National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 1) (PB 5 of 2017) (Cth)

Case

PB 5 of 2017

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 1)

National Health Act 1953

___________________________________________________________________________

I, JULIANNE QUAINE, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

Dated  18 January 2017

Julianne Quaine

Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health

___________________________________________________________________________

Part 1        Preliminary

1                  Name of Instrument

(1)This instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 1).

(2)This instrument may also be cited as PB 5 of 2017.

2              Commencement

This instrument commences on 1 February 2017.

3              Amendment

The Schedule amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

Schedule – Amendments

Schedule

National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

  1. Division 4, Section 24, HSD pharmaceutical benefits that have CAR drugs—quantity exceptions

Insert after existing entry:

(z) for HSD pharmaceutical benefits that have the drug riociguat, for the treatment of Pulmonary arterial hypertension (PAH):

(i)   for Initial 1(new patients), Initial 2 (new patients) and Initial 3 (change or re-commencement of therapy for all patients) – prescriptions for dose titration will provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily. Approvals for subsequent authority prescriptions will be limited to 1 month of treatment.

(ii)  for Initial 4 (Grandfathered patients), Initial 5 (Grandfathered patients), First Continuing treatment and Subsequent Continuing treatment – the maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment.

(iii) for Initial 1 (new patients) or Initial 2 (new patients) or Initial 3 (change or re-commencement of therapy for all patients) or First Continuing treatment – Balance of supply – the treatment must provide no more than the balance of up to six months treatment.

  1. Division 4, Section 25, HSD pharmaceutical benefits that have CAR drugs—repeat exceptions

Insert after existing entry:

(zc) for riociguat, for the treatment of Pulmonary arterial hypertension (PAH):

(i)  for Initial 1 (new patients), Initial 2 (new patients) and Initial 3 (change or re-commencement of therapy for all patients) – up to 4 repeat supplies.

(ii) for Initial 4 (Grandfathered patients), Initial 5 (Grandfathered patients), First Continuing treatment and Subsequent Continuing treatment – up to 5 repeat supplies.

  1. Schedule 1, entry for Ambrisentan

a) Omit from the column headed ‘Circumstances’: C6065 C6066 C6078 C6089 C6102 C6117

b) Omit from the column headed ‘Circumstances’: C4619 C4631 C4633 C4634 C4639

c) Insert (all instances): C6089 C6711 C6722 C6734 C6748 C6765

  1. Schedule 1, entry for Bosentan

Substitute:

Bosentan Tablet 62.5 mg (as monohydrate) Oral Tracleer AT EMP

 C4628 C6089
C6710 C6734
C6748 C6764
C6776 		See Note 1 See Note 2 D
Tablet 125 mg (as monohydrate) Oral Tracleer AT EMP

 C6089 C6710
C6734 C6748
C6764 C6776 		See Note 1 See Note 2 D

  1. Schedule 1, entry for Eltrombopag

a) Omit from the column headed ‘Circumstances’ (all instances): C3855 C3856 C3857 C3858      

b) Insert (all instances): C6724 C6725 C6738 6739 C6790

  1. Schedule 1, entry for Epoprostenol                          a) Omit from the column headed ‘Circumstances (all instances): C6065 C6066 C6090 C6122 C6123                  

    b) Insert (all instances): C6123 C6734 C6748 C6762 C6763

  2. Schedule 1, entry for Iloprost  

    a) Omit from the column headed ‘Circumstances’: C6065 C6066 C6077 C6089 C6113 C6128

    b) Insert: C6089 C6692 C6734 C6747 C6748 C6775

  3. Schedule 1, entry for Infliximab in the form ‘Powder for I.V. infusion 100 mg’ and brands ‘Inflectra’ and ‘Remicade’ [Maximum quantity: 1

    Number of repeats: 0]  

    a) Omit from the column headed ‘Circumstances’: C5149 C5197 C5233 C5234 C5303 C5304 C5376 C5377

b) Insert in the column headed ‘Circumstances’ in numerical order: C6712 C6729 C6741 C6757 C6767 C6768 C6780 C6791

c) Omit from the column headed ‘Purposes’: P5149 P5197 P5233 P5234 P5303 P5304 P5376 P5377

d) Insert in the column headed ‘Purposes’ in numerical order: P6712 P6729 P6741 P6757 P6767 P6768 P6780 P6791

  1. Schedule 1, entry for Lenalidomide                  

    Insert in numerical order in column headed ‘Circumstances’ (all instances): C6750 C6751

  2. Schedule 1, entry for Macitentan

    a) Omit from the column headed ‘Circumstances’: C6065 C6066 C6074 C6089 C6102 C6115

    b) Insert: C6089 C6693 C6722 C6734 C6735 C6748          

  1. Schedule 1, entry for Omalizumab                                   a) Omit from the column headed ‘Circumstances’ (all instances): C6569           

b) Insert: C6788

  1. Schedule 1, entry for Peginterferon alfa-2a

Substitute:

Peginterferon alfa-2a Injection 135 micrograms in 0.5 mL single use pre-filled syringe Injection Pegasys RO EMP C5004 C5010 C5016 C5067 8 5 C
Injection 180 micrograms in 0.5 mL single use pre-filled syringe Injection Pegasys RO EMP C5004 C5010 C5016 C5067 C6745 P6745 4 2
EMP C5004 C5010 C5016 C5067 C6745 P5004 P5010 P5016 P5067 8 5 C

  1. Schedule 1, repeal entry for Ribavirin and peginterferon alfa 2-a

  1. Schedule 1, entry for Riociguat

Insert in numerical order in the column headed ‘Circumstances’ (all instances): C6690 C6691 C6708 C6720 C6733 C6746 C6760 C6774

