1.  The whole of this instrument

1 April 2022

1 April 2022

Azacitidine MSN

C6132 C6143 C6144 C6177 C6186 C6199 C12439

See Schedule 2

See Schedule 2

Cabotegravir

Tablet 30 mg

Oral

Vocabria

C12619

30

0

Cabotegravir and rilpivirine

Pack containing 1 vial cabotegravir 600 mg in 3 mL and 1 vial rilpivirine 900 mg in 3mL

Injection

Cabenuva

C12636

1

5

Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor

Pack containing 56 tablets elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 tablets ivacaftor 150 mg

Oral

Trikafta

C12618 C12626

See Schedule 2

See Schedule 2

Neulasta

C7822 C7843 C9235 C9303

1

11

Tezmota

C7822 C7843 C9235 C9303

1

11

Siltuximab

Powder for injection 100 mg

Injection

Sylvant

C12585 C12594

2

4

Powder for injection 400 mg

Injection

Sylvant

C12585 C12594

2

4

Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor

C12618 C12626

1 pack

5

Ivacaftor

C12624 C12625

1 pack

Sufficient for 24 weeks of treatment

Lumacaftor with Ivacaftor

C12610 C12612 C12621 C12623 C12627 C12633

1 pack

5

Ravulizumab

C12517 C12518 C12519

1 dose

0

C12511 C12593 C12605

1 dose

2

Tezacaftor with Ivacaftor and Ivacaftor

C12609 C12614 C12630 C12635

1 pack

5

Cabotegravir

C12619

HIV infection
Patient must be virologically suppressed on a stable antiretroviral regimen for at least 6 months; AND
The treatment must be in combination with rilpivirine tablets; AND
Patient must intend to proceed to treatment with intramuscular administration of cabotegravir and rilpivirine.

Compliance with Authority Required procedures - Streamlined Authority Code 12619

Cabotegravir and rilpivirine

C12636

HIV infection
Patient must have previously received PBS-subsidised therapy for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 12636

Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor

C12618

Cystic fibrosis
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have at least one F508del mutation in the cystic fibrosis transmembrane conductance (CFTR) gene; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities, prior to initiating treatment with this drug.
Patient must be 12 years of age or older.
The patient must be registered in the Australian Cystic Fibrosis Database Registry.
This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis elexacaftor, tezacaftor with ivacaftor Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(4) details of the name of the molecular testing for the patient having at least one F508del mutation including: (i) name of the pathology report provider (ii) date of pathology report (iii) unique identifying number/code that links the pathology result to the individual patient.

Compliance with Written Authority Required procedures

C12626

Cystic fibrosis
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be 12 years of age or older.
This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis elexacaftor, tezacaftor with ivacaftor Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

Compliance with Written Authority Required procedures

Ivacaftor

C12624

Cystic fibrosis
Initial treatment - New patients
Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND
Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; OR
Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele; AND
Patient must have a sweat chloride value of at least 60 mmol/L by quantitative pilocarpine iontophoresis; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be aged 12 months or older.
Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.
Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.
Ivacaftor is not PBS-subsidised for this condition as a sole therapy.
Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
(3) details of the pathology report substantiating G551D mutation or other gating (class III) mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(5) sweat chloride result.

Compliance with Written Authority Required procedures

C12625

Cystic fibrosis
Continuing treatment
Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND
Patient must have received PBS-subsidised initial therapy with ivacaftor, given concomitantly with standard therapy, for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be aged 12 months or older.
Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.
Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.
Ivacaftor is not PBS-subsidised for this condition as a sole therapy.
Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

Compliance with Written Authority Required procedures

Lumacaftor with ivacaftor

C12610

Cystic fibrosis
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be 2 years of age or older.
Lumacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort.
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin.
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

Compliance with Written Authority Required procedures

C12612

Cystic fibrosis
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.
Patient must be 12 years of age or older.
Lumacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort.
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin.
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

Compliance with Written Authority Required procedures

C12621

Cystic fibrosis
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.
Patient must be 2 years of age or older.
Lumacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort.
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin.
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

Compliance with Written Authority Required procedures

C12623

Cystic fibrosis
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.
Patient must be 12 years of age or older.
Lumacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort.
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin.
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

Compliance with Written Authority Required procedures

C12627

Cystic fibrosis
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.
Patient must be aged between 6 and 11 years inclusive.
Lumacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort.
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin.
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

