National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 4) (PB 33 of 2016) (Cth)

Case

PB 33 of 2016

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 4)

National Health Act 1953

___________________________________________________________________________

I, JULIANNE QUAINE, 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     29 April 2016

Julianne Quaine

Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health

___________________________________________________________________________

Part 1        Preliminary

1                  Name of Instrument

(1)This instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 4).

(2)This instrument may also be cited as PB 33 of 2016.

2              Commencement

This instrument commences on 1 May 2016.

3              Amendment

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

Schedule – Amendments

Schedule

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

  1. Section 4 [Definitions]

After the definition of “approved hospital authority”, insert the following definition:

approved private hospital means a private hospital that has an approved hospital authority.

  1. Section 10 (1)

Substitute:

(1)         This section applies to an HSD pharmaceutical benefit if the circumstances mentioned in Schedule 3 for a circumstances code

mentioned in Schedule 1 for the HSD pharmaceutical benefit includes:

(a)    Compliance with Authority Required procedures;

(b)     Compliance with Written Authority Required procedures;

(c)    Compliance with Written or Telephone Authority Required procedures;

(d)     Compliance with modified Authority Required procedures.

(1A)    If the circumstances mentioned in Schedule 3 for a circumstances code mentioned in Schedule 1 for a HSD pharmaceutical benefit

include ‘Compliance with Written or Telephone Authority Required procedures’ then treat as if the words used are ‘Compliance with  

Authority Required procedures’. 

  1. Section 18

Repeal the section, substitute:

18  Supply of HSD pharmaceutical benefits under this Special Arrangement

(1)Subject to subsection (2), this Special Arrangement only applies to the supply of an HSD pharmaceutical benefit:

(a)by an approved hospital authority for a public hospital to an eligible patient receiving treatment at or from an approved public hospital; or

(b)by an approved hospital authority for a private hospital to an eligible patient receiving treatment at or from an approved private hospital; or

(c)by an approved pharmacist to an eligible patient receiving treatment at or from a private hospital; or

(d)if the HSD pharmaceutical benefit has a CAR drug—by an approved pharmacist to an eligible patient receiving treatment at or from an approved public hospital or an approved private hospital.

(2)Where an eligible patient receives treatment in or at or outside of an approved public hospital or an approved private hospital, then a supplier listed in paragraph (a) may supply, to the eligible patient, HSD pharmaceutical benefits that are referred to in paragraph (b):

(a)The suppliers are:

i.an approved pharmacist; or

ii.an approved medical practitioner; or

iii.an approved hospital authority;

(b)The HSD pharmaceutical benefits are:

i.medication for the treatment of hepatitis B;

ii.medication for the treatment of HIV or AIDS, other than the pharmaceutical benefits containing the drugs azithromycin, doxorubicin - pegylated liposomal and rifabutin; and

iii.medication for the treatment of schizophrenia when used in continuing therapy.

(3)This section does not require an approved hospital authority or an approved pharmacist to supply the HSD pharmaceutical benefit directly to a patient.

(4)The HSD pharmaceutical benefit may be supplied by the approved hospital authority or approved pharmacist through an agent.

(5)Section 94 of the Act applies in a modified manner to pharmaceutical benefits supplied by an approved hospital authority under this Special Arrangement.

  1. Schedule 1 in all instances, column headed ‘Authorised Prescriber’

    Substitute: EMP

  2. Schedule 1, entry for Ambrisentan

Omit from the column headed ‘Circumstances’: C4619 C4631 C4633 C4634 C4639           Insert in numerical order: C6065 C6066 C6078 C6089 C6102 C6117

  1. Schedule 1, entry for Apomorphine

Substitute:

Apomorphine Injection containing apomorphine hydrochloride 10 mg in 1 mL Injection Apomine HH EMP C4833 C4860 360 5 D
Injection containing apomorphine hydrochloride 20 mg in 2 mL Injection Movapo TD EMP C4833 C4860 360 5 D
Injection containing apomorphine hydrochloride 50 mg in 5 mL Injection Movapo TD EMP C4833 C4860 180 5 D

  1. Schedule 1, after entry for Atazanavir

Insert: 

Atazanavir with cobicistat Tablet containing 300 mg atazanavir and 150 mg cobicistat Oral Evotaz BQ EMP C4454 C4512 60 5 D

  1. Schedule 1, entry for Baclofen

Substitute:

Baclofen Intrathecal injection 10 mg in 5 mL Injection Bacthecal DZ EMP C5985 C5990 C6000 C6003 C6025 C6051 C6052 C6054 10 0 PB
Lioresal Intrathecal NV EMP C5985 C5990 C6000 C6003 C6025 C6051 C6052 C6054 10 0 PB

  1. Schedule 1, entry for Bosentan

Substitute:

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

 C4628 C6063 C6064 C6065 C6066 C6089 C6107 See Note 1 See Note 2 D
Tablet 125 mg (as monohydrate) Oral Tracleer AT EMP