  1. Schedule 1, entry for Romiplostim

a) Omit from the column headed ‘Circumstances’ (all instances): C3851 C3852 C3853 C3854

b) Insert (all instances): C6694 C6737 C6738 C6766 C6789

  1. Schedule 1, entry for Sildenafil

a) omit from the column headed ‘Circumstances’ (all instances): C6065 C6066 C6085 C6086 C6089 C6114

b) omit from the column headed ‘Circumstances’: C4608 C4615 C4621 C4636 C4641

c) Insert (all instances): C6089 C6723 C6734 C6736 C6748 C6749

  1. Schedule 1, repeal entry for Simeprevir

  1. Schedule 1, entry for Tacrolimus

Substitute:

Tacrolimus Capsule 0.5 mg Oral Pacrolim AF EMP C5569 C5602 200 5 D
Pharmacor Tacrolimus 0.5 CR EMP C5569 C5602 200 5 D
Prograf LL EMP C5569 C5602 200 5 D
TACROLIMUS APOTEX TX EMP C5569 C5602 200 5 D
Tacrolimus Sandoz SZ EMP C5569 C5602 200 5 D
Capsule 0.5 mg (once daily prolonged release) Oral ADVAGRAF XL LQ EMP C5569 C5602 60 5 D
Prograf XL LL EMP C5569 C5602 60 5 D
Capsule 0.75 mg Oral Tacrolimus Sandoz SZ EMP C5569 C5602 200 5 D
Capsule 1 mg Oral Pacrolim AF EMP C5569 C5602 200 5 D
Pharmacor Tacrolimus 1 CR EMP C5569 C5602 200 5 D
Prograf LL EMP C5569 C5602 200 5 D
TACROLIMUS APOTEX TX EMP C5569 C5602 200 5 D
Tacrolimus Sandoz SZ EMP C5569 C5602 200 5 D
Capsule 1 mg (once daily prolonged release) Oral ADVAGRAF XL LQ EMP C5569 C5602 120 5 D
Prograf XL LL EMP C5569 C5602 120 5 D
Capsule 2 mg Oral Tacrolimus Sandoz SZ EMP C5569 C5602 200 5 D
Capsule 5 mg Oral Pacrolim AF EMP C5569 C5602 100 5 D
Pharmacor Tacrolimus 5 CR EMP C5569 C5602 100 5 D
Prograf LL EMP C5569 C5602 100 5 D
TACROLIMUS APOTEX TX EMP C5569 C5602 100 5 D
Tacrolimus Sandoz SZ EMP C5569 C5602 100 5 D
Capsule 5 mg (once daily prolonged release) Oral ADVAGRAF XL LQ EMP C5569 C5602 60 5 D
Prograf XL LL EMP C5569 C5602 60 5 D

  1. Schedule 1, entry for Tadalafil

a) Omit from the column headed ‘Circumstance’: C6065 C6066 C6071 C6089 C6112 C6127

b) Insert: C6089 C6709 C6721 C6734 C6748 C6761

  1. Schedule 1, entry for Valaciclovir

Omit:

Zelitrex RF EMP C5939 C5975 500 2 C

  1. Schedule 3, entry for Ambrisentan

Substitute:

Ambrisentan C6089

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 1 or Initial 2 (new patients) or Initial 3 (change or re-commencement of therapy for all patients) or First Continuing treatment - Balance of supply

Patient must have received insufficient therapy with this agent under the Initial 1 (new patients) restriction to complete a maximum of six months of treatment; OR

Patient must have received insufficient therapy with this agent under the Initial 2 (new patients) restriction to complete a maximum of six months of treatment; OR

Patient must have received insufficient therapy with this agent under the Initial 3 (change or re-commencement of therapy for all patients) restriction to complete a maximum of six months of treatment; OR

Patient must have received insufficient therapy with this agent under the First Continuing treatment restriction to complete a maximum of six months of treatment; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition; AND

The treatment must provide no more than the balance of up to six months treatment available under one of the above restrictions.

 Compliance with modified Authority Required procedures
C6711

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 2 (new patients)

Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND

Patient must have been assessed by a physician at a designated hospital; AND

Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH, and a mean right atrial pressure of greater than 8 mmHg, as measured by right heart catheterisation (RHC); OR

Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH, with right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; OR

Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg, as measured by RHC; OR

Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease with right ventricular function assessed by ECHO where a RHC cannot be performed on clinical grounds; OR

Patient must have WHO Functional Class IV idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH; OR

Patient must have WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:

(i) RHC composite assessment; and

(ii) ECHO composite assessment; and

(iii) 6 Minute Walk Test (6MWT); and

(3) a signed patient acknowledgement.

Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:

(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 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.

Test requirements to establish baseline for initiation of treatment are as follows:

The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.

Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments;

(2) RHC composite assessment plus 6MWT;

(3) RHC composite assessment only.

In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:

(1) ECHO composite assessment plus 6MWT;

(2) ECHO composite assessment only.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 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.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.

The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

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.

 Compliance with modified Authority Required procedures
C6722

Where the patient is receiving treatment at/from a private or public hospital

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 been assessed by a physician at a designated hospital; AND

Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH; OR

Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease; AND

Patient must have a mean right atrial pressure of 8 mmHg or less as measured by right heart catheterisation (RHC); OR

Patient must have right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; AND

Patient must have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:

(i) RHC composite assessment; and

(ii) ECHO composite assessment; and

(iii) 6 Minute Walk Test (6MWT); and

(3) a signed patient acknowledgement.

Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:

(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 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.

Test requirements to establish baseline for initiation of treatment are as follows:

The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.

Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments;

(2) RHC composite assessment plus 6MWT;

(3) RHC composite assessment only.

In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:

(1) ECHO composite assessment plus 6MWT;

(2) ECHO composite assessment only.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 months old at the time of application.

