National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2021 (No. 2) (PB 17 of 2021) (Cth)

Case

PB 17 of 2021

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2021 (No. 2)

National Health Act 1953

___________________________________________________________________________

I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

Dated         25 February 2021

BEN SLADIC

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

  1. Name of Instrument

(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2021 (No. 2).

(2)This Instrument may also be cited as PB 17 of 2021.

  1. Commencement

This Instrument commences on 1 March 2021.

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

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

Schedule 1     Amendments

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

(a)omit from the column headed “Circumstances” (all instances): C11189 C11191

(b)omit from the column headed “Circumstances” (all instances): C11239 C11256 C11257

(c)insert in numerical order in the column headed “Circumstances” (all instances): C11312 C11313 C11314 C11321 C11354

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

(a)omit from the column headed “Circumstances” (all instances): C11231 C11232 C11253 C11282 C11295

(b)insert in numerical order in the column headed “Circumstances” (all instances): C11312 C11313 C11314 C11317 C11321

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

(a)omit from the column headed “Circumstances” (all instances): C11231 C11232 C11253 C11282 C11295

(b)insert in numerical order in the column headed “Circumstances” (all instances): C11312 C11313 C11314 C11317 C11321

  1. Schedule 1, entry for Epoprostenol in each of the forms: Powder for I.V. infusion 500 micrograms (as sodium); Powder for I.V. infusion                  500 micrograms (as sodium) with 2 vials diluent 50 mL; Powder for I.V. infusion 1.5 mg (as sodium); and Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL

(a)omit from the column headed “Circumstances” (all instances): C10228 C10240

(b)insert in numerical order in the column headed “Circumstances” (all instances): C11322 C11323 C11325 C11329 C11330 C11345 C11356

  1. Schedule 1, entry for Iloprost

(a)omit from the column headed “Circumstances”: C10228

(b)omit from the column headed “Circumstances”: C10284

(c)insert in numerical order in the column headed “Circumstances”: C11322 C11323 C11325 C11343 C11345 C11356 C11365

  1. Schedule 1, entry for Macitentan

(a)omit from the column headed “Circumstances”: C11186

(b)omit from the column headed “Circumstances”: C11237 C11275 C11276 C11285

(c)insert in numerical order in the column headed “Circumstances”: C11312 C11313 C11314 C11317 C11321

  1. Schedule 1, entry for Sildenafil

(a)omit from the column headed “Circumstances” (all instances): C11228

(b)omit from the column headed “Circumstances” (all instances): C11230 C11280 C11281 C11299

(c)insert in numerical order in the column headed “Circumstances” (all instances): C11319 C11338 C11340 C11350 C11352

  1. Schedule 1, entry for Tadalafil

(a)omit from the column headed “Circumstances” (all instances): C11228

(b)omit from the column headed “Circumstances” (all instances): C11240 C11277 C11278 C11281

(c)insert in numerical order in the column headed “Circumstances” (all instances): C11319 C11338 C11340 C11350 C11352

  1. Schedule 3, entry for Ambrisentan

(a)omit:

C11189 Pulmonary arterial hypertension (PAH)
Initial 3 (dual therapy - change)
Patient must have had their most recent course of PBS-subsidised dual therapy with a phosphodiesterase-5 inhibitor (PDE-5i) and an endothelin receptor antagonist (ERA) other than this agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, and macitentan.
For the purposes of PBS subsidy, dual therapy refers to combined use of an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i).
(i) An ERA includes ambrisentan, bosentan monohydrate, or macitentan.
(ii) A PDE-5i includes sildenafil citrate, or tadalafil.
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 patients are approved dual therapy with a PAH agent from the PDE-5i class; or a PAH agent from the ERA class, they may swap between PAH agents within the same class. This means that patients may commence treatment with another PAH agent in the same class, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap within a PAH agent class must be made under the relevant initial treatment restriction.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11191 Pulmonary arterial hypertension (PAH)
Grandfathered patients (dual therapy)
Patient must be receiving dual therapy with this non PBS-subsidised pulmonary arterial hypertension (PAH) agent and a non PBS-subsidised phosphodiesterase-5 inhibitor (PDE-5i) for this condition prior to 1 December 2020.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, and macitentan.
For the purposes of PBS subsidy, dual therapy refers to combined use of an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i).
(i) An ERA includes ambrisentan, bosentan monohydrate, or macitentan.
(ii) A PDE-5i includes sildenafil citrate, or tadalafil.
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.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it was not possible to perform all 3 tests 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 could not 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 were 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.
Where a RHC could not be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria for dual therapy for this condition.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Written Authority Required procedures

