1. The whole of this instrument

1 August 2025

1 August 2025

Eflornithine

Tablet 192 mg (as hydrochloride)

Oral

Ifinwil

C16839 C16841 C16959

See Schedule 2

See Schedule 2

Foslevodopa with foscarbidopa

Solution for subcutaneous infusion containing foslevodopa 2400 mg with foscarbidopa 120 mg in 10 mL

Injection

Vyalev

C16812 C16853 C16883 C16972

P16812 P16883

28

5

C16812 C16853 C16883 C16972

P16853 P16972

56

5

Omalizumab

Injection 75 mg in 0.5 mL single dose pre-filled pen

Injection

Xolair

C15347 C15376 C15846 C15870

See Schedule 2

See Schedule 2

Injection 75 mg in 0.5 mL single dose pre‑filled syringe

Injection

Omlyclo

C15347 C15352 C15376 C15403 C15846 C15870 C16846 C16879 C16904 C16948 C16949

See Schedule 2

See Schedule 2

Xolair

C15347 C15352 C15376 C15403 C15846 C15870 C16879

See Schedule 2

See Schedule 2

Injection 150 mg in 1 mL single dose pre-filled pen

Injection

Xolair

C7046 C15347 C15376 C15846 C15870 C16906

See Schedule 2

See Schedule 2

Injection 150 mg in 1 mL single dose pre‑filled syringe

Injection

Omlyclo

C7046 C15347 C15376 C15403 C15846 C15870 C16846 C16879 C16904 C16905 C16906 C16948 C16949 C16960

See Schedule 2

See Schedule 2

Injection 300 mg in 2 mL single dose pre-filled pen

Injection

Xolair

C7046 C15347 C15376 C15846 C15870 C16906

See Schedule 2

See Schedule 2

Tenofovir APOTEX

C6980 C6982 C6983 C6984 C6992 C6998 C10362

P10362

60

2

Tenofovir APOTEX

C6980 C6982 C6983 C6984 C6992 C6998 C10362

P6980 P6982 P6983 P6984 P6992 P6998

60

5

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg (S19A)

Oral

Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/300 mg Tablets (Laurus Labs, USA)

C6985 C6986

60

5

Steqeyma

C14801 C16824 C16829 C16863 C16866 C16890 C16939 C16944 C16958

See Schedule 2

See Schedule 2

Eflornithine

C16839 C16841 C16959

3 packs

2

Omalizumab

C16906

Sufficient for 4 weeks of treatment

2

C7046 C15347 C15352 C16846 C16904 C16905 C16948 C16949 C16960

Sufficient for 4 weeks of treatment

5

C16879

Sufficient for 4 weeks of treatment

6

C15846 C15870

Sufficient for 4 weeks of treatment

7

C15403

Sufficient for up to 28 weeks of treatment

0

C15376

Sufficient for up to 32 weeks of treatment

0

Eflornithine

C16839

High-risk neuroblastoma

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 August 2025; AND

Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND

The treatment must not exceed a total of 27 cycles (based on 4 weeks per cycle) from the first dose of this drug, regardless of whether it was PBS/non-PBS-subsidised.

Must be treated in a hospital/cancer centre by either a: (i) paediatric oncologist, (ii) haematologist; OR

Must be treated by a medical practitioner under the direct supervision of either a: (i) paediatric oncologist, (ii) haematologist.

At the time of the authority application, the prescriber should request an appropriate quantity and number of repeats based on the patient's Body Surface Area (BSA), according to the dosing schedule in the TGA approved Product Information.

The following maximum quantity units and repeats may be authorised under this restriction (providing 3 months of therapy for each prescription).

Up to a maximum quantity of 100 units and 1 repeat for a BSA 0.25 m2to less than 0.5 m2;

Up to a maximum quantity of 200 units and 1 repeat for a BSA 0.5 m2to less than 0.75 m2;

Up to a maximum quantity of 200 units and 2 repeats for a BSA 0.75 m2to 1.5 m2;

Up to a maximum quantity of 300 units and 2 repeats for a BSA greater than 1.5 m2.