Details of prior vasodilator treatment, including the dose and duration of treatment, must be provided at the time of application. Where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated, details of the nature of the adverse event or contraindication according to the Therapeutic Goods Administration (TGA) approved Product Information must also be provided with the application.

Response to prior vasodilator treatment is defined as follows:

For patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

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.

The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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.

 Compliance with modified Authority Required procedures
C6734

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

First Continuing treatment

Patient must have received a PBS-subsidised initial course of treatment with this agent for this condition; AND

Patient must have been assessed by a physician from a designated hospital to have achieved a response to the PBS-subsidised initial course of treatment; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:

(i) RHC composite assessment; and

(ii) ECHO composite assessment; and

(iii) 6 Minute Walk Test (6MWT).

Test requirements to establish response to treatment for continuation of treatment are as follows:

The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments plus 6MWT;

(2) RHC plus ECHO composite assessments;

(3) RHC composite assessment plus 6MWT;

(4) ECHO composite assessment plus 6MWT;

(5) RHC composite assessment only;

(6) ECHO composite assessment only.

The results of the same tests as conducted at baseline should be provided with the written First Continuing treatment application, except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be provided with the application.

The test results provided with the application for continuing treatment must be no more than 2 months old at the time of application.

Response to a PAH agent is defined as follows:

For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

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 will be authorised.

An application for First Continuing treatment with a PAH agent should be made prior to the completion of the Initial 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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.

 Compliance with modified Authority Required procedures
C6748

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Subsequent Continuing treatment

Patient must have received a PBS-subsidised treatment under First Continuing treatment with this agent for this condition; OR

Patient must have previously received PBS-subsidised treatment under this criteria with this agent for this condition; AND

Patient must have been assessed by a physician at a designated hospital; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

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 will be authorised.

An application for Subsequent Continuing treatment with a PAH agents should be made prior to the completion of the First Continuing treatment course to ensure continuity of treatment.

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 term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.

 Compliance with modified Authority Required procedures
C6765

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 3 (change or re-commencement of therapy for all patients)

Patient must have idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and must wish to re-commence PBS-subsidised therapy with this agent after a break in therapy and must have demonstrated a response to their most recent course of PBS-subsidised treatment with this agent; OR

Patient must have idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with a PAH agent other than this agent; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form; and

(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 months old at the time of application.

Response to a PAH agent is defined as follows:

For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

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.

The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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 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. It also means that no new baseline measurements will be necessary. New baselines may be submitted where the patient has failed to respond to their current treatment. Eligible patients may only swap between PAH agents if they have not failed prior PBS-subsidised treatment with that agent. For eligible patients, applications to swap between the 8 PAH agents must be made under the relevant initial treatment restriction. Patients should be assessed for response to the treatment they are ceasing at the time the application to swap therapy is being made. Patients who fail to demonstrate a response or for whom no assessment results are submitted with the application to swap therapy may not re-commence PBS-subsidised treatment with the drug they are ceasing.

 Compliance with modified Authority Required procedures

  1. Schedule 3, entry for Bosentan

Substitute:

Bosentan C4628

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Cessation of treatment (all patients)

Patient must have received approval for initial PBS-subsidised treatment with this agent; AND

Patient must have not responded to prior PBS-subsidised therapy with this agent; AND

The treatment must be for the purpose of gradual dose reduction prior to ceasing therapy; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

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 modified Authority Required procedures
C6089

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 1 or Initial 2 (new patients) or Initial 3 (change or re-commencement of therapy for all patients) or First Continuing treatment - Balance of supply

Patient must have received insufficient therapy with this agent under the Initial 1 (new patients) restriction to complete a maximum of six months of treatment; OR

Patient must have received insufficient therapy with this agent under the Initial 2 (new patients) restriction to complete a maximum of six months of treatment; OR

Patient must have received insufficient therapy with this agent under the Initial 3 (change or re-commencement of therapy for all patients) restriction to complete a maximum of six months of treatment; OR

Patient must have received insufficient therapy with this agent under the First Continuing treatment restriction to complete a maximum of six months of treatment; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition; AND

The treatment must provide no more than the balance of up to six months treatment available under one of the above restrictions.

 Compliance with modified Authority Required procedures
C6710

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 3 (change or re-commencement of therapy for all patients)

Patient must have idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease or PAH associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) and must wish to re-commence PBS-subsidised therapy with this agent after a break in therapy and must have demonstrated a response to their most recent course of PBS-subsidised treatment with this agent; OR

Patient must have idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease or PAH associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) and whose most recent course of PBS-subsidised treatment was with a PAH agent other than this agent; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) two completed authority prescription forms; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form; and

(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 months old at the time of application.

Response to a PAH agent is defined as follows:

For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

Approvals for the first authority prescription will be limited to 1 month of therapy with the 62.5 mg strength tablet, with the quantity approved based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information. No repeats will be authorised for this prescription.

The second authority prescription may be written for either the 62.5 mg tablet or the 125 mg tablet strengths. Approvals for the second authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.

The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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 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. It also means that no new baseline measurements will be necessary. New baselines may be submitted where the patient has failed to respond to their current treatment. Eligible patients may only swap between PAH agents if they have not failed prior PBS-subsidised treatment with that agent. For eligible patients, applications to swap between the 8 PAH agents must be made under the relevant initial treatment restriction. Patients should be assessed for response to the treatment they are ceasing at the time the application to swap therapy is being made. Patients who fail to demonstrate a response or for whom no assessment results are submitted with the application to swap therapy may not re-commence PBS-subsidised treatment with the drug they are ceasing.

 Compliance with modified Authority Required procedures
C6734

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

First Continuing treatment

Patient must have received a PBS-subsidised initial course of treatment with this agent for this condition; AND

Patient must have been assessed by a physician from a designated hospital to have achieved a response to the PBS-subsidised initial course of treatment; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:

(i) RHC composite assessment; and

(ii) ECHO composite assessment; and

(iii) 6 Minute Walk Test (6MWT).