 C6063 C6064 C6065 C6066 C6089 C6107 See Note 1 See Note 2 D

  1. Schedule 1, entry for Epoprostenol

    Omit from the column headed ‘Circumstances’: C4602 C4617 C4637 C4638      Insert in numerical order: C6065 C6066 C6090 C6122 C6123

  2. Schedule 1, entry for Iloprost

Omit from the column headed ‘Circumstances’:  C4611 C4612 C4613 C4618 C4624   Insert in numerical order: C6065 C6066 C6077 C6089 C6113 C6128

  1. Schedule 1, entry for Infliximab

Substitute:

Infliximab Powder for I.V. infusion 100 mg Injection Inflectra HH EMP C3691 C3693 C3819 C3820 C4524 C4535 C4603 C4625 C4626 C4627 C4630 C4705 C4718 C4846 C4854 C5077 C5078 C5079 C5084 C5097 C5103 C5109 C5110 C5111 C5112 C5118 C5120 C5149 C5197 C5233 C5234 C5303 C5304 C5376 C5377 C5440 C5484 C5485 C5570 C6076 C6082 C6110 P3691 P3693 P3819 P3820 P4603 P4625 P4626 P4627 P4630 P4705 P4718 P4846 P4854 P5077 P5078 P5079 P5084 P5097 P5103 P5109 P5110 P5111 P5112 P5118 P5120 P5149 P5197 P5233 P5234 P5303 P5304 P5376 P5377 P5440 P5484 P5485 P5570 P6076 P6082 P6110 1 0 D
Remicade JC EMP C3691 C3693 C3819 C3820 C4524 C4535 C4603 C4625 C4626 C4627 C4630 C4705 C4718 C4846 C4854 C5077 C5078 C5079 C5084 C5097 C5103 C5109 C5110 C5111 C5112 C5118 C5120 C5149 C5197 C5233 C5234 C5303 C5304 C5376 C5377 C5440 C5484 C5485 C5570 C6076 C6082 C6110 P3691 P3693 P3819 P3820 P4603 P4625 P4626 P4627 P4630 P4705 P4718 P4846 P4854 P5077 P5078 P5079 P5084 P5097 P5103 P5109 P5110 P5111 P5112 P5118 P5120 P5149 P5197 P5233 P5234 P5303 P5304 P5376 P5377 P5440 P5484 P5485 P5570 P6076 P6082 P6110 1 0 D
Inflectra HH EMP C3691 C3693 C3819 C3820 C4524 C4535 C4603 C4625 C4626 C4627 C4630 C4705 C4718 C4846 C4854 C5077 C5078 C5079 C5084 C5097 C5103 C5109 C5110 C5111 C5112 C5118 C5120 C5149 C5197 C5233 C5234 C5303 C5304 C5376 C5377 C5440 C5484 C5485 C5570 C6076 C6082 C6110 P4535 1 1 D
Remicade JC EMP C3691 C3693 C3819 C3820 C4524 C4535 C4603 C4625 C4626 C4627 C4630 C4705 C4718 C4846 C4854 C5077 C5078 C5079 C5084 C5097 C5103 C5109 C5110 C5111 C5112 C5118 C5120 C5149 C5197 C5233 C5234 C5303 C5304 C5376 C5377 C5440 C5484 C5485 C5570 C6076 C6082 C6110 P4535 1 1 D
Inflectra HH EMP C3691 C3693 C3819 C3820 C4524 C4535 C4603 C4625 C4626 C4627 C4630 C4705 C4718 C4846 C4854 C5077 C5078 C5079 C5084 C5097 C5103 C5109 C5110 C5111 C5112 C5118 C5120 C5149 C5197 C5233 C5234 C5303 C5304 C5376 C5377 C5440 C5484 C5485 C5570 C6076 C6082 C6110 P4524 5 1 D
Remicade JC EMP C3691 C3693 C3819 C3820 C4524 C4535 C4603 C4625 C4626 C4627 C4630 C4705 C4718 C4846 C4854 C5077 C5078 C5079 C5084 C5097 C5103 C5109 C5110 C5111 C5112 C5118 C5120 C5149 C5197 C5233 C5234 C5303 C5304 C5376 C5377 C5440 C5484 C5485 C5570 C6076 C6082 C6110 P4524 5 1 D

  1. Schedule 1, entry for Macitentan

Omit from the column headed ‘Circumstances’: C4620 C4631 C4634 C4635 C4639  Insert in numerical order: C6065 C6066 C6074 C6089 C6102 C6115

  1. Schedule 1, after entry for Pamidronic Acid

Insert:

Paritaprevir with ritonavir with ombitasvir and dasabuvir Pack containing 56 tablets paritaprevir 75 mg with ritonavir 50 mg with ombitasvir 12.5 mg and 56 tablets dasabuvir 250 mg Oral Viekira Pak VE EMP

 C5969 1 2 D

  1. Schedule 1, after entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir

Insert:

Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin Pack containing 56 tablets paritaprevir 75 mg with ritonavir 50 mg with ombitasvir 12.5 mg and 56 tablets dasabuvir 250 mg and 56 tablets ribavirin 600 mg Oral Viekira Pak-RBV VE EMP C6130 C6131 P6131 1 2 D
EMP C6130 C6131 P6130 1 5 D
Pack containing 56 tablets paritaprevir 75 mg with ritonavir 50 mg with ombitasvir 12.5 mg and 56 tablets dasabuvir 250 mg and 168 tablets ribavirin 200 mg Oral Viekira Pak-RBV VE EMP C6130 C6131 P6131 1 2 D
EMP C6130 C6131 P6130 1 5 D

  1. Schedule 1, entry for Sildenafil

Omit from the column headed ‘Circumstances’: C4608 C4615 C4621 C4636 C4641                           Insert in numerical order: C6065 C6066 C6085 C6086 C6089 C6114

  1. Schedule 1, entry for Tadalafil

Omit from the column headed ‘Circumstances’: C4608 C4615 C4621 C4636 C4641   Insert in numerical order: C6065 C6066 C6071 C6089 C6112 C6127

  1. Schedule 1, after entry for Tenofovir with emtricitabine and rilpivirine

Substitute:

Tenofovir with emtricitabine, elvitegravir and cobicistat Tablet containing elvitegravir 150 mg with cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg Oral Genvoya GI EMP C4470 C4522 60 5 D
Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg Oral Stribild GI EMP C4470 C4522 60 5 D

  1. Schedule 3, entry for Ambrisentan

Substitute:

Ambrisentan C6065 P6065

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

Pulmonary arterial hypertension (PAH)
First Continuing treatment
Patient must have received a PBS-subsidised initial course of treatment with this agent for this condition; AND
Patient must have been assessed by a physician from a designated hospital to have achieved a response to the PBS-subsidised initial course of treatment; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT).
Test requirements to establish response to treatment for continuation of treatment are as follows:
The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments plus 6MWT;
(2) RHC plus ECHO composite assessments;
(3) RHC composite assessment plus 6MWT;
(4) ECHO composite assessment plus 6MWT;
(5) RHC composite assessment only;
(6) ECHO composite assessment only.
The results of the same tests as conducted at baseline should be provided with the written First Continuing treatment application, except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be provided with the application.
The test results provided with the application for continuing treatment must be no more than 2 months old at the time of application.
Response to a PAH agent is defined as follows:
For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats will be authorised.
An application for First Continuing treatment with a PAH agent should be made prior to the completion of the Initial 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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
C6066 P6066

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

Pulmonary arterial hypertension (PAH)
Subsequent Continuing treatment
Patient must have received a PBS-subsidised treatment under First Continuing treatment with this agent for this condition; OR
Patient must have previously received PBS-subsidised treatment under this criteria with this agent for this condition; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Patients who have previously received PBS-subsidised treatment with this drug for this condition under the Continuing treatment (all patients) prior to 1 May 2016 are eligible to continue PBS subsidised treatment with this drug under this criteria.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats will be authorised.
An application for Subsequent Continuing treatment with a PAH agents should be made prior to the completion of the First Continuing treatment course to ensure continuity of treatment.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, and macitentan.

 Compliance with modified Authority Required procedures
C6078 P6078

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

Pulmonary arterial hypertension (PAH)
Initial 3 (change or re-commencement of therapy for all patients)
Patient must have idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and must wish to re-commence PBS-subsidised therapy with this agent after a break in therapy and must have demonstrated a response to their most recent course of PBS-subsidised treatment with this agent; OR
Patient must have idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with a PAH agent other than this agent; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form; and
(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
Response to a PAH agent is defined as follows:
For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats may be requested.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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
C6089 P6089

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

Pulmonary arterial hypertension (PAH)
Initial 1 or Initial 2 (new patients) or Initial 3 (change or re-commencement of therapy for all patients) or First Continuing treatment - Balance of supply
Patient must have received insufficient therapy with this agent under the Initial 1 (new patients) restriction to complete a maximum of six months of treatment; OR
Patient must have received insufficient therapy with this agent under the Initial 2 (new patients) restriction to complete a maximum of six months of treatment; OR
Patient must have received insufficient therapy with this agent under the Initial 3 (change or re-commencement of therapy for all patients) restriction to complete a maximum of six months of treatment; OR
Patient must have received insufficient therapy with this agent under the First Continuing treatment restriction to complete a maximum of six months of treatment; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition; AND
The treatment must provide no more than the balance of up to six months treatment available under one of the above restrictions.