Compliance with Authority Required procedures

C16841

High-risk neuroblastoma

Initial treatment

Patient must have high-risk neuroblastoma according to a validated risk classification system; AND

Patient must be in remission, with at least a partial response, at the end of multiagent, multimodality therapy for high-risk neuroblastoma; AND

The treatment must be initiated after completing previous therapy; AND

Patient must not have previously received PBS-subsidised treatment with this drug for this condition.

Must be treated in a hospital/cancer centre by either a: (i) paediatric oncologist, (ii) haematologist.

Prior to initiating treatment with this drug, a complete blood count, liver function tests and baseline hearing assessments should be performed and documented in the patient's medical records.

At the time of the authority application, the prescriber should request an appropriate quantity and number of repeats based on the patient's Body Surface Area (BSA), according to the dosing schedule in the TGA approved Product Information.

The following maximum quantity units and repeats may be authorised under this restriction (providing 3 months of therapy for each prescription).

Up to a maximum quantity of 100 units and 1 repeat for a BSA 0.25 m2to less than 0.5 m2;

Up to a maximum quantity of 200 units and 1 repeat for a BSA 0.5 m2to less than 0.75 m2;

Up to a maximum quantity of 200 units and 2 repeats for a BSA 0.75 m2to 1.5 m2;

Up to a maximum quantity of 300 units and 2 repeats for a BSA greater than 1.5 m2.

Authority applications for initial treatment must be made in writing and must include:

(a) details of the proposed prescription; and

(b) a completed PBS authority application form, relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:

(i) details of prior multiagent, multimodality therapy for high-risk neuroblastoma [date of commencement and duration of therapy]; and

(ii) the patient's BSA measurement.

Compliance with Written Authority Required procedures

C16959

High-risk neuroblastoma

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; AND

The treatment must not exceed a total of 27 cycles (based on 4 weeks per cycle) from the first dose of this drug, regardless of whether it was PBS/non-PBS-subsidised.

Must be treated in a hospital/cancer centre by either a: (i) paediatric oncologist, (ii) haematologist; OR

Must be treated by a medical practitioner under the direct supervision of either a: (i) paediatric oncologist, (ii) haematologist.

At the time of the authority application, the prescriber should request an appropriate quantity and number of repeats based on the patient's Body Surface Area (BSA), according to the dosing schedule in the TGA approved Product Information.

The following maximum quantity units and repeats may be authorised under this restriction (providing 3 months of therapy for each prescription).

Up to a maximum quantity of 100 units and 1 repeat for a BSA 0.25 m2to less than 0.5 m2;

Up to a maximum quantity of 200 units and 1 repeat for a BSA 0.5 m2to less than 0.75 m2;

Up to a maximum quantity of 200 units and 2 repeats for a BSA 0.75 m2to 1.5 m2;

Up to a maximum quantity of 300 units and 2 repeats for a BSA greater than 1.5 m2.

Compliance with Authority Required procedures

Foslevodopa with foscarbidopa

C16812

P16812

Advanced Parkinson disease

Must be treated by a specialist physician; OR

Must be treated by a physician who has consulted a specialist physician with expertise in the management of Parkinson's disease.

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 16812

C16853

P16853

Advanced Parkinson disease

Must be treated by a specialist physician; OR

Must be treated by a physician who has consulted a specialist physician with expertise in the management of Parkinson's disease.

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND

Patient must require continuous administration of foslevodopa without an overnight break; OR

Patient must require a total daily dose of more than 2,400 mg of foslevodopa.

Compliance with Authority Required procedures - Streamlined Authority Code 16853

C16883

P16883

Advanced Parkinson disease

Must be treated by a specialist physician; OR

Must be treated by a physician who has consulted a specialist physician with expertise in the management of Parkinson's disease.

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 16883

C16972

P16972

Advanced Parkinson disease

Must be treated by a specialist physician; OR

Must be treated by a physician who has consulted a specialist physician with expertise in the management of Parkinson's disease.