Test requirements to establish response to treatment for continuation of treatment are as follows:

The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments plus 6MWT;

(2) RHC plus ECHO composite assessments;

(3) RHC composite assessment plus 6MWT;

(4) ECHO composite assessment plus 6MWT;

(5) RHC composite assessment only;

(6) ECHO composite assessment only.

The results of the same tests as conducted at baseline should be provided with the written First Continuing treatment application, except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be provided with the application.

The test results provided with the application for continuing treatment must be no more than 2 months old at the time of application.

Response to a PAH agent is defined as follows:

For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

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 will be authorised.

An application for First Continuing treatment with a PAH agent should be made prior to the completion of the Initial 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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.

 Compliance with modified Authority Required procedures
C6748

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Subsequent Continuing treatment

Patient must have received a PBS-subsidised treatment under First Continuing treatment with this agent for this condition; OR

Patient must have previously received PBS-subsidised treatment under this criteria with this agent for this condition; AND

Patient must have been assessed by a physician at a designated hospital; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

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 will be authorised.

An application for Subsequent Continuing treatment with a PAH agents should be made prior to the completion of the First Continuing treatment course to ensure continuity of treatment.

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 term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.

 Compliance with modified Authority Required procedures
C6764

Where the patient is receiving treatment at/from a private or public hospital

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 been assessed by a physician at a designated hospital; AND

Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH; OR

Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease; AND

Patient must have a mean right atrial pressure of 8 mmHg or less as measured by right heart catheterisation (RHC); OR

Patient must have right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; AND

Patient must have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) two completed authority prescription forms; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:

(i) RHC composite assessment; and

(ii) ECHO composite assessment; and

(iii) 6 Minute Walk Test (6MWT); and

(3) a signed patient acknowledgement.

Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:

(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 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.

Test requirements to establish baseline for initiation of treatment are as follows:

The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.

Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments;

(2) RHC composite assessment plus 6MWT;

(3) RHC composite assessment only.

In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:

(1) ECHO composite assessment plus 6MWT;

(2) ECHO composite assessment only.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 months old at the time of application.

Details of prior vasodilator treatment, including the dose and duration of treatment, must be provided at the time of application. Where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated, details of the nature of the adverse event or contraindication according to the Therapeutic Goods Administration (TGA) approved Product Information must also be provided with the application.

Response to prior vasodilator treatment is defined as follows:

For patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

Approvals for the first authority prescription will be limited to 1 month of therapy with the 62.5 mg strength tablet, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information. No repeats will be authorised for this prescription.

The second authority prescription may be written for either the 62.5 mg tablet or the 125 mg tablet strengths. Approvals for the second authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.

The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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.

 Compliance with modified Authority Required procedures
C6776

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 2 (new patients)

Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND

Patient must have been assessed by a physician at a designated hospital; AND

Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH, and a mean right atrial pressure of greater than 8 mmHg, as measured by right heart catheterisation (RHC); OR

Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH, with right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; OR

Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg, as measured by RHC; OR

Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease with right ventricular function assessed by ECHO where a RHC cannot be performed on clinical grounds; OR

Patient must have WHO Functional Class IV idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH; OR

Patient must have WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; OR

Patient must have WHO Functional Class III or IV pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology); AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) two completed authority prescription forms; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:

(i) RHC composite assessment; and

(ii) ECHO composite assessment; and

(iii) 6 Minute Walk Test (6MWT); and

(3) a signed patient acknowledgement.

Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:

(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 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.

Test requirements to establish baseline for initiation of treatment are as follows:

The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.

Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments;

(2) RHC composite assessment plus 6MWT;

(3) RHC composite assessment only.

In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:

(1) ECHO composite assessment plus 6MWT;

(2) ECHO composite assessment only.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 months old at the time of application.

Approvals for the first authority prescription will be limited to 1 month of therapy with the 62.5 mg strength tablet, with the quantity approved based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information. No repeats will be authorised for this prescription.

The second authority prescription may be written for either the 62.5 mg tablet or the 125 mg tablet strengths. Approvals for the second authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.

The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

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.

 Compliance with modified Authority Required procedures

  1. Schedule 3, entry for Eltrombopag

Substitute:

Eltrombopag C6724

Where the patient is receiving treatment at/from a private or public hospital

Severe thrombocytopenia

Initial treatment 2 - New patient

The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND

Patient must not have had a splenectomy; AND

Patient must have failed to acheive an adequate response to, or be intolerant to, corticosteroid therapy at a dose equivalent to 0.5-2 mg/kg/day of prednisone for at least 4-6 weeks; AND

Patient must have failed to acheive an adequate response to, or be intolerant to, immunoglobulin therapy; AND

Patient must be unsuitable for splenectomy due to medical reasons; AND

The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.

Patient must be an adult.

The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of initial application;

(a) a platelet count of less than or equal to 20,000 million per L; OR

(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.

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

(1) a completed authority prescription form,

(2) a signed patient acknowledgement,

(3) a completed Idiopathic Thrombocytopenic Purpura Initial PBS Authority Application - Supporting Information Form,

(4) a copy of a full blood count pathology report supporting the diagnosis of ITP, and

(5) where the application is sought on the basis of a medical contraindication to surgery, a signed and dated letter from the clinician making this assessment which includes the date upon which the patient was assessed for surgery and the clinical grounds upon which surgery is contraindicated.

The full blood count must be no more than 1 month old at the time of application.

A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.

 Compliance with modified Authority Required procedures
C6725

Where the patient is receiving treatment at/from a private or public hospital

Severe thrombocytopenia

First Continuing treatment or Re-initiation of interrupted treatment

The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND

Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; AND

Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction; AND

The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.

