1.  The whole of this instrument

1 December 2022

1 December 2022

Injection 30 mg in 1 mL single dose pre‑filled syringe

Injection

Fasenra

C11841 C11842 C11892 C11893

See Schedule 2

See Schedule 2

Epoprostenol

Powder for I.V. infusion 500 micrograms (as sodium)

Injection

EPOPROSTENOL SUN

C13491 C13492 C13505 C13506 C13510 C13512 C13577 C13634

See Schedule 2

See Schedule 2

Veletri

C13491 C13492 C13505 C13506 C13510 C13512 C13577 C13634

See Schedule 2

See Schedule 2

Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL

Injection

Flolan

C13491 C13492 C13505 C13506 C13510 C13512 C13577 C13634

See Schedule 2

See Schedule 2

Powder for I.V. infusion 1.5 mg (as sodium)

Injection

EPOPROSTENOL SUN

C13491 C13492 C13505 C13506 C13510 C13512 C13577 C13634

See Schedule 2

See Schedule 2

Veletri

C13491 C13492 C13505 C13506 C13510 C13512 C13577 C13634

See Schedule 2

See Schedule 2

Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL

Injection

Flolan

C13491 C13492 C13505 C13506 C13510 C13512 C13577 C13634

See Schedule 2

See Schedule 2

Infliximab

Powder for I.V. infusion 100 mg

Injection

Inflectra

C4524 C7777 C8296 C8646 C8745 C8844 C8881 C8883 C8886 C8940 C8941 C8962 C9065 C9067 C9068 C9111 C9188 C9400 C9402 C9472 C9481 C9487 C9559 C9584 C9587 C9602 C9621 C9632 C9668 C9669 C9677 C9719 C9721 C9732 C9751 C9754 C9775 C9779 C9783 C9787 C9803 C11158 C12003 C12004 C12025 C12039 C12042 C12043 C12049 C12051 C12058 C12059 C12063 C12067 C12069 C12074 C12075 C12313 C12361 C12362 C13518 C13522 C13526 C13529 C13584 C13586 C13587 C13589 C13590 C13591 C13592 C13639 C13640 C13641 C13679 C13689 C13691 C13692 C13702 C13705 C13706 C13714 C13715 C13719

See Schedule 2

See Schedule 2

Remicade

C4524 C7777 C8296 C8646 C8745 C8881 C8883 C8886 C8941 C8962 C9065 C9067 C9068 C9111 C9400 C9402 C9487 C9559 C9587 C9632 C9669 C9677 C9719 C9721 C9751 C9754 C9779 C9783 C9803 C11158 C12003 C12004 C12025 C12039 C12043 C12049 C12058 C12059 C12063 C12313 C12361 C12362 C13518 C13522 C13526 C13529 C13584 C13586 C13587 C13589 C13590 C13591 C13592 C13639 C13640 C13641 C13679 C13689 C13691 C13692 C13702 C13705 C13706 C13714 C13715 C13719

See Schedule 2

See Schedule 2

Renflexis

C4524 C7777 C8296 C8646 C8745 C8844 C8881 C8883 C8886 C8940 C8941 C8962 C9065 C9067 C9068 C9111 C9188 C9400 C9402 C9472 C9481 C9487 C9559 C9584 C9587 C9602 C9621 C9632 C9668 C9669 C9677 C9719 C9721 C9732 C9751 C9754 C9775 C9779 C9783 C9787 C9803 C11158 C12003 C12004 C12025 C12039 C12042 C12043 C12049 C12051 C12058 C12059 C12063 C12067 C12069 C12074 C12075 C12313 C12361 C12362 C13518 C13522 C13526 C13529 C13584 C13586 C13587 C13589 C13590 C13591 C13592 C13639 C13640 C13641 C13679 C13689 C13691 C13692 C13702 C13705 C13706 C13714 C13715 C13719