Compliance with Written Authority Required procedures

C12633

Cystic fibrosis
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be aged between 6 and 11 years inclusive.
Lumacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort.
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin.
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

Compliance with Written Authority Required procedures

C12509

P12509

Paroxysmal nocturnal haemoglobinuria (PNH)
First Continuing Treatment
Patient must have received PBS-subsidised treatment with this drug for this condition under an 'Initial', 'Balance of Supply', or 'Grandfather' treatment criteria; AND
The treatment must not be in combination with eculizumab.
Must be treated by a haematologist; OR
Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
Patient must be aged 18 years or over.
At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH) and the upper limit of normal (ULN) for the reporting laboratory
(viii) Multiple of LDH , ULN

Compliance with Written Authority Required procedures

C12575

P12575

Paroxysmal nocturnal haemoglobinuria (PNH)
Subsequent Continuing Treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Switch' criteria; AND
Patient must have demonstrated clinical improvement or stabilisation of condition; AND
The treatment must not be in combination with eculizumab.
Must be treated by a haematologist; OR
Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
Patient must be aged 18 years or over.
At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.

Compliance with Written Authority Required procedures

C12593

Paroxysmal nocturnal haemoglobinuria (PNH)
First Continuing Treatment
Patient must have received PBS-subsidised treatment with this drug for this condition under an 'Initial' or 'Grandfather' treatment criteria; AND
The treatment must not be in combination with eculizumab.
Must be treated by a haematologist; OR
Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
Patient must be aged 18 years or over.
At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH) and the upper limit of normal (ULN) for the reporting laboratory
(viii) Multiple of LDH , ULN

Compliance with Written Authority Required procedures

C12605

Paroxysmal nocturnal haemoglobinuria (PNH)
Subsequent Continuing Treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Return' criteria; AND
Patient must have demonstrated clinical improvement or stabilisation of condition; AND
The treatment must not be in combination with eculizumab.
Must be treated by a haematologist; OR
Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
Patient must be aged 18 years or over.
At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.

Compliance with Written Authority Required procedures

Siltuximab

C12585

Idiopathic multicentric Castleman disease (iMCD)
Initial treatment
Patient must have a diagnosis of iMCD consistent with the latest international, evidence-based consensus diagnostic criteria for this condition with the relevant diagnostic findings documented in the patient's medical records; AND
The condition must not be, to the prescriber's best knowledge, any of the following diseases that can mimic iMCD: (i) human herpes virus-8 infection, (ii) an Epstein-Barr virus-lymphoproliferative disorder, (iii) an acute/uncontrolled infection (e.g. cytomegalovirus, toxoplasmosis, human immunodeficiency virus, tuberculosis) leading to inflammation with adenopathy, (iv) an autoimmune/autoinflammatory disease, (v) a malignant/lymphoproliferative disorder.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist; AND
Patient must be undergoing treatment through this treatment phase once only in a lifetime, where the full number of repeats are prescribed; OR
Patient must be undergoing treatment through this treatment phase for up to the first 5 doses in a lifetime, where the full number of repeats was not prescribed with the first prescription.
Prescribe the most efficient combination of vials/strengths based on the patient's body weight to keep any amount of unused drug to a minimum.

Compliance with Authority Required procedures

C12594

Idiopathic multicentric Castleman disease (iMCD)
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
Prescribe the most efficient combination of vials/strengths based on the patient's body weight to keep any amount of unused drug to a minimum.

Compliance with Authority Required procedures

Tezacaftor with ivacaftor and ivacaftor

C12609

Cystic fibrosis - one residual function (RF) mutation
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be 12 years of age or older.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

Compliance with Written Authority Required procedures

C12614

Cystic fibrosis - homozygous for the F508del mutation
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be 12 years of age or older.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

Compliance with Written Authority Required procedures

C12630

Cystic fibrosis - one residual function (RF) mutation
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have at least one residual function (RF) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor with ivacaftor; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities.
Patient must be 12 years of age or older.
For the purposes of this restriction, the list of mutations considered to be responsive to tezacaftor with ivacaftor is defined in the TGA approved product information.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
(3) details of the pathology report substantiating the patient having at least one RF mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient ; and
(4) CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

Compliance with Written Authority Required procedures

C12635

Cystic fibrosis - homozygous for the F508del mutation
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities.
Patient must be 12 years of age or older.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

Compliance with Written Authority Required procedures