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND

Patient must require continuous administration of foslevodopa without an overnight break; OR

Patient must require a total daily dose of more than 2,400 mg of foslevodopa.

Compliance with Authority Required procedures - Streamlined Authority Code 16972

Ivacaftor

C16844

Cystic fibrosis

Initial treatment - New patient (non-gating mutations)

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 at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data; AND

Patient must not have either: (i) G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; (ii) other gating (class III) mutation in the CFTR gene; 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 4 months or older.

For the purposes of this restriction, the list of mutations considered to be responsive to ivacaftor is defined in the TGA approved Product Information.

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 made 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 ivacaftor as listed in the TGA-approved Product Information. Quote each of the: (a) the specific mutation listed in the TGA-approved Product Information, (b) name of the pathology report provider, (c) date of pathology report, (d) 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

C16845

Cystic fibrosis

Continuing treatment (non-gating mutations)

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 per authority application; AND

The treatment must be given concomitantly with standard therapy for this condition.

Patient must be aged 4 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 made 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

C16876

Cystic fibrosis

Continuing treatment (gating mutations)

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 per authority application; AND

The treatment must be given concomitantly with standard therapy for this condition.

Patient must be aged 4 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 made 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

C16878

Cystic fibrosis

Initial treatment - New patient (gating mutations)

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 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 4 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 made 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 G551D mutation or other gating (Class III) mutation on the CFTR gene - quote each of the: (a) the specific CFTR mutation listed in the TGA-approved Product Information, (b) name of the pathology report provider, (c) date of pathology report, (d) 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

C7055

Severe chronic spontaneous urticaria

Initial treatment

Must be treated by a clinical immunologist; OR

Must be treated by an allergist; OR

Must be treated by a dermatologist; OR

Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU).

The condition must be based on both physical examination and patient history (to exclude any factors that may be triggering the urticaria); AND

Patient must have experienced itch and hives that persist on a daily basis for at least 6 weeks despite treatment with H1 antihistamines; AND

Patient must have failed to achieve an adequate response after a minimum of 2 weeks treatment with a standard therapy; AND

Patient must not receive more than 12 weeks of treatment under this restriction.

A standard therapy is defined as a combination of therapies that includes H1 antihistamines at maximally tolerated doses in accordance with clinical guidelines, and one of the following:

1) a H2 receptor antagonist (150 mg twice per day); or

2) a leukotriene receptor antagonist (LTRA) (10 mg per day); or

3) doxepin (up to 25 mg three times a day)

If the requirement for treatment with H1 antihistamines and a H2 receptor antagonist, or a leukotriene receptor antagonist or doxepin cannot be met because of contraindications according to the relevant TGA‑approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the authority application.

A failure to achieve an adequate response to standard therapy is defined as a current Urticaria Activity Score 7 (UAS7) score of equal to or greater than 28 with an itch score of greater than 8, as assessed while still on standard therapy.

The authority application must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Chronic Spontaneous Urticaria Omalizumab Initial PBS Authority Application ‑ Supporting Information Form which must include:

(i) demonstration of failure to achieve an adequate response to standard therapy; and

(ii) drug names and doses of standard therapies that the patient has failed; and

(iii) a signed patient acknowledgment that cessation of therapy should be considered after the patient has demonstrated clinical benefit with omalizumab to re‑evaluate the need for continued therapy. Any patient who ceases therapy and whose CSU relapses will need to re‑initiate PBS‑subsidised omalizumab as a new patient.

Compliance with Written Authority Required procedures

C15350

Uncontrolled severe allergic asthma

Initial treatment

Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either: a (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility, (b) airway hyperresponsiveness, (c) peak expiratory flow (PEF) variability; AND

Patient must have a duration of asthma of at least 1 year; AND

Patient must have past or current evidence of atopy, documented by either: (i) skin prick testing, (ii) an in vitro measure of specific IgE; AND

Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to the time of application; AND

Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; AND

Patient must not receive more than 28 weeks of treatment under this restriction.

Patient must be aged 6 to less than 12 years.

Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.

Patient must be under the care of the same physician for at least 6 months.