See Schedule 2

See Schedule 2

Noumed Mycophenolate

C5554 C5795 C9691 C9693

300

5

Pegcetacoplan

Solution for subcutaneous infusion 1,080 mg in 20 mL

Injection

Empaveli

C13616 C13655 C13658 C13710 C13743

See Schedule 2

See Schedule 2

Valganciclovir Viatris

C4980 C4989 C9316

120

5

Ambrisentan

C11229 C13496 C13497 C13499 C13500 C13575 C13576 C13580 C13582

Sufficient for treatment for 1 month

5

Bosentan

C11229 C13495 C13496 C13497 C13499 C13571 C13580 C13582 C13632

Sufficient for treatment for 1 month

5

C12425

Sufficient for treatment for 1 month

0

Eculizumab

C6626

1

Sufficient for 4 weeks of treatment

C6642

1

4

C6668 C6686 C6687 C6688

1

5

C6637

1

6

C13461

1

0

C13464 C13619 C13660 C13661 C13684

6

5

C13458 C13459 C13560

8

0

Epoprostenol

C13491 C13492 C13505 C13506 C13510 C13512 C13577 C13634

Sufficient for treatment for 1 month

5

Iloprost

C13491 C13492 C13505 C13506 C13510 C13577 C13631 C13634

Sufficient for treatment for 1 month

5

Infliximab

C8886 C9111 C9400 C9402 C9487 C9559 C9587 C11158 C13518 C13529 C13584 C13586 C13587 C13589 C13590 C13591 C13592 C13640 C13679 C13689 C13692 C13705 C13706 C13715 C13719

1 dose of 5 mg per kg of patient weight

3

C8646 C12039 C12361 C13522 C13714

1 dose of 3 mg per kg of patient weight

3

C8745 C8844 C8940 C9188 C9472 C9481 C9584 C9602 C9621 C9668 C12004 C12058 C12067 C12075 C12362

1 dose of 3 mg per kg of patient weight

2

C7777 C8296 C8881 C8883 C8941 C8962 C9065 C9067 C9068 C9669 C9677 C9719 C9721 C9732 C9751 C9754 C9775 C9779 C9783 C9787 C9803 C12003 C12025 C12042 C12043 C12049 C12051 C12059 C12063 C12069 C12074 C12313 C13526 C13639 C13641 C13691 C13702

1 dose of 5 mg per kg of patient weight

2

C4524 C9632

5 vials

1

Macitentan

C11229 C13496 C13497 C13499 C13500 C13575 C13576 C13580 C13582

Sufficient for treatment for 1 month

5

Pegcetacoplan

C13655 C13710

Sufficient for treatment for 4 weeks

0

C13616 C13658 C13743

Sufficient for treatment for 4 weeks

5

Ravulizumab

C13456 C13459 C13614 C13620

1 dose

0

C13465 C13466 C13695

1 dose

2

Riociguat

C6664

Sufficient for treatment for 1 month

3

C13514 C13515

Sufficient for treatment for 1 month

4

C6645 C7629 C13502

Sufficient for treatment for 1 month

5

Sildenafil

C11229 C13482 C13484 C13569 C13570 C13572 C13573 C13629 C13671

Sufficient for treatment for 1 month

5

Tadalafil

C11229 C13482 C13484 C13569 C13570 C13572 C13573 C13629 C13671

Sufficient for treatment for 1 month

5

Ambrisentan

C11229

Pulmonary arterial hypertension (PAH)
Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The authority application for selexipag must be approved prior to the authority application for this agent.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested.

Compliance with Authority Required procedures

C13496

Pulmonary arterial hypertension (PAH)
Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
- RHC composite assessment; and
- ECHO composite assessment; and
- 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
- RHC plus ECHO composite assessments;
- RHC composite assessment plus 6MWT;
- RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
- ECHO composite assessment plus 6MWT;
- ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.

Compliance with Written Authority Required procedures

C13497

Pulmonary arterial hypertension (PAH)
Initial 3 - changing to this drug in combination therapy (dual or triple therapy)
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND
Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing.

Compliance with Authority Required procedures

C13499

Pulmonary arterial hypertension (PAH)
Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND
Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application.

Compliance with Authority Required procedures

C13500

Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
- RHC composite assessment; and
- ECHO composite assessment; and
- 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
- RHC plus ECHO composite assessments;
- RHC composite assessment plus 6MWT;
- RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
- ECHO composite assessment plus 6MWT;
- ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested.

Compliance with Written Authority Required procedures

C13575

Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested.

Compliance with Authority Required procedures

C13576

Pulmonary arterial hypertension (PAH)
Initial 2 (change)
Patient must have documented WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND
Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested.