 Compliance with modified Authority Required procedures
C6102 P6102

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

Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have been assessed by a physician at a designated hospital; AND
Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH; OR
Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease; AND
Patient must have a mean right atrial pressure of 8 mmHg or less as measured by right heart catheterisation (RHC); OR
Patient must have right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; AND
Patient must have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT); and
(3) a signed patient acknowledgement.
Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Test requirements to establish baseline for initiation of treatment are as follows:
The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.
Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments;
(2) RHC composite assessment plus 6MWT;
(3) RHC composite assessment only.
In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:
(1) ECHO composite assessment plus 6MWT;
(2) ECHO composite assessment only.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
Details of prior vasodilator treatment, including the dose and duration of treatment, must be provided at the time of application. Where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated, details of the nature of the adverse event or contraindication according to the Therapeutic Goods Administration (TGA) approved Product Information must also be provided with the application.
Response to prior vasodilator treatment is defined as follows:
For patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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
C6117 P6117

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

Pulmonary arterial hypertension (PAH)
Initial 2 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have been assessed by a physician at a designated hospital; AND
Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH, and a mean right atrial pressure of greater than 8 mmHg, as measured by right heart catheterisation (RHC); OR
Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH, with right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; OR
Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg, as measured by RHC; OR
Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease with right ventricular function assessed by ECHO where a RHC cannot be performed on clinical grounds; OR
Patient must have WHO Functional Class IV idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH; OR
Patient must have WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT); and
(3) a signed patient acknowledgement.
Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Test requirements to establish baseline for initiation of treatment are as follows:
The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.
Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments;
(2) RHC composite assessment plus 6MWT;
(3) RHC composite assessment only.
In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:
(1) ECHO composite assessment plus 6MWT;
(2) ECHO composite assessment only.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats may be requested.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, and macitentan.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.

 Compliance with modified Authority Required procedures

  1. Schedule 3, entry for Bosentan

Substitute:

Bosentan C4628 P4628

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

Pulmonary arterial hypertension (PAH)
Cessation of treatment (all patients)
Patient must have received approval for initial PBS-subsidised treatment with this agent; AND
Patient must have not responded to prior PBS-subsidised therapy with this agent; AND
The treatment must be for the purpose of gradual dose reduction prior to ceasing therapy; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment. Treatment beyond 1 month will not be approved.

 Compliance with modified Authority Required procedures
C6063 P6063

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

Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have been assessed by a physician at a designated hospital; AND
Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH; OR
Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease; AND
Patient must have a mean right atrial pressure of 8 mmHg or less as measured by right heart catheterisation (RHC); OR
Patient must have right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; AND
Patient must have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) two completed authority prescription forms; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT); and
(3) a signed patient acknowledgement.
Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Test requirements to establish baseline for initiation of treatment are as follows:
The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.
Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments;
(2) RHC composite assessment plus 6MWT;
(3) RHC composite assessment only.
In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:
(1) ECHO composite assessment plus 6MWT;
(2) ECHO composite assessment only.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
Details of prior vasodilator treatment, including the dose and duration of treatment, must be provided at the time of application. Where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated, details of the nature of the adverse event or contraindication according to the Therapeutic Goods Administration (TGA) approved Product Information must also be provided with the application.
Response to prior vasodilator treatment is defined as follows:
For patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
Approvals for the first authority prescription will be limited to 1 month of therapy with the 62.5 mg strength tablet, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information. No repeats will be authorised for this prescription.
The second authority prescription may be written for either the 62.5 mg tablet or the 125 mg tablet strengths. Approvals for the second authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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
C6064 P6064

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

Pulmonary arterial hypertension (PAH)
Initial 3 (change or re-commencement of therapy for all patients)
Patient must have idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease or PAH associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) and must wish to re-commence PBS-subsidised therapy with this agent after a break in therapy and must have demonstrated a response to their most recent course of PBS-subsidised treatment with this agent; OR
Patient must have idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease or PAH associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) and whose most recent course of PBS-subsidised treatment was with a PAH agent other than this agent; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) two completed authority prescription forms; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form; and
(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
Response to a PAH agent is defined as follows:
For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
Approvals for the first authority prescription will be limited to 1 month of therapy with the 62.5 mg strength tablet, with the quantity approved based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information. No repeats will be authorised for this prescription.
The second authority prescription may be written for either the 62.5 mg tablet or the 125 mg tablet strengths. Approvals for the second authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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
C6065 P6065

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

Pulmonary arterial hypertension (PAH)
First Continuing treatment
Patient must have received a PBS-subsidised initial course of treatment with this agent for this condition; AND
Patient must have been assessed by a physician from a designated hospital to have achieved a response to the PBS-subsidised initial course of treatment; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT).
Test requirements to establish response to treatment for continuation of treatment are as follows:
The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments plus 6MWT;
(2) RHC plus ECHO composite assessments;
(3) RHC composite assessment plus 6MWT;
(4) ECHO composite assessment plus 6MWT;
(5) RHC composite assessment only;
(6) ECHO composite assessment only.
The results of the same tests as conducted at baseline should be provided with the written First Continuing treatment application, except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be provided with the application.
The test results provided with the application for continuing treatment must be no more than 2 months old at the time of application.
Response to a PAH agent is defined as follows:
For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats will be authorised.
An application for First Continuing treatment with a PAH agent should be made prior to the completion of the Initial 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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
C6066 P6066

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

Pulmonary arterial hypertension (PAH)
Subsequent Continuing treatment
Patient must have received a PBS-subsidised treatment under First Continuing treatment with this agent for this condition; OR
Patient must have previously received PBS-subsidised treatment under this criteria with this agent for this condition; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Patients who have previously received PBS-subsidised treatment with this drug for this condition under the Continuing treatment (all patients) prior to 1 May 2016 are eligible to continue PBS subsidised treatment with this drug under this criteria.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats will be authorised.
An application for Subsequent Continuing treatment with a PAH agents should be made prior to the completion of the First Continuing treatment course to ensure continuity of treatment.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, and macitentan.

