | Where the patient is receiving treatment at/from a Public Hospital Advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen | Compliance with Authority Required procedures - Streamlined Authority Code 3905 |
| C3910 | | | Where the patient is receiving treatment at/from a Public Hospital Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane | Compliance with Authority Required procedures - Streamlined Authority Code 3910 |
| C3911 | | | Where the patient is receiving treatment at/from a Public Hospital Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated | Compliance with Authority Required procedures - Streamlined Authority Code 3911 |
Doxycycline | | P1279 | | Pelvic inflammatory disease | |
| C1346 | | | Severe acne | |
| | P1459 | | Urethritis | |
| C1851 | | | Bronchiectasis in patients aged 8 years or older | |
| C1852 | | | Chronic bronchitis in patients aged 8 years or older | |
Duloxetine | C1211 | | | Major depressive disorders | |
Dutasteride | C3667 | | | Treatment, in combination with an alpha-antagonist, of lower urinary tract symptoms due to benign prostatic hyperplasia where treatment is initiated by a urologist | Compliance with Authority Required procedures - Streamlined Authority Code 3667 |
Dutasteride with tamsulosin | C3687 | | | Treatment of lower urinary tract symptoms due to benign prostatic hyperplasia where treatment has been initiated by a urologist | Compliance with Authority Required procedures - Streamlined Authority Code 3687 |
Efavirenz | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Eformoterol | C1752 | | | Patients with frequent episodes of asthma who are currently receiving treatment with oral corticosteroids | |
| C1753 | | | Patients with frequent episodes of asthma who are currently receiving treatment with optimal doses of inhaled corticosteroids. | |
Eletriptan | C3233 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics | Compliance with Authority Required procedures - Streamlined Authority Code 3233 |
Emtricitabine | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Enalapril with Hydrochlorothiazide | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Enfuvirtide | C3596 | | | Where the patient is receiving treatment at/from a private hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity | Compliance with Written or Telephone Authority Required procedures |
| C3597 | | | Where the patient is receiving treatment at/from a public hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3597 |
Enoxaparin | | P1148 | | Haemodialysis | |
Entacapone | C2067 | | | Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations who are experiencing fluctuations in motor function due to end-of-dose effect | Compliance with Authority Required procedures - Streamlined Authority Code 2067 |
Entecavir | C3959 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures |
| C3960 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy | Compliance with Written or Telephone Authority Required procedures |
| C3961 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3961 |
| C3962 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3962 |
| C3963 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient without cirrhosis who has failed lamivudine and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance | Compliance with Written or Telephone Authority Required procedures |
| C3964 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B
Chronic hepatitis B in a patient without cirrhosis who has failed lamivudine and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3964 |
| C3965 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient with cirrhosis who has failed lamivudine and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures |
| C3966 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient with cirrhosis who has failed lamivudine and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3966 |
Eplerenone | C2637 | | | Heart failure with a left ventricular ejection fraction of 40% or less occurring within 3 to 14 days following an acute myocardial infarction, where treatment with eplerenone commences within 14 days of the acute myocardial infarction, and where the date of the acute myocardial infarction and the date of initiation of eplerenone treatment are documented in the patient's medical records when PBS-subsidised treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 2637 |
Epoetin Alfa | C1957 | | | Where the patient is receiving treatment at/from a private hospital Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia. | Compliance with Written or Telephone Authority Required procedures |
| C3334 | | | Where the patient is receiving treatment at/from a public hospital Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3334 |
Epoetin Beta | C1957 | | | Where the patient is receiving treatment at/from a private hospital Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia | Compliance with Written or Telephone Authority Required procedures |
| C3334 | | | Where the patient is receiving treatment at/from a public hospital Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3334 |
Epoetin Lambda | C1957 | | | Where the patient is receiving treatment at/from a private hospital Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia | Compliance with Written or Telephone Authority Required procedures |
| C3334 | | | Where the patient is receiving treatment at/from a public hospital Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3334 |
Eprosartan with Hydrochlorothiazide | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Eptifibatide | C1884 | | | Patients undergoing non-urgent percutaneous intervention with intracoronary stenting | Compliance with Authority Required procedures - Streamlined Authority Code 1884 |
Erlotinib | C2971 | | | Initial PBS-subsidised treatment, as monotherapy, in a patient with locally advanced or metastatic (stage IIIB or IV) non-small cell lung cancer with a World Health Organisation (WHO) performance status of 3 or less, after prior treatment with platinum-based chemotherapy, where:
(1) (a) disease progression has occurred following treatment with docetaxel or pemetrexed; or
(b) treatment with docetaxel and pemetrexed is either contraindicated or cannot be tolerated; and
(2) further cytotoxic chemotherapy is not appropriate | Compliance with Authority Required procedures |
| C2972 | | | Continuing PBS-subsidised treatment, as monotherapy, in a patient with locally advanced or metastatic (stage IIIB or IV) non-small cell lung cancer who has previously been issued with an authority prescription for this drug and who does not have progressive disease. | Compliance with Authority Required procedures |
Escitalopram | C1211 | | | Major depressive disorders | |
| C2964 | | | Moderate to severe generalised anxiety disorder (GAD), as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and for whom a GP Mental Health Care Plan, as described under item 2710 of the Medicare Benefits Schedule, has been prepared | |
| C2965 | | | Moderate to severe generalised anxiety disorder (GAD), as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and who has been assessed by a psychiatrist | |
| C2966 | | | Continuing PBS-subsidised treatment, for moderate to severe generalised anxiety disorder (GAD), of a patient commenced on escitalopram prior to 1 March 2008 | |
| C2967 | | | Moderate to severe social anxiety disorder (social phobia, SAD), as described by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and for whom a GP Mental Health Care Plan, as described under item 2710 of the Medicare Benefits Schedule, has been prepared | |
| C2968 | | | Moderate to severe social anxiety disorder (social phobia, SAD), as described by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and who has been assessed by a psychiatrist | |
| C2969 | | | Continuing PBS-subsidised treatment, for moderate to severe social anxiety disorder (social phobia, SAD), of a patient commenced on escitalopram prior to 1 March 2008 | |
| C3092 | | | Continuing PBS-subsidised treatment, for moderate to severe generalised anxiety disorder (GAD), of a patient commenced on escitalopram prior to 1 November 2008 | |
| C3093 | | | Continuing PBS-subsidised treatment, for moderate to severe social anxiety disorder (social phobia, SAD), of a patient commenced on escitalopram prior to 1 November 2008 | |
Esomeprazole | C1337 | P1337 | | Scleroderma oesophagus | |
| C1628 | P1628 | | Healing of gastro-oesophageal reflux disease | |
| C1629 | P1629 | | Maintenance of healed gastro-oesophageal reflux disease | |
| C2273 | P2273 | | Initial treatment of gastric ulcer | |
| C3429 | P3429 | | Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion | Compliance with Authority Required procedures |
Esomeprazole and Clarithromycin and Amoxycillin | C1096 | | | Eradication of Helicobacter pylori associated with peptic ulcer disease | |
Essential amino acids formula | C1147 | | | Gyrate atrophy of the choroid and retina | |
| C1458 | | | Urea cycle disorders | |
Essential amino acids formula with minerals and vitamin C | C1147 | | | Gyrate atrophy of the choroid and retina | |
| C1458 | | | Urea cycle disorders | |
Essential amino acids formula with vitamins and minerals | C1147 | | | Gyrate atrophy of the choroid and retina | |
| C1458 | | | Urea cycle disorders | |
Etanercept | C3273 | P3273 | | Chronic plaque psoriasis (whole body) — initial treatment 1
Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the whole body; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrated in the patient at the time of the authority application;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with etanercept for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3275 | P3275 | | Chronic plaque psoriasis (face, hand, foot) — initial treatment 1
Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the face, hand or foot; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with etanercept for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3489 | P3489 | | Psoriatic arthritis — initial treatment 1
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have severe active psoriatic arthritis; and
(2) have received no prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
(3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) an active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgment;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment with etanercept in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3510 | P3510 | | Ankylosing spondylitis — initial treatment 1
Initial treatment with etanercept commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
(a) who has not received any PBS-subsidised treatment with a tumour necrosis factor (TNF)-alfa antagonist, or, where the patient has previously received PBS-subsidised TNF-alfa antagonist treatment for this condition, has received no such treatment for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and
(b) who has at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
(iii) limitation of chest expansion relative to normal values for age and gender; and
(c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised TNF-alfa antagonist therapy of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated by:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;
both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;
if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;
if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form; and
(iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment with etanercept in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3524 | P3524 | | Juvenile idiopathic arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)
Initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) has received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(c) has failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg per day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means adalimumab or etanercept; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and (b) either:
(i) an active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of etanercept provided a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in their previous treatment cycle and the date of the first application under the new treatment cycle;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with etanercept for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3708 | P3708 | | Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS-subsidised treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with etanercept for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3770 | P3770 | | Juvenile idiopathic arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)
Initial PBS-subsidised treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or etanercept for this condition; and
(c) has not failed PBS-subsidised therapy with etanercept for this condition more than once in the current treatment cycle; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with etanercept in this treatment cycle and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised etanercept treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised etanercept treatment is a 16 week initial treatment course, is made following a minimum of 12 weeks of therapy;
a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with etanercept for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3771 | P3771 | | Juvenile idiopathic arthritis — continuing treatment
Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older:
(a) who has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) who has demonstrated an adequate response to treatment with etanercept; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with etanercept; and
where bDMARD means adalimumab or etanercept; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) an active joint count of fewer than 10 active (swollen and tender) joints; or
(ii) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(iii) a reduction in the number of the following joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of etanercept therapy is a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a patient who has failed to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of continuing treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3772 | P3772 | | Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with etanercept for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with etanercept and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised etanercept treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised etanercept treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3773 | P3773 | | Rheumatoid arthritis — continuing treatment
Continuing PBS-subsidised treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with etanercept; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with etanercept; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of etanercept therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of continuing treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3774 | P3774 | | Ankylosing spondylitis — initial treatment 2
Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised tumour necrosis factor (TNF)-alfa antagonist treatment for this condition and is eligible to receive further TNF-alfa antagonist therapy, and has not failed PBS-subsidised therapy with etanercept in the current treatment cycle; and
where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
a patient is eligible to receive further therapy with a TNF-alfa antagonist within this treatment cycle provided they have not already failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists within this treatment cycle;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form;
an assessment of response to the patient's most recent course of PBS-subsidised TNF-alfa antagonist treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased;
where the most recent course of TNF-antagonist treatment is an initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
if the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3775 | P3775 | | Ankylosing spondylitis — continuing treatment
Continuing treatment with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated an adequate response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and
where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
(a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
(b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline;
all measurements provided are no more than 1 month old at the time of application;
where only 1 acute phase reactant measurement is supplied to establish baseline in the first application for PBS-subsidised treatment, that same marker is measured and supplied in all subsequent continuing treatment applications;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of etanercept therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of continuing treatment with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3776 | P3776 | | Psoriatic arthritis — initial treatment 2
Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have a documented history of severe active psoriatic arthritis; and
(2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and are eligible to receive further therapy with a biological agent; and
(3) have not failed treatment with etanercept during the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with etanercept within this Treatment Cycle and wishes to recommence therapy with this drug within this same cycle, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised etanercept treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised etanercept treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3777 | P3777 | | Psoriatic arthritis — continuing treatment
Continuing treatment with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
(1) who have a documented history of severe active psoriatic arthritis; and
(2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and
(3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to treatment with etanercept is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of etanercept therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of continuing treatment with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3778 | P3778 | | Chronic plaque psoriasis (whole body) — initial treatment 2
Initial treatment, or recommencement of treatment, with etanercept as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis; and
(b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and
(c) have not failed PBS-subsidised therapy with etanercept for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who have previously demonstrated a response to PBS-subsidised treatment with etanercept within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised etanercept treatment was submitted to the Chief Executive Medicare within 1 month of cessation of that treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment, or of a course which recommences treatment, with etanercept as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3779 | P3779 | | Chronic plaque psoriasis (face, hand, foot) — initial treatment 2
Initial treatment, or recommencement of treatment, with etanercept as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and
(c) have not failed PBS-subsidised therapy with etanercept for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who have previously demonstrated a response to PBS-subsidised treatment with etanercept within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised etanercept treatment was submitted to the Chief Executive Medicare within 1 month of cessation of that treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment, or of a course which recommences treatment, with etanercept as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3780 | P3780 | | Chronic plaque psoriasis (whole body) — continuing treatment
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and
(c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to etanercept treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Chief Executive Medicare no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3781 | P3781 | | Chronic plaque psoriasis (face, hand, foot) — continuing treatment
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and
(c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to etanercept treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Chief Executive Medicare no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C4057 | P4057 | | Chronic plaque psoriasis (Whole body) [Initial treatment — No prior biological agent] Initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who: (a) has severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and (b) has not received any prior PBS-subsidised treatment with etanercept for this condition; and (c) whose parent or authorised guardian has signed a patient acknowledgement; and (d) has failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks If treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or where phototherapy is contraindicated, please provide details at the time of application If intolerance to treatment with phototherapy, methotrexate or acitretin develops during the relevant period of use, which is of a severity to necessitate permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application The following initiation criterion indicates failure to achieve an adequate response and must be demonstrated in all patients at the time of the application: (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment (c) The most recent PASI assessment must be no more than 1 month old at the time of application Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and (iii) the parent or authorised guardian signed patient and prescriber acknowledgements A maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept An adequate response to treatment is defined as: Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, when compared with the pre-etanercept treatment baseline value | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has severe chronic plaque psoriasis and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course | Compliance with Written or Telephone Authority Required procedures |
| C4058 | P4058 | | Chronic plaque psoriasis (Whole body) [Re-Treatment — Received prior etanercept under PBS] Treatment as systemic monotherapy (other than methotrexate) by a dermatologist for a patient under 18 years who has: (a) a documented history of severe chronic plaque psoriasis; and (b) received prior PBS-subsidised treatment with etanercept for this condition; and (c) not failed PBS-subsidised therapy with etanercept for the treatment of this condition more than once in the current Treatment Cycle Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior etanercept treatment, including date A total maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has a documented history of severe chronic plaque psoriasis, who has previously received PBS-subsidised treatment with etanercept for this condition, and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course | Compliance with Written or Telephone Authority Required procedures |
| C4059 | P4059 | | Chronic plaque psoriasis (Face, hand, foot) [Initial treatment — No prior biological agent] Initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who: (a) has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and (b) has not received any prior PBS-subsidised treatment with etanercept for this condition; and (c) whose parent or authorised guardian has signed a patient acknowledgement; and (d) has failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks If treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or where phototherapy is contraindicated, please provide details at the time of application If intolerance to treatment with phototherapy, methotrexate or acitretin develops during the relevant period of use, which is of a severity to necessitate permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application The following initiation criterion indicates failure to achieve an adequate response and must be demonstrated in all patients at the time of the application: (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment (c) The most recent PASI assessment must be no more than 1 month old at the time of application Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and (iii) the parent or authorised guardian signed patient and prescriber acknowledgements A maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, when compared with the pre-etanercept treatment baseline value | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course | Compliance with Written or Telephone Authority Required procedures |
| C4060 | P4060 | | Chronic plaque psoriasis (Face, hand, foot) [Re-Treatment — Received prior etanercept under PBS] Treatment as systemic monotherapy (other than methotrexate) by a dermatologist for a patient under 18 years who has: (a) a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and (b) received prior PBS-subsidised treatment with etanercept for this condition; and (c) not failed PBS-subsidised therapy with etanercept for the treatment of this condition more than once in the current Treatment Cycle Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior etanercept treatment, including date A total maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, who has previously received PBS-subsidised treatment with etanercept for this condition, and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course | Compliance with Written or Telephone Authority Required procedures |
Ethacrynic Acid | C1261 | | | Patients hypersensitive to other oral diuretics | |
Etravirine | C3596 | | | Where the patient is receiving treatment at/from a private hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance. | Compliance with Written or Telephone Authority Required procedures |
| | | | Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity | |
| C3597 | | | Where the patient is receiving treatment at/from a public hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3597 |
Everolimus | C1650 | | | Where the patient is receiving treatment at/from a private hospital Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required | Compliance with Written or Telephone Authority Required procedures |
| C1651 | | | Where the patient is receiving treatment at/from a private hospital Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of cardiac allograft rejection, where management includes initiation, stabilisation and review of therapy as required | Compliance with Written or Telephone Authority Required procedures |
| C2133 | | | Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with everolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | Compliance with Authority Required procedures |
| C2134 | | | Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with everolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | Compliance with Authority Required procedures |
| C3355 | | | Where the patient is receiving treatment at/from a public hospital Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3355 |
| C3356 | | | Where the patient is receiving treatment at/from a public hospital Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of cardiac allograft rejection, where management includes initiation, stabilisation and review of therapy as required | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3356 |
Exemestane | C1541 | | | Treatment of hormone-dependent advanced breast cancer in post-menopausal women with disease progression following treatment with tamoxifen citrate | |
| C2457 | | | Treatment of hormone-dependent early breast cancer in post-menopausal women following a minimum of 2 years' treatment with tamoxifen citrate | |
Exenatide | C3540 | | | Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with either metformin or a sulfonylurea; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and
where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3540 |
| C3542 | | | Treatment of type 2 diabetes, in combination with metformin and a sulfonylurea, in a patient:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with maximally tolerated doses of metformin and a sulfonylurea; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with maximally tolerated doses of metformin and a sulfonylurea; and where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3542 |
Ezetimibe | C1989 | | | Patients eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs) where treatment with an HMG CoA reductase inhibitor (statin) is contraindicated | Compliance with Authority Required procedures - Streamlined Authority Code 1989 |
| C1991 | | | Homozygous sitosterolaemia | Compliance with Authority Required procedures - Streamlined Authority Code 1991 |
| C2438 | | | Patients with homozygous familial hypercholesterolaemia who are eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs), in combination with an HMG CoA reductase inhibitor (statin) | Compliance with Authority Required procedures - Streamlined Authority Code 2438 |
| C3724 | | | Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have coronary heart disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3724
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| C3725 | | | Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have diabetes mellitus.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3725 |
| C3726 | | | Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have peripheral vascular disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3726 |
| C3727 | | | Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have heterozygous familial hypercholesterolaemia.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3727 |
| C3728 | | | Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have symptomatic cerebrovascular disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3728 |
| C3729 | | | Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have family history of coronary heart disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3729 |
| C3730 | | | Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have hypertension.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3730 |
| C3731 | | | Patients eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs) where treatment with an HMG CoA reductase inhibitor (statin) must be discontinued or reduced because the patient developed a clinically important product-related adverse event during treatment with a statin.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin | Compliance with Authority Required procedures - Streamlined Authority Code 3731 |
Ezetimibe with Simvastatin | C2431 | | | Patients with homozygous familial hypercholesterolaemia who are eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs) | Compliance with Authority Required procedures - Streamlined Authority Code 2431 |
| C3732 | | | Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have coronary heart disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3732 |
| C3733 | | | Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have diabetes mellitus.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3733 |
| C3734 | | | Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have peripheral vascular disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3734 |
| C3735 | | | Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have heterozygous familial hypercholesterolaemia.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3735 |
| C3736 | | | Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have cerebrovascular disease which has become symptomatic.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3736 |
| C3737 | | | Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have family history of coronary heart disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3737 |
| C3738 | | | Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have hypertension.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3738 |
| C3739 | | | Patients eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs) where treatment with an HMG CoA reductase inhibitor (statin) must be reduced because the patient developed a clinically important product-related adverse event during treatment with a statin.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin | Compliance with Authority Required procedures - Streamlined Authority Code 3739 |
Famciclovir | C3622 | P3622 | | Treatment of patients with herpes zoster within 72 hours of the onset of the rash | Compliance with Authority Required procedures - Streamlined Authority Code 3622 |
| C3623 | P3623 | | Suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Compliance with Authority Required procedures - Streamlined Authority Code 3623 |
| C3624 | P3624 | | Episodic treatment of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Compliance with Authority Required procedures - Streamlined Authority Code 3624 |
| C3625 | P3625 | | Treatment of immunocompromised patients with herpes zoster within 72 hours of the onset of the rash | Compliance with Authority Required procedures - Streamlined Authority Code 3625 |
| C3626 | P3626 | | Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes in immunocompromised patients, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Compliance with Authority Required procedures - Streamlined Authority Code 3626 |
| C3627 | P3627 | | Episodic treatment of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and a CD4 cell count of less than 500 million per L, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Compliance with Authority Required procedures - Streamlined Authority Code 3627 |
| C3628 | P3628 | | Suppressive therapy of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and a CD4 cell count of less than 150 million per L, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Compliance with Authority Required procedures - Streamlined Authority Code 3628 |
| C3629 | P3629 | | Suppressive therapy of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and other opportunistic infections or Acquired Immunodeficiency Syndrome defining tumours, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Compliance with Authority Required procedures - Streamlined Authority Code 3629 |
Fenofibrate | C1540 | P1540 | | For use in patients that meet the criteria set out in the General Statement for Lipid-Lowering Drugs | |
| C3047 | P3047 | | For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Fentanyl | C1062 | | | Chronic severe disabling pain not responding to non-narcotic analgesics | |
| C3663 | P3663 | | Initial supply for dose titration for breakthrough pain in a palliative care patient with cancer who is receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Compliance with Authority Required procedures |