Optimised asthma therapy includes:

(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;

AND

(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.

If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.

The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:

(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used),

AND

(b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.

The Asthma Control Questionnaire (5 item version) or ACQ-IA assessment of the patient's response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 24 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.

This assessment, which will be used to determine eligibility for continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with omalizumab.

A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.

At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) 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).

The following must be provided at the time of application and documented in the patient's medical records:

(a) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and

(b) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and

(c) the IgE result and date; and

(d) Asthma Control Questionnaire (ACQ-5) score; or

(e) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.

Compliance with Written Authority Required procedures

C16846

Uncontrolled severe asthma

Continuing treatment

Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.

Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND

Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug 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 severe asthma; AND

Patient must not receive more than 24 weeks of treatment under this restriction.

Patient must be aged 12 years or older.

An adequate response to omalizumab treatment is defined as:

(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR

(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR

(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).

For second and subsequent continuing treatment with this drug, a measurement of response to the prior course of therapy must be documented in the patient's medical records. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate should be made from 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated.

The following information must be documented in the patient's medical records:

(a) Asthma Control Questionnaire (ACQ-5) score; and

(b) If applicable, maintenance oral corticosteroid dose; and

(c) For patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the time-adjusted exacerbation rate has reduced.

The most recent Asthma Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application.

Compliance with Authority Required procedures - Streamlined Authority Code 16846

C16879

Uncontrolled severe allergic asthma

Initial treatment

Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either: a (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility, (b) airway hyperresponsiveness, (c) peak expiratory flow (PEF) variability; AND

Patient must have a duration of asthma of at least 1 year; AND

Patient must have past or current evidence of atopy, documented by either: (i) skin prick testing, (ii) an in vitro measure of specific IgE; AND

Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to the time of application; AND

Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; AND

Patient must not receive more than 28 weeks of treatment under this restriction.

Patient must be aged 6 to less than 12 years.

Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.

Patient must be under the care of the same physician for at least 6 months.

Optimised asthma therapy includes:

(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;

AND

(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.

If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.

The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:

(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used),

AND

(b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.

The Asthma Control Questionnaire (5 item version) or ACQ-IA assessment of the patient's response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 24 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.

This assessment, which will be used to determine eligibility for continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with omalizumab.

A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.

At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) 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).

The following must be provided at the time of application and documented in the patient's medical records:

(a) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and

(b) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and

(c) the IgE result and date; and

(d) Asthma Control Questionnaire (ACQ-5) score; or

(e) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.

Compliance with Written Authority Required procedures

C16904

Uncontrolled severe allergic asthma

Continuing treatment

Patient must have a documented history of severe allergic asthma; AND

Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND

Patient must not receive more than 24 weeks of treatment under this restriction.

Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.

An adequate response to omalizumab treatment is defined as:

(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or ACQ-IA score of at least 0.5 from baseline, OR

(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 or ACQ-IA score from baseline, OR

(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.

A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised omalizumab so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.

Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with omalizumab.

A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.

At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks of therapy.

The following information must be provided at the time of application and must be documented in the patient's medical records:

(a) If applicable, the baseline and maintenance oral corticosteroid dose; and

(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or

(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and

(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.

The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.

Compliance with Authority Required procedures - Streamlined Authority Code 16904

C16905

Severe chronic spontaneous urticaria

Continuing treatment

Must be treated by a clinical immunologist; OR

Must be treated by an allergist; OR

Must be treated by a dermatologist; OR

Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU).

Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND

Patient must not receive more than 24 weeks per authorised course of treatment under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 16905

C16906

Severe chronic spontaneous urticaria

Initial treatment

Must be treated by a clinical immunologist; OR

Must be treated by an allergist; OR

Must be treated by a dermatologist; OR

Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU).

The condition must be based on both physical examination and patient history (to exclude any factors that may be triggering the urticaria); AND

Patient must have experienced itch and hives that persist on a daily basis for at least 6 weeks despite treatment with H1 antihistamines; AND

Patient must have failed to achieve an adequate response after a minimum of 2 weeks treatment with a standard therapy; AND

Patient must not receive more than 12 weeks of treatment under this restriction.