 Compliance with modified Authority Required procedures
C6089 P6089

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

Pulmonary arterial hypertension (PAH)
Initial 1 or Initial 2 (new patients) or Initial 3 (change or re-commencement of therapy for all patients) or First Continuing treatment - Balance of supply
Patient must have received insufficient therapy with this agent under the Initial 1 (new patients) restriction to complete a maximum of six months of treatment; OR
Patient must have received insufficient therapy with this agent under the Initial 2 (new patients) restriction to complete a maximum of six months of treatment; OR
Patient must have received insufficient therapy with this agent under the Initial 3 (change or re-commencement of therapy for all patients) restriction to complete a maximum of six months of treatment; OR
Patient must have received insufficient therapy with this agent under the First Continuing treatment restriction to complete a maximum of six months of treatment; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition; AND
The treatment must provide no more than the balance of up to six months treatment available under one of the above restrictions.

 Compliance with modified Authority Required procedures
C6107 P6107

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

Pulmonary arterial hypertension (PAH)
Initial 2 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have been assessed by a physician at a designated hospital; AND
Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH, and a mean right atrial pressure of greater than 8 mmHg, as measured by right heart catheterisation (RHC); OR
Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH, with right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; OR
Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg, as measured by RHC; OR
Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease with right ventricular function assessed by ECHO where a RHC cannot be performed on clinical grounds; OR
Patient must have WHO Functional Class IV idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH; OR
Patient must have WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; OR
Patient must have WHO Functional Class III or IV pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology); AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) two completed authority prescription forms; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT); and
(3) a signed patient acknowledgement.
Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Test requirements to establish baseline for initiation of treatment are as follows:
The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.
Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments;
(2) RHC composite assessment plus 6MWT;
(3) RHC composite assessment only.
In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:
(1) ECHO composite assessment plus 6MWT;
(2) ECHO composite assessment only.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
Approvals for the first authority prescription will be limited to 1 month of therapy with the 62.5 mg strength tablet, with the quantity approved based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information. No repeats will be authorised for this prescription.
The second authority prescription may be written for either the 62.5 mg tablet or the 125 mg tablet strengths. Approvals for the second authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, and macitentan.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.

 Compliance with modified Authority Required procedures

  1. Schedule 3, entry for Epoprostenol

Substitute:

Epoprostenol C6065 P6065

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

Pulmonary arterial hypertension (PAH)
First Continuing treatment
Patient must have received a PBS-subsidised initial course of treatment with this agent for this condition; AND
Patient must have been assessed by a physician from a designated hospital to have achieved a response to the PBS-subsidised initial course of treatment; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT).
Test requirements to establish response to treatment for continuation of treatment are as follows:
The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments plus 6MWT;
(2) RHC plus ECHO composite assessments;
(3) RHC composite assessment plus 6MWT;
(4) ECHO composite assessment plus 6MWT;
(5) RHC composite assessment only;
(6) ECHO composite assessment only.
The results of the same tests as conducted at baseline should be provided with the written First Continuing treatment application, except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be provided with the application.
The test results provided with the application for continuing treatment must be no more than 2 months old at the time of application.
Response to a PAH agent is defined as follows:
For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats will be authorised.
An application for First Continuing treatment with a PAH agent should be made prior to the completion of the Initial 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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
C6066 P6066

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

Pulmonary arterial hypertension (PAH)
Subsequent Continuing treatment
Patient must have received a PBS-subsidised treatment under First Continuing treatment with this agent for this condition; OR
Patient must have previously received PBS-subsidised treatment under this criteria with this agent for this condition; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Patients who have previously received PBS-subsidised treatment with this drug for this condition under the Continuing treatment (all patients) prior to 1 May 2016 are eligible to continue PBS subsidised treatment with this drug under this criteria.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats will be authorised.
An application for Subsequent Continuing treatment with a PAH agents should be made prior to the completion of the First Continuing treatment course to ensure continuity of treatment.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, and macitentan.