| C3664 | P3664 | | Continuing supply for breakthrough pain in a palliative care patient with cancer who is receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Compliance with Authority Required procedures |
Filgrastim | C2912 | | | Where the patient is receiving treatment at/from a private hospital For use in a patient undergoing induction and consolidation therapy for acute myeloid leukaemia | Compliance with Written or Telephone Authority Required procedures |
| C2913 | | | Where the patient is receiving treatment at/from a private hospital Mobilisation of peripheral blood progenitor cells to facilitate harvest of such cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy | Compliance with Written or Telephone Authority Required procedures |
| C2914 | | | Where the patient is receiving treatment at/from a private hospital Mobilisation of peripheral blood progenitor cells, in a normal volunteer, for use in allogeneic transplantation | Compliance with Written or Telephone Authority Required procedures |
| C2915 | | | Where the patient is receiving treatment at/from a private hospital A patient receiving marrow-ablative chemotherapy and subsequent bone marrow transplantation | Compliance with Written or Telephone Authority Required procedures |
| C2916 | | | Where the patient is receiving treatment at/from a private hospital A patient with a non-myeloid malignancy receiving marrow-ablative chemotherapy and subsequent autologous peripheral blood progenitor cell transplantation | Compliance with Written or Telephone Authority Required procedures |
| C2917 | | | Where the patient is receiving treatment at/from a private hospital A patient with breast cancer receiving standard dose adjuvant chemotherapy who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures |
| C2918 | | | Where the patient is receiving treatment at/from a private hospital A patient receiving first-line chemotherapy for Hodgkin disease who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures |
| C2919 | | | Where the patient is receiving treatment at/from a private hospital A patient receiving chemotherapy for myeloma who has had a prior episode of febrile neutropenia, and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures |
| C2920 | | | Where the patient is receiving treatment at/from a private hospital A patient with severe congenital neutropenia (absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart, and in whom a bone marrow examination has shown evidence of maturational arrest of the neutrophil lineage) | Compliance with Written or Telephone Authority Required procedures |
| C2921 | | | Where the patient is receiving treatment at/from a private hospital A patient with severe chronic neutropenia (absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart, or evidence of neutrophil dysfunction, and, either having experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months, or having recurrent clinically significant infections (a minimum of 3 in the previous 12 months)) | Compliance with Written or Telephone Authority Required procedures |
| C2922 | | | Where the patient is receiving treatment at/from a private hospital A patient with chronic cyclic neutropenia (absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles, and, either having experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics, or having recurrent clinically significant infections (a minimum of 3 in the previous 12 months)) | Compliance with Written or Telephone Authority Required procedures |
| C2923 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia | Compliance with Written or Telephone Authority Required procedures |
| C2924 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in breast cancer (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) | Compliance with Written or Telephone Authority Required procedures |
| C2925 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours | Compliance with Written or Telephone Authority Required procedures |
| C2926 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in infants and children with CNS tumours | Compliance with Written or Telephone Authority Required procedures |
| C2927 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma | Compliance with Written or Telephone Authority Required procedures |
| C2928 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen) | Compliance with Written or Telephone Authority Required procedures |
| C2929 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease | Compliance with Written or Telephone Authority Required procedures |
| C2930 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma | Compliance with Written or Telephone Authority Required procedures |
| C3087 | | | Where the patient is receiving treatment at/from a private hospital A patient receiving chemotherapy for B-cell chronic lymphocytic leukaemia with fludarabine and cyclophosphamide who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures |
| C3187 | | | Where the patient is receiving treatment at/from a private hospital A patient with inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures |
| C3357 | | | Where the patient is receiving treatment at/from a public hospital For use in a patient undergoing induction and consolidation therapy for acute myeloid leukaemia | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3357 |
| C3358 | | | Where the patient is receiving treatment at/from a public hospital Mobilisation of peripheral blood progenitor cells to facilitate harvest of such cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3358 |
| C3359 | | | Where the patient is receiving treatment at/from a public hospital Mobilisation of peripheral blood progenitor cells, in a normal volunteer, for use in allogeneic transplantation | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3359 |
| C3360 | | | Where the patient is receiving treatment at/from a public hospital A patient receiving marrow-ablative chemotherapy and subsequent bone marrow transplantation | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3360 |
| C3361 | | | Where the patient is receiving treatment at/from a public hospital A patient with a non-myeloid malignancy receiving marrow-ablative chemotherapy and subsequent autologous peripheral blood progenitor cell transplantation | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3361 |
| C3362 | | | Where the patient is receiving treatment at/from a public hospital A patient with breast cancer receiving standard dose adjuvant chemotherapy who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3362 |
| C3363 | | | Where the patient is receiving treatment at/from a public hospital A patient receiving chemotherapy for B-cell chronic lymphocytic leukaemia with fludarabine and cyclophosphamide who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3363 |
| C3364 | | | Where the patient is receiving treatment at/from a public hospital A patient receiving first-line chemotherapy for Hodgkin disease who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3364 |
| C3365 | | | Where the patient is receiving treatment at/from a public hospital A patient receiving chemotherapy for myeloma who has had a prior episode of febrile neutropenia, and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3365 |
| C3366 | | | Where the patient is receiving treatment at/from a public hospital A patient with severe congenital neutropenia (absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart, and in whom a bone marrow examination has shown evidence of maturational arrest of the neutrophil lineage) | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3366 |
| C3367 | | | Where the patient is receiving treatment at/from a public hospital A patient with severe chronic neutropenia (absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart, or evidence of neutrophil dysfunction, and, either having experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months, or having recurrent clinically significant infections (a minimum of 3 in the previous 12 months)) | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3367 |
| C3368 | | | Where the patient is receiving treatment at/from a public hospital A patient with chronic cyclic neutropenia (absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles, and, either having experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics, or having recurrent clinically significant infections (a minimum of 3 in the previous 12 months)) | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3368 |
| C3369 | | | Where the patient is receiving treatment at/from a public hospital A patient with inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3369 |
| C3370 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3370 |
| C3371 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in breast cancer (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3371 |
| C3372 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3372 |
| C3373 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in infants and children with CNS tumours | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3373 |
| C3374 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3374 |
| C3375 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen) | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3375 |
| C3376 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3376 |
| C3377 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3377 |
| C3833 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Hodgkin disease (first-line chemotherapy with escalated BEACOPP) | Compliance with Written or Telephone Authority Required procedures |
| C3834 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Hodgkin disease (first-line chemotherapy with escalated BEACOPP) | Compliance with
Written or Telephone
Authority Required procedures – Streamlined Authority
Code 3834 |
Fingolimod | C3845 | | | Initial treatment, as monotherapy, of clinically definite relapsing-remitting multiple sclerosis in an ambulatory (without assistance or support) patient who has experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years. The diagnosis must be confirmed by magnetic resonance imaging (MRI) of the brain and/or spinal cord and the date of the scan included in the authority application, unless the authority application is accompanied by written certification provided by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient. The authority will be limited to the maximum quantity and number of repeats indicated in Schedule 1 | Compliance with Authority Required procedures |
| C3846 | | | Continuing treatment, as monotherapy, of clinically definite relapsing-remitting multiple sclerosis in a patient previously issued with an authority prescription for this drug who does not show continuing progression of disability while on treatment with this drug and who has demonstrated compliance with, and an ability to tolerate, this therapy. Authorities will be limited to the maximum quantity and number of repeats indicated in Schedule 1 | Compliance with Authority Required procedures |
Flecainide | C1731 | | | Serious supra-ventricular cardiac arrhythmias | |
| C1732 | | | Serious ventricular cardiac arrhythmias where treatment is initiated in a hospital (in-patient or out-patient) | |
Flucloxacillin | C1345 | | | Serious staphylococcal infections | |
Fluconazole | C3613 | | | Treatment of oropharyngeal candidiasis in immunosuppressed patients | Compliance with Authority Required procedures - Streamlined Authority Code 3613 |
| C3614 | | | Treatment of oesophageal candidiasis in immunosuppressed patients | Compliance with Authority Required procedures - Streamlined Authority Code 3614 |
| C3615 | | | Treatment of cryptococcal meningitis | Compliance with Authority Required procedures - Streamlined Authority Code 3615 |
| C3616 | | | Maintenance therapy in patients with cryptococcal meningitis and immunosuppression | Compliance with Authority Required procedures - Streamlined Authority Code 3616 |
| C3617 | | | Prophylaxis of oropharyngeal candidiasis in immunosuppressed patients | Compliance with Authority Required procedures - Streamlined Authority Code 3617 |
| C3618 | | | Treatment of serious and life-threatening candida infections | Compliance with Authority Required procedures - Streamlined Authority Code 3618 |
| C3835 | | | Treatment of cryptococcal meningitis in a patient unable to take a solid dose form of fluconazole | Compliance with Authority Required procedures |
| C3836 | | | Maintenance therapy in a patient with cryptococcal meningitis and immunosuppression unable to take a solid dose form of fluconazole | Compliance with Authority Required procedures |
| C3837 | | | Treatment of oropharyngeal candidiasis in an immunosuppressed patient unable to take a solid dose form of fluconazole | Compliance with Authority Required procedures |
| C3838 | | | Treatment of oesophageal candidiasis in an immunosuppressed patient unable to take a solid dose form of fluconazole | Compliance with Authority Required procedures |
| C3839 | | | Prophylaxis of oropharyngeal candidiasis in an immunosuppressed patient unable to take a solid dose form of fluconazole | Compliance with Authority Required procedures |
| C3840 | | | Treatment of serious and life-threatening candida infections in a patient unable to take a solid dose form of fluconazole | Compliance with Authority Required procedures |
Fludarabine | C3015 | | | B-cell chronic lymphocytic leukaemia in combination with cyclophosphamide where the patient has advanced disease (Binet Stage B or C) or evidence of progressive Stage A disease, and where:
(1) Stage A progressive disease is defined by at least 1 of the following:
— persistent rise in lymphocyte count with doubling time less than 12 months;
— a downward trend in haemoglobin or platelets, or both;
— more than 50% increase in the size of liver, spleen, or lymph nodes, or appearance of these signs if not previously present;
— constitutional symptoms attributable to disease; and
(2) the diagnosis of chronic lymphocytic leukaemia has been established based on:
(a) a lymphocytosis, with more than 5,000 million lymphocytes per L in the peripheral blood; and
(b) a clonal population of B-cells (CD5/CD19) documented by flow cytometry | Compliance with Authority Required procedures |
| C3887 | | | B-cell chronic lymphocytic leukaemia in combination with cyclophosphamide where the patient has advanced disease (Binet Stage B or C) or evidence of progressive Stage A disease, and where:
(1) Stage A progressive disease is defined by at least 1 of the following:
— persistent rise in lymphocyte count with doubling time less than 12 months;
— a downward trend in haemoglobin or platelets, or both;
— more than 50% increase in the size of liver, spleen, or lymph nodes, or appearance of these signs if not previously present;
— constitutional symptoms attributable to disease; and
(2) the diagnosis of chronic lymphocytic leukaemia has been established based on:
(a) a lymphocytosis, with more than 5,000 million lymphocytes per L in the peripheral blood; and
(b) a clonal population of B-cells (CD5/CD19) documented by flow cytometry | Compliance with Authority Required procedures - Streamlined Authority Code 3887 |
Fluoxetine | C1211 | | | Major depressive disorders | |
| C1241 | | | Obsessive-compulsive disorder | |
Flutamide | C3674 | | | Metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) analogue therapy | Compliance with Authority Required procedures - Streamlined Authority Code 3674 |
Fluticasone with Salmeterol | C1758 | | | Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids and who have been stabilised on concomitant inhaled salmeterol xinafoate and fluticasone propionate; | |
| C1759 | | | Patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled salmeterol xinafoate and fluticasone propionate. | |
| C2680 | | | Symptomatic treatment of chronic obstructive pulmonary disease (COPD), where the forced expiratory volume in 1 second (FEV1) is less than 50% predicted normal and there is a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy | |
Fluvastatin | C1540 | P1540 | | For use in patients that meet the criteria set out in the General Statement for Lipid-Lowering Drugs | |
| C3047 | P3047 | | For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Fluvoxamine | C1211 | | | Major depressive disorders | |
| C1241 | | | Obsessive-compulsive disorder | |
Folinic acid | C1028 | | | Antidote to folic acid antagonists | |
Follitropin Alfa | C1119 | | | In combination with chorionic gonadotrophin, for the treatment of infertility in males due to hypogonadotrophic hypogonadism, following failure of 6 months' treatment with chorionic gonadotrophin to achieve adequate spermatogenesis | |
| C1878 | | | Anovulatory infertility | |
Follitropin Beta | C1119 | | | In combination with chorionic gonadotrophin, for the treatment of infertility in males due to hypogonadotrophic hypogonadism, following failure of 6 months' treatment with chorionic gonadotrophin to achieve adequate spermatogenesis | |
| C1878 | | | Anovulatory infertility | |
Fondaparinux | C2005 | | | Prevention of venous thromboembolic events in patients undergoing major hip surgery | Compliance with Authority Required procedures - Streamlined Authority Code 2005 |
| C2006 | | | Prevention of venous thromboembolic events in patients undergoing total knee replacement | Compliance with Authority Required procedures - Streamlined Authority Code 2006 |
Fosamprenavir | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Wriitten or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Foscarnet | C1413 | | | Where the patient is receiving treatment at/from a private hospital Treatment of aciclovir-resistant herpes simplex virus infection in immunocompromised patients with human immunodeficiency virus infection | Compliance with Written or Telephone Authority Required procedures |
| C1610 | | | Where the patient is receiving treatment at/from a private hospital Treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome | Compliance with Written or Telephone Authority Required procedures |
| C3322 | | | Where the patient is receiving treatment at/from a public hospital Treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3322 |
| C3378 | | | Where the patient is receiving treatment at/from a public hospital Treatment of aciclovir-resistant herpes simplex virus infection in immunocompromised patients with human immunodeficiency virus infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3378 |
Fosinopril with Hydrochlorothiazide | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Fotemustine | C3181 | | | Metastatic malignant melanoma | Compliance with Authority Required procedures - Streamlined Authority Code 3181 |
Fusidic Acid | C1130 | | | For use in combination with another antibiotic in the treatment of proven serious staphylococcal infections | |
Gabapentin | C2664 | | | Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs | Compliance with Authority Required procedures - Streamlined Authority Code 2664 |
Galantamine | C2934 | | | Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more who demonstrate improvement in cognitive function following initial PBS-subsidised therapy, and where:
(1) improvement in cognitive function is demonstrated by:
(a) in the case of patients with a baseline MMSE or SMMSE score of 10 or more and less than 25 — an increase of at least 2 points from baseline on the MMSE or SMMSE; or
(b) in the case of patients with a baseline MMSE or SMMSE score of at least 25 points — an increase of at least 2 points from baseline on the MMSE or SMMSE, or, if a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) was submitted with the application for initial treatment, a decrease of at least 4 points from baseline on the ADAS-Cog; and
(2) the relevant result from the MMSE, SMMSE or ADAS-Cog is included in the authority application for continuing treatment | Compliance with Written Authority Required procedures |
| | | | Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more and with demonstrated improvement in cognitive function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment | Compliance with Written Authority Required procedures |
| C2938 | | | Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease and who demonstrate improvement in function following initial PBS-subsidised therapy, based on a rating of "very much improved" or "much improved" on the Clinicians Interview Based Impression of Change scale, as assessed by the same clinician who initiated treatment, and where the improvement rating achieved on the Clinicians Interview Based Impression of Change scale is stated in the authority application for continuing treatment | Compliance with Written Authority Required procedures |
| | | | Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less and with demonstrated improvement in function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment | Compliance with Written Authority Required procedures |
| C3875 | | | Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application | Compliance with Authority Required procedures |
| | | | Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the baseline scores submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total | Compliance with Written Authority Required procedures |
| | | | Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application | Compliance with Written Authority Required procedures |
| C3876 | | | Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment | Compliance with Authority Required procedures |
| | | | Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the information submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total | Compliance with Written Authority Required procedures |
| | | | Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment | Compliance with Written Authority Required procedures |
Ganciclovir | C1612 | | | Where the patient is receiving treatment at/from a private hospital Cytomegalovirus retinitis in severely immunocompromised patients | Compliance with Written or Telephone Authority Required procedures |
| C1830 | | | Where the patient is receiving treatment at/from a private hospital Prophylaxis of cytomegalovirus disease in bone marrow transplant patients at risk of cytomegalovirus disease | Compliance with Written or Telephone Authority Required procedures |
| C1831 | | | Where the patient is receiving treatment at/from a private hospital Prophylaxis of cytomegalovirus disease in solid organ transplant patients at risk of cytomegalovirus disease | Compliance with Written or Telephone Authority Required procedures |
| C3379 | | | Where the patient is receiving treatment at/from a public hospital Cytomegalovirus retinitis in severely immunocompromised patients | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3379 |
| C3380 | | | Where the patient is receiving treatment at/from a public hospital Prophylaxis of cytomegalovirus disease in bone marrow transplant patients at risk of cytomegalovirus disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3380 |
| C3381 | | | Where the patient is receiving treatment at/from a public hospital Prophylaxis of cytomegalovirus disease in solid organ transplant patients at risk of cytomegalovirus disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3381 |
Gefitinib | C4029 | | | Initial PBS-subsidised treatment, as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a WHO performance status of 2 or less, where:
(1) disease progression has occurred following treatment with at least 1 chemotherapy agent; and
(2) there is evidence that the patient has an activating mutation(s) of the epidermal growth factor receptor (EGFR) gene in tumour material | Compliance with Authority Required procedures |
| C4030 | | | Continuing PBS-subsidised treatment, as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a WHO performance status of 2 or less, where the patient has previously been issued with an authority prescription for gefitinib | Compliance with Authority Required procedures |
Gemfibrozil | C1540 | P1540 | | For use in patients that meet the criteria set out in the General Statement for Lipid-Lowering Drugs | |
| C3047 | P3047 | | For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Gentamicin | C1188 | | | Invasive ocular infection | |
| C1391 | | | Suspected pseudomonal eye infection | |
| C1714 | | | Perioperative use in ophthalmic surgery | |
Gestrinone | C3652 | | | Short term treatment (up to 6 months) of visually proven endometriosis (only 1 course of not more than 6 months’ therapy may be prescribed) | Compliance with Authority Required procedures - Streamlined Authority Code 3652 |
Glatiramer | C1175 | | | Initial treatment of clinically definite relapsing-remitting multiple sclerosis in ambulatory (without assistance or support) patients who have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain or spinal cord and the date of the scan is included in the authority application, or where the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient | Compliance with Authority Required procedures |
| C1751 | | | Continuing treatment of clinically definite relapsing-remitting multiple sclerosis in patients previously issued with an authority prescription for this drug who do not show continuing progression of disability while on treatment with this drug and who have demonstrated compliance with, and an ability to tolerate, this therapy | Compliance with Authority Required procedures |
Glucose and Ketone Indicator—Urine | | P3035 | | For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Glucose Indicator—Blood | | P3035 | | For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
| C3552 | P3552 | | For use in patients on insulin therapy | |
| C3553 | P3553 | | For use in patients on insulin therapy who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Glucose Indicator—Urine | | P3035 | | For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Glycerol | C1025 | P1025 | | Anorectal congenital abnormalities | |
| C1122 | P1122 | | For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult | |
| C1221 | P1221 | | Megacolon | |
| C1254 | P1254 | | Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function | |
| C1263 | P1263 | | Patients receiving palliative care | |
| C1268 | P1268 | | Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities | |
| C1400 | P1400 | | Terminal malignant neoplasia | |
| C3642 | P3642 | | Initial supply, for up to 4 months, for a palliative care patient where constipation is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3642 |
| C3643 | P3643 | | Continuing supply for a palliative care patient where constipation is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3643 |
Golimumab | C3495 | P3495 | | Psoriatic arthritis — initial treatment 1
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have severe active psoriatic arthritis; and
(2) have received no prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
(3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) an active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgment;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment with golimumab in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3497 | P3497 | | Psoriatic arthritis — initial treatment 3
Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of golimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have a documented history of severe active psoriatic arthritis; and
(2) were receiving treatment with golimumab prior to 1 March 2010; and
(3) have demonstrated a response to golimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with golimumab; and
(4) are receiving treatment with golimumab at the time of application; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgment;
the course of treatment is limited to a maximum of 24 weeks of treatment;
patients are eligible for PBS-subsidised treatment under the above criteria once only | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial PBS-subsidised treatment with golimumab commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3516 | P3516 | | Ankylosing spondylitis — initial treatment 1
Initial treatment with golimumab commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
(a) who has not received any PBS-subsidised treatment with a tumour necrosis factor (TNF)-alfa antagonist, or, where the patient has previously received PBS-subsidised TNF-alfa antagonist treatment for this condition, has received no such treatment for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and
(b) who has at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
(iii) limitation of chest expansion relative to normal values for age and gender; and
(c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised TNF-alfa antagonist therapy of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated by:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;
both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;
if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;
if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form; and
(iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment with golimumab in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3518 | P3518 | | Ankylosing spondylitis — initial treatment 3
Commencement of a treatment cycle with an initial PBS-subsidised course of golimumab for continuing treatment, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who was receiving treatment with golimumab prior to 1 March 2010; and
(a) who has demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with golimumab; and
(b) who is receiving treatment with golimumab at the time of application; and
where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form;
the BASDAI assessment and the ESR and/or CRP measurements provided are no more than 1 month old at the time of application;
the course of treatment is limited to a maximum of 24 weeks of treatment;
patients are eligible for PBS-subsidised treatment under the above criteria once only | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial PBS-subsidised treatment with golimumab commencing a treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who was receiving non-PBS-subsidised treatment with golimumab prior to 1 March 2010 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3718 | P3718 | | Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS-subsidised treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with golimumab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3782 | P3782 | | Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with golimumab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with golimumab are not eligible to commence treatment with golimumab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with golimumab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised golimumab treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised golimumab treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3783 | P3783 | | Rheumatoid arthritis — continuing treatment
Continuing PBS-subsidised treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with golimumab; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with golimumab; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with golimumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of golimumab therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of continuing treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3784 | P3784 | | Psoriatic arthritis — initial treatment 2
Initial treatment, or recommencement of treatment, with golimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have a documented history of severe active psoriatic arthritis; and
(2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and are eligible to receive further therapy with a biological agent; and
(3) have not failed treatment with golimumab during the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with golimumab within this Treatment Cycle and wishes to recommence therapy with this drug within this same cycle, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised golimumab treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised golimumab treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment, or of a course which recommences treatment, with golimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3785 | P3785 | | Psoriatic arthritis — continuing treatment
Continuing treatment with golimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
(1) who have a documented history of severe active psoriatic arthritis; and
(2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with golimumab; and
(3) who, at the time of application, demonstrate an adequate response to treatment with golimumab; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to treatment with golimumab is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with golimumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of golimumab therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of continuing treatment with golimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3786 | P3786 | | Ankylosing spondylitis — initial treatment 2
Initial treatment, or recommencement of treatment, with golimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised tumour necrosis factor (TNF)-alfa antagonist treatment for this condition and is eligible to receive further TNF-alfa antagonist therapy, and has not failed PBS-subsidised therapy with golimumab in the current treatment cycle; and
where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
a patient is eligible to receive further therapy with a TNF-alfa antagonist within this treatment cycle provided they have not already failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists within this treatment cycle;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form;
an assessment of response to the patient's most recent course of PBS-subsidised TNF-alfa antagonist treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased;
where the most recent course of TNF-antagonist treatment is an initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
if the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of initial treatment, or of a course which recommences treatment, with golimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3787 | P3787 | | Ankylosing spondylitis — continuing treatment
Continuing treatment with golimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated an adequate response to treatment with golimumab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with golimumab; and
where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
(a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
(b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline;
all measurements provided are no more than 1 month old at the time of application;