Compliance with Authority Required procedures

C13580

Pulmonary arterial hypertension (PAH)
Transitioning from non-PBS to PBS-subsidised supply of combination therapy (dual or triple therapy, excluding selexipag) - Grandfather arrangements where each drug has not been a PBS benefit
Patient must have been receiving, prior to 1 December 2022, non-PBS-subsidised dual therapy consisting of one endothelin receptor antagonist with one prostanoid, where each drug was not a PBS benefit; this authority application is to continue such combination therapy; OR
Patient must have been receiving, prior to 1 December 2022, non-PBS-subsidised triple therapy consisting of one endothelin receptor antagonist, one prostanoid, one phosphodiesterase-5 inhibitor, where each drug was not a PBS benefit; this authority application is to continue such combination therapy; AND
The condition must have, prior to the time non-PBS combination therapy was initiated, progressed to at least Class III PAH despite treatment with at least one drug from the drug classes mentioned above; OR
The condition must have, at the time non-PBS combination therapy was initiated, been both: (i) classed as at least Class III PAH, (ii) untreated with any drug from the drug classes mentioned above.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
- RHC composite assessment; and
- ECHO composite assessment; and
- 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
- RHC plus ECHO composite assessments;
- RHC composite assessment plus 6MWT;
- RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
- ECHO composite assessment plus 6MWT;
- ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.

Compliance with Authority Required procedures

C13582

Pulmonary arterial hypertension (PAH)
Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS-subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.

Compliance with Authority Required procedures

Bosentan

C11229

Pulmonary arterial hypertension (PAH)
Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The authority application for selexipag must be approved prior to the authority application for this agent.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested.

Compliance with Authority Required procedures

C12425

Pulmonary arterial hypertension (PAH)
Cessation of treatment (all patients)
Patient must be receiving PBS-subsidised treatment with this PAH agent; AND
The treatment must be for the purpose of gradual dose reduction prior to ceasing therapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment. Treatment beyond 1 month will not be approved.

Compliance with Authority Required procedures

C13495

Pulmonary arterial hypertension (PAH)
Initial 2 (change)
Patient must have documented WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND
Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information and no repeats.
Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.
If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA-approved Product Information.

Compliance with Authority Required procedures

C13496

Pulmonary arterial hypertension (PAH)
Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
- RHC composite assessment; and
- ECHO composite assessment; and
- 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
- RHC plus ECHO composite assessments;
- RHC composite assessment plus 6MWT;
- RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
- ECHO composite assessment plus 6MWT;
- ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.

Compliance with Written Authority Required procedures

C13497

Pulmonary arterial hypertension (PAH)
Initial 3 - changing to this drug in combination therapy (dual or triple therapy)
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND
Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing.

Compliance with Authority Required procedures

C13499

Pulmonary arterial hypertension (PAH)
Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND
Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application.

Compliance with Authority Required procedures

C13571

Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested.

Compliance with Authority Required procedures

C13580

Pulmonary arterial hypertension (PAH)
Transitioning from non-PBS to PBS-subsidised supply of combination therapy (dual or triple therapy, excluding selexipag) - Grandfather arrangements where each drug has not been a PBS benefit
Patient must have been receiving, prior to 1 December 2022, non-PBS-subsidised dual therapy consisting of one endothelin receptor antagonist with one prostanoid, where each drug was not a PBS benefit; this authority application is to continue such combination therapy; OR
Patient must have been receiving, prior to 1 December 2022, non-PBS-subsidised triple therapy consisting of one endothelin receptor antagonist, one prostanoid, one phosphodiesterase-5 inhibitor, where each drug was not a PBS benefit; this authority application is to continue such combination therapy; AND
The condition must have, prior to the time non-PBS combination therapy was initiated, progressed to at least Class III PAH despite treatment with at least one drug from the drug classes mentioned above; OR
The condition must have, at the time non-PBS combination therapy was initiated, been both: (i) classed as at least Class III PAH, (ii) untreated with any drug from the drug classes mentioned above.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
- RHC composite assessment; and
- ECHO composite assessment; and
- 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
- RHC plus ECHO composite assessments;
- RHC composite assessment plus 6MWT;
- RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
- ECHO composite assessment plus 6MWT;
- ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.

Compliance with Authority Required procedures

C13582

Pulmonary arterial hypertension (PAH)
Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS-subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.

Compliance with Authority Required procedures

C13632

Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
- RHC composite assessment; and
- ECHO composite assessment; and
- 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
- RHC plus ECHO composite assessments;
- RHC composite assessment plus 6MWT;
- RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
- ECHO composite assessment plus 6MWT;
- ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.
If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information and no repeats.
Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.
If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA-approved Product Information.

