1. The whole of this instrument

1 July 2025

1 July 2025

Bosentan Mylan

C11229 C12425 C13495 C13496 C13497 C13499 C13571 C13582 C13632

See Schedule 2

See Schedule 2

Nepexto

C9417 C14068 C14070 C14071 C14154 C14155

See Schedule 2

See Schedule 2

Maribavir

Tablet 200 mg

Oral

Livtencity

C16735 C16806

112

1

Sevelamer Apotex

C5530 C9762

360

5

C15426

Systemic lupus erythematosus

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements

Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 July 2024; AND

Patient must have had a confirmed and documented diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) SLE Classification Criteria 2019 prior to commencing therapy with this drug for this condition; AND

Patient must have had persistent disease activity as supported by a SLE Disease Activity Index 2000 (SLEDAI-2K) score of at least 10 points prior to commencing therapy with this drug for this condition; AND

Patient must have been receiving hydroxychloroquine for at least 12 weeks prior to commencing therapy with this drug for this condition; AND

Patient must have been receiving immunosuppressant medication for at least 12 weeks with either (i) minimum dose of methotrexate 20 mg per week (ii) azathioprine 100 mg per day (iii)mycophenolate 1,000 mg per day, prior to commencing therapy with this drug for this condition unless contraindicated/intolerant necessitating treatment withdrawal; AND

Patient must have been receiving prednisolone or equivalent of at least 7.5 mg per day for at least 4 weeks prior to commencing therapy with this drug for this condition unless contraindicated/intolerant necessitating treatment withdrawal; AND

Patient must not have either: (i) severe active lupus nephritis, (ii) severe active central nervous system systemic lupus erythematosus.

Must be treated by a specialist physician experienced in the management of this condition.

If prednisolone or equivalent is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated of at least 7.5 mg per day, the patient must have received at least 12 weeks of continuous treatment with each of at least 2 of the following: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day.

Where two of: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; or (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to prednisolone or equivalent: at least one of the remaining tolerated therapies must be trialled at a minimum dose as mentioned above.

If the patient has a contraindication/severe intolerance to each of: (i) prednisolone or equivalent of at least 7.5 mg per day; (ii) hydroxychloroquine; (iii) methotrexate at a dose of at least 20 mg per week; (iv) azathioprine at a dose of at least 100 mg per day; (v) mycophenolate at a dose of at least 1,000 mg per day; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application.

The authority application must be made in writing via HPOS form upload or mail and must include:

(a) details of the ACR/EULAR SLE Classification Criteria 2019 confirming diagnosis of SLE;

(b) details (date and score) of the completed SLEDAI-2K score sheet;

(c) details of current systemic therapy used (dosage, date of commencement and duration of therapy including prior anifrolumab use);

(d) details of contraindication/intolerances to prior therapies (drug name, the degree of toxicity and dose).

All the reports must be documented in the patient's medical records.

If the application is submitted through HPOS form upload or mail, it must include:

(i) A completed authority prescription form; and

(ii) 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).

For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Written Authority Required procedures

Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor

C16703

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 mutation in the CFTR gene that is considered responsive to elexacaftor/tezacaftor/ivacaftor potentiation based on clinical and/or in vitro assay data; 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 aged between 2 and 11 years inclusive.

For the purposes of this restriction, the list of mutations considered to be responsive to elexacaftor/tezacaftor/ivacaftor is defined in the TGA approved Product Information (PI). Mutations that are not listed in the TGA approved PI but considered to be responsive to elexacaftor/tezacaftor/ivacaftor can be accepted with a confirmation that these patients do not harbour two Class I mutations.

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 via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the pathology report substantiating the specific mutation considered to be responsive to elexacaftor/tezacaftor/ivacaftor as listed in the TGA approved PI - quote each of the: (i) specific mutation, and if the specific mutation is not listed in the TGA approved PI, confirmation that the patient does not harbour two Class I mutations, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient; and

(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) 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).

Compliance with Written Authority Required procedures

C16704

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 aged between 2 and 11 years inclusive.

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 via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) 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).

Compliance with Written Authority Required procedures

C16706

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 mutation in the CFTR gene that is considered responsive to elexacaftor/tezacaftor/ivacaftor potentiation based on clinical and/or in vitro assay data; 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 2 to 5 years of age.