Patient must be an adult.

For the purposes of this restriction, a sustained platelet response is defined as:

(a) use of rescue medication (corticosteroids or immunoglobulins) on no more than one occasion during the initial period of PBS-subsidised treatment with this drug,

AND either of the following:

(b) a platelet count greater than or equal to 50,000 million per L on at least four (4) occasions, each at least one week apart;

OR

(c) a platelet count greater than 30,000 million per L and which is double the baseline (pre-treatment) platelet count on at least four (4) occasions, each at least one week apart.

Applications for the First continuing PBS-subsidised treatment or Re-initiation of interrupted PBS-subsidised treatment must be made in writing and must include:

(1) a completed authority prescription form, and

(2) a completed Idiopathic Thrombocytopenic Purpura Continuing PBS Authority Application - Supporting Information Form , and

(3) copies of the platelet count pathology reports (unless previously provided for patients re-initiating therapy).

The platelet count must be no more than one month old at the time of application.

A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.

 Compliance with modified Authority Required procedures
C6738

Where the patient is receiving treatment at/from a private or public hospital

Severe thrombocytopenia

Initial 1, Initial 2, First Continuing treatment or Re-initiation of interrupted treatment, and Second and Subsequent Continuing treatment - balance of supply

The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND

The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND

Patient must have received insufficient therapy with this drug for this condition under the Initial 1 restriction to complete 24 weeks treatment; OR

Patient must have received insufficient therapy with this drug for this condition under the Initial 2 restriction to complete 24 weeks treatment; OR

Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted treatment restriction to complete 24 weeks treatment; OR

Patient must have received insufficient therapy with this drug for this condition under the Second and subsequent Continuing treatment restriction to complete 24 weeks treatment; AND

The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.

Patient must be an adult.

 Compliance with modified Authority Required procedures
C6739

Where the patient is receiving treatment at/from a private or public hospital

Severe thrombocytopenia

Initial treatment 1 - New patient

The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND

Patient must have had a splenectomy; AND

Patient must have failed to acheive an adequate response to, or be intolerant to, corticosteroid therapy following the splenectomy; AND

Patient must have failed to acheive an adequate response to, or be intolerant to, immunoglobulin therapy following the splenectomy; AND

The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.

Patient must be an adult.

The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of initial application;

(a) a platelet count of less than or equal to 20,000 million per L; OR

(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.

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

(1) a completed authority prescription form,

(2) a signed patient acknowledgement,

(3) a completed Idiopathic Thrombocytopenic Purpura Initial PBS Authority Application - Supporting Information Form,

(4) a copy of a full blood count pathology report supporting the diagnosis of ITP, and

(5) where the application is sought on the basis of a medical contraindication to surgery, a signed and dated letter from the clinician making this assessment which includes the date upon which the patient was assessed for surgery and the clinical grounds upon which surgery is contraindicated.

The full blood count must be no more than 1 month old at the time of application.

A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.

 Compliance with modified Authority Required procedures
C6790

Where the patient is receiving treatment at/from a private or public hospital

Severe thrombocytopenia

Second or subsequent Continuing treatment

The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have demonstrated a continuing response to treatment with this drug; AND

The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.

Patient must be an adult.

For the purpose of this restriction, a continuing response to treatment with drug is defined as:

(a) use of rescue medication (corticosteroids or immunoglobulins) on no more than one occasion during the most recent 24 week period of PBS-subsidised treatment with this drug

AND either of the following:

(b) a platelet count greater than or equal to 50,000 million per L

OR

(c) a platelet count greater than 30,000 million per L and which is double the baseline platelet count.

The platelet count must be no more than one month old at the time of application.

Authority applications for second and subsequent periods of continuing therapy may be made by telephone

 Compliance with modified Authority Required procedures

  1. Schedule 3, entry for Epoprostenol

Substitute:

Epoprostenol C6123

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 1 (new patients) or Initial 2 (change or re-commencement of therapy for all patients) or First Continuing treatment - Balance of supply

Patient must have received insufficient therapy with this agent under the Initial 1 (new patients) restriction to complete a maximum of six months of treatment; OR

Patient must have received insufficient therapy with this agent under the Initial 2 (change or re-commencement of therapy for all patients) restriction to complete a maximum of six months of treatment; OR

Patient must have received insufficient therapy with this agent under the First Continuing treatment restriction to complete a maximum of six months of treatment; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition; AND

The treatment must provide no more than the balance of up to six months treatment available under one of the above restrictions.

 Compliance with modified Authority Required procedures
C6734

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

First Continuing treatment

Patient must have received a PBS-subsidised initial course of treatment with this agent for this condition; AND

Patient must have been assessed by a physician from a designated hospital to have achieved a response to the PBS-subsidised initial course of treatment; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:

(i) RHC composite assessment; and

(ii) ECHO composite assessment; and

(iii) 6 Minute Walk Test (6MWT).

Test requirements to establish response to treatment for continuation of treatment are as follows:

The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments plus 6MWT;

(2) RHC plus ECHO composite assessments;

(3) RHC composite assessment plus 6MWT;

(4) ECHO composite assessment plus 6MWT;

(5) RHC composite assessment only;

(6) ECHO composite assessment only.

The results of the same tests as conducted at baseline should be provided with the written First Continuing treatment application, except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be provided with the application.

The test results provided with the application for continuing treatment must be no more than 2 months old at the time of application.

Response to a PAH agent is defined as follows:

For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

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 will be authorised.

An application for First Continuing treatment with a PAH agent should be made prior to the completion of the Initial 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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.

 Compliance with modified Authority Required procedures
C6748

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Subsequent Continuing treatment

Patient must have received a PBS-subsidised treatment under First Continuing treatment with this agent for this condition; OR

Patient must have previously received PBS-subsidised treatment under this criteria with this agent for this condition; AND

Patient must have been assessed by a physician at a designated hospital; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

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 will be authorised.

