National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 5) (PB 47 of 2017) (Cth)

PB 47 of 2017

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

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 Minister for Sport, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

Dated 28 June 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. 5).

(2)This instrument may also be cited as PB 47 of 2017.

2 Commencement

This instrument commences on 1 July 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)

Schedule 1, entry for Azacitidine

Substitute:

Azacitidine Powder for injection 100 mg Injection Azadine RZ EMP C6132 C6143 C6144 C6177 C6186 C6199 See Note 1 See Note 2 D

Celazadine JU EMP C6132 C6143 C6144 C6177 C6186 C6199 See Note 1 See Note 2 D

Vidaza CJ EMP C6132 C6143 C6144 C6177 C6186 C6199 See Note 1 See Note 2 D

Schedule 1, entry for Epoprostenol

Substitute:

Epoprostenol Powder for I.V. infusion 500 micrograms (as sodium) Injection Veletri AT EMP C6123 C6734 C6748 C6762 C6763 1 0 D

Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL Injection Flolan GK EMP C6123 C6734 C6748 C6945 C6955 1 0 D

Powder for I.V. infusion 1.5 mg (as sodium) Injection Veletri AT EMP C6123 C6734 C6748 C6762 C6763 1 0 D

Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL Injection Flolan GK EMP C6123 C6734 C6748 C6945 C6955 1 0 D

Schedule 3, entry for Epoprostenol

Insert in numerical order:

C6945 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 Written Authority Required procedures

C6955 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 Written Authority Required procedures

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National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 5) (PB 47 of 2017) (Cth)

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Azacitidine	Powder for injection 100 mg	Injection	Azadine	RZ	EMP	C6132 C6143 C6144 C6177 C6186 C6199	See Note 1	See Note 2	D
			Celazadine	JU	EMP	C6132 C6143 C6144 C6177 C6186 C6199	See Note 1	See Note 2	D
			Vidaza	CJ	EMP	C6132 C6143 C6144 C6177 C6186 C6199	See Note 1	See Note 2	D

Epoprostenol	Powder for I.V. infusion 500 micrograms (as sodium)	Injection	Veletri	AT	EMP	C6123 C6734 C6748 C6762 C6763	1	0	D
Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL	Injection	Flolan	GK	EMP	C6123 C6734 C6748 C6945 C6955	1	0	D
Powder for I.V. infusion 1.5 mg (as sodium)	Injection	Veletri	AT	EMP	C6123 C6734 C6748 C6762 C6763	1	0	D
Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL	Injection	Flolan	GK	EMP	C6123 C6734 C6748 C6945 C6955	1	0	D

C6945	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 Written Authority Required procedures
C6955	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 Written Authority Required procedures