where only 1 acute phase reactant measurement is supplied to establish baseline in the first application for PBS-subsidised treatment, that same marker is measured and supplied in all subsequent continuing treatment applications;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with golimumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of golimumab therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of a course of continuing treatment with golimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
Goserelin | C1377 | | | Treatment of visually proven endometriosis where the duration of treatment provided for by this prescription, in combination with any previous prescriptions, does not exceed 6 months' uninterrupted therapy | Compliance with Authority Required procedures |
| C1871 | | | Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate | Compliance with Authority Required procedures |
| C1872 | | | Hormone-dependent locally advanced (equivalent to stage III) or metastatic (equivalent to stage IV) breast cancer in pre-menopausal women | Compliance with Authority Required procedures |
| C3228 | | | Hormone-dependent breast cancer as an alternative to adjuvant chemotherapy in peri- or pre-menopausal women. | Compliance with Authority Required procedures |
| C3229 | | | Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate | Compliance with Authority Required procedures - Streamlined Authority Code 3229 |
Goserelin and Bicalutamide | C3239 | | | Metastatic (equivalent to stage D) prostatic carcinoma in patients for whom a combination of an antiandrogen and a gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist is required | Compliance with Authority Required procedures - Streamlined Authority Code 3239 |
Granisetron | C3050 | P3050 | | Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration | |
| C3611 | P3611 | | Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Compliance with Authority Required procedures - Streamlined Authority Code 3611 |
High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate | C1578 | | | Patients with intractable seizures requiring treatment with a ketogenic diet | |
| C1579 | | | Glucose transport protein defects | |
| C1580 | | | Pyruvate dehydrogenase deficiency | |
Hydrocortisone | C1294 | | | Proctitis | |
| C1422 | | | Treatment of corticosteroid-responsive dermatoses | |
| C1454 | | | Ulcerative colitis | |
| C1128 | P1128 | | For use in a hospital | |
Hydromorphone | C1062 | | | Chronic severe disabling pain not responding to non-narcotic analgesics | |
| C1358 | | | Severe disabling pain not responding to non-narcotic analgesics | |
Hydroxocobalamin | C1250 | | | Other proven vitamin B 12 deficiencies | |
| C1281 | | | Pernicious anaemia | |
| C1298 | | | Prophylaxis after gastrectomy | |
Hyoscine | C3638 | P3638 | | Initial supply, for up to 4 months, for a palliative care patient where colicky pain is a symptom | Compliance with Authority Required procedures - Streamlined Authority Code 3638 |
| C3639 | P3639 | | Continuing supply for a palliative care patient where colicky pain is a symptom | Compliance with Authority Required procedures - Streamlined Authority Code 3639 |
Hypromellose | C1362 | P1362 | | Severe dry eye syndrome, including Sjogren's syndrome | |
| C3036 | P3036 | | For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
| C3636 | P3636 | | Initial supply, for up to 4 months, for a palliative care patient where dry mouth is a symptom | Compliance with Authority Required procedures - Streamlined Authority Code 3636 |
| C3637 | P3637 | | Continuing supply for a palliative care patient where dry mouth is a symptom | Compliance with Authority Required procedures - Streamlined Authority Code 3637 |
Hypromellose With Carbomer 980 | C1362 | P1362 | | Severe dry eye syndrome, including Sjogren's syndrome | |
| C3036 | P3036 | | For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Hypromellose with Dextran | C1359 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures - Streamlined Authority Code 1359 |
| C1362 | | | Severe dry eye syndrome, including Sjogren's syndrome | |
| C2802 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures |
| C3036 | | | For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Ibandronic acid | C1035 | | | Where the patient is receiving treatment at/from a private hospital Bone metastases from breast cancer | Compliance with Written or Telephone Authority Required procedures |
| C3343 | | | Where the patient is receiving treatment at/from a public hospital Bone metastases from breast cancer | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3343 |
Ibuprofen | | P1036 | | Bone pain due to malignant disease | |
| | P1054 | | Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
| | P3665 | | Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem | Compliance with Authority Required procedures |
| | P3666 | | Continuing supply for a palliative care patient where severe pain is a problem | Compliance with Authority Required procedures |
Icatibant | C4055 | | | Initial supply for anticipated emergency treatment of an acute attack of hereditary angioedema in a patient with confirmed diagnosis of C1-esterase inhibitor deficiency who has been assessed to be at significant risk of an acute attack of hereditary angioedema by or in consultation with a clinical immunologist, respiratory physician, specialist allergist or general physician experienced in the management of patients with hereditary angioedema The name of the specialist consulted must be provided at the time of application for initial supply The name of the Approved Pathology Authority and date of the diagnosing pathology test must be included in the authority application | Compliance with Authority Required procedures |
| C4056 | | | Continuing supply for anticipated emergency treatment of an acute attack of hereditary angioedema, where the patient has previously been issued with an authority prescription for this drug | Compliance with Authority Required procedures |
Idarubicin | C1006 | | | Acute myelogenous leukaemia | |
Ifosfamide | C1325 | | | Relapsed or refractory germ cell tumours following first-line chemotherapy | |
| C1327 | | | Relapsed or refractory sarcomas following first-line chemotherapy | |
Imatinib | C1816 | P1816 | | Chronic myeloid leukaemia (accelerated phase)
Treatment of patients in the accelerated phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and
where progress to the accelerated phase is defined by the presence of 1 or more of the following:
(1) percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
(2) percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or
(3) peripheral basophils greater than or equal to 20%; or
(4) progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
(5) karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and
where the application for authorisation includes:
(a) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and
(b) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criteria (1), (2), (3) and (5) above, or details of the dates of assessments in the case of progressive splenomegaly | Compliance with Written Authority Required procedures |
| C1817 | P1817 | | Chronic myeloid leukaemia (blast phase)
Treatment of patients in the blast phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and
where progress to myeloid blast crisis is defined as either:
(1) percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or
(2) extramedullary involvement other than spleen and liver; and
where the application for authorisation includes:
(a) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and
(b) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criterion (1) above, or details of the date of assessment in the case of extramedullary involvement | Compliance with Written Authority Required procedures |
| C1818 | P1818 | | Chronic myeloid leukaemia (accelerated phase)
Continuing treatment of patients with chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, where the patient has previously received PBS-subsidised treatment with imatinib mesylate of the accelerated phase of chronic myeloid leukaemia | Compliance with Written or Telephone Authority Required procedures |
| C1819 | P1819 | | Chronic myeloid leukaemia (blast phase)
Continuing treatment of patients with chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, where the patient has previously received PBS-subsidised treatment with imatinib mesylate of the blast phase of chronic myeloid leukaemia | Compliance with Written or Telephone Authority Required procedures |
| C2766 | P2766 | | Acute lymphoblastic leukaemia
Initial treatment in combination with chemotherapy as induction or consolidation of a newly diagnosed patient with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR-ABL; and
where the authority application includes:
(a) a completed copy of the appropriate Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application - Supporting Information Form; and
(b) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow, along with the date of the relevant report; and
(c) a signed patient acknowledgement | Compliance with Written Authority Required procedures |
| C2767 | P2767 | | Acute lymphoblastic leukaemia
Initial treatment of a patient with acute lymphoblastic leukaemia bearing the Philadelphia chromosome or expressing the transcript BCR-ABL who was previously treated with imatinib mesylate under the Imatinib Compassionate Program and who meets all the PBS criteria; and
where the authority application includes:
(a) a completed copy of the appropriate Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application - Supporting Information Form; and
(b) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow, along with the date of the relevant report; and
(c) a signed patient acknowledgement | Compliance with Written Authority Required procedures |
| C2978 | P2978 | | Dermatofibrosarcoma protuberans
Initial PBS-subsidised treatment (at a dose that does not exceed 800 mg per day) of a patient with unresectable, locally recurrent or metastatic dermatofibrosarcoma protuberans, and where:
(1) the application for authorisation includes:
(a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(b) a signed patient acknowledgement; and
(2) if the application for authority to prescribe is being sought on the basis of unresectable tumour, written evidence in support of that claim is provided; and
(3) if the application for authority to prescribe is being sought on the basis of locally recurrent disease, the site of the local recurrence is specified; and
(4) if the application for authority to prescribe is being sought on the basis of metastatic disease, the site(s) of metastatic disease are provided | Compliance with Written Authority Required procedures |
| C2979 | P2979 | | Dermatofibrosarcoma protuberans
Continuing PBS-subsidised treatment (at a dose that does not exceed 800 mg per day) of a patient with unresectable, locally recurrent or metastatic dermatofibrosarcoma protuberans who has previously been issued with an authority prescription for imatinib and who has demonstrated a response, but whose disease remains unresectable, and where the application for authorisation includes:
(a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(b) a statement that the disease has not progressed on imatinib therapy | Compliance with Written Authority Required procedures |
| C2980 | P2980 | | Hypereosinophilic syndrome or chronic eosinophilic leukaemia
Initial PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with hypereosinophilic syndrome or chronic eosinophilic leukaemia requiring treatment and confirmed to carry the FIP1L1-PDGFRA fusion gene, and where the application for authorisation includes:
(a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(b) a copy of the pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene; and
(c) a copy of the full blood examination report confirming the presence of hypereosinophilic syndrome or chronic eosinophilic leukaemia; and
(d) details of organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate; and
(e) a signed patient acknowledgement | Compliance with Written Authority Required procedures |
| C2981 | P2981 | | Hypereosinophilic syndrome or chronic eosinophilic leukaemia
Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with hypereosinophilic syndrome or chronic eosinophilic leukaemia who has previously been issued with an authority prescription for imatinib and who has achieved and maintained a complete haematological response, and where the application for authorisation includes:
(a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(b) a copy of the full blood examination report which demonstrates a complete haematological response, with a normal eosinophil count; and
(c) a statement that the disease has not progressed on imatinib therapy | Compliance with Written Authority Required procedures |
| C2982 | P2982 | | Myelodysplastic or myeloproliferative disorder
Initial PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with a myelodysplastic or myeloproliferative disorder where:
(1) there is confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement either by standard karyotyping, or FISH, or PDGFRB fusion gene transcript; and
(2) the patient has previously failed an adequate trial of 1 or more of the following conventional therapies:
— cytarabine;
— etoposide;
— hydroxyurea; and
(3) the application for authorisation includes:
(a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(b) a copy of the pathology report confirming the platelet-derived growth factor receptor (PDGFR) gene re-arrangement; and
(c) a copy of the bone marrow biopsy report which demonstrates the presence of a myelodysplastic or myeloproliferative disorder; and
(d) details of the prior therapy trialled and the response; and
(e) a signed patient acknowledgement | Compliance with Written Authority Required procedures |
| C2984 | P2984 | | Systemic mastocytosis with eosinophilia
Initial PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with aggressive systemic mastocytosis with eosinophilia where:
(1) there is confirmed evidence of the FIP1L1-PDGFRA fusion gene; and
(2) the patient has previously failed an adequate trial of 1 or more of the following conventional therapies:
— corticosteroids;
— hydroxyurea; and
(3) the application for authorisation includes:
(a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(b) a copy of the pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene; and
(c) a copy of the bone marrow biopsy report and/or other tissue biopsy report confirming the diagnosis of aggressive systemic mastocytosis and a copy of the full blood examination report demonstrating eosinophilia; and
(d) details of symptomatic organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate; and
(e) details of prior treatment trialled and the response; and
(f) a signed patient acknowledgement | Compliance with Written Authority Required procedures |
| C3033 | P3033 | | Myelodysplastic or myeloproliferative disorder
Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with a PDGFRB fusion gene-positive myelodysplastic or myeloproliferative disorder who has previously been issued with an authority prescription for imatinib and who has demonstrated a complete haematological response, and where the application for authorisation includes:
(a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(b) a copy of the full blood examination report which demonstrates a complete haematological response; and
(c) a statement that the disease has not progressed on imatinib therapy | Compliance with Written Authority Required procedures |
| C3034 | P3034 | | Systemic mastocytosis with eosinophilia
Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with aggressive systemic mastocytosis confirmed to carry the FIP1L1-PDGFRA fusion gene, who has previously been issued with an authority prescription for imatinib and who has demonstrated a complete haematological response, and where the application for authorisation includes:
(a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(b) a copy of the full blood examination report which demonstrates a complete haematological response; and
(c) a statement that the disease has not progressed on imatinib therapy | Compliance with Written Authority Required procedures |
| C3144 | P3144 | | Acute lymphoblastic leukaemia
Continuing treatment in combination with chemotherapy as maintenance of first complete remission of patients with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR-ABL;
imatinib mesylate is available with a lifetime maximum of 24 months for continuing treatment with imatinib mesylate therapy for patients with acute lymphoblastic leukaemia reimbursed through the PBS | Compliance with Written or Telephone Authority Required procedures |
| C3847 | P3847 | | Resectable gastrointestinal stromal tumour
Adjuvant treatment of a patient at high risk of recurrence following complete resection of primary gastrointestinal stromal tumour (GIST) which has been histologically confirmed by the detection of CD117 on immunohistochemical staining, at a dose not exceeding 400 mg per day for a period of 12 months.
High risk of recurrence is defined as:
Primary GIST greater than 5 cm with a mitotic count of greater than 5/50 high power fields (HPF); or
Primary GIST greater than 10 cm with any mitotic rate; or
Primary GIST with a mitotic count of greater than 10/50 HPF.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in Adjuvant Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and
(ii) a copy of the pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented, which must not be more than 3 months prior to the date of this application | Compliance with Written Authority Required procedures |
| C3848 | P3848 | | Resectable gastrointestinal stromal tumour
Initial treatment of a patient who was receiving adjuvant imatinib mesylate for gastrointestinal stromal tumour (GIST) prior to 1 September 2011 and who meets the PBS eligibility criteria for adjuvant treatment with imatinib mesylate of a patient at high risk of recurrence following complete resection of primary GIST. The patient is eligible to receive sufficient imatinib at a dose of 400 mg per day to complete 12 months of combined PBS-subsidised and non-PBS-subsidised therapy.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in Adjuvant Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and
(ii) a copy of the pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented | Compliance with Written Authority Required procedures |
| C3849 | P3849 | | Metastatic or unresectable gastrointestinal stromal tumour
Initial PBS-subsidised treatment, for up to 3 months, of a patient with a metastatic or unresectable malignant gastrointestinal stromal tumour which has been histologically confirmed by the detection of CD117 on immunohistochemical staining, where treatment is commenced at a dose that does not exceed 400 mg per day for at least 3 months, and where the application for authorisation is made in writing and includes a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Metastatic or Unresectable Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and
(ii) a copy of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour or tumours, including whether or not there is evidence of metastatic disease; and
(iii) where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence in support of that claim | Compliance with Written Authority Required procedures |
| C3850 | P3850 | | Metastatic or unresectable gastrointestinal stromal tumour
Continuing PBS-subsidised treatment, at a dose of up to 600 mg per day, of a patient with a metastatic or unresectable malignant gastrointestinal stromal tumour who has previously been issued with an authority prescription for this drug, and where the patient has not failed to respond, or is not intolerant, to imatinib | Compliance with Written or Telephone Authority Required procedures |
| C4007 | P4007 | | Chronic myeloid leukaemia (chronic phase)
Initial treatment, as the sole PBS-subsidised therapy, of a patient in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, BCR-ABL tyrosine kinase, and who has a primary diagnosis of chronic myeloid leukaemia
Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved
Patients should be commenced on a dose of imatinib mesylate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesylate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and
(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and
(4) a signed patient acknowledgement form | Compliance with Written Authority Required procedures |
| C4008 | P4008 | | Chronic myeloid leukaemia (chronic phase)
Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial PBS-subsidised treatment with imatinib mesylate for the chronic phase of chronic myeloid leukaemia and who has demonstrated either a major cytogenetic response or less than 1% BCR-ABL level in the blood
First continuing applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) demonstration of a response to treatment as evidenced by either:
(a) major cytogenetic response; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale
Definitions of response
A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells
A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response | Compliance with Written Authority Required procedures |
| | | | Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has previously been issued with an authority prescription for continuing treatment with imatinib mesylate for the chronic phase of chronic myeloid leukaemia. Patients must maintain a major cytogenetic response or have a peripheral blood BCR-ABL of less than 1% to receive continuing therapy | Compliance with Written or Telephone Authority Required procedures |
Imiquimod | C2816 | | | Treatment of biopsy confirmed primary (previously untreated) superficial basal cell carcinoma (sBCC) in patients with normal immune function for whom surgical excision, cryotherapy, or curettage with diathermy are inappropriate and topical drug therapy is required, and where the date of the pathology report and name of the Approved Pathology Authority are included in the authority application | Compliance with Authority Required procedures |
Indacaterol | C3883 | | | Chronic obstructive pulmonary disease | |
Indinavir | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Indomethacin | C1036 | P1036 | | Bone pain due to malignant disease | |
| C1054 | P1054 | | Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
| C3645 | P3645 | | Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3645 |
| C3646 | P3646 | | Continuing supply for a palliative care patient where severe pain is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3646 |
| | P3665 | CN3665 | Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem | Compliance with Authority Required procedures |
| | P3666 | CN3666 | Continuing supply for a palliative care patient where severe pain is a problem | Compliance with Authority Required procedures |
Insulin Detemir | C2418 | | | Type 1 diabetes | |
Interferon Alfa-2a | C1149 | P1149 | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Hairy cell leukaemia | Compliance with Authority Required procedures |
| C1196 | P1196 | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy | Compliance with Authority Required procedures |
| C1234 | P1234 | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Myeloproliferative disease with excessive thrombocytosis | Compliance with Authority Required procedures |
| C1463 | | | Where the patient is receiving treatment at/from a private hospital Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase | Compliance with Written or Telephone Authority Required procedures |
| C3180 | | | Where the patient is receiving treatment at/from a Public Hospital Hairy cell leukaemia | Compliance with Authority Required procedures - Streamlined Authority Code 3180 |
| C3382 | | | Where the patient is receiving treatment at/from a public hospital Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3382 |
| C3895 | | | Where the patient is receiving treatment at/from a Public Hospital Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy | Compliance with Authority Required procedures - Streamlined Authority Code 3895 |
| C3899 | | | Where the patient is receiving treatment at/from a Public Hospital Myeloproliferative disease with excessive thrombocytosis | Compliance with Authority Required procedures - Streamlined Authority Code 3899 |
| C3959 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures |
| C3960 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy | Compliance with Written or Telephone Authority Required procedures |
| C3961 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3961 |
| C3962 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3962 |
Interferon Alfa-2b | C1009 | | | Where the patient is receiving treatment at/from a private hospital Adjunctive therapy of malignant melanoma following surgery in patients with nodal involvement | Compliance with Written or Telephone Authority Required procedures |
| C1149 | P1149 | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Hairy cell leukaemia | Compliance with Authority Required procedures |
| C1196 | P1196 | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy | Compliance with Authority Required procedures |
| C1206 | P1206 | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy | Compliance with Authority Required procedures |
| C1463 | | | Where the patient is receiving treatment at/from a private hospital Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase | Compliance with Written or Telephone Authority Required procedures |
| C3180 | | | Where the patient is receiving treatment at/from a Public Hospital Hairy cell leukaemia | Compliance with Authority Required procedures - Streamlined Authority Code 3180 |
| C3382 | | | Where the patient is receiving treatment at/from a public hospital Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3382 |
| C3384 | | | Where the patient is receiving treatment at/from a public hospital Adjunctive therapy of malignant melanoma following surgery in patients with nodal involvement | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3384 |
| C3895 | | | Where the patient is receiving treatment at/from a Public Hospital Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy | Compliance with Authority Required procedures - Streamlined Authority Code 3895 |
| C3898 | | | Where the patient is receiving treatment at/from a Public Hospital Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy | Compliance with Authority Required procedures - Streamlined Authority Code 3898 |
| C3959 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures |
| C3960 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy | Compliance with Written or Telephone Authority Required procedures |
| C3961 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3961 |
| C3962 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3962 |
Interferon Beta-1a | C1175 | | | Initial treatment of clinically definite relapsing-remitting multiple sclerosis in ambulatory (without assistance or support) patients who have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain or spinal cord and the date of the scan is included in the authority application, or where the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient | Compliance with Authority Required procedures |
| C1751 | | | Continuing treatment of clinically definite relapsing-remitting multiple sclerosis in patients previously issued with an authority prescription for this drug who do not show continuing progression of disability while on treatment with this drug and who have demonstrated compliance with, and an ability to tolerate, this therapy | Compliance with Authority Required procedures |
Interferon Beta-1b | C1175 | | | Initial treatment of clinically definite relapsing-remitting multiple sclerosis in ambulatory (without assistance or support) patients who have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain or spinal cord and the date of the scan is included in the authority application, or where the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient | Compliance with Authority Required procedures |
| C1751 | | | Continuing treatment of clinically definite relapsing-remitting multiple sclerosis in patients previously issued with an authority prescription for this drug who do not show continuing progression of disability while on treatment with this drug and who have demonstrated compliance with, and an ability to tolerate, this therapy | Compliance with Authority Required procedures |
Interferon Gamma-1b | C1058 | | | Where the patient is receiving treatment at/from a private hospital Treatment of chronic granulomatous disease in patients with frequent and severe infections despite adequate prophylaxis with antimicrobial agents. | Compliance with Written or Telephone Authority Required procedures |
| C3385 | | | Where the patient is receiving treatment at/from a public hospital Treatment of chronic granulomatous disease in patients with frequent and severe infections despite adequate prophylaxis with antimicrobial agents | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3385 |
Ipratropium | C1754 | | | Asthma in patients unable to use this drug delivered from an oral pressurised inhalation device via a spacer | |
| C1755 | | | Chronic obstructive pulmonary disease in patients unable to use this drug delivered from an oral pressurised inhalation device via a spacer | |
Irbesartan With Hydrochlorothiazide | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Irinotecan | C3184 | | | Metastatic colorectal cancer in patients with a World Health Organisation performance status of 2 or less | Compliance with Authority Required procedures - Streamlined Authority Code 3184 |
Iron Sucrose | C2070 | | | Iron deficiency anaemia, when used in combination with either epoetin alfa or darbepoetin alfa, in patients undergoing chronic haemodialysis who have had a documented hypersensitivity reaction to iron polymaltose and in whom continued intravenous iron therapy is appropriate | Compliance with Authority Required procedures - Streamlined Authority Code 2070 |
Isoleucine with carbohydrate | C1220 | | | Maple syrup urine disease | |
Isotretinoin | C1354 | | | Severe cystic acne not responsive to other therapy | Compliance with Authority Required procedures - Streamlined Authority Code 1354 |
Itraconazole | C3607 | | | Systemic aspergillosis | Compliance with Authority Required procedures - Streamlined Authority Code 3607 |
| C3608 | | | Systemic sporotrichosis | Compliance with Authority Required procedures - Streamlined Authority Code 3608 |
| C3609 | | | Systemic histoplasmosis | Compliance with Authority Required procedures - Streamlined Authority Code 3609 |
| C3610 | | | Treatment and maintenance therapy in patients with Acquired Immunodeficiency Syndrome who have disseminated pulmonary histoplasmosis infection | Compliance with Authority Required procedures - Streamlined Authority Code 3610 |
| C3612 | | | Treatment and maintenance therapy in patients with Acquired Immunodeficiency Syndrome who have chronic pulmonary histoplasmosis infection | Compliance with Authority Required procedures - Streamlined Authority Code 3612 |
| C3613 | | | Treatment of oropharyngeal candidiasis in immunosuppressed patients | Compliance with Authority Required procedures - Streamlined Authority Code 3613 |
| C3614 | | | Treatment of oesophageal candidiasis in immunosuppressed patients | Compliance with Authority Required procedures - Streamlined Authority Code 3614 |
Ivermectin | C1242 | | | Onchocerciasis | Compliance with Authority Required procedures - Streamlined Authority Code 1242 |
| C1388 | | | Strongyloidiasis | Compliance with Authority Required procedures - Streamlined Authority Code 1388 |
Ketoconazole | C2354 | | | Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person | Compliance with Authority Required procedures - Streamlined Authority Code 2354 |
| C3604 | P3604 | | Oral candidiasis in severely immunocompromised persons where topical therapy has failed | Compliance with Authority Required procedures - Streamlined Authority Code 3604 |
| C3605 | P3605 | | Systemic or deep mycoses where other forms of therapy have failed | Compliance with Authority Required procedures - Streamlined Authority Code 3605 |
| C3606 | P3606 | | Symptomatic genital candidiasis recurring after treatment of at least 2 episodes with topical therapy | Compliance with Authority Required procedures - Streamlined Authority Code 3606 |
Ketoprofen | C1054 | | | Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
Lacosamide | C3303 | | | Treatment, initiated by a neurologist, in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent, of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs in a patient aged 16 years or older with intractable epilepsy;
the patient must have trialled and failed to achieve satisfactory seizure control with:
(i) at least one first-line anti-epileptic agent; and
(ii) at least two second-line adjunctive anti-epileptic agents | Compliance with Authority Required procedures |
| C3304 | | | Continuing treatment, in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent, of partial epileptic seizures in a patient aged 16 years or older, who has previously been treated with PBS-subsidised lacosamide | Compliance with Authority Required procedures |
Lactulose | C1150 | P1150 | | Hepatic coma or precoma (chronic porto-systemic encephalopathy) | |
| C1613 | P1613 | | Constipation in patients with malignant neoplasia | |
| C3642 | P3642 | | Initial supply, for up to 4 months, for a palliative care patient where constipation is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3642 |
| C3643 | P3643 | | Continuing supply for a palliative care patient where constipation is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3643 |
Lamivudine | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
| C3959 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures |
| C3960 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy | Compliance with Written or Telephone Authority Required procedures |
| C3961 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3961
|
| C3962 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3962 |
Lamivudine with Zidovudine | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Lamotrigine | C1426 | | | Treatment of epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs | Compliance with Authority Required procedures - Streamlined Authority Code 1426 |
Lanreotide | C2619 | | | Where the patient is receiving treatment at/from a private hospital Active acromegaly
Active acromegaly in a patient with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre and:
(a) after failure of other therapy including dopamine agonists; or
(b) as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or
(c) if the patient is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated.