Compliance with Written Authority Required procedures

Burosumab

C13330

X-linked hypophosphataemia
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have achieved normalisation in serum phosphate levels; AND
Patient must have radiographical evidence of stabilisation/improvement in rickets in patients without growth plate fusion.
Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.
Where adequate response to treatment with this drug cannot be demonstrated, the treating physician must confirm that continuing therapy has been determined to be clinically required by a second specialist physician with expertise in the treatment of X-linked hypophosphataemia.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

Compliance with Authority Required procedures

C13377

X-linked hypophosphataemia
Initial treatment - New patient
Patient must have a documented confirmation of PHEX pathogenic variant; OR
Patient must have a confirmed diagnosis of X-linked hypophosphataemia demonstrated by the presence of all of the following: (i) a serum phosphate concentration below the age adjusted lower limit of normal; (ii) current or historical (for those with growth plate fusion) radiographic X-ray evidence of rickets; (iii) elevated (or inappropriately normal) serum or plasma FGF-23 levels of above the mean of the assay-specific reference range; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine.
Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

Compliance with Authority Required procedures

C13400

X-linked hypophosphataemia
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2022; AND
Patient must have a documented confirmation of PHEX pathogenic variant; OR
Patient must have, prior to commencing non-PBS-subsidised supply, a confirmed diagnosis of X-linked hypophosphataemia demonstrated by the presence of all of the following: (i) a serum phosphate concentration below the age adjusted lower limit of normal; (ii) current or historical (for those with growth plate fusion) radiographic evidence of rickets; (iii) elevated (or inappropriately normal) serum or plasma FGF-23 levels of above the mean of the assay-specific reference range; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine; AND
Patient must have achieved normalisation in serum phosphate levels; AND
Patient must have radiographical evidence of stabilisation/improvement in rickets in patients without growth plate fusion.
Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.
Where adequate response to treatment with this drug cannot be demonstrated, the treating physician must confirm that continuing therapy has been determined to be clinically required by a second specialist physician with expertise in the treatment of X-linked hypophosphataemia.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

Compliance with Authority Required procedures

C12944

Paroxysmal nocturnal haemoglobinuria (PNH)
First Continuing Treatment
Patient must have received PBS‑subsidised treatment with this drug for this condition under an 'Initial', 'Balance of Supply', or 'Grandfather' treatment criteria; AND
The treatment must not be in combination with ravulizumab.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH) and the upper limit of normal (ULN) for the reporting laboratory
(viii) Multiple of LDH , ULN

Compliance with Written Authority Required procedures

C12945

Paroxysmal nocturnal haemoglobinuria (PNH)
Grandfather 2 (transition from LSDP‑funded eculizumab)
Patient must have previously received eculizumab for the treatment of this condition funded under the Australian Government's Life Saving Drugs Program (LSDP); AND
Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND
Patient must have demonstrated clinical improvement or stabilisation of condition; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND
The treatment must not be in combination with ravulizumab.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH) and the upper limit of normal (ULN) for the reporting laboratory
(viii) Multiple of LDH , ULN

Compliance with Written Authority Required procedures

C12953

Paroxysmal nocturnal haemoglobinuria (PNH)
Initial treatment ‑ Initial 1 (new patient) induction doses
Patient must not have received prior treatment with this drug for this condition; AND
Patient must have a diagnosis of PNH established by flow cytometry; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10%; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND
The treatment must not be in combination with ravulizumab.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH) and the upper limit of normal (ULN) for the reporting laboratory
(viii) Multiple of LDH , ULN

Compliance with Written Authority Required procedures

C12954

Paroxysmal nocturnal haemoglobinuria (PNH)
Subsequent Continuing Treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Switch' criteria; AND
Patient must have demonstrated clinical improvement or stabilisation of condition; AND
The treatment must not be in combination with ravulizumab.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).

Compliance with Written Authority Required procedures

C12955

Paroxysmal nocturnal haemoglobinuria (PNH)
Balance of Supply (transition from non‑PBS‑subsidised treatment during induction phase)
Patient must have received non‑PBS‑subsidised eculizumab for this condition prior to 1 March 2022; AND
Patient must have received insufficient quantity to complete the induction treatment phase; AND
Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND
The treatment must not be in combination with ravulizumab.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).
At the time of the authority application, medical practitioners should request the appropriate number of vials to complete the induction treatment phase, as per the Product Information.
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH) and the upper limit of normal (ULN) for the reporting laboratory
(viii) Multiple of LDH , ULN

Compliance with Written Authority Required procedures

C12964

Paroxysmal nocturnal haemoglobinuria (PNH)
Initial treatment ‑ Initial 2 (switching from PBS‑subsidised ravulizumab for pregnancy)
Patient must be planning pregnancy; OR
Patient must be pregnant; AND
Patient must have received PBS‑subsidised treatment with ravulizumab for this condition; AND
The treatment must not be in combination with ravulizumab.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).
Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS‑subsidised treatment, a 'Switching' patient must proceed under the 'Subsequent Continuing Treatment' criteria.