 Compliance with modified Authority Required procedures
C6090 P6090

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

Pulmonary arterial hypertension (PAH)
Initial 2 (change or re-commencement of therapy for all patients)
Patient must have idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and must wish to re-commence PBS-subsidised therapy with this agent after a break in therapy and must have demonstrated a response to their most recent course of PBS-subsidised treatment with this agent; OR
Patient must have WHO Functional Class IV idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and must have received prior treatment with a PBS-subsidised PAH agent other than this agent; OR
Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and must have failed to respond to a prior PBS-subsidised PAH agent; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form; and
(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent; and
(4) for WHO Functional Class III patients, where this is the first application for this agent, assessment details of the PBS-subsidised PAH agent they have failed to respond to.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
Response to a PAH agent is defined as follows:
For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats may be requested.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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
C6122 P6122

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

Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have been assessed by a physician at a designated hospital; AND
Patient must have WHO Functional Class IV idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH; OR
Patient must have WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT); and
(3) a signed patient acknowledgement.
Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Test requirements to establish baseline for initiation of treatment are as follows:
The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.
Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments;
(2) RHC composite assessment plus 6MWT;
(3) RHC composite assessment only.
In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:
(1) ECHO composite assessment plus 6MWT;
(2) ECHO composite assessment only.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats may be requested.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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
C6123 P6123

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

Pulmonary arterial hypertension (PAH)
Initial 1 (new patients) or Initial 2 (change or re-commencement of therapy for all patients) or First Continuing treatment - Balance of supply
Patient must have received insufficient therapy with this agent under the Initial 1 (new patients) restriction to complete a maximum of six months of treatment; OR
Patient must have received insufficient therapy with this agent under the Initial 2 (change or re-commencement of therapy for all patients) restriction to complete a maximum of six months of treatment; OR
Patient must have received insufficient therapy with this agent under the First Continuing treatment restriction to complete a maximum of six months of treatment; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition; AND
The treatment must provide no more than the balance of up to six months treatment available under one of the above restrictions.

 Compliance with modified Authority Required procedures

  1. Schedule 3, entry for Iloprost

Substitute:

Iloprost C6065 P6065

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

Pulmonary arterial hypertension (PAH)
First Continuing treatment
Patient must have received a PBS-subsidised initial course of treatment with this agent for this condition; AND
Patient must have been assessed by a physician from a designated hospital to have achieved a response to the PBS-subsidised initial course of treatment; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT).
Test requirements to establish response to treatment for continuation of treatment are as follows:
The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments plus 6MWT;
(2) RHC plus ECHO composite assessments;
(3) RHC composite assessment plus 6MWT;
(4) ECHO composite assessment plus 6MWT;
(5) RHC composite assessment only;
(6) ECHO composite assessment only.
The results of the same tests as conducted at baseline should be provided with the written First Continuing treatment application, except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be provided with the application.
The test results provided with the application for continuing treatment must be no more than 2 months old at the time of application.
Response to a PAH agent is defined as follows:
For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats will be authorised.
An application for First Continuing treatment with a PAH agent should be made prior to the completion of the Initial 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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
C6066 P6066

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

Pulmonary arterial hypertension (PAH)
Subsequent Continuing treatment
Patient must have received a PBS-subsidised treatment under First Continuing treatment with this agent for this condition; OR
Patient must have previously received PBS-subsidised treatment under this criteria with this agent for this condition; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Patients who have previously received PBS-subsidised treatment with this drug for this condition under the Continuing treatment (all patients) prior to 1 May 2016 are eligible to continue PBS subsidised treatment with this drug under this criteria.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats will be authorised.
An application for Subsequent Continuing treatment with a PAH agents should be made prior to the completion of the First Continuing treatment course to ensure continuity of treatment.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, and macitentan.

 Compliance with modified Authority Required procedures
C6077 P6077

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

Pulmonary arterial hypertension (PAH)
Initial 2 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have been assessed by a physician at a designated hospital; AND
Patient must have WHO Functional Class III drug-induced PAH and a mean right atrial pressure greater than 8 mmHg, as measured by right heart catheterisation (RHC); OR
Patient must have WHO Functional Class III drug-induced PAH with right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; OR
Patient must have WHO Functional Class IV idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH; OR
Patient must have WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; OR
Patient must have WHO Functional Class IV drug-induced PAH; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT); and
(3) a signed patient acknowledgement.
Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Test requirements to establish baseline for initiation of treatment are as follows:
The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.
Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments;
(2) RHC composite assessment plus 6MWT;
(3) RHC composite assessment only.
In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:
(1) ECHO composite assessment plus 6MWT;
(2) ECHO composite assessment only.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats may be requested.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, and macitentan.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.

 Compliance with modified Authority Required procedures
C6089 P6089

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

Pulmonary arterial hypertension (PAH)
Initial 1 or Initial 2 (new patients) or Initial 3 (change or re-commencement of therapy for all patients) or First Continuing treatment - Balance of supply
Patient must have received insufficient therapy with this agent under the Initial 1 (new patients) restriction to complete a maximum of six months of treatment; OR
Patient must have received insufficient therapy with this agent under the Initial 2 (new patients) restriction to complete a maximum of six months of treatment; OR
Patient must have received insufficient therapy with this agent under the Initial 3 (change or re-commencement of therapy for all patients) restriction to complete a maximum of six months of treatment; OR
Patient must have received insufficient therapy with this agent under the First Continuing treatment restriction to complete a maximum of six months of treatment; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition; AND
The treatment must provide no more than the balance of up to six months treatment available under one of the above restrictions.

