1.  The whole of this instrument

1 April 2023

1 April 2023

EPOPROSTENOL SUN

C13491 C13492 C13505 C13506 C13510 C13512 C13577 C13634

See Schedule 2

See Schedule 2

EPOPROSTENOL SUN

C13491 C13492 C13505 C13506 C13510 C13512 C13577 C13634

See Schedule 2

See Schedule 2

Injection 50 mg in 1 mL single use dose‑dispenser cartridges, 4

Injection

Enbrel

C9384 C9417 C10548 C10578 C10579 C10599 C12357 C12407

1

0

Ruxolitinib

Tablet 5 mg

Oral

Jakavi

C13876 C13877 C13891 C13892 C13907 C13911

P13907 P13911

56

0

C13876 C13877 C13891 C13892 C13907 C13911

P13876 P13877 P13891 P13892

56

5

Tablet 10 mg

Oral

Jakavi

C13876 C13877 C13891 C13892 C13907 C13911

P13907 P13911

56

0

C13876 C13877 C13891 C13892 C13907 C13911

P13876 P13877 P13891 P13892

56

5

Concentrate for injection 80 mg in 4 mL s19A

Injection

RoActemra

C10532 C10535 C10536 C10567 C10570 C10571

See Schedule 2

See Schedule 2

Concentrate for injection 200 mg in 10 mL s19A

Injection

RoActemra

C10532 C10535 C10536 C10567 C10570 C10571

See Schedule 2

See Schedule 2

Concentrate for injection 400 mg in 20 mL s19A

Injection

RoActemra

C10532 C10535 C10536 C10567 C10570 C10571

See Schedule 2

See Schedule 2

Mepolizumab

C11841 C11848 C11950

1

Sufficient for 32 weeks of treatment

C11842

1

Sufficient for 24 weeks of treatment

C13864 C13865 C13890

1

5

C13920

Human immunodeficiency virus (HIV) infection
Patient must be less than 13.00 years of age.
Patient must be unable to take a solid dose form of this drug; AND
The treatment must be in combination with other antiretroviral agents.

Compliance with Authority Required procedures

C13864

Chronic rhinosinusitis with nasal polyps (CRSwNP)
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP.
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2023; AND
Patient must have met all initial treatment PBS-eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are described below.
Patient must be at least 18 years of age.
Criteria for Grandfathered patients are that:
(a) the diagnosis of CRSwNP was confirmed by at least one of: (i) nasal endoscopy, (ii) computed tomography (CT) scan; or from at least two physicians of the above mentioned prescriber types
(b) the patient has undergone surgery for the removal of nasal polyps; or the patient has the written advice from at least two physicians of the above mentioned prescriber types demonstrating inappropriateness for surgery
(c) the patient had, despite optimised nasal polyp therapy, at least two of: (i) bilateral endoscopic nasal polyp score of at least 5 (out of a maximum score of 8, with a minimum score of 2 in each nasal cavity), (ii) nasal obstruction visual analogue scale (VAS) score greater than 5 (out of a maximum score of 10), (iii) overall symptom VAS score greater than 7 (out of a maximum score of 10)
(d) the treatment was/is not used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma
(e) the patient had failed to achieve adequate control with optimised nasal polyp therapy which has been documented
(f) the patient had a blood eosinophil count greater than or equal to 300 cells per microlitre in the 12 months preceding treatment.
Optimised nasal polyp therapy includes:
(a) adherence to intranasal corticosteroid therapy for at least 2 months, unless contraindicated or not tolerated
(b) if required, nasal irrigation with saline
Where the patient has a contraindication or intolerance to intranasal corticosteroid therapy, document the reasons for the contraindication or intolerance in the patient's medical file.
The authority application must be made in writing and must include:
(a) a completed authority prescription form,
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice),
(c) details (date of commencement and duration of therapy) of prior optimised nasal polyp medicine treatment,
(d) details (date and treatment) of nasal polyp surgery; or
(e) if applicable, details of surgical exception including serious comorbid disease (e.g. cardiovascular, stroke) making the risk of surgery unacceptable,
(f) the eosinophil count and date,
(g) two of the following, measured within the 12 months prior to non-PBS-subsidised treatment: (i) baseline bilateral endoscopic nasal polyp score, (ii) baseline nasal obstruction VAS score, (iii) baseline overall VAS score.

Compliance with Written Authority Required procedures

C13865

Chronic rhinosinusitis with nasal polyps (CRSwNP)
Continuing treatment
Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have both demonstrated and sustained an adequate response to this drug, defined as having at least one of: (i) an improvement in bilateral endoscopic nasal polyp score of at least 1.0 compared to the baseline level provided with the initial authority application, (ii) an improvement in nasal obstruction visual analogue scale (VAS) score of at least 3.0 compared to the baseline level provided with the initial authority application, (iii) an improvement in overall symptom VAS score of at least 2.5 compared to the baseline level provided with the initial authority application.
Patient must be at least 18 years of age.