Compliance with Written Authority Required procedures

C12969

Paroxysmal nocturnal haemoglobinuria (PNH)
Grandfather 1 (transition from non‑PBS‑subsidised treatment) ‑ maintenance phase
Patient must have received non‑PBS‑subsidised eculizumab for this condition prior to 1 March 2022; AND
Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND
Patient must have demonstrated clinical improvement or stabilisation of condition; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND
The treatment must not be in combination with ravulizumab.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH) and the upper limit of normal (ULN) for the reporting laboratory
(viii) Multiple of LDH , ULN

Compliance with Written Authority Required procedures

C13458

Paroxysmal nocturnal haemoglobinuria (PNH)
Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan for pregnancy (induction doses)
Patient must be planning pregnancy; OR
Patient must be pregnant; AND
Patient must have received PBS-subsidised treatment with pegcetacoplan for this condition; AND
The treatment must not be in combination with any of (i) ravulizumab, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).
Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS-subsidised treatment, a 'Switching' patient must proceed under the 'Subsequent Continuing Treatment' criteria.

Compliance with Written Authority Required procedures

C13459

Paroxysmal nocturnal haemoglobinuria (PNH)
Return from PBS-subsidised pegcetacoplan - induction doses
Patient must have received PBS-subsidised treatment with at least one Complement 5 (C5) inhibitor for this condition; AND
Patient must have received PBS-subsidised treatment with pegcetacoplan for this condition; AND
Patient must have developed resistance or intolerance to pegcetacoplan; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).
For continuing PBS-subsidised treatment with this drug, a 'Returning' patient must proceed under the 'Subsequent Continuing Treatment' criteria.

Compliance with Written Authority Required procedures

C13461

Paroxysmal nocturnal haemoglobinuria (PNH)
Balance of Supply (transition from non-PBS-subsidised treatment during induction phase)
Patient must have received non-PBS-subsidised eculizumab for this condition prior to 1 March 2022; AND
Patient must have received insufficient quantity to complete the induction treatment phase; AND
Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).
At the time of the authority application, medical practitioners should request the appropriate number of vials to complete the induction treatment phase, as per the Product Information.
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C13464

Paroxysmal nocturnal haemoglobinuria (PNH)
Grandfather 1 (transition from non-PBS-subsidised treatment) - maintenance phase
Patient must have received non-PBS-subsidised eculizumab for this condition prior to 1 March 2022; AND
Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND
Patient must have experienced clinical improvement as a result of treatment with this drug; OR
Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C13560

Paroxysmal nocturnal haemoglobinuria (PNH)
Initial treatment - initial 1 (new patient) induction doses
Patient must not have received prior treatment with this drug for this condition; AND
Patient must have a diagnosis of PNH established by flow cytometry; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10%; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C13619

Paroxysmal nocturnal haemoglobinuria (PNH)
First Continuing Treatment
Patient must have received PBS-subsidised treatment with this drug for this condition under an 'Initial', 'Balance of Supply', or 'Grandfather' treatment criteria; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C13660

Paroxysmal nocturnal haemoglobinuria (PNH)
Grandfather 2 (transition from LSDP-funded eculizumab)
Patient must have previously received eculizumab for the treatment of this condition funded under the Australian Government's Life Saving Drugs Program (LSDP); AND
Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND
Patient must have experienced clinical improvement as a result of treatment with this drug; OR
Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C13661

Paroxysmal nocturnal haemoglobinuria (PNH)
Subsequent Continuing Treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Switch' criteria; AND
Patient must have experienced clinical improvement as a result of treatment with this drug; OR
Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).

Compliance with Written Authority Required procedures

C13684

Paroxysmal nocturnal haemoglobinuria (PNH)
Initial treatment - Initial 2 (switching from PBS-subsidised ravulizumab for pregnancy)
Patient must be planning pregnancy; OR
Patient must be pregnant; AND
Patient must have received PBS-subsidised treatment with ravulizumab for this condition; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
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).
Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS-subsidised treatment, a 'Switching' patient must proceed under the 'Subsequent Continuing Treatment' criteria.

Compliance with Written Authority Required procedures

Epoprostenol

C13491

Pulmonary arterial hypertension (PAH)
Initial 2 (change)
Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested.