A standard therapy is defined as a combination of therapies that includes H1 antihistamines at maximally tolerated doses in accordance with clinical guidelines, and one of the following:

1) a H2 receptor antagonist (150 mg twice per day); or

2) a leukotriene receptor antagonist (LTRA) (10 mg per day); or

3) doxepin (up to 25 mg three times a day)

If the requirement for treatment with H1 antihistamines and a H2 receptor antagonist, or a leukotriene receptor antagonist or doxepin cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the authority application.

A failure to achieve an adequate response to standard therapy is defined as a current Urticaria Activity Score 7 (UAS7) score of equal to or greater than 28 with an itch score of greater than 8, as assessed while still on standard therapy.

The authority application must be made in writing and must include:

(a) details of the proposed prescription; and

(b) a completed Chronic Spontaneous Urticaria Omalizumab Initial PBS Authority Application - Supporting Information Form which must include:

(i) demonstration of failure to achieve an adequate response to standard therapy; and

(ii) drug names and doses of standard therapies that the patient has failed; and

(iii) a signed patient acknowledgment that cessation of therapy should be considered after the patient has demonstrated clinical benefit with omalizumab to re-evaluate the need for continued therapy. Any patient who ceases therapy and whose CSU relapses will need to re-initiate PBS-subsidised omalizumab as a new patient.

Compliance with Written Authority Required procedures

C16948

Uncontrolled severe allergic asthma

Continuing treatment

Patient must have a documented history of severe allergic asthma; AND

Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND

Patient must not receive more than 24 weeks of treatment under this restriction.

Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.

An adequate response to omalizumab treatment is defined as:

(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or ACQ-IA score of at least 0.5 from baseline, OR

(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 or ACQ-IA score from baseline, OR

(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.

A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised omalizumab so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.

Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with omalizumab.

A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.

At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks of therapy.

The following information must be provided at the time of application and must be documented in the patient's medical records:

(a) If applicable, the baseline and maintenance oral corticosteroid dose; and

(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or

(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and

(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.

The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.

Compliance with Authority Required procedures - Streamlined Authority Code 16948

C16949

Uncontrolled severe asthma

Continuing treatment

Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.

Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND

Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug 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 severe asthma; AND

Patient must not receive more than 24 weeks of treatment under this restriction.

Patient must be aged 12 years or older.

An adequate response to omalizumab treatment is defined as:

(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR

(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR

(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).

For second and subsequent continuing treatment with this drug, a measurement of response to the prior course of therapy must be documented in the patient's medical records. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate should be made from 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated.

The following information must be documented in the patient's medical records:

(a) Asthma Control Questionnaire (ACQ-5) score; and

(b) If applicable, maintenance oral corticosteroid dose; and

(c) For patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the time-adjusted exacerbation rate has reduced.

The most recent Asthma Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application.

Compliance with Authority Required procedures - Streamlined Authority Code 16949

C16960

Severe chronic spontaneous urticaria

Continuing treatment

Must be treated by a clinical immunologist; OR

Must be treated by an allergist; OR

Must be treated by a dermatologist; OR

Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU).

Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND

Patient must not receive more than 24 weeks per authorised course of treatment under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 16960

Ustekinumab

C14801

Complex refractory Fistulising Crohn disease

Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) - balance of supply

Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR

Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND

The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]

Compliance with Authority Required procedures

C16824

Severe Crohn disease

Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

Patient must have confirmed severe 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; AND

Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; OR

Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR

Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND

Patient must have evidence of intestinal inflammation; OR

Patient must be assessed clinically as being in a high faecal output state; OR

Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND

The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.

Patient must be at least 18 years of age.

Applications for authorisation must be made in writing and must include:

(a) details of the two proposed prescriptions; and

(b) a completed 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 if relevant; and

(ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and

(iii) the date of the most recent clinical assessment.

Evidence of intestinal inflammation includes:

(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; or

(ii) faeces: higher than normal lactoferrin or calprotectin level; 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.

Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for a total dose of 90 mg and no repeats.