In a patient treated with radiotherapy, treatment must cease if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose). Lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.
Treatment must cease if IGF1 is not lower after 3 months treatment | Compliance with Written or Telephone Authority Required procedures |
| C2620 | | | Where the patient is receiving treatment at/from a private hospital Active acromegaly
Active acromegaly in a patient with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre and:
(a) after failure of other therapy including dopamine agonists; or
(b) as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or
(c) if the patient is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated.
In a patient treated with radiotherapy, treatment must cease if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose). Lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.
Treatment must cease if IGF1 is not lower after 3 months treatment | Compliance with Written or Telephone Authority Required procedures |
| C2621 | | | Where the patient is receiving treatment at/from a private hospital Functional carcinoid tumour
Functional carcinoid tumour causing intractable symptoms. The patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, and surgery or antineoplastic therapy must have failed or be inappropriate.
Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose | Compliance with Written or Telephone Authority Required procedures |
| C3387 | | | Where the patient is receiving treatment at/from a public hospital Active acromegaly
Active acromegaly in a patient with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre and:
(a) after failure of other therapy including dopamine agonists; or
(b) as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or
(c) if the patient is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated.
In a patient treated with radiotherapy, treatment must cease if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose). Lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.
Treatment must cease if IGF1 is not lower after 3 months treatment | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3387 |
| C3388 | | | Where the patient is receiving treatment at/from a public hospital Active acromegaly
Active acromegaly in a patient with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre and:
(a) after failure of other therapy including dopamine agonists; or
(b) as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or
(c) if the patient is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated.
In a patient treated with radiotherapy, treatment must cease if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose). Lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.
Treatment must cease if IGF1 is not lower after 3 months treatment | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3388 |
| C3389 | | | Where the patient is receiving treatment at/from a public hospital Functional carcinoid tumour
Functional carcinoid tumour causing intractable symptoms. The patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, and surgery or antineoplastic therapy must have failed or be inappropriate.
Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3389 |
Lansoprazole | C1177 | P1177 | | Initial treatment of peptic ulcer | |
| C1337 | P1337 | | Scleroderma oesophagus | |
| C1533 | P1533 | | Gastro-oesophageal reflux disease | |
Lanthanum | C3103 | | | Where the patient is receiving treatment at/from a private hospital Management (which includes initiation, stabilisation and review of therapy as required) of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where serum phosphate is greater than 1.6 mmol per L at the commencement of therapy | Compliance with Written or Telephone Authority Required procedures |
| C3104 | | | Where the patient is receiving treatment at/from a private hospital Management (which includes initiation, stabilisation and review of therapy as required) of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where the serum calcium times phosphate product is greater than 4.0 at the commencement of therapy | Compliance with Written or Telephone Authority Required procedures |
| C3390 | | | Where the patient is receiving treatment at/from a public hospital Management (which includes initiation, stabilisation and review of therapy as required) of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where serum phosphate is greater than 1.6 mmol per L at the commencement of therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3390 |
| C3391 | | | Where the patient is receiving treatment at/from a public hospital Management (which includes initiation, stabilisation and review of therapy as required) of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where the serum calcium times phosphate product is greater than 4.0 at the commencement of therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3391 |
| C3546 | P3546 | | Maintenance therapy, following initiation and stabilisation of treatment with lanthanum carbonate, of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where serum phosphate is greater than 1.6 mmol per L at the commencement of therapy | Compliance with Authority Required procedures - Streamlined Authority Code 3546 |
| C3547 | P3547 | | Maintenance therapy, following initiation and stabilisation of treatment with lanthanum carbonate, of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where the serum calcium times phosphate product is greater than 4.0 at the commencement of therapy | Compliance with Authority Required procedures - Streamlined Authority Code 3547 |
Lapatinib | C2890 | | | Continuing treatment, in combination with capecitabine, of a patient with HER2 positive metastatic breast cancer who has previously received treatment with PBS-subsidised lapatinib and who does not have progressive disease, and where the authority application includes a statement from the prescribing doctor that the disease has not progressed | Compliance with Written Authority Required procedures |
| C3433 | | | Initial treatment, in combination with capecitabine, of a patient with HER2 positive metastatic breast cancer (equivalent to Stage IIIC or Stage IV) who has received prior therapy with a taxane, for at least 3 cycles, and whose disease has progressed despite treatment with trastuzumab for metastatic disease, and where the authority application includes:
(a) a pathology report demonstrating HER2 positivity has been demonstrated by in situ hybridisation (ISH); and
(b) date of last treatment with a taxane and total number of cycles; and
(c) a signed patient acknowledgment; and
(d) dates of treatment with trastuzumab; and
(e) date of demonstration of disease progression whilst on treatment with trastuzumab | Compliance with Written Authority Required procedures |
Latanoprost with Timolol | C3426 | | | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy | |
| C3427 | | | Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy | |
Leflunomide | C2643 | | | Initial treatment of severe active rheumatoid arthritis where other disease modifying anti-rheumatic drugs (including methotrexate) are ineffective and/or inappropriate and where treatment is initiated by a physician | Compliance with Authority Required procedures - Streamlined Authority Code 2643 |
| C2644 | | | Treatment of severe active rheumatoid arthritis where other disease modifying anti-rheumatic drugs (including methotrexate) are ineffective and/or inappropriate and where treatment is initiated by a physician | Compliance with Authority Required procedures - Streamlined Authority Code 2644 |
| C2681 | | | Initial treatment of severe active psoriatic arthritis where other disease modifying anti-rheumatic drugs (including methotrexate) are ineffective and/or inappropriate and where treatment is initiated by a physician | Compliance with Authority Required procedures - Streamlined Authority Code 2681 |
| C2682 | | | Treatment of severe active psoriatic arthritis where other disease modifying anti-rheumatic drugs (including methotrexate) are ineffective and/or inappropriate and where treatment is initiated by a physician | Compliance with Authority Required procedures - Streamlined Authority Code 2682 |
Lenograstim | C1005 | | | Where the patient is receiving treatment at/from a private hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia | Compliance with Written or Telephone Authority Required procedures |
| C1046 | | | Where the patient is receiving treatment at/from a private hospital Patients with breast cancer receiving standard dose adjuvant chemotherapy who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures |
| C1051 | | | Where the patient is receiving treatment at/from a private hospital Patients receiving first-line chemotherapy for Hodgkin's disease who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures |
| C1097 | | | Where the patient is receiving treatment at/from a private hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Ewing's sarcoma | Compliance with Written or Telephone Authority Required procedures |
| C1140 | | | Where the patient is receiving treatment at/from a private hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours | Compliance with Written or Telephone Authority Required procedures |
| C1168 | | | Where the patient is receiving treatment at/from a private hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in infants and children with CNS tumours | Compliance with Written or Telephone Authority Required procedures |
| C1228 | | | Where the patient is receiving treatment at/from a private hospital Mobilisation of peripheral blood progenitor cells to facilitate harvest of such cells for reinfusion into patients with non-myeloid malignancies who have had myeloablative or myelosuppressive therapy | Compliance with Written or Telephone Authority Required procedures |
| C1238 | | | Where the patient is receiving treatment at/from a private hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma | Compliance with Written or Telephone Authority Required procedures |
| C1240 | | | Where the patient is receiving treatment at/from a private hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin's lymphoma (intermediate or high grade) | Compliance with Written or Telephone Authority Required procedures |
| C1249 | | | Where the patient is receiving treatment at/from a private hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in osteosarcoma | Compliance with Written or Telephone Authority Required procedures |
| C1274 | | | Where the patient is receiving treatment at/from a private hospital Patients with non-myeloid malignancies receiving marrow-ablative chemotherapy and subsequent peripheral blood progenitor cell or bone marrow transplantation | Compliance with Written or Telephone Authority Required procedures |
| C1324 | | | Where the patient is receiving treatment at/from a private hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin's disease | Compliance with Written or Telephone Authority Required procedures |
| C1333 | | | Where the patient is receiving treatment at/from a private hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in rhabdomyosarcoma | Compliance with Written or Telephone Authority Required procedures |
| C1555 | | | Where the patient is receiving treatment at/from a private hospital Mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic transplantation to facilitate harvest of such cells in healthy donors; | Compliance with Written or Telephone Authority Required procedures |
| C3392 | | | Where the patient is receiving treatment at/from a public hospital Mobilisation of peripheral blood progenitor cells to facilitate harvest of such cells for reinfusion into patients with non-myeloid malignancies who have had myeloablative or myelosuppressive therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3392 |
| C3393 | | | Where the patient is receiving treatment at/from a public hospital Mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic transplantation to facilitate harvest of such cells in healthy donors | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3393 |
| C3394 | | | Where the patient is receiving treatment at/from a public hospital Patients with non-myeloid malignancies receiving marrow-ablative chemotherapy and subsequent peripheral blood progenitor cell or bone marrow transplantation | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3394 |
| C3395 | | | Where the patient is receiving treatment at/from a public hospital Patients with breast cancer receiving standard dose adjuvant chemotherapy who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3395 |
| C3396 | | | Where the patient is receiving treatment at/from a public hospital Patients receiving first-line chemotherapy for Hodgkin's disease who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3396 |
| C3397 | | | Where the patient is receiving treatment at/from a public hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3397 |
| C3398 | | | Where the patient is receiving treatment at/from a public hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Ewing's sarcoma | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3398 |
| C3399 | | | Where the patient is receiving treatment at/from a public hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3399 |
| C3400 | | | Where the patient is receiving treatment at/from a public hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in infants and children with CNS tumours | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3400 |
| C3401 | | | Where the patient is receiving treatment at/from a public hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3401 |
| C3402 | | | Where the patient is receiving treatment at/from a public hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin's lymphoma (intermediate or high grade) | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3402 |
| C3403 | | | Where the patient is receiving treatment at/from a public hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in osteosarcoma | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3403 |
| C3404 | | | Where the patient is receiving treatment at/from a public hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin's disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3404 |
| C3405 | | | Where the patient is receiving treatment at/from a public hospital Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in rhabdomyosarcoma | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3405 |
Lercanidipine with enalapril | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Letrozole | C1608 | | | Treatment of hormone-dependent advanced breast cancer in post-menopausal women | |
| C2691 | | | Treatment of hormone-dependent early breast cancer in post-menopausal women | |
| C2692 | | | Extended adjuvant treatment of hormone-dependent early breast cancer in post-menopausal women commencing within 6 months of ceasing treatment with tamoxifen citrate | |
Leuprorelin | C3229 | | | Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate | Compliance with Authority Required procedures - Streamlined Authority Code 3229 |
Levetiracetam | C2664 | | | Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs | Compliance with Authority Required procedures - Streamlined Authority Code 2664 |
| C3291 | | | Treatment of partial epileptic seizures, which are not controlled satisfactorily by other anti-epileptic drugs in a patient unable to take a solid dose form of levetiracetam | Compliance with Authority Required procedures - Streamlined Authority Code 3291 |
Levodopa With Carbidopa | C1257 | | | Parkinson's disease where fluctuations in motor function are not adequately controlled by frequent dosing with conventional formulations of levodopa with decarboxylase inhibitor | Compliance with Authority Required procedures - Streamlined Authority Code 1257 |
| C3703 | P3703 | | Maintenance therapy following treatment which was commenced in a hospital-based movement disorder clinic, of a patient with advanced Parkinson disease with severe disabling motor fluctuations not adequately controlled by oral therapy. | Compliance with Authority Required procedures |
| C3704 | P3704 | | Where the patient is receiving treatment at/from a public hospital Management of advanced Parkinson disease in a patient with severe disabling motor fluctuations not adequately controlled by oral therapy.
Treatment must be commenced in a hospital-based movement disorder clinic | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3704 |
| C3705 | P3705 | | Where the patient is receiving treatment at/from a private hospital Management of advanced Parkinson disease in a patient with severe disabling motor fluctuations not adequately controlled by oral therapy.
Treatment must be commenced in a hospital-based movement disorder clinic | Compliance with Written or Telephone Authority Required procedures |
Levodopa With Carbidopa And Entacapone | C3305 | | | Parkinson disease in patients being treated with levodopa—decarboxylase inhibitor combinations who are experiencing fluctuations in motor function due to end-of-dose effect | Compliance with Authority Required procedures - Streamlined Authority Code 3305 |
| C3306 | | | Parkinson disease in patients stabilised on concomitant treatment with levodopa—decarboxylase inhibitor combinations and entacapone | Compliance with Authority Required procedures - Streamlined Authority Code 3306 |
Levonorgestrel | C1643 | | | Contraception | |
| C2689 | | | Idiopathic menorrhagia where oral treatments are ineffective | |
| C2690 | | | Idiopathic menorrhagia where oral treatments are contraindicated | |
Linagliptin | C3540 | | | Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with either metformin or a sulfonylurea; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and
where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3540 |
Liothyronine | C1182 | | | Initiation of thyroid therapy in severely hypothyroid patients | Compliance with Authority Required procedures - Streamlined Authority Code 1182 |
| C1219 | | | Management of patients with thyroid cancer | Compliance with Authority Required procedures - Streamlined Authority Code 1219 |
| C1858 | | | Replacement therapy for hypothyroid patients who have documented intolerance to thyroxine sodium | Compliance with Authority Required procedures - Streamlined Authority Code 1858 |
| C1859 | | | Replacement therapy for hypothyroid patients who have documented resistance to thyroxine sodium | Compliance with Authority Required procedures - Streamlined Authority Code 1859 |
Lopinavir with Ritonavir | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Macrogol 3350 | C1263 | P1263 | | Patients receiving palliative care | |
| C1613 | P1613 | | Constipation in patients with malignant neoplasia | |
| C2693 | P2693 | | Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function not responding to other oral therapies | |
| C2823 | P2823 | | Chronic constipation or faecal impaction not adequately controlled with first line interventions such as bulk-forming agents | |
| C3642 | P3642 | | Initial supply, for up to 4 months, for a palliative care patient where constipation is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3642 |
| C3643 | P3643 | | Continuing supply for a palliative care patient where constipation is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3643 |
Magnesium | C3937 | | | Hypomagnesaemia in an Aboriginal or a Torres Strait Islander person | Compliance with Authority Required procedures |
| C3938 | | | Chronic renal disease in an Aboriginal or a Torres Strait Islander person | Compliance with Authority Required procedures |
Mannitol | C4061 | | | Where the patient is receiving treatment at/from a private hospital Treatment of cystic fibrosis in a patient who satisfies all of the following criteria: (1) Prior to mannitol therapy, the patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved PI mannitol initiation dose assessment. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol; (2) Is 6 years of age or older; (3) Has a FEV1 greater than 30% predicted for age, gender and height; (4) Is intolerant or inadequately responsive to dornase alfa; (5) Has evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease); (6) Is participating in a 4 week trial, as detailed below, or has achieved a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) after a 4 week trial In order for patients to be eligible for participation in the HSD program, the following conditions must be met: (1) Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of mannitol therapy under the HSD program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit; (2) The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at established lung function testing laboratories, unless this is not possible because of geographical isolation; (3) Prior to mannitol therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease; (4) Initial therapy is limited to 4 weeks' treatment with mannitol at a dose of 400 mg twice daily; (5) At or towards the end of the initial 4 weeks' trial, patients must be reassessed and a further FEV1 measurement be undertaken (single test under conditions as above). Patients who achieve a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) are eligible for continued subsidy under the HSD program at a dose of 400mg twice daily; (6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 400 mg twice daily, may have 1 further trial in the next 12 months but not before 3 months after the initial trial; (7) Following an initial 6 months' therapy, a global assessment must be undertaken involving the patient, the patient's family (in the case of paediatric patients) and the treating physician(s) to establish that all agree that mannitol powder for inhalation treatment is continuing to produce worthwhile benefits. (Mannitol therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.) Further reassessments are to be undertaken at six-monthly intervals; (8) Other aspects of treatment, such as physiotherapy, must be continued; (9) Where there is documented evidence that a patient already receiving mannitol therapy would have met the criteria for subsidy (i.e. satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period) | Compliance with Written or Telephone Authority Required procedures |
| C4062 | | | Where the patient is receiving treatment at/from a private hospital Grandfather — for patients who initiated mannitol treatment prior to 1 August 2012 Continuation of treatment of cystic fibrosis in a patient 6 years of age or older, who initiated treatment with mannitol prior to 1 August 2012 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, documents agreement that mannitol treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use | Compliance with Written or Telephone Authority Required procedures |
| C4063 | | | Where the patient is receiving treatment at/from a public hospital Treatment of cystic fibrosis in a patient who satisfies all of the following criteria: (1) Prior to mannitol therapy, the patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved PI mannitol initiation dose assessment. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol; (2) Is 6 years of age or older; (3) Has a FEV1 greater than 30% predicted for age, gender and height; (4) Is intolerant or inadequately responsive to dornase alfa; (5) Has evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease); (6) Is participating in a 4 week trial, as detailed below, or has achieved a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) after a 4 week trial In order for patients to be eligible for participation in the HSD program, the following conditions must be met: (1) Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of mannitol therapy under the HSD program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit; (2) The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at established lung function testing laboratories, unless this is not possible because of geographical isolation; (3) Prior to mannitol therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease; (4) Initial therapy is limited to 4 weeks' treatment with mannitol at a dose of 400 mg twice daily; (5) At or towards the end of the initial 4 weeks' trial, patients must be reassessed and a further FEV1 measurement be undertaken (single test under conditions as above). Patients who achieve a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) are eligible for continued subsidy under the HSD program at a dose of 400mg twice daily; (6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 400 mg twice daily, may have 1 further trial in the next 12 months but not before 3 months after the initial trial; (7) Following an initial 6 months' therapy, a global assessment must be undertaken involving the patient, the patient's family (in the case of paediatric patients) and the treating physician(s) to establish that all agree that mannitol powder for inhalation treatment is continuing to produce worthwhile benefits. (Mannitol therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.) Further reassessments are to be undertaken at six-monthly intervals; (8) Other aspects of treatment, such as physiotherapy, must be continued; (9) Where there is documented evidence that a patient already receiving mannitol therapy would have met the criteria for subsidy (i.e. satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period) | Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4063 |
| C4064 | | | Where the patient is receiving treatment at/from a public hospital Grandfather — for patients who initiated mannitol treatment prior to 1 August 2012 Continuation of treatment of cystic fibrosis in a patient 6 years of age or older, who initiated treatment with mannitol prior to 1 August 2012 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, documents agreement that mannitol treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use | Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4064 |
Maraviroc | C3598 | | | Where the patient is receiving treatment at/from a private hospital Treatment, in addition to optimised background therapy in combination with other antiretroviral agents, of an antiretroviral experienced patient infected with only CCR5-tropic human immunodeficiency virus type 1 (HIV-1), who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance. A tropism assay to determine CCR5 only strain status is required prior to initiation. Individuals with CXCR4 tropism demonstrated at any time point are not eligible
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity | Compliance with Written or Telephone Authority Required procedures |
| C3599 | | | Where the patient is receiving treatment at/from a public hospital Treatment, in addition to optimised background therapy in combination with other antiretroviral agents, of an antiretroviral experienced patient infected with only CCR5-tropic human immunodeficiency virus type 1 (HIV-1), who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance. A tropism assay to determine CCR5 only strain status is required prior to initiation. Individuals with CXCR4 tropism demonstrated at any time point are not eligible
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3599 |
Medroxyprogesterone | C1088 | | | Endometrial cancer | |
| | P1089 | | Endometriosis | |
| C1542 | | | Hormone-dependent breast cancer | |
| C1543 | | | Hormone-dependent advanced breast cancer | |
Mefenamic Acid | C1087 | | | Dysmenorrhoea | |
| C1222 | | | Menorrhagia | |
Megestrol | C1543 | | | Hormone-dependent advanced breast cancer | |
Meloxicam | C1547 | | | Symptomatic treatment of osteoarthritis | |
| C1848 | | | Symptomatic treatment of rheumatoid arthritis | |
Memantine | C2609 | | | Continuing treatment, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14 who demonstrate improvement in cognitive function following initial PBS-subsidised therapy, where improvement in cognitive function is demonstrated by an increase of at least 2 points from baseline on the MMSE or SMMSE, and where the relevant result from the MMSE or SMMSE is included in the authority application for continuing treatment | Compliance with Written Authority Required procedures |
| | | | Continuing treatment, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14 and with demonstrated improvement in cognitive function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment | Compliance with Written Authority Required procedures |
| C2611 | | | Continuing treatment, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 to 14 for reasons other than their Alzheimer's disease and who demonstrate improvement in function following initial PBS-subsidised therapy, based on a rating of "very much improved" or "much improved" on the Clinicians Interview Based Impression of Change (CIBIC) scale, as assessed by the same clinician who initiated treatment, and where the improvement rating achieved on the Clinicians Interview Based Impression of Change scale is stated in the authority application for continuing treatment | Compliance with Written Authority Required procedures |
| | | | Continuing treatment, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less and with demonstrated improvement in function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment | Compliance with Written Authority Required procedures |
| C3877 | | | Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the result of the baseline MMSE or SMMSE is included in the authority application | Compliance with Authority Required procedures
|
| | | | Continuation of initial treatment, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the baseline score submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total | Compliance with Written Authority Required procedures |
| | | | Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the result of the baseline MMSE or SMMSE is included in the authority application | Compliance with Written Authority Required procedures |
| C3878 | | | Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 to 14 for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment | Compliance with Authority Required procedures |
| | | | Continuation of initial treatment, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 to 14 for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the information submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total | Compliance with Written Authority Required procedures |
| | | | Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 to 14 for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment | Compliance with Written Authority Required procedures |
Mesalazine | C1707 | | | Acute episode of mild to moderate ulcerative colitis | Compliance with Authority Required procedures - Streamlined Authority Code 1707 |
| C1708 | | | Ulcerative colitis where hypersensitivity to sulfonamides exists | Compliance with Authority Required procedures - Streamlined Authority Code 1708 |
| C1709 | | | Ulcerative colitis where intolerance to sulfasalazine exists | Compliance with Authority Required procedures - Streamlined Authority Code 1709 |
| C1978 | | | Acute episode of mild to moderate ulcerative proctitis | |
| C2268 | | | Crohn disease where hypersensitivity to sulfonamides exists | Compliance with Authority Required procedures - Streamlined Authority Code 2268 |
| C2269 | | | Crohn disease where intolerance to sulfasalazine exists | Compliance with Authority Required procedures - Streamlined Authority Code 2269 |
Mesna | C1618 | | | Adjunctive therapy for use with ifosfamide or high dose cyclophosphamide | |
Methadone | C1358 | | | Severe disabling pain not responding to non-narcotic analgesics | |
| C3659 | P3659 | | Initial supply, for up to 3 months, for a palliative care patient with chronic severe disabling pain not responding to non-narcotic analgesics | Compliance with Authority Required procedures |
| C3660 | P3660 | | Continuing supply for a palliative care patient with chronic severe disabling pain not responding to non-narcotic analgesics | Compliance with Authority Required procedures |
Methotrexate | | P2884 | | For patients requiring doses greater than 20 mg per week | |
Methoxy polyethylene glycol-epoetin beta | C1957 | | | Where the patient is receiving treatment at/from a private hospital Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia | Compliance with Written or Telephone Authority Required procedures |
| C3334 | | | Where the patient is receiving treatment at/from a public hospital Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3334 |
Methylnaltrexone | C3235 | P3235 | | Initial supply, in combination with oral laxatives, for a palliative care patient with opioid-induced constipation who has failed to respond to laxatives | Compliance with Authority Required procedures |
| C3238 | P3238 | | Continuing supply, in combination with oral laxatives, for a palliative care patient with opioid-induced constipation who has demonstrated a response to methylnaltrexone | Compliance with Authority Required procedures |
Methylphenidate | C1461 | | | Use in attention deficit hyperactivity disorder, in accordance with State/Territory law | Compliance with Authority Required procedures |
| C3188 | | | Treatment of attention deficit hyperactivity disorder (ADHD) in a patient diagnosed between the ages of 6 and 18 years inclusive, who has demonstrated a response to immediate release methylphenidate hydrochloride with no emergence of serious adverse events, and who requires continuous coverage over 12 hours | Compliance with Authority Required procedures |
| C3189 | | | Treatment of attention deficit hyperactivity disorder (ADHD) in a patient diagnosed between the ages of 6 and 18 years inclusive, who has demonstrated a response to immediate release methylphenidate hydrochloride with no emergence of serious adverse events, and who requires continuous coverage over 8 hours | Compliance with Authority Required procedures |
Methylprednisolone | C1102 | | | For local intra-articular or peri-articular infiltration | |
| C1422 | | | Treatment of corticosteroid-responsive dermatoses | |
| C1622 | | | Eczema | |
Metoprolol succinate | C3234 | | | Moderate to severe heart failure in a patient stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor or angiotensin II antagonist, if tolerated | Compliance with Authority Required procedures - Streamlined Authority Code 3234 |
Metronidazole | C1300 | | | Prophylaxis in large bowel surgery | |
| | P1416 | | Treatment of anaerobic infections | |
| C1448 | | | Treatment, in a hospital, of acute anaerobic sepsis | |
Mianserin | C1355 | | | Severe depression | |
Miconazole | C2354 | | | Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person | Compliance with Authority Required procedures - Streamlined Authority Code 2354 |
Milk powder — lactose free formula | C2760 | P2760 | | Proven chronic lactose intolerance in infants up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven by:
(a) relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food; or
(b) not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet; or
(c) hydrogen breath test | Compliance with Authority Required procedures |
| C2762 | P2762 | | Acute lactose intolerance in infants up to the age of 12 months, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose | Compliance with Authority Required procedures |
Milk powder — lactose modified | C1790 | P1790 | | Acute lactose intolerance in children aged 1 year and over, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose | Compliance with Authority Required procedures |
| C2761 | P2761 | | Proven chronic lactose intolerance in children aged 1 year and over who are significantly malnourished, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven by:
(a) relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food; or
(b) not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet; or
(c) hydrogen breath test | Compliance with Authority Required procedures |
Milk powder — synthetic | C1158 | | | Hypercalcaemia in children under the age of 4 years | Compliance with Authority Required procedures |
Milk protein and fat formula with vitamins and minerals — carbohydrate free | C1578 | | | Patients with intractable seizures requiring treatment with a ketogenic diet | |
| C1579 | | | Glucose transport protein defects | |
| C1580 | | | Pyruvate dehydrogenase deficiency | |
| C1581 | | | Infants and young children with glucose-galactose intolerance and multiple monosaccharide intolerance | |
Minocycline | C1347 | | | Severe acne not responding to other tetracyclines | |
Minoxidil | C2759 | | | Severe refractory hypertension where treatment is initiated by a consultant physician | Compliance with Authority Required procedures - Streamlined Authority Code 2759 |
Mirtazapine | C1211 | | | Major depressive disorders | |
Misoprostol | C2630 | | | Reduction in the incidence of gastrointestinal complications in patients who have a history of peptic ulcer disease and where non-steroidal anti-inflammatory drug therapy is essential | Compliance with Authority Required procedures - Streamlined Authority Code 2630 |
| C2631 | | | Duodenal ulcer (including pyloric and stomal ulcers), proven by current or prior x-ray, endoscopy or surgery, where the date on which, and the method by which, the ulcer was proven are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 2631 |
| C2632 | | | Gastric ulcer, proven by x-ray, endoscopy or surgery within the previous 2 years, where the date on which, and the method by which, the ulcer was proven are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 2632 |
Moclobemide | C1211 | | | Major depressive disorders | |
Modafinil | C2090 | | | Continuing treatment of narcolepsy, where the patient has previously been issued with an authority prescription for this drug | Compliance with Written or Telephone Authority Required procedures |
| C3145 | | | Initial treatment, by a qualified sleep medicine practitioner or neurologist, of patients with narcolepsy where:
(i) intolerance to dexamphetamine sulfate of a severity necessitating treatment withdrawal develops; or
(ii) therapy with dexamphetamine sulfate poses an unacceptable medical risk, as indicated by the presence of any 1 of the following:
(a) a psychiatric disorder;
(b) a cardiovascular disorder;
(c) a history of substance abuse;
(d) glaucoma;
(e) any other absolute contraindication to dexamphetamine sulfate as specified in the Therapeutic Goods Administration-approved Product Information; and
where the patient meets the following definition of narcolepsy:
excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months, and:
(i) a definite history of cataplexy; or
a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT), where the MSLT is preceded by nocturnal polysomnography and sleep prior to the MSLT is at least 6 hours in duration; or
an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; and
(ii) absence of any medical or psychiatric disorder that could otherwise account for the hypersomnia; and
where the authority application includes the following:
(a) a completed copy of the appropriate Modafinil (Modavigil) PBS Authority Application - Supporting Information Form; and
(b) details of the contraindication or intolerance to dexamphetamine sulfate; and
(c) either:
(i) the result and date of the polysomnography test and MSLT, conducted by, or under the supervision of, a qualified sleep medicine practitioner; or
(ii) the result and date of the EEG, conducted by, or under the supervision of, a neurologist; and where the polysomnography and MSLT, or the EEG, test reports are provided with the authority application | Compliance with Written Authority Required procedures |
Mometasone | C1422 | | | Treatment of corticosteroid-responsive dermatoses | |
Montelukast | C2617 | | | First-line preventer medication, as the single preventer agent for children aged from 2 to less than 6 years with frequent intermittent or mild persistent asthma, as an alternative to sodium cromoglycate or nedocromil sodium | Compliance with Authority Required procedures - Streamlined Authority Code 2617 |
| C2618 | | | First-line preventer medication, as the single preventer agent for children aged from 6 to less than 15 years with frequent intermittent or mild persistent asthma, as an alternative to sodium cromoglycate or nedocromil sodium | Compliance with Authority Required procedures - Streamlined Authority Code 2618 |
| C3217 | | | Prevention of exercise-induced asthma, as an alternative to adding salmeterol xinafoate or eformoterol fumarate, in a child aged from 6 to less than 15 years whose asthma is otherwise well controlled while receiving optimal dose inhaled corticosteroid, but who requires short-acting beta-2 agonist 3 or more times per week for prevention or relief of residual exercise-related symptoms | Compliance with Authority Required procedures - Streamlined Authority Code 3217 |
Morphine | C1062 | | | Chronic severe disabling pain not responding to non-narcotic analgesics | |
| C1358 | | | Severe disabling pain not responding to non-narcotic analgesics | |
| C1499 | P1499 | | Chronic severe disabling pain due to cancer | Compliance with Authority Required procedures |
| C1789 | P1789 | | Severe disabling pain due to cancer not responding to non-narcotic analgesics | |
| C3659 | P3659 | | Initial supply, for up to 3 months, for a palliative care patient with chronic severe disabling pain not responding to non-narcotic analgesics | Compliance with Authority Required procedures |
| C3660 | P3660 | | Continuing supply for a palliative care patient with chronic severe disabling pain not responding to non-narcotic analgesics | Compliance with Authority Required procedures |
| C3661 | P3661 | | Initial supply, for up to 3 months, for a palliative care patient with severe disabling pain not responding to non-narcotic analgesics | Compliance with Authority Required procedures |
| C3662 | P3662 | | Continuing supply for a palliative care patient with severe disabling pain not responding to non-narcotic analgesics | Compliance with Authority Required procedures |
Moxonidine | C2385 | | | Hypertension in patients receiving concurrent antihypertensive therapy | |
Mupirocin | C3136 | | | Nasal colonisation with Staphylococcus aureus in an Aboriginal or a Torres Strait Islander person | Compliance with Authority Required procedures - Streamlined Authority Code 3136 |
Mycophenolic Acid | C1650 | | | Where the patient is receiving treatment at/from a private hospital Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required | Compliance with Written or Telephone Authority Required procedures |
| C1651 | | | Where the patient is receiving treatment at/from a private hospital Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of cardiac allograft rejection, where management includes initiation, stabilisation and review of therapy as required | Compliance with Written or Telephone Authority Required procedures |
| C1763 | | | Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with mycophenolate sodium, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | Compliance with Authority Required procedures |
| C1765 | | | Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | Compliance with Authority Required procedures |
| C1766 | | | Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | Compliance with Authority Required procedures |
| C3355 | | | Where the patient is receiving treatment at/from a public hospital Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3355 |
| C3356 | | | Where the patient is receiving treatment at/from a public hospital Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of cardiac allograft rejection, where management includes initiation, stabilisation and review of therapy as required | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3356 |
Nafarelin | C1172 | | | Initial treatment, for up to 6 months, of visually proven endometriosis | Compliance with Authority Required procedures |
| C1389 | | | Subsequent treatment, for up to 6 months, of visually proven endometriosis, where 2 years or more have elapsed since the end of the previous course and where a recent bone density assessment has been made and where the date of the assessment is included in the authority application | Compliance with Authority Required procedures |
Naltrexone | C1135 | | | For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence | Compliance with Authority Required procedures |
Nandrolone Decanoate | C1262 | | | Patients on long-term treatment with corticosteroids | Compliance with Authority Required procedures |
| C1976 | | | Patients receiving PBS-subsidised therapy with this drug for osteoporosis prior to 1 February 2004 | Compliance with Authority Required procedures |
| C2024 | | | Monotherapy for osteoporosis where other treatment has failed, where monotherapy does not preclude concomitant calcium supplementation, and where, if the authority application is the initial authority application for this purpose for the patient, specialist advice has been obtained confirming that this drug is the only suitable treatment option for the patient | Compliance with Authority Required procedures |
| C2025 | | | Monotherapy for osteoporosis where other treatment is not tolerated, where monotherapy does not preclude concomitant calcium supplementation, and where, if the authority application is the initial authority application for this purpose for the patient, specialist advice has been obtained confirming that this drug is the only suitable treatment option for the patient | Compliance with Authority Required procedures |
| C2026 | | | Monotherapy for osteoporosis where other treatment is contraindicated, where monotherapy does not preclude concomitant calcium supplementation, and where, if the authority application is the initial authority application for this purpose for the patient, specialist advice has been obtained confirming that this drug is the only suitable treatment option for the patient | Compliance with Authority Required procedures |
Naproxen | C1036 | P1036 | | Bone pain due to malignant disease | |
| C1054 | P1054 | | Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
| C3645 | P3645 | | Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3645 |
| C3646 | P3646 | | Continuing supply for a palliative care patient where severe pain is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3646 |
| C3647 | P3647 | | Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent | Compliance with Authority Required procedures - Streamlined Authority Code 3647 |
| C3648 | P3648 | | Continuing supply for a palliative care patient where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent | Compliance with Authority Required procedures - Streamlined Authority Code 3648 |
Naratriptan | C3280 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics | Compliance with Authority Required procedures |
| C3281 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where adverse events have occurred with other suitable PBS-listed drugs | Compliance with Authority Required procedures |
| C3282 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where drug interactions have occurred with other suitable PBS-listed drugs | Compliance with Authority Required procedures |
| C3283 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where drug interactions are expected to occur with other suitable PBS-listed drugs | Compliance with Authority Required procedures |
| C3284 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where transfer to another suitable PBS-listed drug would cause patient confusion resulting in problems with compliance | Compliance with Authority Required procedures |
| C3285 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where transfer to another suitable PBS-listed drug is likely to result in adverse clinical consequences | Compliance with Authority Required procedures |
Natalizumab | C3423 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment, as monotherapy, by a neurologist, of clinically definite relapsing-remitting multiple sclerosis in an ambulatory (without assistance or support) patient 18 years of age or older who has experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain and/or spinal cord and the date of the scan is included in the authority application, unless the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient | Compliance with Written or Telephone Authority Required procedures |
| C3424 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment, as monotherapy, of clinically definite relapsing-remitting multiple sclerosis in a patient previously issued with an authority prescription for this drug who does not show continuing progression of disability while on treatment with this drug, and who has demonstrated compliance with, and an ability to tolerate, this therapy. | Compliance with Written or Telephone Authority Required procedures |
| C3425 | | | Where the patient is receiving treatment at/from a public hospital Treatment, as monotherapy, by a neurologist, of clinically definite relapsing-remitting multiple sclerosis in an ambulatory (without assistance or support) patient 18 years of age or older who has experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years, and where:
the diagnosis is confirmed by magnetic resonance imaging of the brain and/or spinal cord and the date of the scan is included in the patient's medical notes, unless written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient is included in the patient's medical notes;
natalizumab must be ceased if there is continuing progression of disability while on treatment with natalizumab;
for continued treatment the patient must demonstrate compliance with, and an ability to tolerate, natalizumab | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3425
|
Nebivolol | C3234 | | | Moderate to severe heart failure in a patient stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor or angiotensin II antagonist, if tolerated | Compliance with Authority Required procedures - Streamlined Authority Code 3234 |
Nevirapine | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
| C3994 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient who has been stabilised on nevirapine immediate release with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3995 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient who has been stabilised on nevirapine immediate release with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3995 |
Nicotine | C3042 | P3042 | | Nicotine dependence in an Aboriginal or a Torres Strait Islander person as the sole PBS-subsidised therapy | Compliance with Authority Required procedures |
| C3447 | P3447 | | Short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who has entered a comprehensive support and counselling program, and where details of the program are specified in the initial authority application | Compliance with Authority Required procedures |
| C3448 | P3448 | | Short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who is entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the initial authority application | Compliance with Authority Required procedures |
Nilotinib | C4001 | | | Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in chronic or accelerated phase who has failed an adequate trial of imatinib or dasatinib as first-line treatment
Failure of an adequate trial of imatinib or dasatinib is defined as:
(i) Lack of response to initial imatinib or dasatinib therapy, defined as either:
— failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib for patients initially treated in chronic phase; or
— failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or
— failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib; OR
(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib therapy; OR
(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib therapy; OR
(iv) Development of accelerated phase in a patient previously prescribed imatinib or dasatinib for the chronic phase of chronic myeloid leukaemia
Accelerated phase is defined by the presence of 1 or more of the following:
(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or
(3) Peripheral basophils greater than or equal to 20%; or
(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR
(v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or dasatinib therapy in patients with accelerated phase chronic myeloid leukaemia, provided that blast crisis has been excluded on bone marrow biopsy
Patients should be commenced on a dose of nilotinib of 400 mg twice daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to nilotinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals
Applications for authorisation must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Chronic Myeloid Leukaemia - Second and Third Line - Supporting Information Form; and
(c) a signed patient acknowledgement; and
(d) a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale. (The date of the relevant pathology report needs to be provided); and
(e) where there has been a loss of response to imatinib or dasatinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement | Compliance with Written Authority Required procedures
|
| C4002 | | | Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial PBS-subsidised treatment with nilotinib for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response, or less than 1% BCR-ABL level in the blood, to dasatinib in the preceding 18 months and thereafter at 12 monthly intervals
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Chronic Myeloid Leukaemia - Second and Third Line - Application Form for continuing treatment; and
(3) demonstration of continued response to treatment as evidenced by either:
(a) major cytogenetic response. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided
Definitions of response
A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells
A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response | Compliance with Written Authority Required procedures
|
| C4005 | | | Initial treatment, as the sole PBS-subsidised therapy, of a patient in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, BCR-ABL tyrosine kinase, and who has a primary diagnosis of chronic myeloid leukaemia
Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved
Patients should be commenced on a dose of nilotinib of 300 mg twice daily. Continuing therapy is dependent on patients demonstrating a response to nilotinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and
(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and
(4) a signed patient acknowledgement form | Compliance with Written Authority Required procedures
|
| C4006 | | | Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial PBS-subsidised treatment with nilotinib for the chronic phase of chronic myeloid leukaemia and who has demonstrated either a major cytogenetic response or less than 1% BCR-ABL level in the blood
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) demonstration of continued response to treatment as evidenced by either:
(a) major cytogenetic response. Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale. Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided
Definitions of response
A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells
A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response | Compliance with Written Authority Required procedures
|
Nilutamide | C3300 | | | Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) prostatic carcinoma, when used in conjunction with surgical orchidectomy | Compliance with Authority Required procedures - Streamlined Authority Code 3300 |
| C3675 | | | Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) analogue therapy | Compliance with Authority Required procedures - Streamlined Authority Code 3675 |
Nitrazepam | | P1123 | CN1123 | For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal | Compliance with Authority Required procedures |
| | P1126 | CN1126 | For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal | Compliance with Authority Required procedures |
| | P1216 | CN1216 | Malignant neoplasia (late stage) | Compliance with Authority Required procedures |
| | P1235 | CN1235 | Myoclonic epilepsy | Compliance with Authority Required procedures |
| | P3653 | CN3653 | Initial supply, for up to 4 months, for a palliative care patient where insomnia is a problem | Compliance with Authority Required procedures |
| | P3654 | CN3654 | Continuing supply for a palliative care patient where insomnia is a problem | Compliance with Authority Required procedures |
Norfloxacin | C1002 | | | Acute bacterial enterocolitis | Compliance with Authority Required procedures |
| C1070 | | | Complicated urinary tract infection | Compliance with Authority Required procedures |
Nortriptyline | C1860 | | | Major depression where other antidepressant therapy has failed | |
| C1861 | | | Major depression where other antidepressant therapy is contraindicated | |
Nystatin | C2354 | | | Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person | Compliance with Authority Required procedures - Streamlined Authority Code 2354 |
Octreotide | C2622 | | | Where the patient is receiving treatment at/from a private hospital Active acromegaly
Active acromegaly in a patient with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre and:
(a) after failure of other therapy including dopamine agonists; or
(b) as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or
(c) if the patient is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated.
In a patient treated with radiotherapy, treatment must cease if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks. Octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Treatment must cease if IGF1 is not lower after 3 months treatment at a dose of 100 micrograms 3 times daily | Compliance with Written or Telephone Authority Required procedures |
| C2623 | | | Where the patient is receiving treatment at/from a private hospital Functional carcinoid tumour or VIPoma
Functional carcinoid tumour or vasoactive intestinal peptide secreting tumour (VIPoma) causing intractable symptoms. The patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, and surgery or antineoplastic therapy must have failed or be inappropriate
Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose | Compliance with Written or Telephone Authority Required procedures |
| C2624 | | | Where the patient is receiving treatment at/from a private hospital Acromegaly
Acromegaly in a patient controlled on Sandostatin subcutaneous injections
In a patient treated with radiotherapy, treatment must cease if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose). Octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Treatment must cease if IGF1 is not lower after 3 months of treatment | Compliance with Written or Telephone Authority Required procedures |
| C2625 | | | Where the patient is receiving treatment at/from a private hospital Functional carcinoid tumour or VIPoma
Functional carcinoid tumour or vasoactive intestinal peptide secreting tumour (VIPoma) with symptom control on Sandostatin subcutaneous injections
Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with Sandostatin subcutaneous injections. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose | Compliance with Written or Telephone Authority Required procedures |
| C3407 | | | Where the patient is receiving treatment at/from a public hospital Active acromegaly
Active acromegaly in a patient with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre and:
(a) after failure of other therapy including dopamine agonists; or
(b) as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or
(c) if the patient is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated
In a patient treated with radiotherapy, treatment must cease if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks. Octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Treatment must cease if IGF1 is not lower after 3 months treatment at a dose of 100 micrograms 3 times daily | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3407 |
| C3408 | | | Where the patient is receiving treatment at/from a public hospital Functional carcinoid tumour or VIPoma
Functional carcinoid tumour or vasoactive intestinal peptide secreting tumour (VIPoma) causing intractable symptoms. The patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, and surgery or antineoplastic therapy must have failed or be inappropriate
Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3408 |
| C3409 | | | Where the patient is receiving treatment at/from a public hospital Acromegaly
Acromegaly in a patient controlled on Sandostatin subcutaneous injections.
In a patient treated with radiotherapy, treatment must cease if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose). Octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.