An application for Subsequent Continuing treatment with a PAH agents should be made prior to the completion of the First Continuing treatment course to ensure continuity of treatment.

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 term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.

 Compliance with modified Authority Required procedures
C6762

Where the patient is receiving treatment at/from a private or public hospital

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 been assessed by a physician at a designated hospital; AND

Patient must have WHO Functional Class IV idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH; OR

Patient must have WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:

(i) RHC composite assessment; and

(ii) ECHO composite assessment; and

(iii) 6 Minute Walk Test (6MWT); and

(3) a signed patient acknowledgement.

Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:

(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 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.

Test requirements to establish baseline for initiation of treatment are as follows:

The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.

Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments;

(2) RHC composite assessment plus 6MWT;

(3) RHC composite assessment only.

In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:

(1) ECHO composite assessment plus 6MWT;

(2) ECHO composite assessment only.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 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.

The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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.

 Compliance with modified Authority Required procedures
C6763

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 2 (change or re-commencement of therapy for all patients)

Patient must have idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and must wish to re-commence PBS-subsidised therapy with this agent after a break in therapy and must have demonstrated a response to their most recent course of PBS-subsidised treatment with this agent; OR

Patient must have WHO Functional Class IV idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and must have received prior treatment with a PBS-subsidised PAH agent other than this agent; OR

Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and must have failed to respond to a prior PBS-subsidised PAH agent; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form; and

(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent; and

(4) for WHO Functional Class III patients, where this is the first application for this agent, assessment details of the PBS-subsidised PAH agent they have failed to respond to.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 months old at the time of application.

Response to a PAH agent is defined as follows:

For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

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.

The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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 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. It also means that no new baseline measurements will be necessary. New baselines may be submitted where the patient has failed to respond to their current treatment. Eligible patients may only swap between PAH agents if they have not failed prior PBS-subsidised treatment with that agent. For eligible patients, applications to swap between the 8 PAH agents must be made under the relevant initial treatment restriction. Patients should be assessed for response to the treatment they are ceasing at the time the application to swap therapy is being made. Patients who fail to demonstrate a response or for whom no assessment results are submitted with the application to swap therapy may not re-commence PBS-subsidised treatment with the drug they are ceasing.

 Compliance with modified Authority Required procedures

  1. Schedule 3, entry for Iloprost

Substitute:

Iloprost C6089

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 1 or Initial 2 (new patients) or Initial 3 (change or re-commencement of therapy for all patients) or First Continuing treatment - Balance of supply

Patient must have received insufficient therapy with this agent under the Initial 1 (new patients) restriction to complete a maximum of six months of treatment; OR

Patient must have received insufficient therapy with this agent under the Initial 2 (new patients) restriction to complete a maximum of six months of treatment; OR

Patient must have received insufficient therapy with this agent under the Initial 3 (change or re-commencement of therapy for all patients) restriction to complete a maximum of six months of treatment; OR

Patient must have received insufficient therapy with this agent under the First Continuing treatment restriction to complete a maximum of six months of treatment; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition; AND

The treatment must provide no more than the balance of up to six months treatment available under one of the above restrictions.

 Compliance with modified Authority Required procedures
C6692

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 3 (change or re-commencement of therapy for all patients)

Patient must have idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease or drug-induced PAH and must wish to re-commence PBS-subsidised therapy with this agent after a break in therapy and must have demonstrated a response to their most recent course of PBS-subsidised treatment with this agent; OR

Patient must have WHO Functional Class IV idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and must have received prior treatment with a PBS-subsidised PAH agent other than this agent; OR

Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and must have failed to respond to a prior PBS-subsidised PAH agent; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form; and

(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent; and

(4) for WHO Functional Class III patients, where this is the first application for this agent, assessment details of the PBS-subsidised PAH agent they have failed to respond to.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 months old at the time of application.

Response to a PAH agent is defined as follows:

For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

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.

The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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 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. It also means that no new baseline measurements will be necessary. New baselines may be submitted where the patient has failed to respond to their current treatment. Eligible patients may only swap between PAH agents if they have not failed prior PBS-subsidised treatment with that agent. For eligible patients, applications to swap between the 8 PAH agents must be made under the relevant initial treatment restriction. Patients should be assessed for response to the treatment they are ceasing at the time the application to swap therapy is being made. Patients who fail to demonstrate a response or for whom no assessment results are submitted with the application to swap therapy may not re-commence PBS-subsidised treatment with the drug they are ceasing.

 Compliance with modified Authority Required procedures
C6734

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

First Continuing treatment

Patient must have received a PBS-subsidised initial course of treatment with this agent for this condition; AND

Patient must have been assessed by a physician from a designated hospital to have achieved a response to the PBS-subsidised initial course of treatment; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:

(i) RHC composite assessment; and

(ii) ECHO composite assessment; and

(iii) 6 Minute Walk Test (6MWT).

Test requirements to establish response to treatment for continuation of treatment are as follows:

The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments plus 6MWT;

(2) RHC plus ECHO composite assessments;

(3) RHC composite assessment plus 6MWT;

(4) ECHO composite assessment plus 6MWT;

(5) RHC composite assessment only;

(6) ECHO composite assessment only.

The results of the same tests as conducted at baseline should be provided with the written First Continuing treatment application, except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be provided with the application.

The test results provided with the application for continuing treatment must be no more than 2 months old at the time of application.

Response to a PAH agent is defined as follows:

For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

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 will be authorised.

An application for First Continuing treatment with a PAH agent should be made prior to the completion of the Initial 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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.