(b)omit:

C11239 Pulmonary arterial hypertension (PAH)
Continuing treatment (dual therapy)
Patient must have received their most recent course of PBS-subsidised dual therapy with this PAH agent and a phosphodiesterase-5 inhibitor (PDE-5i) for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, and macitentan.
For the purposes of PBS subsidy, dual therapy refers to combined use of an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i).
(i) An ERA includes ambrisentan, bosentan monohydrate, or macitentan.
(ii) A PDE-5i includes sildenafil citrate, or tadalafil.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11256 Pulmonary arterial hypertension (PAH)
Initial 1 (dual therapy - previously untreated patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must be in combination with a PBS-subsidised phosphodiesterase-5 inhibitor (PDE-5i) for this condition.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, and macitentan.
For the purposes of PBS subsidy, dual therapy refers to combined use of an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i).
(i) An ERA includes ambrisentan, bosentan monohydrate, or macitentan.
(ii) A PDE-5i includes sildenafil citrate, or tadalafil.
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.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it is not possible to perform all 3 tests 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.
Where a RHC cannot be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
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 TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Written Authority Required procedures
C11257 Pulmonary arterial hypertension (PAH)
Initial 2 (dual therapy - previously treated patients)
Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have documented a failure to achieve or maintain WHO Functional Class II status with prior PBS-subsidised monotherapy treatment with a phosphodiesterase-5 inhibitor (PDE-5i) for this condition; AND
The treatment must be in combination with the PBS-subsidised PDE-5i for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, and macitentan.
For the purposes of PBS subsidy, dual therapy refers to combined use of an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i).
(i) An ERA includes ambrisentan, bosentan monohydrate, or macitentan.
(ii) A PDE-5i includes sildenafil citrate, or tadalafil.
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.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures

(c)insert in numerical order after existing text:

C11312 Pulmonary arterial hypertension (PAH)
Initial 1 (starting dual therapy in an untreated patient for the first time)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it is not possible to perform all 3 tests 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.
Where a RHC cannot be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
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 TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Written Authority Required procedures
C11313 Pulmonary arterial hypertension (PAH)
Continuing treatment (dual therapy)
Patient must have received PBS-subsidised dual therapy through one of the following treatment phase restrictions: (i) Initial 1 for dual therapy, (ii) Initial 2 for dual therapy (iii) 'Grandfathered' treatment for dual therapy, with this agent in the combination remaining unchanged from the most recent PBS-subsidised supply; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11314 Pulmonary arterial hypertension (PAH)
Initial 2 (starting dual therapy in a treated patient for the first time)
The condition must be PAH of WHO Functional Class III severity at the time dual therapy is initiated; OR
The condition must be PAH of WHO Functional Class IV severity at the time dual therapy is initiated; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS-subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11321 Pulmonary arterial hypertension (PAH)
Initial 3 (dual therapy - change)
Patient must have received PBS-subsidised dual combination therapy through one of the following treatment phase restrictions: (i) Initial 1 for dual therapy, (ii) Initial 2 for dual therapy, (iii) 'Grandfather' treatment for dual therapy, with at least one agent in the combination changing; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11354 Pulmonary arterial hypertension (PAH)
Grandfathered patient (dual therapy)
Patient must be receiving dual therapy with this non PBS-subsidised pulmonary arterial hypertension (PAH) agent and a non PBS-subsidised phosphodiesterase-5 inhibitor (PDE-5i) for this condition prior to 1 December 2020; AND
Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
For the purposes of PBS subsidy, dual therapy refers to combined use of an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i).
(i) An ERA includes ambrisentan, bosentan monohydrate, or macitentan.
(ii) A PDE-5i includes sildenafil citrate, or tadalafil.
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.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it was not possible to perform all 3 tests 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 could not 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 were 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.
Where a RHC could not be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria for dual therapy for this condition.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Written Authority Required procedures

  1. Schedule 3, entry for Bosentan

(a)omit:

C11231 Pulmonary arterial hypertension (PAH)
Initial 3 (dual therapy - change)
Patient must have had their most recent course of PBS-subsidised dual therapy with a phosphodiesterase-5 inhibitor (PDE-5i) and an endothelin receptor antagonist (ERA) other than this agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
For the purposes of PBS subsidy, dual therapy refers to combined use of an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i).
(i) An ERA includes ambrisentan, bosentan monohydrate, or macitentan.
(ii) A PDE-5i includes sildenafil citrate, or tadalafil.
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 patients are approved dual therapy with a PAH agent from the PDE-5i class; or a PAH agent from the ERA class, they may swap between PAH agents within the same class. This means that patients may commence treatment with another PAH agent in the same class, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap within a PAH agent class must be made under the relevant initial treatment restriction.
If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information and no repeats.
Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.
If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA-approved Product Information. 		Compliance with Authority Required procedures
C11232 Pulmonary arterial hypertension (PAH)
Grandfathered patients (dual therapy)
Patient must be receiving dual therapy with this non PBS-subsidised pulmonary arterial hypertension (PAH) agent and a non PBS-subsidised phosphodiesterase-5 inhibitor (PDE-5i) for this condition prior to 1 October 2020.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
For the purposes of PBS subsidy, dual therapy refers to combined use of an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i).
(i) An ERA includes ambrisentan, bosentan monohydrate, or macitentan.
(ii) A PDE-5i includes sildenafil citrate, or tadalafil.
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.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it was not possible to perform all 3 tests 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 could not 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 were 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.
Where a RHC could not be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria for dual therapy for this condition.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Written Authority Required procedures
C11253 Pulmonary arterial hypertension (PAH)
Initial 2 (dual therapy - previously treated patients)
Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have documented a failure to achieve or maintain WHO Functional Class II status with prior PBS-subsidised monotherapy treatment with a phosphodiesterase-5 inhibitor (PDE-5i) for this condition; AND
The treatment must be in combination with the PBS-subsidised PDE-5i for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
For the purposes of PBS subsidy, dual therapy refers to combined use of an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i).
(i) An ERA includes ambrisentan, bosentan monohydrate, or macitentan.
(ii) A PDE-5i includes sildenafil citrate, or tadalafil.
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.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information and no repeats.
Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.
If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA-approved Product Information. 		Compliance with Authority Required procedures
C11282 Pulmonary arterial hypertension (PAH)
Initial 1 (dual therapy - previously untreated patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must be in combination with a PBS-subsidised phosphodiesterase-5 inhibitor (PDE-5i) for this condition.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
For the purposes of PBS subsidy, dual therapy refers to combined use of an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i).
(i) An ERA includes ambrisentan, bosentan monohydrate, or macitentan.
(ii) A PDE-5i includes sildenafil citrate, or tadalafil.
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.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it is not possible to perform all 3 tests 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.
Where a RHC cannot be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
The test results provided must not be more than 2 months old at the time of application.
If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information and no repeats.
Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.
If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA-approved Product Information. 		Compliance with Written Authority Required procedures
C11295 Pulmonary arterial hypertension (PAH)
Continuing treatment (dual therapy)
Patient must have received their most recent course of PBS-subsidised dual therapy with this PAH agent and a phosphodiesterase-5 inhibitor (PDE-5i) for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
For the purposes of PBS subsidy, dual therapy refers to combined use of an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i).
(i) An ERA includes ambrisentan, bosentan monohydrate, or macitentan.
(ii) A PDE-5i includes sildenafil citrate, or tadalafil.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C11312 Pulmonary arterial hypertension (PAH)
Initial 1 (starting dual therapy in an untreated patient for the first time)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it is not possible to perform all 3 tests 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.
Where a RHC cannot be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
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 TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Written Authority Required procedures

C11313

Pulmonary arterial hypertension (PAH)
Continuing treatment (dual therapy)
Patient must have received PBS-subsidised dual therapy through one of the following treatment phase restrictions: (i) Initial 1 for dual therapy, (ii) Initial 2 for dual therapy (iii) 'Grandfathered' treatment for dual therapy, with this agent in the combination remaining unchanged from the most recent PBS-subsidised supply; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11314 Pulmonary arterial hypertension (PAH)
Initial 2 (starting dual therapy in a treated patient for the first time)
The condition must be PAH of WHO Functional Class III severity at the time dual therapy is initiated; OR
The condition must be PAH of WHO Functional Class IV severity at the time dual therapy is initiated; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS-subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11317 Pulmonary arterial hypertension (PAH)
Grandfathered patient (dual therapy)
Patient must be receiving dual therapy with this non PBS-subsidised pulmonary arterial hypertension (PAH) agent and a non PBS-subsidised phosphodiesterase-5 inhibitor (PDE-5i) for this condition prior to 1 October 2020; AND
Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
For the purposes of PBS subsidy, dual therapy refers to combined use of an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i).
(i) An ERA includes ambrisentan, bosentan monohydrate, or macitentan.
(ii) A PDE-5i includes sildenafil citrate, or tadalafil.
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.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it was not possible to perform all 3 tests 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 could not 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 were 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.
Where a RHC could not be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria for dual therapy for this condition.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Written Authority Required procedures
C11321 Pulmonary arterial hypertension (PAH)
Initial 3 (dual therapy - change)
Patient must have received PBS-subsidised dual combination therapy through one of the following treatment phase restrictions: (i) Initial 1 for dual therapy, (ii) Initial 2 for dual therapy, (iii) 'Grandfather' treatment for dual therapy, with at least one agent in the combination changing; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures

  1. Schedule 3, entry for Ciclosporin

omit entry for Circumstances Code “C9695” and substitute:

C9695 Severe atopic dermatitis
Management (initiation, stabilisation and review of therapy)
Must be treated by a dermatologist; OR
Must be treated by a clinical immunologist.
The condition must be ineffective to other systemic therapies; OR
The condition must be inappropriate for other systemic therapies. 		Compliance with Authority Required procedures - Streamlined Authority Code 9695

  1. Schedule 3, entry for Epoprostenol

(a)omit:

C10228 Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
The term ‘PAH agents’ refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C10240 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 with expertise in the management of PAH; AND
Patient must have WHO Functional Class IV PAH; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
The term ‘PAH agents’ refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it is not possible to perform all 3 tests 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.
Where a RHC cannot be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
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. 		Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C11322 Pulmonary arterial hypertension (PAH)
Initial 1 (starting dual therapy in an untreated patient for the first time)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have documented PAH of WHO Functional Class IV severity at the time dual therapy is initiated; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, a phosphodiesterase-5 inhibitor is one of: (a) sildenafil, (b) tadalafil; a prostanoid is one of: (c) epoprostenol, (d) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it is not possible to perform all 3 tests 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.
Where a RHC cannot be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
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 TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Written Authority Required procedures
C11323 Pulmonary arterial hypertension (PAH)
'Grandfathered' patient (dual therapy) - transitioning from non-PBS subsidised to PBS-subsidised dual therapy where each PAH agent has been non-PBS subsidised
Patient must have been receiving non-PBS-subsidised dual therapy with PAH agents consisting of a phosphodiesterase-5 inhibitor combined with a prostanoid, where each agent was non-PBS-subsidised, prior to 1 March 2021; AND
The condition must be PAH that was of WHO Functional Class III severity at the time dual therapy was initiated; OR
The condition must be PAH that was of WHO Functional Class IV severity at the time dual therapy was initiated; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS-subsidised therapies if non-PBS-subsidised dual therapy was initiated for WHO Functional Class III/IV PAH: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy; OR
The treatment must have been initiated as part of non-PBS-subsidised dual therapy for an untreated patient with WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Applications for authorisation must be lodged either electronically or via mail/postal service and include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension Initial Grandfather dual therapy authority application 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).
Where it was not possible to perform all 3 tests 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 could not 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 were 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.
Where a RHC could not be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria for dual therapy for this condition.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Written Authority Required procedures
C11325 Pulmonary arterial hypertension (PAH)
Initial 3 (dual therapy - change)
Patient must have received PBS-subsidised dual combination therapy through one of the following treatment phase restrictions: (i) Initial 1 for dual therapy, (ii) Initial 2 for dual therapy, (iii) 'Grandfather' treatment for dual therapy, with at least one agent in the combination changing; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor.
For the purposes of PBS subsidy, a phosphodiesterase-5 inhibitor is one of: (a) sildenafil, (b) tadalafil; a prostanoid is one of: (c) epoprostenol, (d) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11329 Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have WHO Functional Class IV PAH; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it is not possible to perform all 3 tests 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.
Where a RHC cannot be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
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. 		Compliance with Written Authority Required procedures
C11330 Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11345 Pulmonary arterial hypertension (PAH)
Continuing treatment (dual therapy)
Patient must have received PBS-subsidised dual therapy through one of the following treatment phase restrictions: (i) Initial 1 for dual therapy, (ii) Initial 2 for dual therapy (iii) 'Grandfathered' treatment for dual therapy, with this agent in the combination remaining unchanged from the most recent PBS-subsidised supply; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, a phosphodiesterase-5 inhibitor is one of: (a) sildenafil, (b) tadalafil; a prostanoid is one of: (c) epoprostenol, (d) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11356 Pulmonary arterial hypertension (PAH)
Initial 2 (starting dual therapy in a treated patient for the first time)
The condition must be PAH of WHO Functional Class III severity at the time dual therapy is initiated; OR
The condition must be PAH of WHO Functional Class IV severity at the time dual therapy is initiated; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS-subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures

  1. Schedule 3, entry for Iloprost

(a)omit:

C10228 Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
The term ‘PAH agents’ refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures

(b)omit:

C10284 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 with expertise in the management of PAH; AND
Patient must have WHO Functional Class III drug and toxins induced PAH, or WHO Functional Class IV PAH; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
The term ‘PAH agents’ refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it is not possible to perform all 3 tests 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.
Where a RHC cannot be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
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. 		Compliance with Written Authority Required procedures

(c)insert in numerical order after existing text:

C11322 Pulmonary arterial hypertension (PAH)
Initial 1 (starting dual therapy in an untreated patient for the first time)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have documented PAH of WHO Functional Class IV severity at the time dual therapy is initiated; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, a phosphodiesterase-5 inhibitor is one of: (a) sildenafil, (b) tadalafil; a prostanoid is one of: (c) epoprostenol, (d) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it is not possible to perform all 3 tests 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.
Where a RHC cannot be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
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 TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Written Authority Required procedures
C11323 Pulmonary arterial hypertension (PAH)
'Grandfathered' patient (dual therapy) - transitioning from non-PBS subsidised to PBS-subsidised dual therapy where each PAH agent has been non-PBS subsidised
Patient must have been receiving non-PBS-subsidised dual therapy with PAH agents consisting of a phosphodiesterase-5 inhibitor combined with a prostanoid, where each agent was non-PBS-subsidised, prior to 1 March 2021; AND
The condition must be PAH that was of WHO Functional Class III severity at the time dual therapy was initiated; OR
The condition must be PAH that was of WHO Functional Class IV severity at the time dual therapy was initiated; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS-subsidised therapies if non-PBS-subsidised dual therapy was initiated for WHO Functional Class III/IV PAH: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy; OR
The treatment must have been initiated as part of non-PBS-subsidised dual therapy for an untreated patient with WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Applications for authorisation must be lodged either electronically or via mail/postal service and include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension Initial Grandfather dual therapy authority application 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).
Where it was not possible to perform all 3 tests 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 could not 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 were 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.
Where a RHC could not be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria for dual therapy for this condition.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Written Authority Required procedures
C11325 Pulmonary arterial hypertension (PAH)
Initial 3 (dual therapy - change)
Patient must have received PBS-subsidised dual combination therapy through one of the following treatment phase restrictions: (i) Initial 1 for dual therapy, (ii) Initial 2 for dual therapy, (iii) 'Grandfather' treatment for dual therapy, with at least one agent in the combination changing; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor.
For the purposes of PBS subsidy, a phosphodiesterase-5 inhibitor is one of: (a) sildenafil, (b) tadalafil; a prostanoid is one of: (c) epoprostenol, (d) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11343 Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have WHO Functional Class III drug and toxins induced PAH, or WHO Functional Class IV PAH; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it is not possible to perform all 3 tests 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.
Where a RHC cannot be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
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. 		Compliance with Written Authority Required procedures
C11345 Pulmonary arterial hypertension (PAH)
Continuing treatment (dual therapy)
Patient must have received PBS-subsidised dual therapy through one of the following treatment phase restrictions: (i) Initial 1 for dual therapy, (ii) Initial 2 for dual therapy (iii) 'Grandfathered' treatment for dual therapy, with this agent in the combination remaining unchanged from the most recent PBS-subsidised supply; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, a phosphodiesterase-5 inhibitor is one of: (a) sildenafil, (b) tadalafil; a prostanoid is one of: (c) epoprostenol, (d) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11356 Pulmonary arterial hypertension (PAH)
Initial 2 (starting dual therapy in a treated patient for the first time)
The condition must be PAH of WHO Functional Class III severity at the time dual therapy is initiated; OR
The condition must be PAH of WHO Functional Class IV severity at the time dual therapy is initiated; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS-subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11365 Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures

(c)insert in numerical order after existing text:

C11319 Pulmonary arterial hypertension (PAH)
Initial 1 (starting dual therapy in an untreated patient for the first time)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor, but only for WHO Functional Class IV PAH.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
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).
Where it is not possible to perform all 3 tests 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.
Where a RHC cannot be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
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 TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Written Authority Required procedures
C11338 Pulmonary arterial hypertension (PAH)
Initial 2 (starting dual therapy in a treated patient for the first time)
The condition must be PAH of WHO Functional Class III severity at the time dual therapy is initiated; OR
The condition must be PAH of WHO Functional Class IV severity at the time dual therapy is initiated; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS-subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11340 Pulmonary arterial hypertension (PAH)
'Grandfathered' patient (dual therapy) - transitioning from non-PBS subsidised to PBS-subsidised dual therapy where each PAH agent has been non-PBS subsidised
Patient must have been receiving non-PBS subsidised dual therapy with PAH agents consisting of a phosphodiesterase-5 inhibitor combined with an endothelin receptor antagonist, where each agent was non-PBS subsidised, prior to 1 October 2020; OR
Patient must have been receiving non-PBS-subsidised dual therapy with PAH agents consisting of a phosphodiesterase-5 inhibitor combined with a prostanoid, where each agent was non-PBS-subsidised, prior to 1 March 2021; AND
The condition must be PAH that was of WHO Functional Class III severity at the time dual therapy was initiated; OR
The condition must be PAH that was of WHO Functional Class IV severity at the time dual therapy was initiated; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS-subsidised therapies if non-PBS-subsidised dual therapy was initiated for WHO Functional Class III/IV PAH: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor, where non-PBS subsidised prostanoid-PDE-5i dual therapy was initiated in an untreated patient with Class IV disease severity; OR
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor, where non-PBS subsidised prostanoid-PDE-5i dual therapy was initiated in a patient with Class III/IV disease severity that had been treated with at least endothelin receptor/phosphodiesterase-5 inhibitor/prostanoid monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Applications for authorisation must be lodged either electronically or via mail/postal service and include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension Initial Grandfather dual therapy authority application 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).
Where it was not possible to perform all 3 tests 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 could not 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 were 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.
Where a RHC could not be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria for dual therapy for this condition.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Written Authority Required procedures
C11350 Pulmonary arterial hypertension (PAH)
Continuing treatment (dual therapy)
Patient must have received PBS-subsidised dual therapy through one of the following treatment phase restrictions: (i) Initial 1 for dual therapy, (ii) Initial 2 for dual therapy (iii) 'Grandfathered' treatment for dual therapy, with this agent in the combination remaining unchanged from the most recent PBS-subsidised supply; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures
C11352 Pulmonary arterial hypertension (PAH)
Initial 3 (dual therapy - change)
Patient must have received PBS-subsidised dual combination therapy through one of the following treatment phase restrictions: (i) Initial 1 for dual therapy, (ii) Initial 2 for dual therapy, (iii) 'Grandfather' treatment for dual therapy, with at least one agent in the combination changing; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
A maximum of 5 repeats may be requested. 		Compliance with Authority Required procedures

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

substitute:

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

1        Criteria for eligibility for drugs for the treatment of chronic hepatitis C

The criteria for patient eligibility for drugs for the treatment of chronic hepatitis C are that:

(1)the patient has been assessed in accordance with paragraph 2 of this Part; and

(2)     the patient is:

(a)       treated by a medical practitioner or an authorised nurse practitioner who is experienced in the treatment of patients with chronic hepatitis C infection; or

(b)       treated by a medical practitioner or an authorised nurse practitioner in consultation with:

(i)       a gastroenterologist; or

(ii)      a hepatologist; or

(iii)     an infectious diseases physician.

2        Assessment of patient

For the purpose of subparagraph 1(2) of this Part, the patient has been assessed if the treating medical practitioner has:

(1)documented the following information in the patient’s medical records:

(a)evidence of chronic hepatitis C infection; and

(b)where possible, evidence of the patient’s hepatitis C virus genotype; and

(2)chosen a regimen in accordance with paragraph 3 of this Part; and

(3)collected the following information for the purposes of the authority application:

(a)whether the patient is:

(i)cirrhotic; or

(ii)non-cirrhotic

(b)details of the previous treatment regimen (only for requests for sofosbuvir with velpatasvir and voxilaprevir or glecaprevir with pibrentasvir for treatment in patients who have previously failed a treatment with a regimen containing an NS5A inhibitor).