Compliance with Authority Required procedures

C13890

Chronic rhinosinusitis with nasal polyps (CRSwNP)
Initial treatment
Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP.
Patient must have a diagnosis of CRSwNP confirmed by at least one of: (i) nasal endoscopy, (ii) computed tomography (CT) scan, with the results documented in the patient's medical records; OR
Patient must have a diagnosis of CRSwNP from at least two physicians of the above mentioned prescriber types; AND
Patient must have undergone surgery for the removal of nasal polyps; OR
Patient must have the written advice from at least two physicians of the above mentioned prescriber types demonstrating inappropriateness for surgery; AND
Patient must have, despite optimised nasal polyp therapy, at least two of: (i) bilateral endoscopic nasal polyp score of at least 5 (out of a maximum score of 8, with a minimum score of 2 in each nasal cavity), (ii) nasal obstruction visual analogue scale (VAS) score greater than 5 (out of a maximum score of 10), (iii) overall symptom VAS score greater than 7 (out of a maximum score of 10); AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; OR
Patient must have had a 12 month break in PBS-subsidised treatment with a biological medicine for this condition; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma; AND
Patient must have failed to achieve adequate control with optimised nasal polyp therapy which has been documented; AND
Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months.
Patient must be at least 18 years of age.
Optimised nasal polyp therapy includes:
(a) adherence to intranasal corticosteroid therapy for at least 2 months, unless contraindicated or not tolerated
(b) if required, nasal irrigation with saline
Where the patient has a contraindication or intolerance to intranasal corticosteroid therapy, document the reasons for the contraindication or intolerance in the patient's medical file.
The authority application must be made in writing and must include:
(a) a completed authority prescription form,
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice),
(c) details (date of commencement and duration of therapy) of prior optimised nasal polyp medicine treatment,
(d) details (date and treatment) of nasal polyp surgery; or
(e) if applicable, details of surgical exception including serious comorbid disease (e.g. cardiovascular, stroke) making the risk of surgery unacceptable,
(f) the eosinophil count and date,
(g) two of the following, measured within the past 12 months: (i) baseline bilateral endoscopic nasal polyp score, (ii) baseline nasal obstruction VAS score, (iii) baseline overall VAS score.

Compliance with Written Authority Required procedures

Ruxolitinib

C13876

P13876

Grade II to IV acute graft versus host disease (aGVHD)
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response.
Must be treated by a haematologist; OR
Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.
Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.
(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.
(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.
The assessment of response must be documented in the patient's medical records.
Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.

Compliance with Authority Required procedures - Streamlined Authority Code 13876

C13877

P13877

Grade II to IV acute graft versus host disease (aGVHD)
Grandfather treatment (transition from non-PBS-subsidised treatment)
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2023; AND
Patient must have received systemic steroid treatment prior to initiation of this drug for this condition; AND
Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND
Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response.
Must be treated by a haematologist; OR
Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.
Steroid-refractory disease is defined as:
(a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or
(b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD.
Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria:
(a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or
(b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days.
Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.
Details of prior steroid use should be documented in the patient's medical records.
Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.
(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.
(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.
The assessment of response must be documented in the patient's medical records.
Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.

Compliance with Authority Required procedures - Streamlined Authority Code 13877

C13891

P13891

Grade II to IV acute graft versus host disease (aGVHD)
Grandfather treatment (transition from non-PBS-subsidised treatment)
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2023; AND
Patient must have received systemic steroid treatment prior to initiation of this drug for this condition; AND
Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND
Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response.
Must be treated by a haematologist; OR
Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.
Steroid-refractory disease is defined as:
(a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or
(b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD.
Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria:
(a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or
(b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days.
Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.
Details of prior steroid use should be documented in the patient's medical records.
Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.
(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.
(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.
The assessment of response must be documented in the patient's medical records.
Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.

Compliance with Authority Required procedures - Streamlined Authority Code 13891

C13892

P13892

Grade II to IV acute graft versus host disease (aGVHD)
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response.
Must be treated by a haematologist; OR
Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.
Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.
(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.
(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.
The assessment of response must be documented in the patient's medical records.
Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.

Compliance with Authority Required procedures - Streamlined Authority Code 13892

C13907

P13907

Grade II to IV acute graft versus host disease (aGVHD)
Initial treatment
Patient must have received prior systemic steroid treatment for this condition; AND
Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment.
Must be treated by a haematologist; OR
Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.
The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016).
Steroid-refractory disease is defined as:
(a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or
(b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD.
Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria:
(a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or
(b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days.
Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.
Details of prior steroid use should be documented in the patient's medical records.
A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment.
Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.
(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.
(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.
The assessment of response must be documented in the patient's medical records.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.

Compliance with Authority Required procedures - Streamlined Authority Code 13907

C13911

P13911

Grade II to IV acute graft versus host disease (aGVHD)
Initial treatment
Patient must have received prior systemic steroid treatment for this condition; AND
Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment.
Must be treated by a haematologist; OR
Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.
The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016).
Steroid-refractory disease is defined as:
(a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or
(b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD.
Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria:
(a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or
(b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days.
Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.
Details of prior steroid use should be documented in the patient's medical records.
A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment.
Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.
(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.
(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.
The assessment of response must be documented in the patient's medical records.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.

Compliance with Authority Required procedures - Streamlined Authority Code 13911