 Compliance with modified Authority Required procedures
C6113 P6113

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

Pulmonary arterial hypertension (PAH)
Initial 3 (change or re-commencement of therapy for all patients)
Patient must have idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease or drug-induced PAH and must wish to re-commence PBS-subsidised therapy with this agent after a break in therapy and must have demonstrated a response to their most recent course of PBS-subsidised treatment with this agent; OR
Patient must have WHO Functional Class IV idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and must have received prior treatment with a PBS-subsidised PAH agent other than this agent; OR
Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and must have failed to respond to a prior PBS-subsidised PAH agent; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form; and
(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent; and
(4) for WHO Functional Class III patients, where this is the first application for this agent, assessment details of the PBS-subsidised PAH agent they have failed to respond to.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
Response to a PAH agent is defined as follows:
For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats may be requested.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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
C6128 P6128

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

Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS-subsidised treatment with this agent; AND
Patient must have been assessed by a physician at a designated hospital; AND
Patient must have WHO Functional Class III drug-induced PAH; AND
Patient must have a mean right atrial pressure of 8 mmHg or less as measured by right heart catheterisation (RHC); OR
Patient must have right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; AND
Patient must have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT); and
(3) a signed patient acknowledgement.
Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Test requirements to establish baseline for initiation of treatment are as follows:
The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.
Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments;
(2) RHC composite assessment plus 6MWT;
(3) RHC composite assessment only.
In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:
(1) ECHO composite assessment plus 6MWT;
(2) ECHO composite assessment only.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
Details of prior vasodilator treatment, including the dose and duration of treatment, must be provided at the time of application. Where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated, details of the nature of the adverse event or contraindication according to the Therapeutic Goods Administration (TGA) approved Product Information must also be provided with the application.
Response to prior vasodilator treatment is defined as follows:
For patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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

  1. Schedule 3, entry for Infliximab

Omit:

A)

C4823 P4823 Where the patient is receiving treatment at/from a private or public hospital
Severe psoriatic arthritis - Initial treatment – Initial 2 (change or recommencement of treatment)
Patient must have a documented history of severe active psoriatic arthritis,
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle,
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle,
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle,
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be an adult.
Treatment criteria: Must be treated by a rheumatologist; or must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats may be authorised.
Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug.
Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). 		Compliance with modified Authority Required procedures
C4836 P4836 Where the patient is receiving treatment at/from a private or public hospital
Severe psoriatic arthritis - Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more)
Patient must have severe active psoriatic arthritis,
Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; or
Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition,
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months,
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months,
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be an adult.
Treatment criteria: Must be treated by a rheumatologist; or must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats may be authorised. 		Compliance with modified Authority Required procedures

B)

C5311 P5311

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

Severe psoriatic arthritis
Continuing treatment
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must demonstrate, at the time of application, an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications.
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised 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 with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 2 repeats may be authorised.

 Compliance with modified Authority Required procedures

Insert in numerical order:

C6076 P6076

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

Severe psoriatic arthritis
Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more)
Patient must have severe active psoriatic arthritis; AND
Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab or ustekinumab.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats may be authorised.

 Compliance with modified Authority Required procedures
C6082 P6082

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

Severe psoriatic arthritis
Initial treatment – Initial 2 (change or recommencement of treatment)
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle; AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab or ustekinumab.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats may be authorised.
Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug.
Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).

 Compliance with modified Authority Required procedures
C6110 P6110

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

Severe psoriatic arthritis
Continuing treatment
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must demonstrate, at the time of application, an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab or ustekinumab.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications.
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised 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 with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 2 repeats may be authorised.

 Compliance with modified Authority Required procedures

  1. Schedule 3, entry for Tadalafil

Substitute:

Tadalafil C6065 P6065

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

Pulmonary arterial hypertension (PAH)
First Continuing treatment
Patient must have received a PBS-subsidised initial course of treatment with this agent for this condition; AND
Patient must have been assessed by a physician from a designated hospital to have achieved a response to the PBS-subsidised initial course of treatment; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT).
Test requirements to establish response to treatment for continuation of treatment are as follows:
The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments plus 6MWT;
(2) RHC plus ECHO composite assessments;
(3) RHC composite assessment plus 6MWT;
(4) ECHO composite assessment plus 6MWT;
(5) RHC composite assessment only;
(6) ECHO composite assessment only.
The results of the same tests as conducted at baseline should be provided with the written First Continuing treatment application, except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be provided with the application.
The test results provided with the application for continuing treatment must be no more than 2 months old at the time of application.
Response to a PAH agent is defined as follows:
For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats will be authorised.
An application for First Continuing treatment with a PAH agent should be made prior to the completion of the Initial 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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
C6066 P6066

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

Pulmonary arterial hypertension (PAH)
Subsequent Continuing treatment
Patient must have received a PBS-subsidised treatment under First Continuing treatment with this agent for this condition; OR
Patient must have previously received PBS-subsidised treatment under this criteria with this agent for this condition; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Patients who have previously received PBS-subsidised treatment with this drug for this condition under the Continuing treatment (all patients) prior to 1 May 2016 are eligible to continue PBS subsidised treatment with this drug under this criteria.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats will be authorised.
An application for Subsequent Continuing treatment with a PAH agents should be made prior to the completion of the First Continuing treatment course to ensure continuity of treatment.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, and macitentan.