(4)In this paragraph, evidence of chronic hepatitis C infection is documentation of:

(a)repeat test results showing antibody to hepatitis C virus (anti-HCV) positive; and

(b)test result showing hepatitis C virus ribonucleic acid (RNA) positive.

3        Treatment regimen

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

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

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

Item Kind of patient Regimen
1

Patient:

(a)     all genotypes (pan-genotypic); and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic.

Either:

(a)     SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b)     GLECAPREVIR with PIBRENTASVIR for 8 weeks.
2

Patient:

(a)     all genotypes (pan-genotypic); and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic.

Either:

(a)     SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b)     SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks; or

(c)     GLECAPREVIR with PIBRENTASVIR for 8 weeks; or

(d)     GLECAPREVIR with PIBRENTASVIR for 12 weeks; or

(e)     GLECAPREVIR with PIBRENTASVIR 16 weeks.
3

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
4

Patient:

(a)     with Genotype 1; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic.

 LEDIPASVIR with SOFOSBUVIR for 12 weeks
5

Patient:

(a)     with Genotype 2; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic.

 Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
6

Patient:

(a)     with Genotype 2; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic.

 Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
7

Patient:

(a)    with Genotype 3; and

(b)    who is treatment naïve; and

(c)    who is non-cirrhotic.

 Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
8

Patient:

(a)    with Genotype 3; and

(b)    who is treatment experienced; and

(c)    who is non-cirrhotic.

 Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
9

Patient:

(a)    with Genotype 4; and

(b)    who is treatment naïve; and

(c)    who is non-cirrhotic.

 Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
10

Patient:

(a)    with Genotype 4; and

(b)    who is treatment experienced; and

(c)    who is non-cirrhotic.

 Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
11

Patient:

(a)    with:

   (i)   Genotype 5; or

  (ii)  Genotype 6; and

(b)    who is treatment naïve; and

(c)    who is non-cirrhotic.

 Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
12

Patient:

(a)    with:

   (i)   Genotype 5; or

   (ii)  Genotype 6; and

(b)    who is treatment experienced; and

(c)    who is non-cirrhotic.

 Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
13

Patient:

(a)    all genotypes (pan-genotypic); and

(b)    who is treatment naïve; and

(c)    who is cirrhotic.

Either:

(a)    SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b)    GLECAPREVIR with PIBRENTASVIR for 12 weeks.
14

Patient:

(a)    all genotypes (pan-genotypic); and

(b)    who is treatment experienced; and

(c)    who is cirrhotic.

Either:

(a)    SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b)    SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks; or

(c)    GLECAPREVIR with PIBRENTASVIR for 12 weeks; or

(d)    GLECAPREVIR with PIBRENTASVIR 16 weeks.
15

Patient:

(a)    with Genotype 1; and

(b)    who is treatment naïve; and

(c)    who is cirrhotic.

 LEDIPASVIR with SOFOSBUVIR for 12 weeks
16

Patient:

(a)    with Genotype 1; and

(b)    who is treatment experienced; and

(c)    who is cirrhotic.

 LEDIPASVIR with SOFOSBUVIR for 24 weeks
17

Patient:

(a)    with Genotype 2; and

(b)    who is treatment naïve; and

(c)    who is cirrhotic.

 Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
18

Patient:

(a)    with Genotype 2; and

(b)    who is treatment experienced; and

(c)    who is cirrhotic.

 Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
19

Patient:

(a)    with Genotype 3; and

(b)    who is treatment naïve; and

(c)    who is cirrhotic.

 Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
20

Patient:

(a)    with Genotype 3; and

(b)    who is treatment experienced; and

(c)    who is cirrhotic.

 Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
21

Patient:

(a)    with Genotype 4; and

(b)    who is treatment naïve; and

(c)    who is cirrhotic.

 Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
22

Patient:

(a)    with Genotype 4; and

(b)    who is treatment experienced; and

(c)    who is cirrhotic.

 Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
23

Patient:

(a)    with:

   (i)   Genotype 5; or

   (ii)  Genotype 6; and

(b)            who is treatment naïve; and

      (c)            who is cirrhotic.

 Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
24

Patient:

 (a)    with:

   (i)   Genotype 5; or

   (ii)  Genotype 6; and

 (b)    who is treatment           experienced; and

 (c)    who is cirrhotic.

 Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
Actions
Download as PDF Download as Word Document
Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0