Compliance with Authority Required procedures

C13492

Pulmonary arterial hypertension (PAH)
Transitioning from non-PBS to PBS-subsidised supply of combination therapy (dual or triple therapy, excluding selexipag) - Grandfather arrangements where each drug has not been a PBS benefit
Patient must have been receiving, prior to 1 December 2022, non-PBS-subsidised dual therapy consisting of one endothelin receptor antagonist with one prostanoid, where each drug was not a PBS benefit; this authority application is to continue such combination therapy; OR
Patient must have been receiving, prior to 1 December 2022, non-PBS-subsidised triple therapy consisting of one endothelin receptor antagonist, one prostanoid, one phosphodiesterase-5 inhibitor, where each drug was not a PBS benefit; this authority application is to continue such combination therapy; AND
The condition must have, prior to the time non-PBS combination therapy was initiated, progressed to at least Class III PAH despite treatment with at least one drug from the drug classes mentioned above; OR
The condition must have, at the time non-PBS combination therapy was initiated, been both: (i) classed as at least Class III PAH, (ii) untreated with any drug from the drug classes mentioned above.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
- RHC composite assessment; and
- ECHO composite assessment; and
- 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
- RHC plus ECHO composite assessments;
- RHC composite assessment plus 6MWT;
- RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
- ECHO composite assessment plus 6MWT;
- ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.

Compliance with Authority Required procedures

C13505

Pulmonary arterial hypertension (PAH)
Initial 3 - changing to this drug in combination therapy (dual or triple therapy)
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.
Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.

Compliance with Authority Required procedures

C13506

Pulmonary arterial hypertension (PAH)
Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.
Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; AND
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.

Compliance with Authority Required procedures

C13510

Pulmonary arterial hypertension (PAH)
Initial 1 - starting combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
- RHC composite assessment; and
- ECHO composite assessment; and
- 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
- RHC plus ECHO composite assessments;
- RHC composite assessment plus 6MWT;
- RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
- ECHO composite assessment plus 6MWT;
- ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.

Compliance with Written Authority Required procedures

C13512

Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have WHO Functional Class IV PAH; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
- RHC composite assessment; and
- ECHO composite assessment; and
- 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
- RHC plus ECHO composite assessments;
- RHC composite assessment plus 6MWT;
- RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
- ECHO composite assessment plus 6MWT;
- ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats may be requested.

Compliance with Written Authority Required procedures

C13577

Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested.

Compliance with Authority Required procedures

C13634

Pulmonary arterial hypertension (PAH)
Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS-subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.

Compliance with Authority Required procedures

Iloprost

C13491

Pulmonary arterial hypertension (PAH)
Initial 2 (change)
Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested.

Compliance with Authority Required procedures

C13492

Pulmonary arterial hypertension (PAH)
Transitioning from non-PBS to PBS-subsidised supply of combination therapy (dual or triple therapy, excluding selexipag) - Grandfather arrangements where each drug has not been a PBS benefit
Patient must have been receiving, prior to 1 December 2022, non-PBS-subsidised dual therapy consisting of one endothelin receptor antagonist with one prostanoid, where each drug was not a PBS benefit; this authority application is to continue such combination therapy; OR
Patient must have been receiving, prior to 1 December 2022, non-PBS-subsidised triple therapy consisting of one endothelin receptor antagonist, one prostanoid, one phosphodiesterase-5 inhibitor, where each drug was not a PBS benefit; this authority application is to continue such combination therapy; AND
The condition must have, prior to the time non-PBS combination therapy was initiated, progressed to at least Class III PAH despite treatment with at least one drug from the drug classes mentioned above; OR
The condition must have, at the time non-PBS combination therapy was initiated, been both: (i) classed as at least Class III PAH, (ii) untreated with any drug from the drug classes mentioned above.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
- RHC composite assessment; and
- ECHO composite assessment; and
- 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
- RHC plus ECHO composite assessments;
- RHC composite assessment plus 6MWT;
- RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
- ECHO composite assessment plus 6MWT;
- ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.

Compliance with Authority Required procedures

C13505

Pulmonary arterial hypertension (PAH)
Initial 3 - changing to this drug in combination therapy (dual or triple therapy)
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.
Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.

Compliance with Authority Required procedures

C13506

Pulmonary arterial hypertension (PAH)
Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.
Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; AND
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.

Compliance with Authority Required procedures

C13510

Pulmonary arterial hypertension (PAH)
Initial 1 - starting combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
- RHC composite assessment; and
- ECHO composite assessment; and
- 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
- RHC plus ECHO composite assessments;
- RHC composite assessment plus 6MWT;
- RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
- ECHO composite assessment plus 6MWT;
- ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.

Compliance with Written Authority Required procedures

C13577

Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested.