A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised

Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.

Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.

Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.

An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

C16829

Complex refractory Fistulising Crohn disease

Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)

Patient must have 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; AND

Patient must have an externally draining enterocutaneous or rectovaginal fistula.

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

Applications for authorisation must be made in writing and must include:

(1) details of the two proposed prescriptions; and

(2) 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) which includes a completed current Fistula Assessment Form including the date of assessment of the patient's condition of no more than 4 weeks old at the time of application.

Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 1 vial or pre-filled syringe of 90 mg and no repeats.

An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised

Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.

Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.

Compliance with Written Authority Required procedures

C16863

Severe Crohn disease

Initial treatment - Initial 1 (new patient)

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

Patient must have confirmed severe 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; AND

Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND

Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR

Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR

Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND

The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND

Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR

Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR

Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.

Patient must be at least 18 years of age.

Applications for authorisation must be made in writing and must include:

(a) details of the two proposed prescriptions; and

(b) a completed 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 if relevant; and

(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and

(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and

(iv) the date of the most recent clinical assessment.

Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:

(a) patient must have evidence of intestinal inflammation;

(b) patient must be assessed clinically as being in a high faecal output state;

(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.

Evidence of intestinal inflammation includes:

(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; or

(ii) faeces: higher than normal lactoferrin or calprotectin level; 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.

Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for a total dose of 90 mg and no repeats.

A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised

Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.

Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.

All assessments, pathology tests and diagnostic imaging studies must be made within 4 weeks of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.

If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application.

If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.

Details of the accepted toxicities including severity can be found on the Services Australia website.

Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.

An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

C16866

Moderate to severe ulcerative colitis

Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

Patient must have a Mayo clinic score greater than or equal to 6; OR

Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND

The treatment must not exceed a single dose to be administered at week 0 under this restriction.

Patient must be at least 18 years of age.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) 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), which includes:

(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and

(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.

All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.

The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.

An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.

An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

A maximum of 16 weeks of treatment with this drug will be approved under this criterion.

Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.

Details of the accepted toxicities including severity can be found on the Services Australia website.

Compliance with Written Authority Required procedures

C16890

Severe Crohn disease

Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.

Patient must be at least 18 years of age.

Applications for authorisation must be made in writing and must include:

(a) details of the two proposed prescriptions; and

(b) a completed 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, if relevant; or

(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and

(iii) the date of clinical assessment; and

(iv) the details of prior biological medicine treatment including the details of date and duration of treatment.

Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for a total dose of 90 mg and no repeats.

A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised

Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.

Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.

To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.

Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and submitted to Services Australia no later than 4 weeks from the date of completion of treatment.

An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

C16939

Moderate to severe ulcerative colitis

Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must not exceed a single dose to be administered at week 0 under this restriction.

Patient must be at least 18 years of age.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) 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), which includes:

(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and

(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.

An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.

An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.

A maximum of 16 weeks of treatment with this drug will be approved under this criterion.

Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.

Details of the accepted toxicities including severity can be found on the Services Australia website.

Compliance with Written Authority Required procedures

C16944

Complex refractory Fistulising Crohn disease

Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted between 8 and 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

Applications for authorisation must be made in writing and must include:

(1) details of the two proposed prescriptions; and

(2) 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) 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 biological medicine treatment including details of date and duration of treatment.

Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 1 vial or pre-filled syringe of 90 mg and no repeats.

The most recent fistula assessment must be no more than 4 weeks old at the time of application.

A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised

Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.

Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.

Compliance with Written Authority Required procedures

C16958

Moderate to severe ulcerative colitis

Initial treatment - Initial 1 (new patient)

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND

Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR

Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR

Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND

Patient must have a Mayo clinic score greater than or equal to 6; OR

Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND

The treatment must not exceed a single dose to be administered at week 0 under this restriction.

Patient must be at least 18 years of age.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) 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), which includes:

(i) the completed current Mayo clinic or partial Mayo clinic 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).

All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.

The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.

An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.

If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.

A maximum of 16 weeks of treatment with this drug will be approved under this criterion.

Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.

Compliance with Written Authority Required procedures