 Compliance with modified Authority Required procedures
C6747

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 1 (new patients)

Patient must not have received prior PBS-subsidised treatment with this agent; AND

Patient must have been assessed by a physician at a designated hospital; AND

Patient must have WHO Functional Class III drug-induced PAH; AND

Patient must have a mean right atrial pressure of 8 mmHg or less as measured by right heart catheterisation (RHC); OR

Patient must have right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; AND

Patient must have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:

(i) RHC composite assessment; and

(ii) ECHO composite assessment; and

(iii) 6 Minute Walk Test (6MWT); and

(3) a signed patient acknowledgement.

Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:

(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 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.

Test requirements to establish baseline for initiation of treatment are as follows:

The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.

Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments;

(2) RHC composite assessment plus 6MWT;

(3) RHC composite assessment only.

In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:

(1) ECHO composite assessment plus 6MWT;

(2) ECHO composite assessment only.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 months old at the time of application.

Details of prior vasodilator treatment, including the dose and duration of treatment, must be provided at the time of application. Where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated, details of the nature of the adverse event or contraindication according to the Therapeutic Goods Administration (TGA) approved Product Information must also be provided with the application.

Response to prior vasodilator treatment is defined as follows:

For patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

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.

The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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.

 Compliance with modified Authority Required procedures
C6748

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Subsequent Continuing treatment

Patient must have received a PBS-subsidised treatment under First Continuing treatment with this agent for this condition; OR

Patient must have previously received PBS-subsidised treatment under this criteria with this agent for this condition; AND

Patient must have been assessed by a physician at a designated hospital; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

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 will be authorised.

An application for Subsequent Continuing treatment with a PAH agents should be made prior to the completion of the First Continuing treatment course to ensure continuity of treatment.

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 term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.

 Compliance with modified Authority Required procedures
C6775

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 2 (new patients)

Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND

Patient must have been assessed by a physician at a designated hospital; AND

Patient must have WHO Functional Class III drug-induced PAH and a mean right atrial pressure greater than 8 mmHg, as measured by right heart catheterisation (RHC); OR

Patient must have WHO Functional Class III drug-induced PAH with right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; OR

Patient must have WHO Functional Class IV idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH; OR

Patient must have WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; OR

Patient must have WHO Functional Class IV drug-induced PAH; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:

(i) RHC composite assessment; and

(ii) ECHO composite assessment; and

(iii) 6 Minute Walk Test (6MWT); and

(3) a signed patient acknowledgement.

Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:

(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 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.

Test requirements to establish baseline for initiation of treatment are as follows:

The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.

Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments;

(2) RHC composite assessment plus 6MWT;

(3) RHC composite assessment only.

In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:

(1) ECHO composite assessment plus 6MWT;

(2) ECHO composite assessment only.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 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.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.

The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

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.

 Compliance with modified Authority Required procedures

  1. Schedule 3, repeal entry for Simeprevir

  1. Schedule 3, entry for Tadalafil

Substitute:

Tadalafil C6089

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 1 or Initial 2 (new patients) or Initial 3 (change or re-commencement of therapy for all patients) or First Continuing treatment - Balance of supply

Patient must have received insufficient therapy with this agent under the Initial 1 (new patients) restriction to complete a maximum of six months of treatment; OR

Patient must have received insufficient therapy with this agent under the Initial 2 (new patients) restriction to complete a maximum of six months of treatment; OR

Patient must have received insufficient therapy with this agent under the Initial 3 (change or re-commencement of therapy for all patients) restriction to complete a maximum of six months of treatment; OR

Patient must have received insufficient therapy with this agent under the First Continuing treatment restriction to complete a maximum of six months of treatment; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition; AND

The treatment must provide no more than the balance of up to six months treatment available under one of the above restrictions.

 Compliance with modified Authority Required procedures
C6709

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 3 (change or re-commencement of therapy for all patients)

Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and must wish to re-commence PBS-subsidised therapy with this agent after a break in therapy and must have demonstrated a response to their most recent course of PBS-subsidised treatment with this agent; OR

Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with a PAH agent other than this agent; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form; and

(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 months old at the time of application.

Response to a PAH agent is defined as follows:

For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

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.

The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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 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. It also means that no new baseline measurements will be necessary. New baselines may be submitted where the patient has failed to respond to their current treatment. Eligible patients may only swap between PAH agents if they have not failed prior PBS-subsidised treatment with that agent. For eligible patients, applications to swap between the 8 PAH agents must be made under the relevant initial treatment restriction. Patients should be assessed for response to the treatment they are ceasing at the time the application to swap therapy is being made. Patients who fail to demonstrate a response or for whom no assessment results are submitted with the application to swap therapy may not re-commence PBS-subsidised treatment with the drug they are ceasing.

 Compliance with modified Authority Required procedures
C6721

Where the patient is receiving treatment at/from a private or public hospital

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 been assessed by a physician at a designated hospital; AND

Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH; OR

Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease; AND

Patient must have a mean right atrial pressure of 8 mmHg or less as measured by right heart catheterisation (RHC); OR

Patient must have right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; AND

Patient must have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:

(i) RHC composite assessment; and

(ii) ECHO composite assessment; and

(iii) 6 Minute Walk Test (6MWT); and

(3) a signed patient acknowledgement.

Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:

(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 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.

Test requirements to establish baseline for initiation of treatment are as follows:

The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.

Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments;

(2) RHC composite assessment plus 6MWT;

(3) RHC composite assessment only.

In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:

(1) ECHO composite assessment plus 6MWT;

(2) ECHO composite assessment only.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 months old at the time of application.

Details of prior vasodilator treatment, including the dose and duration of treatment, must be provided at the time of application. Where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated, details of the nature of the adverse event or contraindication according to the Therapeutic Goods Administration (TGA) approved Product Information must also be provided with the application.

Response to prior vasodilator treatment is defined as follows:

For patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

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.

The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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.

