National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No. 8) (No. PB 63 of 2014) (Cth)

Case

PB 63 of 2014

National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No. 8)

National Health Act 1953

___________________________________________________________________________

I, KIM BESSELL, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.

Dated  21 August 2014

KIM BESSELL

Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health

___________________________________________________________________________

1       Name of Instrument

(1)This Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No.8).

(2)This Instrument may also be cited as PB 63 of 2014.

2              Commencement

This Instrument commences on 1 September 2014.

3              Amendments to PB 116 of 2010

Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).

Schedule 1       Amendments

  1. Division 1, Section 4, definition for CAR drug

substitute:

(a)   abatacept;

(b)   adalimumab;

(c)   ambrisentan;

(d)   azacitidine;

(e)   bosentan;

(f)   eltrombopag;

(g)   epoprostenol;

(h)   etanercept;

(i)   iloprost;

(j)   infliximab;

(k)   lenalidomide;

(l)   macitentan;

(m)   omalizumab;

(n)   rituximab;

(o)   romiplostim;

(p)   sildenafil;

(q)   tadalafil;

(r)   tocilizumab

  1. Schedule 1, entry for Ambrisentan in each of the forms: Tablet 10 mg; and Tablet 5 mg

omit from the column headed “Circumstances”:                          C3214 C3215 C4019 C4020           substitute:      C4619 C4631 C4633 C4634 C4639

  1. Schedule 1, entry for Bosentan in the form: Tablet 62.5 mg (as monohydrate)

omit from the column headed “Circumstances”:                          C3162 C4009 C4010 C4011 C4012         substitute:      C4616 C4622 C4623 C4628 C4634 C4639

  1. Schedule 1, entry for Bosentan in the form: Tablet 125 mg (as monohydrate)

omit from the column headed “Circumstances”:                          C3162 C4009 C4010 C4011 C4012         substitute:      C4616 C4622 C4623 C4634 C4639

  1. Schedule 1, entry for Darunavir in the form: Tablet 400 mg (as ethanolate)

omit

  1. Schedule 1, entry for Epoprostenol in each of the forms: Powder for I.V. infusion, 500 micrograms (as sodium) infusion administration set; Powder for I.V. infusion, 1.5 mg (as sodium) infusion administration set; 500 microgram injection; and 1.5 mg injection

omit from the column headed “Circumstances”:                          C3167 C4013 C4014            substitute:      C4602 C4617 C4637 C4638

  1. Schedule 1, entry for Iloprost in the form: Solution for inhalation 20 micrograms (as trometamol) in 2 mL

omit from the column headed “Circumstances”:                          C3170 C3171 C4015 C4016           substitute:      C4611 C4612 C4613 C4618 C4624

  1. Schedule 1, entry for Infliximab

substitute

Infliximab Powder for I.V. infusion 100 mg Injection Remicade JC EMP C2996 C2999 C3002 C3004 C3005 C3008 C3259 C3262 C3492 C3585 C3691 C3693 C3710 C3805 C3806 C3807 C3808 C3809 C3810 C3811 C3812 C3813 C3814 C3815 C3816 C3817 C3818 C3819 C3820 C4524 C4535 C4603 C4625 C4626 C4627 C4630 P2996 P2999 P3002 P3004 P3005 P3008 P3259 P3262 P3492 P3585 P3691 P3693 P3710 P3805 P3806 P3807 P3808 P3809 P3810 P3811 P3812 P3813 P3814 P3815 P3816 P3817 P3818 P3819 P3820 P4603 P4625 P4626 P4627 P4630 1 0 D
C2996 C2999 C3002 C3004 C3005 C3008 C3259 C3262 C3492 C3585 C3691 C3693 C3710 C3805 C3806 C3807 C3808 C3809 C3810 C3811 C3812 C3813 C3814 C3815 C3816 C3817 C3818 C3819 C3820 C4524 C4535 C4603 C4625 C4626 C4627 C4630 P4535 1 1 D
C2996 C2999 C3002 C3004 C3005 C3008 C3259 C3262 C3492 C3585 C3691 C3693 C3710 C3805 C3806 C3807 C3808 C3809 C3810 C3811 C3812 C3813 C3814 C3815 C3816 C3817 C3818 C3819 C3820 C4524 C4535 C4603 C4625 C4626 C4627 C4630 P4524 5 1 D

  1. Schedule 1, after entry for Lopinavir with Ritonavir

insert

Macitentan Tablet 10 mg Oral Opsumit AT EMP

 C4620 C4631 C4634 C4635 C4639 30 0 D

  1. Schedule 1, entry for Sildenafil in the form: Tablet 20 mg (as citrate)

omit from the column headed “Circumstances”:                          C3174 C3175 C4017 C4018           substitute:      C4608 C4615 C4621 C4636 C4641

  1. Schedule 1, entry for Tadalafil in the form: Tablet 20 mg

omit from the column headed “Circumstances”:                          C4021 C4022 C4023 C4024           substitute:      C4608 C4615 C4621 C4636 C4641

  1. Schedule 3, entry for Ambrisentan

substitute:

Ambrisentan C4619

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 3 (change or re-commencement of therapy for all patients)
Clinical criteria:
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.
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, and macitentan.
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 7 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 7 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
C4631

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 1 (new patients)
Clinical criteria:
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.
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, and macitentan.
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
C4633

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 2 (new patients)
Clinical criteria:
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, and macitentan.
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
C4634

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Continuing treatment (all patients)
Clinical criteria:
Patient must have received approval for initial PBS-subsidised treatment with this agent; AND
Patient must have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of treatment with 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 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 each written continuing treatment application (i.e., every 6 months), 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.
The assessment of the patient's response to the first and subsequent 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Applications for continuing treatment with a PAH agent should be made prior to the completion of the 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, and macitentan.
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
C4639

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 1 or Initial 2 (new patients) or Initial 3 (change or re-commencement of therapy for all patients) or Continuing treatment (all patients) – balance of supply
Clinical criteria:
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 Continuing treatment (all patients) 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 the above restrictions.

 Compliance with modified Authority Required procedures

  1. Schedule 3, entry for Bosentan

substitute:

Bosentan C4616 Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 2 (new patients)
Clinical criteria:
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, and macitentan.
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 Written Authority Required procedures
C4622

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 1 (new patients)
Clinical criteria:
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.
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, and macitentan.
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
C4623

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 3 (change or re-commencement of therapy for all patients)
Clinical criteria:
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.
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, and macitentan.
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 7 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 7 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
C4628

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Cessation of treatment (all patients)
Clinical criteria:
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 Written or Telephone Authority Required procedures
C4634

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Continuing treatment (all patients)
Clinical criteria:
Patient must have received approval for initial PBS-subsidised treatment with this agent; AND
Patient must have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of treatment with 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 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 each written continuing treatment application (i.e., every 6 months), 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.
The assessment of the patient's response to the first and subsequent 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Applications for continuing treatment with a PAH agent should be made prior to the completion of the 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, and macitentan.
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
C4639

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 1 or Initial 2 (new patients) or Initial 3 (change or re-commencement of therapy for all patients) or Continuing treatment (all patients) – balance of supply
Clinical criteria:
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 Continuing treatment (all patients) 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 the above restrictions.

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 3, entry for Epoprostenol

substitute:

Epoprostenol C4602

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 1 (new patients) or Initial 2 (change or re-commencement of therapy for all patients) or Continuing treatment (all patients) – balance of supply
Clinical criteria:
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 Continuing treatment (all patients) 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 the above restrictions.

 Compliance with Written or Telephone Authority Required procedures
C4617

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 2 (change or re-commencement of therapy for all patients)
Clinical criteria:
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.
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, and macitentan.
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 7 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 7 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
C4637

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 1 (new patients)
Clinical criteria:
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.
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, and macitentan.
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
C4638

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Continuing treatment (all patients)
Clinical criteria:
Patient must have received approval for initial PBS-subsidised treatment with this agent; AND
Patient must have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of treatment with 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 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 each written continuing treatment application (i.e., every 6 months), 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.
The assessment of the patient's response to the first and subsequent 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Applications for continuing treatment with a PAH agent should be made prior to the completion of the 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, and macitentan.
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

  1. Schedule 3, entry for Iloprost

substitute:

Iloprost C4611

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 1 (new patients)
Clinical criteria:
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.
Where the patient is receiving treatment at/from a private or public 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.
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, and macitentan.
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
C4612

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 2 (new patients)
Clinical criteria:
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, and macitentan.
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 Written Authority Required procedures
C4613

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 1 or Initial 2 (new patients) or Initial 3 (change or re-commencement of therapy for all patients) or Continuing treatment (all patients) – balance of supply
Clinical criteria:
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 Continuing treatment (all patients) 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 the above restrictions.

 Compliance with Written or Telephone Authority Required procedures
C4618

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Continuing treatment (all patients)
Clinical criteria:
Patient must have received approval for initial PBS-subsidised treatment with this agent; AND
Patient must have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of treatment with 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 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 each written continuing treatment application (i.e., every 6 months), 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.
The assessment of the patient's response to the first and subsequent 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Applications for continuing treatment with a PAH agent should be made prior to the completion of the 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, and macitentan.
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
C4624

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 3 (change or re-commencement of therapy for all patients)
Clinical criteria:
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.
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, and macitentan.
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 7 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 7 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

  1. Schedule 3, entry for Infliximab

omit:

C3513 P3513

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

Ankylosing spondylitis — initial treatment 1
Initial treatment with infliximab commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
(a) who has not received any PBS‑subsidised treatment with a tumour necrosis factor (TNF)‑alfa antagonist, or, where the patient has previously received PBS‑subsidised TNF‑alfa antagonist treatment for this condition, has received no such treatment for a period of 5 years or more starting from the date the last course of PBS‑subsidised treatment was approved; and
(b) who has at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
(iii) limitation of chest expansion relative to normal values for age and gender; and
(c) who has failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS‑subsidised TNF‑alfa antagonist therapy of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated by:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L;
both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)‑approved Product Information, the authority application includes the reason why a higher dose cannot be used;
if treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the authority application includes details of the contraindication;
if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form; and
(iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 18 weeks of treatment;
if less than 18 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 18 weeks of treatment in total may be submitted by telephone

 Compliance with modified Authority Required procedures

insert in numerical order following existing text:

C4603 P4603

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

Ankylosing spondylitis
Treatment Phase: Initial 2 (change or recommencement for all patients)
Clinical criteria:
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be eligible to receive further bDMARD therapy.
Population criteria:
Patient must be an adult.
Treatment criteria:
Must be treated by a rheumatologist.
Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
A maximum of 18 weeks of treatment with this drug will be approved under this criterion.
At the time of authority application, the doctor should request the appropriate number of vials, based on the weight of the patient, to provide for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle.

