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

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

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

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

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

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

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

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

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

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

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

C11186

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.
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

C11237

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

C11275

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.
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

C11276

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.
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

C11285

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

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

C11195

P11195

Pulmonary arterial hypertension (PAH)
Initial treatment following dose titration
Patient must have WHO Functional Class III PAH at treatment initiation with this drug; OR
Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
Patient must have completed the dose titration phase; AND
The treatment must not be as 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.
Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.
Select one appropriate strength (determined under the 'Initial treatment - dose titration' phase) and apply under this treatment phase (Initial treatment following dose titration) once only. Should future dose adjustments be required, apply under the 'Continuing treatment' restriction.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
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.

Compliance with Authority Required procedures

C11241

P11241

Pulmonary arterial hypertension (PAH)
Transitioning from non-PBS subsidised to PBS-subsidised supply - 'Grandfather' treatment
Patient must have received non-PBS subsidised treatment with this drug prior to 1 February 2021; AND
Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy, prior to treatment initiation with this drug; AND
Patient must have had WHO Functional Class III PAH at treatment initiation with this drug; OR
Patient must have had WHO Functional Class IV PAH at treatment initiation with this drug; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
The treatment must not be as 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.
Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
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.
For the purposes of administering this restriction, disease progression has developed if at least one of the following has occurred:
(i) Hospitalisation due to worsening PAH;
(ii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with worsening of WHO functional class status;
(iii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with the need for additional PAH-specific therapy;
(iv) Initiation of parenteral prostanoid therapy or long-term oxygen therapy for worsening of PAH;
(v) Need for lung transplantation or balloon atrial septostomy for worsening of PAH.
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.

Compliance with Authority Required procedures

C11261

P11261

Pulmonary arterial hypertension (PAH)
Initial treatment - dose titration
Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy; AND
Patient must have WHO Functional Class III PAH at treatment initiation with this drug; OR
Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND
The treatment must be for dose titration purposes with the intent of completing the titration within 12 weeks; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
The treatment must not be as 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.
Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
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.

Compliance with Authority Required procedures

C11228

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 endothelin receptor antagonist (ERA) 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.
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

C11230

Pulmonary arterial hypertension (PAH)
Initial 3 (dual therapy - change)
Patient must have had their most recent course of PBS-subsidised dual therapy with an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i) 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.
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

C11280

Pulmonary arterial hypertension (PAH)
Continuing treatment (dual therapy)
Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent and an endothelin receptor antagonist (ERA) 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

C11281

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 endothelin receptor antagonist (ERA) 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

C11299

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 an endothelin receptor antagonist (ERA) for this condition; AND
The treatment must be in combination with a PBS-subsidised endothelin receptor antagonist (ERA) 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.
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

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

C11228

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 endothelin receptor antagonist (ERA) 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.
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

C11240

Pulmonary arterial hypertension (PAH)
Initial 3 (dual therapy - change)
Patient must have had their most recent course of PBS-subsidised dual therapy with an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i) 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.
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

C11277

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 an endothelin receptor antagonist (ERA) for this condition; AND
The treatment must be in combination with a PBS-subsidised endothelin receptor antagonist (ERA) 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.
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

C11278

Pulmonary arterial hypertension (PAH)
Continuing treatment (dual therapy)
Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent and an endothelin receptor antagonist (ERA) 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


 

C11281

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 endothelin receptor antagonist (ERA) 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

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

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).