For the purposes of this restriction, the list of mutations considered to be responsive to elexacaftor/tezacaftor/ivacaftor is defined in the TGA approved Product Information (PI). Mutations that are not listed in the TGA approved PI but considered to be responsive to elexacaftor/tezacaftor/ivacaftor can be accepted with a confirmation that these patients do not harbour two Class I mutations.

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 via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the pathology report substantiating the specific mutation considered to be responsive to elexacaftor/tezacaftor/ivacaftor as listed in the TGA approved PI - quote each of the: (i) specific mutation, and if the specific mutation is not listed in the TGA approved PI, confirmation that the patient does not harbour two Class I mutations, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient; and

(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) 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).

Compliance with Written Authority Required procedures

C16734

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 2 to 5 years of age.

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 via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) 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).

Compliance with Written Authority Required procedures

C16799

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 mutation in the CFTR gene that is considered responsive to elexacaftor/tezacaftor/ivacaftor potentiation based on clinical and/or in vitro assay data; 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 at least 6 years of age.

For the purposes of this restriction, the list of mutations considered to be responsive to elexacaftor/tezacaftor/ivacaftor is defined in the TGA approved Product Information (PI). Mutations that are not listed in the TGA approved PI but considered to be responsive to elexacaftor/tezacaftor/ivacaftor can be accepted with a confirmation that these patients do not harbour two Class I mutations.

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 via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the pathology report substantiating the specific mutation considered to be responsive to elexacaftor/tezacaftor/ivacaftor as listed in the TGA approved PI - quote each of the: (i) specific mutation, and if the specific mutation is not listed in the TGA approved PI, confirmation that the patient does not harbour two Class I mutations, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient; and

(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) 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).

Compliance with Written Authority Required procedures

C16800

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 at least 6 years of age.

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 via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) 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).

Compliance with Written Authority Required procedures

C15482

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 2 to 5 years of age.

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) details of the proposed 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 F508del mutation - 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

C15511

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 2 to 5 years of age.

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) details of the proposed 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

Maribavir

C16735

Cytomegalovirus infection and disease

Patient must have received a hematopoietic stem-cell transplant; OR

Patient must have received a solid-organ transplant; AND

Patient must have a cytomegalovirus infection or cytomegalovirus disease that is resistant, refractory or intolerant/contraindicated to appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; OR

Patient must have received and is intolerant to continued use of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; AND

The treatment must be used as monotherapy for this condition under this restriction; AND

Patient must not have previously demonstrated resistance to this drug; AND

Patient must not have cytomegalovirus disease that involves the central nervous system; AND

Patient must not have cytomegalovirus retinitis.

For the purpose of administering this restriction:

(i) A patient is determined to be refractory if after at least two weeks of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet, they fail to achieve a greater than 1log10 decrease in cytomegalovirus DNA level.

(ii) A patient is determined to be resistant by the identification of a genetic alteration that decreases susceptibility to ganciclovir, valganciclovir, cidofovir or foscarnet.

(iii) A patient with Grade 3 neutropenia (an absolute neutrophil count less than 1000 cells per cubic millimetre) or impaired renal function (creatinine clearance less than 50 mL/min) is determined to be intolerant/contraindicated.

Compliance with Authority Required procedures - Streamlined Authority Code 16735

C16806

Cytomegalovirus infection and disease

Patient must have received a hematopoietic stem-cell transplant; OR

Patient must have received a solid-organ transplant; AND

Patient must have a cytomegalovirus infection or cytomegalovirus disease that is resistant, refractory or intolerant/contraindicated to appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; OR

Patient must have received and is intolerant to continued use of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; AND

The treatment must be used as monotherapy for this condition under this restriction; AND

Patient must not have previously demonstrated resistance to this drug; AND

Patient must not have cytomegalovirus disease that involves the central nervous system; AND

Patient must not have cytomegalovirus retinitis.

For the purpose of administering this restriction:

(i) A patient is determined to be refractory if after at least two weeks of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet, they fail to achieve a greater than 1log10 decrease in cytomegalovirus DNA level.

(ii) A patient is determined to be resistant by the identification of a genetic alteration that decreases susceptibility to ganciclovir, valganciclovir, cidofovir or foscarnet.

(iii) A patient with Grade 3 neutropenia (an absolute neutrophil count less than 1000 cells per cubic millimetre) or impaired renal function (creatinine clearance less than 50 mL/min) is determined to be intolerant/contraindicated.

Compliance with Authority Required procedures - Streamlined Authority Code 16806