 Compliance with modified Authority Required procedures
C6071 P6071

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

Pulmonary arterial hypertension (PAH)
Initial 2 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have been assessed by a physician at a designated hospital; AND
Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH, and a mean right atrial pressure of greater than 8 mmHg, as measured by right heart catheterisation (RHC); OR
Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH, with right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; OR
Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg, as measured by RHC; OR
Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease with right ventricular function assessed by ECHO where a RHC cannot be performed on clinical grounds; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT); and
(3) a signed patient acknowledgement.
Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Test requirements to establish baseline for initiation of treatment are as follows:
The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.
Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments;
(2) RHC composite assessment plus 6MWT;
(3) RHC composite assessment only.
In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:
(1) ECHO composite assessment plus 6MWT;
(2) ECHO composite assessment only.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats may be requested.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, and macitentan.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.

 Compliance with modified Authority Required procedures
C6089 P6089

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

Pulmonary arterial hypertension (PAH)
Initial 1 or Initial 2 (new patients) or Initial 3 (change or re-commencement of therapy for all patients) or First Continuing treatment - Balance of supply
Patient must have received insufficient therapy with this agent under the Initial 1 (new patients) restriction to complete a maximum of six months of treatment; OR
Patient must have received insufficient therapy with this agent under the Initial 2 (new patients) restriction to complete a maximum of six months of treatment; OR
Patient must have received insufficient therapy with this agent under the Initial 3 (change or re-commencement of therapy for all patients) restriction to complete a maximum of six months of treatment; OR
Patient must have received insufficient therapy with this agent under the First Continuing treatment restriction to complete a maximum of six months of treatment; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition; AND
The treatment must provide no more than the balance of up to six months treatment available under one of the above restrictions.

 Compliance with modified Authority Required procedures
C6112 P6112

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

Pulmonary arterial hypertension (PAH)
Initial 3 (change or re-commencement of therapy for all patients)
Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and must wish to re-commence PBS-subsidised therapy with this agent after a break in therapy and must have demonstrated a response to their most recent course of PBS-subsidised treatment with this agent; OR
Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH or PAH secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with a PAH agent other than this agent; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form; and
(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
Response to a PAH agent is defined as follows:
For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats may be requested.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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
C6127 P6127

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

Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have been assessed by a physician at a designated hospital; AND
Patient must have WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH; OR
Patient must have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease; AND
Patient must have a mean right atrial pressure of 8 mmHg or less as measured by right heart catheterisation (RHC); OR
Patient must have right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; AND
Patient must have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT); and
(3) a signed patient acknowledgement.
Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Test requirements to establish baseline for initiation of treatment are as follows:
The first written application for PBS-subsidised treatment with the first PAH agent should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.
Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments;
(2) RHC composite assessment plus 6MWT;
(3) RHC composite assessment only.
In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:
(1) ECHO composite assessment plus 6MWT;
(2) ECHO composite assessment only.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
Details of prior vasodilator treatment, including the dose and duration of treatment, must be provided at the time of application. Where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated, details of the nature of the adverse event or contraindication according to the Therapeutic Goods Administration (TGA) approved Product Information must also be provided with the application.
Response to prior vasodilator treatment is defined as follows:
For patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, 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

  1. Schedule 3 Part 1, after subparagraph 3(2)

Substitute:

Item Kind of patient Regimen
1

Patient:

(a)     with Genotype 1; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 8 weeks; or

(b)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

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

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

(f)    PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks.
2

Patient:

(a)     with Genotype 1; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

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

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

(f)    PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks.
3

Patient:

(a)     with Genotype 2; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
4

Patient:

(a)     with Genotype 2; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
5

Patient:

(a)     with Genotype 3; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

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

Patient:

(a)     with Genotype 3; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

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

Patient:

(a)     with:

(i)     Genotype 4; or

(ii)     Genotype 5; or

(iii)    Genotype 6; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
8

Patient:

(a)     with:

(i)     Genotype 4; or

(ii)     Genotype 5; or

(iii)    Genotype 6; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
9

Patient:

(a)     with Genotype 1; and

(b)   who is treatment naïve; and

(c)    who is cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

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

(c)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

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

(e)     PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks.
10

Patient:

(a)     with Genotype 1; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 24 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

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

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

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

(f)    PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 24 weeks.
11

Patient:

(a)     with Genotype 2; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
12

Patient:

(a)     with Genotype 2; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
13

Patient:

(a)     with Genotype 3; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

Either:

(a)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
14

Patient:

(a)     with Genotype 3; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
15

Patient:

(a)     with:

(i)     Genotype 4; or

(ii)     Genotype 5; or

(iii)    Genotype 6; and

(b)   who is treatment naïve; and

(c)    who is cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
16

Patient:

(a)     with:

(i)     Genotype 4; or

(ii)     Genotype 5; or

(iii)    Genotype 6; and

(b)   who is treatment experienced; and

(c)    who is cirrhotic

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