Treatment must cease if IGF1 is not lower after 3 months of treatment | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3409 |
| C3410 | | | Where the patient is receiving treatment at/from a public hospital Functional carcinoid tumour or VIPoma
Functional carcinoid tumour or vasoactive intestinal peptide secreting tumour (VIPoma) with symptom control on Sandostatin subcutaneous injections
Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with Sandostatin subcutaneous injections. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3410 |
Ofloxacin | C1031 | | | Bacterial keratitis | Compliance with Authority Required procedures |
| C3830 | | | Bacterial keratitis under the supervision and direction of an ophthalmologist | Compliance with Authority Required procedures |
Olanzapine | C1589 | | | Schizophrenia | Compliance with Authority Required procedures - Streamlined Authority Code 1589 |
| C2044 | | | Maintenance treatment of bipolar I disorder | Compliance with Authority Required procedures - Streamlined Authority Code 2044 |
Olmesartan with amlodipine | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Olmesartan with Hydrochlorothiazide | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Olsalazine | C1708 | | | Ulcerative colitis where hypersensitivity to sulfonamides exists | Compliance with Authority Required procedures - Streamlined Authority Code 1708 |
| C1709 | | | Ulcerative colitis where intolerance to sulfasalazine exists | Compliance with Authority Required procedures - Streamlined Authority Code 1709 |
Omeprazole | C1177 | P1177 | | Initial treatment of peptic ulcer | |
| C1337 | P1337 | | Scleroderma oesophagus | |
| C1476 | P1476 | | Zollinger-Ellison syndrome | |
| C1533 | P1533 | | Gastro-oesophageal reflux disease | |
Omeprazole and Clarithromycin and Amoxycillin | C1096 | | | Eradication of Helicobacter pylori associated with peptic ulcer disease | |
Ondansetron | C3050 | P3050 | | Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration | |
| C3611 | P3611 | | Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Compliance with Authority Required procedures - Streamlined Authority Code 3611 |
Oxaliplatin | C3900 | | | Metastatic colorectal cancer in a patient with a World Health Organisation performance status of 2 or less, when used in combination with capecitabine | Compliance with Authority Required procedures - Streamlined Authority Code 3900 |
| C3901 | | | Metastatic colorectal cancer in a patient with a World Health Organisation performance status of 2 or less, when used in combination with fluorouracil and folinic acid | Compliance with Authority Required procedures - Streamlined Authority Code 3901 |
| C3930 | | | Adjuvant treatment of stage III (Dukes C) colon cancer following complete resection of the primary tumour used in combination with capecitabine | Compliance with Authority Required procedures - Streamlined Authority Code 3930 |
| C3939 | | | Adjuvant treatment of stage III (Dukes C) colon cancer following complete resection of the primary tumour used in combination with 5-fluorouracil and folinic acid | Compliance with Authority Required procedures - Streamlined Authority Code 3939 |
Oxazepam | | P1123 | CN1123 | For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal | Compliance with Authority Required procedures |
| | P1126 | CN1126 | For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual | Compliance with Authority Required procedures |
| | P1216 | CN1216 | Malignant neoplasia (late stage) | Compliance with Authority Required procedures |
| | P3655 | CN3655 | Initial supply, for up to 4 months, for a palliative care patient where anxiety is a problem | Compliance with Authority Required procedures |
| | P3656 | CN3656 | Continuing supply for a palliative care patient where anxiety is a problem | Compliance with Authority Required procedures |
Oxcarbazepine | C1587 | | | Treatment of partial epileptic seizures and primary generalised tonic-clonic seizures, which are not controlled satisfactorily by other anti-epileptic drugs | Compliance with Authority Required procedures - Streamlined Authority Code 1587 |
Oxybutynin | C1081 | | | Detrusor overactivity | |
| C3152 | | | Detrusor overactivity in a patient who cannot tolerate oral oxybutynin, or who cannot swallow oral oxybutynin | |
Oxycodone | C1062 | | | Chronic severe disabling pain not responding to non-narcotic analgesics | |
| C1358 | | | Severe disabling pain not responding to non-narcotic analgesics | |
Oxycodone with naloxone | C1062 | | | Chronic severe disabling pain not responding to non-narcotic analgesics. | |
Paclitaxel | C3186 | | | Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound | Compliance with Authority Required procedures - Streamlined Authority Code 3186 |
| C3890 | | | Locally advanced or metastatic non-small cell lung cancer | Compliance with Authority Required procedures - Streamlined Authority Code 3890 |
| C3902 | | | Primary treatment of ovarian cancer in combination with a platinum compound | Compliance with Authority Required procedures - Streamlined Authority Code 3902 |
| C3917 | | | Adjuvant treatment of node-positive breast cancer administered sequentially to an anthracycline and cyclophosphamide | Compliance with Authority Required procedures - Streamlined Authority Code 3917 |
| C3955 | | | Metastatic breast cancer | Compliance with Authority Required procedures - Streamlined Authority Code 3955 |
| C3956 | | | Treatment of HER2 positive breast cancer in combination with trastuzumab | Compliance with Authority Required procedures - Streamlined Authority Code 3956 |
Paclitaxel, nanoparticle albumin-bound | C3955 | | | Metastatic breast cancer | Compliance with Authority Required procedures - Streamlined Authority Code 3955 |
| C3956 | | | Treatment of HER2 positive breast cancer in combination with trastuzumab | Compliance with Authority Required procedures - Streamlined Authority Code 3956 |
Paliperidone | C1589 | | | Schizophrenia | Compliance with Authority Required procedures - Streamlined Authority Code 1589 |
Palonosetron | C3545 | | | Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration | |
Pamidronic Acid | C1035 | | | Where the patient is receiving treatment at/from a private hospital Bone metastases from breast cancer | Compliance with Written or Telephone Authority Required procedures |
| C1233 | | | Where the patient is receiving treatment at/from a private hospital Multiple myeloma | Compliance with Written or Telephone Authority Required procedures |
| C1500 | | | Where the patient is receiving treatment at/from a private hospital Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy | Compliance with Written or Telephone Authority Required procedures |
| C3256 | | | Symptomatic Paget disease of bone | Compliance with Authority Required procedures - Streamlined Authority Code 3256 |
| C3341 | | | Where the patient is receiving treatment at/from a public hospital Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3341 |
| C3342 | | | Where the patient is receiving treatment at/from a public hospital Multiple myeloma | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3342 |
| C3343 | | | Where the patient is receiving treatment at/from a public hospital Bone metastases from breast cancer | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3343 |
Pancreatic Extract | | P3046 | | For use in patients with cystic fibrosis, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Pancrelipase | | P3046 | | For use in patients with cystic fibrosis, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Pantoprazole | C1177 | P1177 | | Initial treatment of peptic ulcer | |
| C1337 | P1337 | | Scleroderma oesophagus | |
| C1476 | P1476 | | Zollinger-Ellison syndrome | |
| C1533 | P1533 | | Gastro-oesophageal reflux disease | |
Paracetamol | | P2046 | | Chronic arthropathies | |
| C2094 | P2094 | | Relief of persistent pain associated with osteoarthritis | |
| C3649 | P3649 | | Initial supply, for up to 4 months, for a palliative care patient for analgesia or fever where alternative therapy cannot be tolerated | Compliance with Authority Required procedures - Streamlined Authority Code 3649 |
| C3650 | P3650 | | Continuing supply for a palliative care patient for analgesia or fever where alternative therapy cannot be tolerated | Compliance with Authority Required procedures - Streamlined Authority Code 3650 |
Paraffin | | P3035 | | For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Paroxetine | C1211 | | | Major depressive disorders | |
| C1241 | | | Obsessive-compulsive disorder | |
| C1862 | | | Panic disorder | |
Pazopanib | C4065 | P4065 | | Initial treatment, as the sole PBS-subsidised tyrosine kinase inhibitor therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who meets the Memorial Sloan Kettering Cancer Centre (MSKCC) low to intermediate risk group and has a World Health Organisation performance status of 2 or less | Compliance with Authority Required procedures |
| C4066 | P4066 | | Continuing treatment beyond 3 months, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who has previously been issued with an authority prescription for pazopanib and who has stable or responding disease according to RECIST (Response Evaluation Criteria in Solid Tumours) criteria | Compliance with Authority Required procedures |
| C4067 | P4067 | | Initial treatment, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who was receiving treatment with pazopanib prior to 1 October 2012 | Compliance with Authority Required procedures |
Pegfilgrastim | C2912 | | | Where the patient is receiving treatment at/from a private hospital For use in a patient undergoing induction and consolidation therapy for acute myeloid leukaemia | Compliance with Written or Telephone Authority Required procedures |
| C2917 | | | Where the patient is receiving treatment at/from a private hospital A patient with breast cancer receiving standard dose adjuvant chemotherapy who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures |
| C2918 | | | Where the patient is receiving treatment at/from a private hospital A patient receiving first-line chemotherapy for Hodgkin disease who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures |
| C2919 | | | Where the patient is receiving treatment at/from a private hospital A patient receiving chemotherapy for myeloma who has had a prior episode of febrile neutropenia, and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures |
| C2923 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia | Compliance with Written or Telephone Authority Required procedures |
| C2924 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in breast cancer (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) | Compliance with Written or Telephone Authority Required procedures |
| C2925 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours | Compliance with Written or Telephone Authority Required procedures |
| C2926 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in infants and children with CNS tumours | Compliance with Written or Telephone Authority Required procedures |
| C2927 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma | Compliance with Written or Telephone Authority Required procedures |
| C2928 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen) | Compliance with Written or Telephone Authority Required procedures |
| C2929 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease | Compliance with Written or Telephone Authority Required procedures |
| C2930 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma | Compliance with Written or Telephone Authority Required procedures |
| C3087 | | | Where the patient is receiving treatment at/from a private hospital A patient receiving chemotherapy for B-cell chronic lymphocytic leukaemia with fludarabine and cyclophosphamide who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures |
| C3187 | | | Where the patient is receiving treatment at/from a private hospital A patient with inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures |
| C3357 | | | Where the patient is receiving treatment at/from a public hospital For use in a patient undergoing induction and consolidation therapy for acute myeloid leukaemia | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3357 |
| C3362 | | | Where the patient is receiving treatment at/from a public hospital A patient with breast cancer receiving standard dose adjuvant chemotherapy who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3362 |
| C3363 | | | Where the patient is receiving treatment at/from a public hospital A patient receiving chemotherapy for B-cell chronic lymphocytic leukaemia with fludarabine and cyclophosphamide who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3363 |
| C3364 | | | Where the patient is receiving treatment at/from a public hospital A patient receiving first-line chemotherapy for Hodgkin disease who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3364 |
| C3365 | | | Where the patient is receiving treatment at/from a public hospital A patient receiving chemotherapy for myeloma who has had a prior episode of febrile neutropenia, and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3365 |
| C3369 | | | Where the patient is receiving treatment at/from a public hospital A patient with inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3369 |
| C3370 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3370 |
| C3371 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in breast cancer (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3371 |
| C3372 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3372 |
| C3373 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in infants and children with CNS tumours | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3373 |
| C3374 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3374 |
| C3375 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen) | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3375 |
| C3376 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3376 |
| C3377 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3377 |
| C3833 | | | Where the patient is receiving treatment at/from a private hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Hodgkin disease (first-line chemotherapy with escalated BEACOPP) | Compliance with Written or Telephone Authority Required procedures |
| C3834 | | | Where the patient is receiving treatment at/from a public hospital A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Hodgkin disease (first-line chemotherapy with escalated BEACOPP) | Compliance with
Written or Telephone
Authority Required procedures – Streamlined Authority
Code 3834 |
Peginterferon Alfa-2a | C2334 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis C
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and have a contraindication to ribavirin, who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception
The treatment course is limited to up to 48 weeks.
Patients may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop | Compliance with Written or Telephone Authority Required procedures |
| C3412 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis C
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and have a contraindication to ribavirin, who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.
The treatment course is limited to up to 48 weeks.
Patients may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3412 |
| C3975 | | | Where the patient is receiving treatment at/from a private hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Has received no prior peginterferon alfa therapy for the treatment of hepatitis B | Compliance with Written or Telephone Authority Required procedures |
| C3976 | | | Where the patient is receiving treatment at/from a private hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks | Compliance with Written or Telephone Authority Required procedures |
| C3977 | | | Where the patient is receiving treatment at/from a public hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Has received no prior peginterferon alfa therapy for the treatment of hepatitis B | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3977
|
| C3978 | | | Where the patient is receiving treatment at/from a public hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3978 |
Pemetrexed | C2957 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where the dose per treatment cycle does not exceed 500 mg per metre squared body surface area (BSA) and where the patient's BSA is included in the authority application | Compliance with Authority Required procedures
|
| C2958 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Mesothelioma, in combination with cisplatin, where the dose per treatment cycle does not exceed 500 mg per metre squared body surface area (BSA) and where the patient's BSA is included in the authority application | Compliance with Authority Required procedures
|
| C3885 | | | Where the patient is receiving treatment at/from a Public Hospital Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where the dose per treatment cycle does not exceed 500 mg per metre squared body surface area (BSA) and where the patient's BSA is documented in the patient's medical records at the time the treatment cycle is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3885 |
| C3886 | | | Where the patient is receiving treatment at/from a Public Hospital Mesothelioma, in combination with cisplatin, where the dose per treatment cycle does not exceed 500 mg per metre squared body surface area (BSA) and where the patient's BSA is documented in the patient's medical records at the time the treatment cycle is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3886 |
Pergolide | C1863 | | | Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations | |
Perhexiline | C1023 | | | Angina not responding to other therapy | Compliance with Authority Required procedures - Streamlined Authority Code 1023 |
Perindopril with amlodipine | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
| C3308 | | | Stable coronary heart disease in a patient who is stabilised on treatment with perindopril and amlodipine at the same doses | |
Perindopril with Indapamide | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Phenelzine | C1609 | | | Depression where all other anti-depressant therapy has failed or is inappropriate | |
Phenobarbitone | C1093 | | | Epilepsy | |
Phenoxybenzamine | C1239 | | | Neurogenic urinary retention | |
| C1285 | | | Phaeochromocytoma | |
Phenoxymethylpenicillin | | P1304 | | Prophylaxis of recurrent streptococcal infections (including rheumatic fever) | |
Phenylalanine with carbohydrate | C1453 | | | Tyrosinaemia | |
Pimecrolimus | C2455 | | | Treatment of facial or eyelid atopic dermatitis in patients aged at least 3 months who have 1 or more of the following contraindications to topical corticosteroids:
perioral dermatitis;
periorbital dermatitis;
rosacea;
epidermal atrophy;
dermal atrophy;
allergy to topical corticosteroids;
cataracts;
glaucoma;
raised intraocular pressure; and
where a period of 6 months or more has elapsed since an application was last approved for the issue of an authority prescription to the patient for this purpose | Compliance with Authority Required procedures |
| C2456 | | | Short-term (up to 3 weeks) intermittent treatment of atopic dermatitis of the face or eyelids in patients aged at least 3 months who fail to achieve satisfactory disease control with intermittent topical corticosteroid therapy and where more than 3 months have passed since the initial diagnosis of atopic dermatitis; and
where failure to achieve satisfactory disease control with intermittent topical corticosteroid therapy is manifest by:
failure of the facial skin to clear despite at least 2 weeks of topical hydrocortisone 1% applied every day; or
failure of the facial skin to clear despite at least 1 week of a moderate or potent topical corticosteroid applied every day; or
clearing of the facial skin with at least 2 weeks of topical hydrocortisone 1% applied every day, but almost immediate and significant flare in facial disease (within 48 hours) upon stopping topical corticosteroids, occurring on at least 2 consecutive occasions; or
clearing of the facial skin with at least 1 week of a moderate or potent topical corticosteroid applied every day, but almost immediate and significant flare in facial disease (within 48 hours) upon stopping topical corticosteroids, occurring on at least 2 consecutive occasions; and
where a period of 6 months or more has elapsed since an application was last approved for the issue of an authority prescription to the patient for this purpose | Compliance with Authority Required procedures |
Pioglitazone | C3540 | | | Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with either metformin or a sulfonylurea; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and
where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3540 |
| C3541 | | | Treatment of type 2 diabetes, in combination with insulin, in a patient:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with insulin and oral anti-diabetic agents, or with insulin alone where metformin is contraindicated; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with insulin and oral anti-diabetic agents, or with insulin alone where metformin is contraindicated; and
where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3541 |
| C3542 | | | Treatment of type 2 diabetes, in combination with metformin and a sulfonylurea, in a patient:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with maximally tolerated doses of metformin and a sulfonylurea; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with maximally tolerated doses of metformin and a sulfonylurea; and | Compliance with Authority Required procedures - Streamlined Authority Code 3542 |
| | | | where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | |
Piroxicam | C1054 | | | Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
Pneumococcal Vaccine - Polyvalent | C1282 | | | Persons at high risk of pneumococcal infections | |
| C1284 | | | Persons with Hodgkin's disease | |
| C1385 | | | Splenectomised persons over 2 years of age | |
Polyethylene glycol 400 | C1359 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures - Streamlined Authority Code 1359 |
| C1362 | P1362 | | Severe dry eye syndrome, including Sjogren's syndrome | |
| C2802 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures |
| C3036 | P3036 | | For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Polyethylene Glycol 400 with Propylene Glycol | C1359 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures - Streamlined Authority Code 1359 |
| C1362 | P1362 | | Severe dry eye syndrome, including Sjogren's syndrome | |
| C2802 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures |
| C3036 | P3036 | | For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Poly-l-lactic acid | C3182 | P3182 | | Initial PBS-subsidised treatment, for facial administration only, of severe facial lipoatrophy caused by therapy for HIV infection;
accreditation following completion of injection administration training with Sanofi-Aventis is required to prescribe poly-l-lactic acid under the PBS;
patients must be referred from the HIV physician to the accredited injector | Compliance with Written or Telephone Authority Required procedures |
| C3183 | P3183 | | Maintenance PBS-subsidised treatment, for facial administration only, of severe facial lipoatrophy caused by therapy for HIV infection;
accreditation following completion of injection administration training with Sanofi-Aventis is required to prescribe poly-l-lactic acid under the PBS;
patients must be referred from the HIV physician to the accredited injector | Compliance with Written or Telephone Authority Required procedures |
Polyvinyl Alcohol | C1362 | P1362 | | Severe dry eye syndrome, including Sjogren's syndrome | |
| C3036 | P3036 | | For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Posaconazole | C3058 | | | Treatment of invasive aspergillosis in patients intolerant to, or with disease refractory to, alternative therapy | Compliance with Authority Required procedures |
| C3059 | | | Treatment of fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis and mycetoma in patients intolerant to, or with disease refractory to, alternative therapy | Compliance with Authority Required procedures |
| C3060 | | | Prophylaxis of invasive fungal infections, including both yeasts and moulds, in a patient who is at high risk of developing these infections, defined as follows:
(1) neutropenia — patients with anticipated neutropenia (an absolute neutrophil count of less than 500 cells per cubic millimetre) for at least 10 days, who are receiving chemotherapy for acute myelogenous leukaemia or myelodysplastic syndrome
treatment should continue until recovery of the neutrophil count to at least 500 cells per cubic millimetre;
patients who have had a previous invasive fungal infection should have secondary prophylaxis during subsequent episodes of neutropenia;
(2) graft versus host disease (GVHD) — patients with acute GVHD grades II to IV or extensive chronic GVHD, who are receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant;
PBS-subsidised treatment is limited to a maximum of 6 months therapy per episode | Compliance with Authority Required procedures |
Pramipexole | C3088 | P3088 | | Treatment of severe primary restless legs syndrome in a patient who manifests all 4 diagnostic criteria listed below and whose baseline International Restless Legs Syndrome Rating Scale (IRLSRS) score is greater than or equal to 21 points prior to initiation of pramipexole, where the date and IRLSRS score are documented in the patient's medical records at the time pramipexole treatment is initiated, and where the diagnostic criteria for restless legs syndrome are:
(a) an urge to move the legs usually accompanied or caused by unpleasant sensations in the legs; and
(b) the urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting; and
(c) the urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues; and
(d) the urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur during the evening or night | |
| C3216 | P3216 | | Parkinson disease | |
Prasugrel | C3208 | | | Treatment of acute coronary syndrome (myocardial infarction or unstable angina) managed by percutaneous coronary intervention in combination with aspirin | Compliance with Authority Required procedures - Streamlined Authority Code 3208 |
Pravastatin | C1540 | P1540 | | For use in patients that meet the criteria set out in the General Statement for Lipid-Lowering Drugs | |
| C3047 | P3047 | | For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Praziquantel | C3147 | | | Schistosomiasis | Compliance with Authority Required procedures - Streamlined Authority Code 3147 |
Prednisolone | C1294 | | | Proctitis | |
| C1454 | | | Ulcerative colitis | |
Prednisolone with Phenylephrine | C1077 | | | Corneal grafts | |
| C1465 | | | Uveitis | |
Propantheline | C1081 | | | Detrusor overactivity | |
Protein hydrolysate formula with medium chain triglycerides | C1034 | | | Biliary atresia | Compliance with Authority Required procedures |
| C1059 | | | Chronic liver failure with fat malabsorption | Compliance with Authority Required procedures |
| C1068 | | | Chylothorax | Compliance with Authority Required procedures |
| C1080 | | | Cystic fibrosis | Compliance with Authority Required procedures |
| C1092 | | | Enterokinase deficiency | Compliance with Authority Required procedures |
| C1310 | | | Proven fat malabsorption | Compliance with Authority Required procedures |
| C1364 | | | Severe intestinal malabsorption including short bowel syndrome | Compliance with Authority Required procedures |
| C1670 | | | Chylous ascites | Compliance with Authority Required procedures |
| C2567 | | | Severe diarrhoea of greater than 2 weeks' duration in an infant aged less than 4 months, where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C4040 | | | Initial treatment by, or in consultation with, a specialist allergist, clinical immunologist, paediatrician or specialist paediatric gastroenterologist for both cows' milk protein enteropathy and intolerance to soy protein (not isolated infant colic or reflux) in a child up to the age of 24 months. The child should have failed to respond to a strict soy-based cows' milk protein free diet. The date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4041 | | | Continuing treatment by, or in consultation with, a specialist allergist, clinical immunologist, paediatrician or specialist paediatric gastroenterologist for both cows' milk protein enteropathy and intolerance to soy protein (not isolated infant colic or reflux) in a child up to the age of 24 months, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides. The date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4042 | | | Treatment by a specialist allergist, clinical immunologist, paediatrician or specialist paediatric gastroenterologist for both cows' milk protein enteropathy and intolerance to soy protein (not isolated infant colic or reflux) in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
Quetiapine | C1589 | | | Schizophrenia | Compliance with Authority Required procedures - Streamlined Authority Code 1589 |
| C2044 | | | Maintenance treatment of bipolar I disorder | Compliance with Authority Required procedures - Streamlined Authority Code 2044 |
| C2765 | | | Monotherapy, for up to 6 months, of an episode of acute mania associated with bipolar I disorder | Compliance with Authority Required procedures - Streamlined Authority Code 2765 |
Quinagolide | C2659 | | | Pathological hyperprolactinaemia where surgery is not indicated | Compliance with Authority Required procedures - Streamlined Authority Code 2659 |
| C2660 | | | Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution | Compliance with Authority Required procedures - Streamlined Authority Code 2660 |
| C2661 | | | Pathological hyperprolactinaemia where radiotherapy is not indicated | Compliance with Authority Required procedures - Streamlined Authority Code 2661 |
| C2662 | | | Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution | Compliance with Authority Required procedures - Streamlined Authority Code 2662 |
Quinapril with Hydrochlorothiazide | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Quinine | C2142 | | | Malaria | Compliance with Authority Required procedures - Streamlined Authority Code 2142 |
Rabeprazole | C1177 | P1177 | | Initial treatment of peptic ulcer | |
| C1337 | P1337 | | Scleroderma oesophagus | |
| C1533 | P1533 | | Gastro-oesophageal reflux disease | |
Raloxifene | C2647 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for established post-menopausal osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | Compliance with Authority Required procedures - Streamlined Authority Code 2647 |
Raltegravir | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Raltitrexed | C3185 | | | For use as a single agent in the treatment of advanced colorectal cancer | Compliance with Authority Required procedures - Streamlined Authority Code 3185 |
Ramipril with Felodipine | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Ranibizumab | C2677 | | | Continuing treatment by an ophthalmologist, as the sole PBS-subsidised therapy, of subfoveal choroidal neovascularisation due to age-related macular degeneration, where the patient has previously been granted an authority prescription for ranibizumab for treatment of the same eye | Compliance with Written or Telephone Authority Required procedures |
| C3859 | | | Initial treatment by an ophthalmologist, as the sole PBS-subsidised therapy, of subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration, as diagnosed by fluorescein angiography or, where a fluorescein angiogram cannot be performed due to a contraindication as listed in the Therapeutic Goods Administration (TGA)-approved Product Information, by an alternative method of diagnosis, and where:
the patient has not previously received PBS-subsidised treatment with ranibizumab in the eye for which treatment is being sought;
the authority application includes a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and either a copy of the fluorescein angiogram or, where applicable, details of the contraindication to fluorescein angiography and a copy of the report of the alternative method of diagnosis (e.g. optical coherence tomography (OCT) or red free photography) | Compliance with Written Authority Required procedures |
| | | | Initial treatment by an ophthalmologist, as the sole PBS-subsidised therapy, of subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration, as diagnosed by fluorescein angiography or, where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved Product Information, by an alternative method of diagnosis, and where:
the patient has not previously received PBS-subsidised treatment with ranibizumab in the eye for which treatment is being sought;
the authority application includes a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and either a copy of the fluorescein angiogram or, where applicable, details of the contraindication to fluorescein angiography and a copy of the report of the alternative method of diagnosis (e.g. optical coherence tomography (OCT) or red free photography), is submitted to the Chief Executive Medicare by facsimile prior to contact by telephone and is resubmitted to the Chief Executive Medicare by post after the application has been authorised | Compliance with Telephone Authority Required procedures |
Rasagiline | C4053 | | | Parkinson disease | Compliance with Authority Required procedures – Streamlined Authority Code 4053 |
Reboxetine | C1211 | | | Major depressive disorders | |
Reteplase | C1480 | | | Treatment of acute myocardial infarction within 6 hours of onset of attack | |
Ribavirin and Peginterferon Alfa-2a | C3053 | | | Where the patient is receiving treatment at/from a private hospital Patients who have failed one prior attempt at interferon based therapies (non-pegylated or pegylated)
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant
The treatment course is limited to 48 weeks. Patients may only continue treatment after the first 12 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 12 | Compliance with Written or Telephone Authority Required procedures |
| C3055 | | | Where the patient is receiving treatment at/from a private hospital Patients naive to interferon based therapies (non-pegylated or pegylated)
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant.