 Compliance with modified Authority Required procedures
C4625 P4625

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

Active ankylosing spondylitis
Treatment Phase: Initial 1 (new patients)
Clinical criteria:
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received any PBS-subsidised treatment with either adalimumab, certolizumab pegol, etanercept, golimumab or infliximab in this treatment cycle; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months.
Population criteria:
Patient must be an adult.
Treatment criteria:
Must be treated by a rheumatologist.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application.
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which must include the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) a signed patient acknowledgment.
The assessment of the patient's response to the initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
A maximum of 18 weeks of treatment with this drug will be approved under this criterion.
At the time of authority application, the doctor should request the appropriate number of vials, based on the weight of the patient, to provide for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) was approved in this cycle and the date of the first application under a new cycle.

 Compliance with modified Authority Required procedures
C4626 P4626

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

Ankylosing spondylitis
Treatment Phase: Initial treatment – Initial 1 (new patients) or Initial 2 (change or recommencement for all patients) – balance of supply
Clinical criteria:
Patient must have active, or a documented history of active, ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Initial 1 (new patients) restriction to complete 18 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement for all patients) restriction to complete 18 weeks treatment; AND
The treatment must provide no more than the balance of up to 18 weeks treatment available under the above restrictions.
Population criteria:
Patient must be an adult.
Treatment criteria:
Must be treated by a rheumatologist.

 Compliance with modified Authority Required procedures
C4627 P4627

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

Ankylosing spondylitis
Treatment Phase: Continuing treatment – balance of supply
Clinical criteria:
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the 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.
Population criteria:
Patient must be an adult.
Treatment criteria:
Must be treated by a rheumatologist.

 Compliance with modified Authority Required procedures
C4630 P4630

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

Ankylosing spondylitis
Treatment Phase: Continuing treatment
Clinical criteria:
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Population criteria:
Patient must be an adult.
Treatment criteria:
Must be treated by a rheumatologist.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
All measurements provided 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.
At the time of authority application, the doctor should request the appropriate number of vials, based on the weight of the patient, to provide for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment following an initial treatment course it must be made following a minimum of 12 weeks of treatment with this drug. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle.

 Compliance with modified Authority Required procedures

  1. Schedule 3, after entry for Lopinavir with Ritonavir

insert

Macitentan C4620

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 2 (new patients)
Clinical criteria:
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) 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, and macitentan.
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 Written Authority Required procedures
C4631

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 1 (new patients)
Clinical criteria:
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.
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, and macitentan.
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
C4634

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Continuing treatment (all patients)
Clinical criteria:
Patient must have received approval for initial PBS-subsidised treatment with this agent; AND
Patient must have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of treatment with 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 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 each written continuing treatment application (i.e., every 6 months), 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.
The assessment of the patient's response to the first and subsequent 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Applications for continuing treatment with a PAH agent should be made prior to the completion of the 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, and macitentan.
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
C4635

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 3 (change or re-commencement of therapy for all patients)
Clinical criteria:
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) 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.
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, and macitentan.
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 7 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 7 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
C4639

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 1 or Initial 2 (new patients) or Initial 3 (change or re-commencement of therapy for all patients) or Continuing treatment (all patients) – balance of supply
Clinical criteria:
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 Continuing treatment (all patients) 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 the above restrictions.

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 3, entry for Tadalafil

substitute:

Tadalafil C4608

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 1 or Initial 2 (new patients) or Initial 3 (change or re-commencement of therapy for all patients) or Continuing treatment (all patients) – balance of supply
Clinical criteria:
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 Continuing treatment (all patients) 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 the above restrictions.

 Compliance with modified Authority Required procedures
C4615

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Continuing treatment (all patients)
Clinical criteria:
Patient must have received approval for initial PBS-subsidised treatment with this agent; AND
Patient must have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of treatment with 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 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 each written continuing treatment application (i.e., every 6 months), 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.
The assessment of the patient's response to the first and subsequent 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Applications for continuing treatment with a PAH agent should be made prior to the completion of the 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, and macitentan.
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
C4621

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 1 (new patients)
Clinical criteria:
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.
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, and macitentan.
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
C4636

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 3 (change or re-commencement of therapy for all patients)
Clinical criteria:
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.
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, and macitentan.
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 7 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 7 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
C4641

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

Pulmonary arterial hypertension (PAH)
Treatment Phase: Initial 2 (new patients)
Clinical criteria:
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, and macitentan.
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
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