 Compliance with modified Authority Required procedures
C6734

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

First Continuing treatment

Patient must have received a PBS-subsidised initial course of treatment with this agent for this condition; AND

Patient must have been assessed by a physician from a designated hospital to have achieved a response to the PBS-subsidised initial course of treatment; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:

(i) RHC composite assessment; and

(ii) ECHO composite assessment; and

(iii) 6 Minute Walk Test (6MWT).

Test requirements to establish response to treatment for continuation of treatment are as follows:

The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments plus 6MWT;

(2) RHC plus ECHO composite assessments;

(3) RHC composite assessment plus 6MWT;

(4) ECHO composite assessment plus 6MWT;

(5) RHC composite assessment only;

(6) ECHO composite assessment only.

The results of the same tests as conducted at baseline should be provided with the written First Continuing treatment application, except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be provided with the application.

The test results provided with the application for continuing treatment must be no more than 2 months old at the time of application.

Response to a PAH agent is defined as follows:

For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

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 will be authorised.

An application for First Continuing treatment with a PAH agent should be made prior to the completion of the Initial 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and 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.

 Compliance with modified Authority Required procedures
C6748

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Subsequent Continuing treatment

Patient must have received a PBS-subsidised treatment under First Continuing treatment with this agent for this condition; OR

Patient must have previously received PBS-subsidised treatment under this criteria with this agent for this condition; AND

Patient must have been assessed by a physician at a designated hospital; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

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 will be authorised.

An application for Subsequent Continuing treatment with a PAH agents should be made prior to the completion of the First Continuing treatment course to ensure continuity of treatment.

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 term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.

 Compliance with modified Authority Required procedures
C6761

Where the patient is receiving treatment at/from a private or public hospital

Pulmonary arterial hypertension (PAH)

Initial 2 (new patients)

Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND

Patient must have been assessed by a physician at a designated hospital; AND

Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH, and a mean right atrial pressure of greater than 8 mmHg, as measured by right heart catheterisation (RHC); OR

Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH, with right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; OR

Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg, as measured by RHC; OR

Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease with right ventricular function assessed by ECHO where a RHC cannot be performed on clinical grounds; AND

The treatment must be the sole PBS-subsidised PAH agent for this condition.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:

(i) RHC composite assessment; and

(ii) ECHO composite assessment; and

(iii) 6 Minute Walk Test (6MWT); and

(3) a signed patient acknowledgement.

Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:

(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 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.

Test requirements to establish baseline for initiation of treatment are as follows:

The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.

Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:

(1) RHC plus ECHO composite assessments;

(2) RHC composite assessment plus 6MWT;

(3) RHC composite assessment only.

In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:

(1) ECHO composite assessment plus 6MWT;

(2) ECHO composite assessment only.

Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.

The test results provided must not be more than 2 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.

The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.

The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

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.

 Compliance with modified Authority Required procedures

  1. Schedule 3 Part 1—General statement for drugs for the treatment of hepatitis C

Section 3 Treatment regimen, substitute:

3  Treatment regimen

   For the purpose of subparagraph 2(2) of this Part, the treating medical practitioner has chosen a regimen in accordance with this paragraph if the patient:

(1)   is a kind of patient mentioned for an Item in column 2 of the following table; and

(2)   is to receive one of the regimens mentioned in column 3 of the same Item of the following table

Item Kind of patient Regimen
1

Patient:

(a)     with Genotype 1; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 8 weeks; or

(b)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or

(e)     PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or

(f)    PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or

(g)     GRAZOPREVIR with ELBASVIR for 12 weeks.
2

Patient:

(a)     with Genotype 1; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or

(e)     PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or

(f)    PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or

(g)     GRAZOPREVIR with ELBASVIR for 12 weeks; or

(h)     GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
3

Patient:

(a)     with Genotype 2; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
4

Patient:

(a)     with Genotype 2; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
5

Patient:

(a)     with Genotype 3; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks.
6

Patient:

(a)     with Genotype 3; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks.
7

Patient:

(a)     with Genotype 4; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

Either:

(a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or

(b)     GRAZOPREVIR with ELBASVIR for 12 weeks.
8

Patient:

(a)     with Genotype 4; and

(b)     who is treatment experienced; and

(c)              who is non-cirrhotic

Either:

(a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or

(b)     GRAZOPREVIR with ELBASVIR for 12 weeks; or

(c)     GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
9

Patient:

(a)     with:

(i)     Genotype 5; or

(ii)     Genotype 6; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks.
10

Patient:

(a)     with:

(i)     Genotype 5; or

(ii)     Genotype 6; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks.
11

Patient:

(a)     with Genotype 1; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or

(e)     PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or

(f)    GRAZOPREVIR with ELBASVIR for 12 weeks.
12

Patient:

(a)     with Genotype 1; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 24 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or

(e)     PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or

(f)    PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 24 weeks; or

(g)     GRAZOPREVIR with ELBASVIR for 12 weeks; or

(h)     GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
13

Patient:

(a)     with Genotype 2; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
14

Patient:

(a)     with Genotype 2; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
15

Patient:

(a)     with Genotype 3; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

Either:

(a)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or

(d)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(e)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks.
16

Patient:

(a)     with Genotype 3; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or

(d)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(e)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks.

17

Patient:

(a)     with Genotype 4; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

Either:

(a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or

(b)     GRAZOPREVIR with ELBASVIR for 12 weeks.
18

Patient:

(a)     with Genotype 4; and

(b)     who is treatment experienced; and

(c)             who is cirrhotic

Either:

(a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or

(b)     GRAZOPREVIR with ELBASVIR for 12 weeks; or

(c)     GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
19

Patient:

(a)     with:

(i)     Genotype 5; or

(ii)     Genotype 6; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks.
20

Patient:

(a)     with:

(i)     Genotype 5; or

(ii)     Genotype 6; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks.
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