For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks
Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. (An HCV RNA assay at week 12 is unnecessary for genotype 2 and 3 patients because of the high likelihood of early viral response by week 12).
Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12 | Compliance with Written or Telephone Authority Required procedures |
| C3413 | | | Where the patient is receiving treatment at/from a public hospital Patients naive to interferon based therapies (non-pegylated or pegylated)
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant.
For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks
Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. (An HCV RNA assay at week 12 is unnecessary for genotype 2 and 3 patients because of the high likelihood of early viral response by week 12).
Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12 | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3413 |
| C3414 | | | Where the patient is receiving treatment at/from a public hospital Patients who have failed one prior attempt at interferon based therapies (non-pegylated or pegylated)
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant
The treatment course is limited to 48 weeks. Patients may only continue treatment after the first 12 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 12 | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3414 |
Ribavirin and Peginterferon Alfa-2b | C3053 | | | Where the patient is receiving treatment at/from a private hospital Patients who have failed one prior attempt at interferon based therapies (non-pegylated or pegylated)
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant
The treatment course is limited to 48 weeks. Patients may only continue treatment after the first 12 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 12 | Compliance with Written or Telephone Authority Required procedures |
| C3055 | | | Where the patient is receiving treatment at/from a private hospital Patients naive to interferon based therapies (non-pegylated or pegylated)
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant
For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks
Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. (An HCV RNA assay at week 12 is unnecessary for genotype 2 and 3 patients because of the high likelihood of early viral response by week 12).
Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12 | Compliance with Written or Telephone Authority Required procedures |
| C3413 | | | Where the patient is receiving treatment at/from a public hospital Patients naive to interferon based therapies (non-pegylated or pegylated)
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant.
For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks
Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. (An HCV RNA assay at week 12 is unnecessary for genotype 2 and 3 patients because of the high likelihood of early viral response by week 12).
Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12 | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3413 |
| C3414 | | | Where the patient is receiving treatment at/from a public hospital Patients who have failed one prior attempt at interferon based therapies (non-pegylated or pegylated)
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant
The treatment course is limited to 48 weeks. Patients may only continue treatment after the first 12 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 12 | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3414 |
| C3948 | | | Where the patient is receiving treatment at/from a Private Hospital Patients naive to interferon based therapies (non-pegylated or pegylated)
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients weighing at least 27 kg who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant
For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks
Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. (An HCV RNA assay at week 12 is unnecessary for genotype 2 and 3 patients because of the high likelihood of early viral response by week 12).
Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12 | Compliance with Written or Telephone Authority Required procedures |
| C3949 | | | Where the patient is receiving treatment at/from a public hospital Patients naive to interferon based therapies (non-pegylated or pegylated)
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients weighing at least 27 kg who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant
For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks
Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. (An HCV RNA assay at week 12 is unnecessary for genotype 2 and 3 patients because of the high likelihood of early viral response by week 12).
Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12 | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3949
|
Rifabutin | C1299 | | | Where the patient is receiving treatment at/from a private hospital Prophylaxis against Mycobacterium avium complex infections in human immunodeficiency virus-positive patients with CD4 cell counts of less than 75 per cubic millimetre | Compliance with Written or Telephone Authority Required procedures |
| C1435 | | | Where the patient is receiving treatment at/from a private hospital Treatment of Mycobacterium avium complex infections in human immunodeficiency virus-positive patients | Compliance with Written or Telephone Authority Required procedures |
| C3317 | | | Where the patient is receiving treatment at/from a public hospital Prophylaxis against Mycobacterium avium complex infections in human immunodeficiency virus-positive patients with CD4 cell counts of less than 75 per cubic millimetre | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3317 |
| C3415 | | | Where the patient is receiving treatment at/from a public hospital Treatment of Mycobacterium avium complex infections in human immunodeficiency virus-positive patients | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3415 |
Rifampicin | C1190 | P1190 | | Leprosy in adults | Compliance with Authority Required procedures |
| C1297 | P1297 | | Prophylactic treatment of contacts of patients with Haemophilus influenzae type B | |
| C1303 | P1303 | | Prophylaxis of meningococcal disease in close contacts and carriers | |
Rilpivirine | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Riluzole | C1762 | | | Continuing treatment of amyotrophic lateral sclerosis in patients who have previously been issued with an authority prescription for this drug and who have not undergone tracheostomy, have not experienced respiratory failure and, if not ambulatory, are either able to use upper limbs or able to swallow | Compliance with Authority Required procedures |
| C2718 | | | Initial treatment of amyotrophic lateral sclerosis, as diagnosed by a neurologist, in patients with disease duration of 5 years or less who have at least 60 percent of predicted forced vital capacity within 2 months prior to commencing riluzole therapy, and who have not undergone tracheostomy, have not experienced respiratory failure and, if not ambulatory, are either able to use upper limbs or able to swallow, and where the date of diagnosis and the date and results of spirometry (in terms of percent of predicted forced vital capacity) are included in the authority application | Compliance with Authority Required procedures |
Risedronic Acid | C2645 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 2645 |
| C2646 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | Compliance with Authority Required procedures - Streamlined Authority Code 2646 |
| C3070 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3070 |
| C3256 | | | Symptomatic Paget disease of bone | Compliance with Authority Required procedures - Streamlined Authority Code 3256 |
Risedronic Acid and Calcium | C2645 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 2645 |
| C2646 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | Compliance with Authority Required procedures - Streamlined Authority Code 2646 |
| C3070 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3070 |
Risedronic acid and calcium with colecalciferol | C2645 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 2645 |
| C2646 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | Compliance with Authority Required procedures - Streamlined Authority Code 2646 |
| C3070 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3070 |
Risperidone | C1589 | P1589 | | Schizophrenia | Compliance with Authority Required procedures - Streamlined Authority Code 1589 |
| C2061 | P2061 | | Behavioural disturbances characterised by psychotic symptoms and aggression in patients with dementia where non-pharmacological methods have been unsuccessful | Compliance with Authority Required procedures - Streamlined Authority Code 2061 |
| C2272 | P2272 | | Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder | Compliance with Authority Required procedures - Streamlined Authority Code 2272 |
| C3083 | P3083 | | Treatment under the supervision of a paediatrician or psychiatrist, in combination with non-pharmacological measures, of severe behavioural disturbances in either a patient aged less than 18 years with autism, or a patient 18 years of age or older with autism who was commenced on PBS-subsidised treatment with risperidone prior to turning 18 years of age and is continuing PBS-subsidised treatment, where behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful, and where the diagnosis of autism has been made based on either the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or the ICD-10 international classification of mental and behavioural disorders | Compliance with Authority Required procedures - Streamlined Authority Code 3083 |
| C3841 | | | Maintenance treatment, in combination with lithium or sodium valproate, of treatment refractory bipolar I disorder | Compliance with Authority Required procedures - Streamlined Authority Code 3841 |
Ritonavir | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Rituximab | C1744 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma | Compliance with Authority Required procedures |
| C1745 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma | Compliance with Authority Required procedures |
| C2068 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy | Compliance with Authority Required procedures |
| C2386 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma in combination with chemotherapy | Compliance with Authority Required procedures |
| C3908 | | | Where the patient is receiving treatment at/from a Public Hospital Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma | Compliance with Authority Required procedures - Streamlined Authority Code 3908 |
| C3909 | | | Where the patient is receiving treatment at/from a Public Hospital Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma | Compliance with Authority Required procedures - Streamlined Authority Code 3909 |
| C3912 | | | Where the patient is receiving treatment at/from a Public Hospital Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy | Compliance with Authority Required procedures - Streamlined Authority Code 3912 |
| C3915 | | | Where the patient is receiving treatment at/from a Public Hospital Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma in combination with chemotherapy | Compliance with Authority Required procedures - Streamlined Authority Code 3915 |
| C3931 | | | Where the patient is receiving treatment in the community setting or at/from a Private Hospital CD20 positive, chronic lymphocytic leukaemia, in combination with fludarabine and cyclophosphamide | Compliance with Authority Required procedures |
| C3932 | | | Where the patient is receiving treatment at/from a Public Hospital CD20 positive, chronic lymphocytic leukaemia, in combination with fludarabine and cyclophosphamide | Compliance with Authority Required procedures - Streamlined Authority Code 3932 |
Rivaroxaban | C3957 | P3957 | | Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy | Compliance with Authority Required procedures |
| C3993 | P3993 | | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days of therarpy | Compliance with Authority Required procedures |
| C4047 | P4047 | | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 20 days supply to complete a course of treatment | Compliance with Authority Required procedures |
| C4048 | P4048 | | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days supply to complete a course of treatment | Compliance with Authority Required procedures |
| C4050 | P4050 | | Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 15 days of therapy | Compliance with Authority Required procedures |
Rivastigmine | C2934 | | | Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more who demonstrate improvement in cognitive function following initial PBS-subsidised therapy, and where:
(1) improvement in cognitive function is demonstrated by:
(a) in the case of patients with a baseline MMSE or SMMSE score of 10 or more and less than 25 — an increase of at least 2 points from baseline on the MMSE or SMMSE; or
(b) in the case of patients with a baseline MMSE or SMMSE score of at least 25 points — an increase of at least 2 points from baseline on the MMSE or SMMSE, or, if a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) was submitted with the application for initial treatment, a decrease of at least 4 points from baseline on the ADAS-Cog; and
(2) the relevant result from the MMSE, SMMSE or ADAS-Cog is included in the authority application for continuing treatment | Compliance with Written Authority Required procedures |
| | | | Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more and with demonstrated improvement in cognitive function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment | Compliance with Written Authority Required procedures |
| C2938 | | | Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease and who demonstrate improvement in function following initial PBS-subsidised therapy, based on a rating of "very much improved" or "much improved" on the Clinicians Interview Based Impression of Change scale, as assessed by the same clinician who initiated treatment, and where the improvement rating achieved on the Clinicians Interview Based Impression of Change scale is stated in the authority application for continuing treatment | Compliance with Written Authority Required procedures |
| | | | Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less and with demonstrated improvement in function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment | Compliance with Written Authority Required procedures |
| C3875 | | | Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application | Compliance with Authority Required procedures |
| | | | Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the baseline scores submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total | Compliance with Written Authority Required procedures |
| | | | Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application | Compliance with Written Authority Required procedures |
| C3876 | | | Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment | Compliance with Authority Required procedures |
| | | | Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the information submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total | Compliance with Written Authority Required procedures |
| | | | Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment | Compliance with Written Authority Required procedures |
Rizatriptan | C3233 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics | Compliance with Authority Required procedures - Streamlined Authority Code 3233 |
Rosiglitazone | C3722 | | | Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with either metformin or a sulfonylurea; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and
where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures |
Rosiglitazone with Metformin | C3723 | | | Treatment of type 2 diabetes in a patient in whom a sulfonylurea is contraindicated or not tolerated, and:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with metformin; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with metformin; and
where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures |
Rosuvastatin | C1540 | | | For use in patients that meet the criteria set out in the General Statement for Lipid-Lowering Drugs | |
| C3047 | | | For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Salbutamol | C1266 | | | Patients unable to achieve co-ordinated use of other metered dose inhalers containing this drug | |
| C1754 | | | Asthma in patients unable to use this drug delivered from an oral pressurised inhalation device via a spacer | |
| C1755 | | | Chronic obstructive pulmonary disease in patients unable to use this drug delivered from an oral pressurised inhalation device via a spacer | |
Salcatonin | C1412 | | | Treatment initiated in a hospital (in-patient or out-patient) of hypercalcaemia | Compliance with Authority Required procedures - Streamlined Authority Code 1412 |
| C3256 | | | Symptomatic Paget disease of bone | Compliance with Authority Required procedures - Streamlined Authority Code 3256 |
Salmeterol | C1752 | | | Patients with frequent episodes of asthma who are currently receiving treatment with oral corticosteroids | |
| C1753 | | | Patients with frequent episodes of asthma who are currently receiving treatment with optimal doses of inhaled corticosteroids | |
Saquinavir | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Saxagliptin | C3540 | | | Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with either metformin or a sulfonylurea; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and
where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3540 |
Selegiline | C1864 | | | Late stage Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations. | |
Sertraline | C1211 | | | Major depressive disorders | |
| C1241 | | | Obsessive-compulsive disorder | |
| C1975 | | | Panic disorder where other treatments have failed or are inappropriate | |
Sevelamer | C3103 | P3103 | | Where the patient is receiving treatment at/from a private hospital Management (which includes initiation, stabilisation and review of therapy as required) of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where serum phosphate is greater than 1.6 mmol per L at the commencement of therapy | Compliance with Written or Telephone Authority Required procedures |
| C3104 | P3104 | | Where the patient is receiving treatment at/from a private hospital Management (which includes initiation, stabilisation and review of therapy as required) of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where the serum calcium times phosphate product is greater than 4.0 at the commencement of therapy | Compliance with Written or Telephone Authority Required procedures |
| C3390 | P3390 | | Where the patient is receiving treatment at/from a public hospital Management (which includes initiation, stabilisation and review of therapy as required) of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where serum phosphate is greater than 1.6 mmol per L at the commencement of therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3390 |
| C3391 | P3391 | | Where the patient is receiving treatment at/from a public hospital Management (which includes initiation, stabilisation and review of therapy as required) of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where the serum calcium times phosphate product is greater than 4.0 at the commencement of therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3391 |
| C3548 | P3548 | | Maintenance therapy, following initiation and stabilisation of treatment with sevelamer hydrochloride, of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where serum phosphate is greater than 1.6 mmol per L at the commencement of therapy | Compliance with Authority Required procedures - Streamlined Authority Code 3548 |
| C3549 | P3549 | | Maintenance therapy, following initiation and stabilisation of treatment with sevelamer hydrochloride, of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where the serum calcium times phosphate product is greater than 4.0 at the commencement of therapy | Compliance with Authority Required procedures - Streamlined Authority Code 3549 |
Silver sulfadiazine | C1386 | | | Stasis ulcers | |
| C1865 | | | Prevention and treatment of infection in partial or full skin thickness loss due to burns | |
| C1866 | | | Prevention and treatment of infection in partial or full skin thickness loss due to epidermolysis bullosa | |
Simvastatin | C1540 | P1540 | | For use in patients that meet the criteria set out in the General Statement for Lipid-Lowering Drugs | |
| C3047 | P3047 | | For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Sirolimus | C1650 | | | Where the patient is receiving treatment at/from a private hospital Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required | Compliance with Written or Telephone Authority Required procedures |
| C1952 | | | Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with sirolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | Compliance with Authority Required procedures |
| C3355 | | | Where the patient is receiving treatment at/from a public hospital Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3355 |
Sitagliptin | C3540 | | | Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with either metformin or a sulfonylurea; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and
where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3540 |
Sitagliptin with metformin | C3149 | | | Continuation of therapy in type 2 diabetes mellitus in a patient who has previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and sitagliptin | Compliance with Authority Required procedures - Streamlined Authority Code 3149 |
| C3543 | | | Treatment of type 2 diabetes in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with metformin; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with metformin; and
where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3543 |
Sodium Acid Phosphate | C1099 | | | Familial hypophosphataemia | Compliance with Authority Required procedures - Streamlined Authority Code 1099 |
| C1157 | | | Hypercalcaemia | Compliance with Authority Required procedures - Streamlined Authority Code 1157 |
| C1167 | | | Hypophosphataemic rickets | Compliance with Authority Required procedures - Streamlined Authority Code 1167 |
| C1467 | | | Vitamin D-resistant rickets | Compliance with Authority Required procedures - Streamlined Authority Code 1467 |
Sorafenib | C3071 | | | Initial treatment, as the sole PBS-subsidised agent, of advanced (Barcelona Clinic Liver Cancer Stage C) hepatocellular carcinoma in a patient with a World Health Organisation performance status of 2 or less and Child Pugh class A | Compliance with Authority Required procedures |
| C3072 | | | Continuing treatment, as the sole PBS-subsidised agent, of advanced hepatocellular carcinoma in a patient who has previously been treated with PBS-subsidised sorafenib and who does not have progressive disease | Compliance with Authority Required procedures |
Sorbitol With Sodium Citrate And Sodium Lauryl Sulfoacetate | C1025 | P1025 | | Anorectal congenital abnormalities | |
| C1122 | P1122 | | For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult | |
| C1221 | P1221 | | Megacolon | |
| C1254 | P1254 | | Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function | |
| C1263 | P1263 | | Patients receiving palliative care | |
| C1268 | P1268 | | Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities | |
| C1400 | P1400 | | Terminal malignant neoplasia | |
| C3642 | P3642 | | Initial supply, for up to 4 months, for a palliative care patient where constipation is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3642 |
| C3643 | P3643 | | Continuing supply for a palliative care patient where constipation is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3643 |
Sotalol | C1350 | | | Severe cardiac arrhythmias | |
Soy lecithin | C1359 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures - Streamlined Authority Code 1359 |
| C2802 | | | Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | Compliance with Authority Required procedures |
Soy protein and fat formula with vitamins and minerals — carbohydrate free | C1578 | | | Patients with intractable seizures requiring treatment with a ketogenic diet | |
| C1579 | | | Glucose transport protein defects | |
| C1580 | | | Pyruvate dehydrogenase deficiency | |
| C1581 | | | Infants and young children with glucose-galactose intolerance and multiple monosaccharide intolerance. | |
Stavudine | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Sterculia With Frangula Bark | C1025 | P1025 | | Anorectal congenital abnormalities | |
| C1122 | P1122 | | For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult | |
| C1221 | P1221 | | Megacolon | |
| C1254 | P1254 | | Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function | |
| C1263 | P1263 | | Patients receiving palliative care | |
| C1268 | P1268 | | Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities | |
| C1400 | P1400 | | Terminal malignant neoplasia | |
| C3642 | P3642 | | Initial supply, for up to 4 months, for a palliative care patient where constipation is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3642 |
| C3643 | P3643 | | Continuing supply for a palliative care patient where constipation is a problem | Compliance with Authority Required procedures - Streamlined Authority Code 3643 |
Strontium | C2647 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for established post-menopausal osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | Compliance with Authority Required procedures - Streamlined Authority Code 2647 |
| C2758 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a woman aged 70 years or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 2758 |
Sulfasalazine | | P3035 | | For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
Sumatriptan | C3233 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics | Compliance with Authority Required procedures - Streamlined Authority Code 3233 |
Sunitinib | C3109 | P3109 | | Initial treatment, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who meets the Memorial Sloan Kettering Cancer Centre (MSKCC) low to intermediate risk group and has a World Health Organisation performance status of 2 or less | Compliance with Authority Required procedures |
| C3206 | P3206 | | Initial PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour after failure of imatinib mesylate treatment due to resistance or intolerance, and where the application for authorisation includes:
(1) a completed copy of the appropriate Sunitinib Malate (Sutent) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form; and
(2) a signed patient acknowledgement | Compliance with Written Authority Required procedures |
| C3207 | P3207 | | Continuing PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour who has previously been issued with an authority prescription for sunitinib and who does not have progressive disease on sunitinib | Compliance with Written or Telephone Authority Required procedures |
| C4065 | P4065 | | Initial treatment, as the sole PBS-subsidised tyrosine kinase inhibitor therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who meets the Memorial Sloan Kettering Cancer Centre (MSKCC) low to intermediate risk group and has a World Health Organisation performance status of 2 or less | Compliance with Authority Required procedures |
Tacrolimus | C1654 | | | Where the patient is receiving treatment at/from a private hospital Management of rejection in patients following organ or tissue transplantation, under the supervision and direction of a transplant unit, where management includes initiation, stabilisation and review of therapy as required | Compliance with Written or Telephone Authority Required procedures |
| C3080 | | | Maintenance therapy, following initiation and stabilisation of treatment with tacrolimus, of patients with organ or tissue transplants, where therapy remains under the supervision and direction of the transplant unit reviewing the patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | Compliance with Authority Required procedures |
| C3328 | | | Where the patient is receiving treatment at/from a public hospital Management of rejection in patients following organ or tissue transplantation, under the supervision and direction of a transplant unit, where management includes initiation, stabilisation and review of therapy as required | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3328 |
Tamoxifen | C1749 | | | Treatment of hormone-dependent breast cancer | |
Telbivudine | C3967 | | | Where the patient is receiving treatment at/from a private hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy | Compliance with Written or Telephone Authority Required procedures |
| C3968 | | | Where the patient is receiving treatment at/from a private hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures |
| C3969 | | | Where the patient is receiving treatment at/from a public hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3969
|
| C3970 | | | Where the patient is receiving treatment at/from a public hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3970 |
Telmisartan with amlodipine | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination. | |
Telmisartan With Hydrochlorothiazide | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Temazepam | | P1123 | CN1123 | For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal | Compliance with Authority Required procedures |
| | P1126 | CN1126 | For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal | Compliance with Authority Required procedures |
| | P1216 | CN1216 | Malignant neoplasia (late stage) | Compliance with Authority Required procedures |
| | P3653 | CN3653 | Initial supply, for up to 4 months, for a palliative care patient where insomnia is a problem | Compliance with Authority Required procedures |
| | P3654 | CN3654 | Continuing supply for a palliative care patient where insomnia is a problem | Compliance with Authority Required procedures |
Temozolomide | C1736 | P1736 | | Recurrence of anaplastic astrocytoma following standard therapy | Compliance with Authority Required procedures |
| C1737 | P1737 | | Recurrence of glioblastoma multiforme following standard therapy | Compliance with Authority Required procedures |
| C2100 | P2100 | | Glioblastoma multiforme concomitantly with radiotherapy | Compliance with Authority Required procedures |
| C2101 | P2101 | | Glioblastoma multiforme following radiotherapy | Compliance with Authority Required procedures |
Tenecteplase | C1481 | | | Treatment of acute myocardial infarction within 12 hours of onset of attack | |
Tenofovir | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
| C3967 | | | Where the patient is receiving treatment at/from a private hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy | Compliance with Written or Telephone Authority Required procedures |
| C3968 | | | Where the patient is receiving treatment at/from a private hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures |
| C3969 | | | Where the patient is receiving treatment at/from a public hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3969
|
| C3970 | | | Where the patient is receiving treatment at/from a public hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3970 |
| C3971 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient without cirrhosis who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance | Compliance with Written or Telephone Authority Required procedures |
| C3972 | | | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures |
| C3973 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient without cirrhosis who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3973 |
| C3974 | | | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3974 |
Tenofovir with Emtricitabine | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Tenofovir with emtricitabine and efavirenz | C3983 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3984 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3985 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3985 |
| C3986 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3986 |
Tenofovir with Emtricitabine and Rilpivirine | C3983 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3984 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3985 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures Streamlined Authority Code 3985 |