Compliance with Authority Required procedures

C13631

Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have WHO Functional Class III drug and toxins induced PAH, or WHO Functional Class IV PAH; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
- RHC composite assessment; and
- ECHO composite assessment; and
- 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
- RHC plus ECHO composite assessments;
- RHC composite assessment plus 6MWT;
- RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
- ECHO composite assessment plus 6MWT;
- ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats may be requested.

Compliance with Written Authority Required procedures

C13634

Pulmonary arterial hypertension (PAH)
Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS-subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.

Compliance with Authority Required procedures

C8800

Severe chronic plaque psoriasis
Initial treatment ‑ Initial 3, Whole body (re‑commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received 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
The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 1 month old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient’s condition.
It is recommended that an assessment of a patient’s response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
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 under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C8983

Severe chronic plaque psoriasis
Initial treatment ‑ Initial 3, Face, hand, foot (re‑commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received 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
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 1 month old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient’s condition.
It is recommended that an assessment of a patient’s response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
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 under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C9110

Severe psoriatic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
An assessment of a patient’s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
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

C9169

Severe psoriatic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have previously received 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
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
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.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient’s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
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

C9191

Severe psoriatic arthritis
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 rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
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 3 biological medicines for this condition within 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
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
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.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient’s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
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

C9401

Ankylosing spondylitis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
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
The condition must be radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0‑10 scale that is no more than 4 weeks old at the time of application; AND
Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR
Patient must have a C‑reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR
Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND
Patient must not receive more than 18 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
Up to a maximum of 3 repeats will be authorised.
An assessment of a patient’s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
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

C9558

Ankylosing spondylitis
Initial treatment ‑ Initial 1 (new patient)
The condition must be radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must not receive more than 18 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA‑approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0‑10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L.
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application.
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
Up to a maximum of 3 repeats will be authorised.
An assessment of a patient’s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
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

C9752

Moderate to 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)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND
Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR
Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra‑indication to each of prednisolone (or equivalent), azathioprine, 6‑mercaptopurine and methotrexate; AND
Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30 preferably whilst still on treatment; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be aged 6 to 17 years inclusive.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application ‑Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient’s condition which must be no more than one month old at the time of application; and
(ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition.
The PCDAI score should preferably be obtained whilst on conventional treatment but must be obtained within one month of the last conventional treatment dose.
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 Department of Human Services website.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
A PCDAI assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this 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.

Compliance with Written Authority Required procedures

C9799

Moderate to 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)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
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 diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND
Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be aged 6 to 17 years inclusive.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient’s condition which must be no more than one month old at the time of application.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
A PCDAI assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this 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.

Compliance with Authority Required procedures

C9877

Severe chronic plaque psoriasis
Initial treatment ‑ Initial 2, Face, hand, foot (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 already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within 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 be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS‑subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, it is recommended that an assessment of a patient’s response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
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.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient’s condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within 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.

Compliance with Written Authority Required procedures

C9900

Complex refractory Fistulising Crohn disease
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy ‑ Initial 1)
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 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.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient’s condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
An assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this 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.

Compliance with Written Authority Required procedures

C9994

Severe chronic plaque psoriasis
Initial treatment ‑ Initial 2, Whole body (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 already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within 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 be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS‑subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, it is recommended that an assessment of a patient’s response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
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.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient’s condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within 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.

Compliance with Written Authority Required procedures

C11094

Severe chronic plaque psoriasis
Initial treatment ‑ Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 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.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
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 under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C11095

Severe chronic plaque psoriasis
Initial treatment ‑ Initial 2, Face, hand, foot (change or re‑commencement 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 already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within 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 be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 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.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
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.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within 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.

Compliance with Written Authority Required procedures

C11111

Severe chronic plaque psoriasis
Initial treatment ‑ Initial 3, Whole body (re‑commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received 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
The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 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.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C11112

Severe chronic plaque psoriasis
Initial treatment ‑ Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 1 month old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to Services Australia no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
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 under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C11127

Severe chronic plaque psoriasis
Initial treatment ‑ Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 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.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C11128

Severe chronic plaque psoriasis
Initial treatment ‑ Initial 2, Whole body (change or re‑commencement 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 already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within 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 be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 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.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within 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.

Compliance with Written Authority Required procedures

C11129

Severe chronic plaque psoriasis
Initial treatment ‑ Initial 3, Face, hand, foot (re‑commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received 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
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 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.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
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 under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C11159

Severe chronic plaque psoriasis
Initial 1 ‑ Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 1 month old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to Services Australia no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
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 under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C12007

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 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; 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.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS 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 first or subsequent continuing treatment restrictions. 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.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
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 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

C12024

Severe active rheumatoid arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recent PBS‑subsidised biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS‑subsidised biological medicine treatment for this condition 5 times; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed 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 under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.