| C3986 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3986 |
Terbinafine | C2191 | P2191 | | Proximal or extensive (greater than 80% nail involvement) onychomycosis due to dermatophyte infection where topical treatment has failed, where the infection is proven by microscopy or culture and confirmed by an Approved Pathology Authority not more than 12 months prior to the date of the authority application and where the date of the pathology report is included in the authority application | Compliance with Authority Required procedures |
| C2354 | | | Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person | Compliance with Authority Required procedures - Streamlined Authority Code 2354 |
| C2865 | P2865 | | Treatment of a dermatophyte infection in an Aboriginal or a Torres Strait Islander person where topical treatment has failed | Compliance with Authority Required procedures |
| C3243 | | | Treatment of a fungal or a yeast infection in a patient aged up to 18 years inclusive | Compliance with Authority Required procedures - Streamlined Authority Code 3243 |
| C3244 | P3244 | | Treatment of a dermatophyte infection in a patient aged up to 18 years inclusive where topical treatment and griseofulvin have failed | Compliance with Authority Required procedures |
Teriparatide | C4031 | | | Initial treatment, as the sole PBS-subsidised agent, by a specialist or consultant physician, for severe, established osteoporosis in a patient with a very high risk of fracture who:
(a) has a bone mineral density (BMD) T-score of -3.0 or less; and
(b) has had 2 or more fractures due to minimal trauma; and
(c) has experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
If treatment with anti-resorptive therapy is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, details of the contraindication must be provided at the time of application
If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of 1 anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details of toxicities including severity must be provided at the time of application
Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months, disodium etidronate 200 mg with calcium carbonate 1.25 g per day, strontium ranelate 2 g per day and zoledronic acid 5 mg per annum
Details of prior anti-resorptive therapy, fracture history including the date(s) and site(s), the symptoms associated with the fracture(s) which developed during the course of anti-resorptive therapy, and the score of the qualifying BMD measurement must be provided to Medicare Australia at the time of application | Compliance with Authority Required procedures |
| C4032 | | | Continuing treatment for severe established osteoporosis where the patient has previously been issued with an authority prescription for this drug
Teriparatide must only be used for a lifetime maximum of 18 months therapy (18 pens). Up to a maximum of 18 pens will be reimbursed through the PBS | Compliance with Authority Required procedures |
Testosterone | C1021 | | | Androgen deficiency in males 40 years and older who do not have established pituitary or testicular disorders other than aging, confirmed by at least 2 morning blood samples taken on different mornings, where androgen deficiency is confirmed by testosterone less than 8 nmol per L, or from 8 to 15 nmol per L with luteinising hormone greater than 1.5 times the upper limit of the eugonadal reference range for young men | Compliance with Authority Required procedures |
| C1022 | | | Androgen deficiency in males with established pituitary or testicular disorders | Compliance with Authority Required procedures |
| C1226 | | | Micropenis, pubertal induction, or constitutional delay of growth or puberty, in males under 18 years of age | Compliance with Authority Required procedures |
Tetrabenazine | C1161 | | | Hyperkinetic extrapyramidal disorders | Compliance with Authority Required procedures - Streamlined Authority Code 1161 |
Thalidomide | C1233 | | | Where the patient is receiving treatment at/from a private hospital Multiple myeloma | Compliance with Written or Telephone Authority Required procedures |
| C3342 | | | Where the patient is receiving treatment at/from a public hospital Multiple myeloma | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3342 |
Thiamine | C2384 | | | Prophylaxis of thiamine deficiency in an Aboriginal or a Torres Strait Islander person | Compliance with Authority Required procedures - Streamlined Authority Code 2384 |
Thyrotropin Alfa | C3193 | | | Ablation of thyroid remnant tissue, in combination with radioactive iodine, in a post thyroidectomy patient without known metastatic disease | Compliance with Authority Required procedures - Streamlined Authority Code 3193 |
Tiagabine | C2664 | | | Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs | Compliance with Authority Required procedures - Streamlined Authority Code 2664 |
Tiaprofenic Acid | C1054 | | | Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
Ticagrelor | C3879 | | | Treatment of acute coronary syndrome (myocardial infarction or unstable angina) in combination with aspirin | Compliance with Authority Required procedures – Streamlined Authority Code 3879 |
Ticarcillin with Clavulanic Acid | C1169 | | | Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | |
| C1846 | | | Septicaemia, suspected | |
| C1847 | | | Septicaemia, proven | |
Ticlopidine | C1260 | | | Patients established on this drug as a pharmaceutical benefit prior to 1 November 1999 | Compliance with Authority Required procedures - Streamlined Authority Code 1260 |
| C1719 | | | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients with a history of symptomatic cerebrovascular ischaemic episodes while on therapy with low-dose aspirin | Compliance with Authority Required procedures - Streamlined Authority Code 1719 |
| C1720 | | | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding | Compliance with Authority Required procedures - Streamlined Authority Code 1720 |
| C1721 | | | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs | Compliance with Authority Required procedures - Streamlined Authority Code 1721 |
Tiludronic Acid | C3256 | | | Symptomatic Paget disease of bone | Compliance with Authority Required procedures - Streamlined Authority Code 3256 |
Tiotropium | C3883 | | | Chronic obstructive pulmonary disease | |
Tipranavir | C3600 | | | Where the patient is receiving treatment at/from a private hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 200 mg ritonavir twice daily in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity | Compliance with Written or Telephone Authority Required procedures |
| C3601 | | | Where the patient is receiving treatment at/from a public hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 200 mg ritonavir twice daily in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3601 |
Tirofiban | C1275 | | | Patients with non-Q-wave myocardial infarction | Compliance with Authority Required procedures - Streamlined Authority Code 1275 |
| C1729 | | | Patients with high risk unstable angina who have new transient or persistent ST-T ischaemic changes and anginal pain lasting longer than 20 minutes | Compliance with Authority Required procedures - Streamlined Authority Code 1729 |
| C1730 | | | Patients with high risk unstable angina who have new transient or persistent ST-T ischaemic changes and repetitive episodes of angina at rest or during minimal exercise in the previous 12 hours | Compliance with Authority Required procedures - Streamlined Authority Code 1730 |
Tobramycin | C1169 | | | Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | |
| C1188 | | | Invasive ocular infection | |
| C1391 | | | Suspected pseudomonal eye infection | |
| C1714 | | | Perioperative use in ophthalmic surgery | |
| C1846 | | | Septicaemia, suspected | |
| C1847 | | | Septicaemia, proven | |
| C3190 | | | Systemic treatment of Pseudomonas aeruginosa infection in a patient with cystic fibrosis | |
| C3842 | | | Management of a proven Pseudomonas aeruginosa infection in a patient with cystic fibrosis | Compliance with Authority Required procedures - Streamlined Authority Code 3842 |
Topiramate | C2797 | | | Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs | Compliance with Authority Required procedures - Streamlined Authority Code 2797 |
| C2798 | | | Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate | Compliance with Authority Required procedures - Streamlined Authority Code 2798 |
| C2799 | | | Prophylaxis of migraine in a patient who has experienced an average of 3 or more migraines per month over a period of at least 6 months, and who:
(1) either has a contraindication to beta-blockers, as described in the relevant Therapeutic Goods Administration-approved Product Information, or has experienced intolerance of a severity necessitating permanent withdrawal during treatment with a beta-blocker; and
(2) either has a contraindication to pizotifen because the weight gain associated with this drug poses an unacceptable risk, or has experienced intolerance of a severity necessitating permanent withdrawal during treatment with pizotifen; and
where details of the contraindication(s) and/or intolerance(s) are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 2799 |
Topotecan | C3186 | | | Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound | Compliance with Authority Required procedures - Streamlined Authority Code 3186 |
Toremifene | C1750 | | | Treatment of hormone-dependent metastatic breast cancer in post-menopausal patients | |
Tramadol | C1378 | | | Short-term treatment of acute pain | |
| C1497 | P1497 | | For acute pain where aspirin or paracetamol alone is inappropriate or has failed | |
| C1537 | | | For pain where aspirin or paracetamol alone is inappropriate or has failed | |
| C1615 | P1615 | | For dosage titration in chronic pain where aspirin or paracetamol alone is inappropriate or has failed | |
Trandolapril with Verapamil | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Travoprost with Timolol | C3426 | | | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy | |
| C3427 | | | Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy | |
Triamcinolone | C1020 | | | Alopecia areata | |
| C1102 | | | For local intra-articular or peri-articular infiltration | |
| C1146 | | | Granulomata, dermal | |
| C1189 | | | Keloid | |
| C1191 | | | Lichen planus hypertrophic | |
| C1192 | | | Lichen simplex chronicus | |
| C1197 | | | Lupus erythematosus, chronic discoid | |
| C1237 | | | Necrobiosis lipoidica | |
| C1313 | | | Psoriasis | |
| C1422 | | | Treatment of corticosteroid-responsive dermatoses | |
Triglycerides, long chain with glucose polymer | C1276 | | | Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae | |
Triglycerides, medium chain | C1068 | | | Chylothorax | Compliance with Authority Required procedures |
| C1511 | | | Long chain fatty acid oxidation disorders | Compliance with Authority Required procedures |
| C1513 | | | Hyperlipoproteinaemia type 1 | Compliance with Authority Required procedures |
| C1670 | | | Chylous ascites | Compliance with Authority Required procedures |
| C1671 | | | Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders | Compliance with Authority Required procedures |
| C1672 | | | Intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect, requiring a ketogenic diet | Compliance with Authority Required procedures |
Triglycerides — medium chain, formula | C1068 | | | Chylothorax | Compliance with Authority Required procedures |
| C1511 | | | Long chain fatty acid oxidation disorders | Compliance with Authority Required procedures |
| C1513 | | | Hyperlipoproteinaemia type 1 | Compliance with Authority Required procedures |
| C1670 | | | Chylous ascites | Compliance with Authority Required procedures |
| C1671 | | | Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders | Compliance with Authority Required procedures |
Triglycerides, medium chain and long chain with glucose polymer | C1276 | | | Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae. | |
Triptorelin | C3229 | | | Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate | Compliance with Authority Required procedures - Streamlined Authority Code 3229 |
Tropisetron | C3050 | | | Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration | |
Tyrosine with carbohydrate | C1286 | | | Phenylketonuria | |
Ursodeoxycholic Acid | C1700 | | | Primary biliary cirrhosis | Compliance with Authority Required procedures - Streamlined Authority Code 1700 |
Ustekinumab | C3248 | P3248 | | Chronic plaque psoriasis (whole body) — initial treatment 1
Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the whole body; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrated in the patient at the time of the authority application;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 28 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with ustekinumab for a period of less than 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3250 | P3250 | | Chronic plaque psoriasis (face, hand, foot) — initial treatment 1
Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the face, hand or foot; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 28 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with ustekinumab for a period of less than 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3789 | P3789 | | Chronic plaque psoriasis (whole body) — initial treatment 2
Initial treatment, or recommencement of treatment, with ustekinumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis; and
(b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and
(c) have not failed PBS-subsidised therapy with ustekinumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who have previously demonstrated a response to PBS-subsidised treatment with ustekinumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised ustekinumab treatment was submitted to the Chief Executive Medicare within 1 month of cessation of that treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 28 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment, or of a course which recommences treatment, with ustekinumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3790 | P3790 | | Chronic plaque psoriasis (face, hand, foot) — initial treatment 2
Initial treatment, or recommencement of treatment, with ustekinumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and
(c) have not failed PBS-subsidised therapy with ustekinumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who have previously demonstrated a response to PBS-subsidised treatment with ustekinumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised ustekinumab treatment was submitted to the Chief Executive Medicare within 1 month of cessation of that treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 28 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuation of initial treatment, or of a course which recommences treatment, with ustekinumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3791 | P3791 | | Chronic plaque psoriasis (whole body) — continuing treatment
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with ustekinumab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with ustekinumab; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to ustekinumab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 28-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Chief Executive Medicare no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with ustekinumab;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with ustekinumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
| C3792 | P3792 | | Chronic plaque psoriasis (face, hand, foot) — continuing treatment
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with ustekinumab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with ustekinumab; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to ustekinumab treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 28-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Chief Executive Medicare no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with ustekinumab;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| | | | Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with ustekinumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
Valaciclovir | C1494 | | | Where the patient is receiving treatment at/from a private hospital Prophylaxis of cytomegalovirus infection and disease following renal transplantation in patients at risk of cytomegalovirus disease | Compliance with Written or Telephone Authority Required procedures |
| C3419 | | | Where the patient is receiving treatment at/from a public hospital Prophylaxis of cytomegalovirus infection and disease following renal transplantation in patients at risk of cytomegalovirus disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3419 |
| C3622 | P3622 | | Treatment of patients with herpes zoster within 72 hours of the onset of the rash | Compliance with Authority Required procedures - Streamlined Authority Code 3622 |
| C3623 | P3623 | | Suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Compliance with Authority Required procedures - Streamlined Authority Code 3623 |
| C3624 | P3624 | | Episodic treatment of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Compliance with Authority Required procedures - Streamlined Authority Code 3624 |
| C3631 | P3631 | | Herpes zoster ophthalmicus | Compliance with Authority Required procedures - Streamlined Authority Code 3631 |
| C3632 | P3632 | | Moderate to severe initial genital herpes | Compliance with Authority Required procedures - Streamlined Authority Code 3632 |
Valganciclovir | C1620 | | | Where the patient is receiving treatment at/from a private hospital Cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome | Compliance with Written or Telephone Authority Required procedures |
| C1964 | | | Where the patient is receiving treatment at/from a private hospital Prophylaxis of cytomegalovirus infection and disease in solid organ transplant patients at risk of cytomegalovirus disease | Compliance with Written or Telephone Authority Required procedures |
| C3420 | | | Where the patient is receiving treatment at/from a public hospital Cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3420 |
| C3421 | | | Where the patient is receiving treatment at/from a public hospital Prophylaxis of cytomegalovirus infection and disease in solid organ transplant patients at risk of cytomegalovirus disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3421 |
Valine with carbohydrate | C1220 | | | Maple syrup urine disease | |
Valsartan with hydrochlorothiazide | C3307 | | | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination | |
Vancomycin | C1091 | P1091 | | Endophthalmitis | |
| C1302 | P1302 | | Prophylaxis of endocarditis in patients hypersensitive to penicillin | |
| C1464 | P1464 | | Use initiated in a hospital for infections where vancomycin hydrochloride is an appropriate antibiotic | |
| C1701 | | | Antibiotic associated pseudomembranous colitis due to Clostridium difficile which is unresponsive to metronidazole | Compliance with Authority Required procedures |
| C1702 | | | Antibiotic associated pseudomembranous colitis due to Clostridium difficile where there is intolerance to metronidazole | Compliance with Authority Required procedures |
Varenicline | C2774 | | | Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who has entered a comprehensive support and counselling program, and where details of the program are specified in the authority application | Compliance with Authority Required procedures |
| C2775 | | | Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who is entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the authority application | Compliance with Authority Required procedures |
| C3670 | P3670 | | Continuation of short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has previously been issued with an authority prescription for this drug and who is enrolled in a comprehensive support and counselling program | Compliance with Authority Required procedures |
| C3671 | P3671 | | Completion of short-term sole PBS-subsidised therapy as an aid to achieving long-term abstinence after completion of an initial 12-week PBS-subsidised course in a patient who has ceased smoking, and who is enrolled in a comprehensive support and counselling program | Compliance with Authority Required procedures |
Venlafaxine | C1211 | | | Major depressive disorders | |
Verteporfin | C3860 | | | Initial treatment by an ophthalmologist, as the sole PBS-subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration, as diagnosed by fluorescein angiography, in a patient with a baseline visual acuity equal to or better than 6/60 (20/200), where the patient has not previously received PBS-subsidised treatment with verteporfin in the eye for which treatment is being sought, and where the authority application includes a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram demonstrating that the CNV is predominantly (greater than or equal to 50%) classic | Compliance with Written Authority Required procedures |
| | | | Initial treatment by an ophthalmologist, as the sole PBS-subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration, as diagnosed by fluorescein angiography, in a patient with a baseline visual acuity equal to or better than 6/60 (20/200), where the patient has not previously received PBS-subsidised treatment with verteporfin in the eye for which treatment is being sought, and where the authority application includes a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram demonstrating that the CNV is predominantly (greater than or equal to 50%) classic, is submitted to the Chief Executive Medicare by facsimile prior to contact by telephone and is resubmitted to the Chief Executive Medicare by post after the application has been authorised | Compliance with Telephone Authority Required procedures |
| C3861 | | | Initial PBS-subsidised treatment by an ophthalmologist, as the sole PBS-subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation (CNV) due to macular degeneration, where:
(a) the patient has been authorised by the Angiogram Review Panel to receive treatment with verteporfin in the same eye under the Medicare Benefits Scheme (MBS) Visudyne Therapy Program and has received no more than 14 such treatments; and
(b) the authority application includes:
(i) a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form which includes the date of review by the Angiogram Review Panel and the number of treatments administered in that eye under the MBS Visudyne Therapy Program; and
(ii) a copy of the fluorescein angiogram demonstrating that the CNV is predominantly (greater than or equal to 50%) classic | Compliance with Written Authority Required procedures |
| | | | Initial PBS-subsidised treatment by an ophthalmologist, as the sole PBS-subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation (CNV) due to macular degeneration, where:
(a) the patient has been authorised by the Angiogram Review Panel to receive treatment with verteporfin in the same eye under the Medicare Benefits Scheme (MBS) Visudyne Therapy Program and has received no more than 14 such treatments; and
(b) the authority application includes:
(i) a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form which includes the date of review by the Angiogram Review Panel and the number of treatments administered in that eye under the MBS Visudyne Therapy Program; and
(ii) a copy of the fluorescein angiogram demonstrating that the CNV is predominantly (greater than or equal to 50%) classic; and
(c) the authority application is submitted to the Chief Executive Medicare by facsimile prior to contact by telephone and is resubmitted to the Chief Executive Medicare by post after the application has been authorised | Compliance with Telephone Authority Required procedures |
| C3795 | | | Continuing treatment by an ophthalmologist, as the sole PBS-subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation due to macular degeneration, where:
(a) the patient has previously been granted an authority prescription for verteporfin for treatment of the same eye; and
(b) the patient has previously received no more than 14 subsidised treatments with verteporfin in that eye, treatments administered under the MBS Visudyne Therapy Program and treatments administered under the PBS included; and
(c) a course of treatment abandoned prior to completion of the laser activation step but after infusion of verteporfin is not regarded to be a subsidised treatment for the purposes of (b) above, provided that the Chief Executive Medicare has been notified and advised of the reason for the abandonment | Compliance with Written or Telephone Authority Required procedures |
Vigabatrin | C1426 | | | Treatment of epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs | Compliance with Authority Required procedures - Streamlined Authority Code 1426 |
Vildagliptin | C3540 | | | Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with either metformin or a sulfonylurea; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and
where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3540 |
Vildagliptin with metformin | C3543 | | | Treatment of type 2 diabetes in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with metformin; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with metformin; and
where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3543
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| C3686 | | | Continuation of therapy in type 2 diabetes mellitus in a patient who has previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and vildagliptin | Compliance with Authority Required procedures - Streamlined Authority Code 3686 |
Vinorelbine | C1194 | | | Locally advanced or metastatic non-small cell lung cancer | Compliance with Authority Required procedures |
| C3890 | | | Locally advanced or metastatic non-small cell lung cancer | Compliance with Authority Required procedures - Streamlined Authority Code 3890 |
| C3907 | | | Advanced breast cancer after failure of prior therapy which includes an anthracycline | Compliance with Authority Required procedures - Streamlined Authority Code 3907 |
Vitamins, minerals and trace elements with carbohydrate | C3301 | | | Infants and children whose vitamin and mineral intake is insufficient due to a specific diagnosis requiring a highly restrictive therapeutic diet, and whose vitamin, mineral and trace element needs cannot be adequately met with other proprietary vitamin and mineral preparations | Compliance with Authority Required procedures |
Voriconazole | C3061 | | | For the treatment and maintenance therapy of definite or probable invasive aspergillosis in immunocompromised patients | Compliance with Authority Required procedures |
| C3062 | | | For the treatment and maintenance therapy of serious fungal infections caused by Scedosporium species or Fusarium species | Compliance with Authority Required procedures |
| C3065 | | | For the treatment and maintenance therapy of serious Candida infections where treatment with fluconazole has failed | Compliance with Authority Required procedures |
| C3066 | | | For the treatment and maintenance therapy of serious Candida infections where treatment with fluconazole is not tolerated | Compliance with Authority Required procedures |
| C3297 | | | For the treatment and maintenance therapy of serious Candida infections where the causative species is not susceptible to fluconazole | Compliance with Authority Required procedures |
| C3298 | | | For the treatment and maintenance therapy of other serious invasive mycosis | Compliance with Authority Required procedures |
Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose | C1596 | | | Infants and young children with chronic renal failure requiring treatment with a low protein and a low phosphorus diet, or a low protein, a low phosphorus and a low potassium diet | Compliance with Authority Required procedures |
Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose | C1596 | | | Infants and young children with chronic renal failure requiring treatment with a low protein and a low phosphorus diet, or a low protein, a low phosphorus and a low potassium diet | Compliance with Authority Required procedures |
Zidovudine | C3586 | | | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | | | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | | | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | | | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
Ziprasidone | C1589 | | | Schizophrenia | Compliance with Authority Required procedures - Streamlined Authority Code 1589 |
| C3084 | | | Monotherapy, for up to 6 months, of an episode of acute mania or mixed episodes associated with bipolar I disorder | Compliance with Authority Required procedures - Streamlined Authority Code 3084 |
Zoledronic acid | C1035 | | | Where the patient is receiving treatment at/from a private hospital Bone metastases from breast cancer | Compliance with Written or Telephone Authority Required procedures |
| C1233 | | | Where the patient is receiving treatment at/from a private hospital Multiple myeloma | Compliance with Written or Telephone Authority Required procedures |
| C1500 | | | Where the patient is receiving treatment at/from a private hospital Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy | Compliance with Written or Telephone Authority Required procedures |
| C3290 | | | Symptomatic Paget disease of bone, and where PBS-subsidised treatment is limited to 1 dose each year | Compliance with Authority Required procedures |
| C3341 | | | Where the patient is receiving treatment at/from a public hospital Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3341 |
| C3342 | | | Where the patient is receiving treatment at/from a public hospital Multiple myeloma | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3342 |
| C3343 | | | Where the patient is receiving treatment at/from a public hospital Bone metastases from breast cancer | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3343 |
| C3945 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated, and where PBS-subsidised treatment is limited to 1 dose per patient each year | Compliance with Authority Required procedures - Streamlined Authority Code 3945 |
| C3946 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in a patient with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body, and where PBS-subsidised treatment is limited to 1 dose per patient per year | Compliance with Authority Required procedures - Streamlined Authority Code 3946
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| C3947 | | | Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated, and where PBS-subsidised treatment is limited to 1 dose per patient each year | Compliance with Authority Required procedures - Streamlined Authority Code 3947 |
| C4051 | | | Where the patient is receiving treatment at/from a private hospital Bone metastases from castration-resistant prostate cancer | Compliance with Written or Telephone Authority Required procedures |
| C4052 | | | Where the patient is receiving treatment at/from a public hospital Bone metastases from castration-resistant prostate cancer | Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4052 |
Zolmitriptan | C3280 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics | Compliance with Authority Required procedures |
| C3281 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where adverse events have occurred with other suitable PBS-listed drugs | Compliance with Authority Required procedures |
| C3282 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where drug interactions have occurred with other suitable PBS-listed drugs | Compliance with Authority Required procedures |
| C3283 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where drug interactions are expected to occur with other suitable PBS-listed drugs | Compliance with Authority Required procedures |
| C3284 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where transfer to another suitable PBS-listed drug would cause patient confusion resulting in problems with compliance | Compliance with Authority Required procedures |
| C3285 | | | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where transfer to another suitable PBS-listed drug is likely to result in adverse clinical consequences | Compliance with Authority Required procedures |
Zonisamide | C2664 | | | Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs | Compliance with Authority Required procedures - Streamlined Authority Code 2664 |