Compliance with Written Authority Required procedures

C12061

Severe active rheumatoid arthritis
Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, 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 methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
If methotrexate is contraindicated according to the TGA‑approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed 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 under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.

Compliance with Written Authority Required procedures

C12076

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 be aged 18 years or older.
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
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; 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
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.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; 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.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month 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.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
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.
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 first or subsequent continuing treatment restrictions. 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.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
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.

Compliance with Written Authority Required procedures

C13518

Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
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

C13522

Severe active rheumatoid arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed 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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

Compliance with Written Authority Required procedures

C13526

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 be at least 18 years of age.
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
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; 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
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.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; 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.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month 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.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
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.
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 first or subsequent continuing treatment restrictions. 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.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
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.

Compliance with Written Authority Required procedures

C13529

Severe chronic plaque psoriasis
Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received 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
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 1 month old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C13584

Severe psoriatic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have previously received 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
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
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.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
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

C13586

Severe chronic plaque psoriasis
Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received 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
The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 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.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C13587

Severe chronic plaque psoriasis
Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received 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
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 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.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C13589

Ankylosing spondylitis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
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
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND
Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR
Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR
Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND
Patient must not receive more than 18 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
Up to a maximum of 3 repeats will be authorised.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
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

C13590

Severe chronic plaque psoriasis
Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received 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
The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 1 month old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C13591

Severe chronic plaque psoriasis
Initial treatment - Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 1 month old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to Services Australia no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C13592

Severe chronic plaque psoriasis
Initial treatment - Initial 2, Face, hand, foot (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 already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within 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 be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
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.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within 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.

Compliance with Written Authority Required procedures

C13639

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 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be at least 18 years of age.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; 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.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS 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 first or subsequent continuing treatment restrictions. 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.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
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 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

C13640

Severe psoriatic arthritis
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 rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
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 3 biological medicines for this condition within 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
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
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.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
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

C13641

Complex refractory Fistulising Crohn disease
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
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 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.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial 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.

Compliance with Written Authority Required procedures

C13679

Severe chronic plaque psoriasis
Initial treatment - Initial 2, Whole body (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 already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within 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 be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
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.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within 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.

Compliance with Written Authority Required procedures

C13689

Ankylosing spondylitis
Initial treatment - Initial 1 (new patient)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must not receive more than 18 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application.
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
Up to a maximum of 3 repeats will be authorised.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
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

C13691

Moderate to 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)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
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 diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND
Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be aged 6 to 17 years inclusive.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition which must be no more than one month old at the time of application.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial 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.

Compliance with Authority Required procedures

C13692

Severe chronic plaque psoriasis
Initial treatment - Initial 2, Whole body (change or re-commencement 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 already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within 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 be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 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.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within 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.

Compliance with Written Authority Required procedures

C13702

Moderate to 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)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND
Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR
Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND
Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30 preferably whilst still on treatment; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be aged 6 to 17 years inclusive.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application -Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition which must be no more than one month old at the time of application; and
(ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition.
The PCDAI score should preferably be obtained whilst on conventional treatment but must be obtained within one month of the last conventional treatment dose.
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 Department of Human Services website.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial 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.

Compliance with Written Authority Required procedures

C13705

Severe chronic plaque psoriasis
Initial treatment - Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 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.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C13706

Severe chronic plaque psoriasis
Initial treatment - Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 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.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C13714

Severe active rheumatoid arthritis
Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, 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 methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed 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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

Compliance with Written Authority Required procedures

C13715

Severe chronic plaque psoriasis
Initial 1 - Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 1 month old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to Services Australia no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C13719

Severe chronic plaque psoriasis
Initial treatment - Initial 2, Face, hand, foot (change or re-commencement 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 already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within 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 be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 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.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
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.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within 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.

Compliance with Written Authority Required procedures

Macitentan

C11229

Pulmonary arterial hypertension (PAH)
Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The authority application for selexipag must be approved prior to the authority application for this agent.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested.

Compliance with Authority Required procedures

C13496

Pulmonary arterial hypertension (PAH)
Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
- RHC composite assessment; and
- ECHO composite assessment; and
- 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
- RHC plus ECHO composite assessments;
- RHC composite assessment plus 6MWT;
- RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
- ECHO composite assessment plus 6MWT;
- ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.