Bosentan Cipla

LR

C10228 C10238 C10924 C10945 C11229 C11231 C11232 C11253 C11282 C11295

See Note 1

See Note 2

D

Bosentan Cipla

LR

C10228 C10924 C10945 C11229 C11231 C11232 C11253 C11282 C11295

See Note 1

See Note 2

D

Eculizumab

Solution concentrate for I.V. infusion 300 mg in 30 mL

Injection

Soliris

XI

C6626 C6637 C6642 C6668 C6686 C6687 C6688

See Note 1

See Note 2

D

Ivacaftor

Sachet containing granules
50 mg

Oral

Kalydeco

VR

C9889 C9890

See Note 1

See Note 2

D

Sachet containing granules
75 mg

Oral

Kalydeco

VR

C9889 C9890

See Note 1

See Note 2

D

Tablet 150 mg

Oral

Kalydeco

VR

C9889 C9890

See Note 1

See Note 2

D

Lumacaftor with ivacaftor

Sachet containing granules, lumacaftor 100 mg and ivacaftor 125 mg

Oral

Orkambi

VR

C10005 C10007

See Note 1

See Note 2

D

Sachet containing granules, lumacaftor 150 mg and ivacaftor 188 mg

Oral

Orkambi

VR

C10005 C10007

See Note 1

See Note 2

D

Tablet containing lumacaftor
100 mg with ivacaftor 125 mg

Oral

Orkambi

VR

C9891 C9920

See Note 1

See Note 2

D

Tablet containing lumacaftor
200 mg with ivacaftor 125 mg

Oral

Orkambi

VR

C9857 C9943

See Note 1

See Note 2

D

Mepolizumab

Injection 100 mg in 1 mL single dose pre-filled pen

Injection

Nucala

GK

C9885 C10221 C10222 C10280 C10483 C10484

See Note 1

See Note 2

D

Powder for injection 100 mg

Injection

Nucala

GK

C9885 C10221 C10222 C10280

See Note 1

See Note 2

D

Midostaurin

Capsule 25 mg

Oral

Rydapt

NV

C8138 C8177 C8193 C8218

See Note 1

See Note 2

D

Pomalidomide

Capsule 3 mg

Oral

Pomalyst

CJ

C7791 C7952

See Note 1

See Note 2

D

Capsule 4 mg

Oral

Pomalyst

CJ

C7791 C7952

See Note 1

See Note 2

D

Selexipag

Tablet 200 micrograms

Oral

Uptravi

JC

C11193 C11195 C11241 C11261

P11193 P11195 P11241

60

5

D

C11193 C11195 C11241 C11261

P11241 P11261

140

2

D

Tablet 400 micrograms

Oral

Uptravi

JC

C11193 C11195 C11241

60

5

D

Tablet 600 micrograms

Oral

Uptravi

JC

C11193 C11195 C11241

60

5

D

Tablet 800 micrograms

Oral

Uptravi

JC

C11193 C11195 C11241 C11261

P11261

60

3

D

C11193 C11195 C11241 C11261

P11193 P11195 P11241

60

5

D

Tablet 1 mg

Oral

Uptravi

JC

C11193 C11195 C11241

60

5

D

Tablet 1.2 mg

Oral

Uptravi

JC

C11193 C11195 C11241

60

5

D

Tablet 1.4 mg

Oral

Uptravi

JC

C11193 C11195 C11241

60

5

D

Tablet 1.6 mg

Oral

Uptravi

JC

C11193 C11195 C11241

60

5

D

Sildenafil PHT APOTEX

TY

C10228 C10234 C10304 C11228 C11229 C11230 C11280 C11281 C11299

See Note 1

See Note 2

D

TY

Apotex Pty Ltd

52 096 916 148

ZE

Seekwell Pty Ltd

91 624 401 618

C11007

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.
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

C11008

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; AND
Patient must have been assessed by a physician with expertise in the management of PAH; AND
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

C11010

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.
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

C11024

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.
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

C11037

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; AND
Patient must have been assessed by a physician with expertise in the management of PAH; AND
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

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

C11229

Pulmonary arterial hypertension (PAH)
Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised 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').
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 authority application for selexipag must be approved prior to the authority application for this agent.
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.
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

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

C11004

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; AND
Patient must have been assessed by a physician with expertise in the management of PAH; AND
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

C11022

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.
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

C11023

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.
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

C11036

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; AND
Patient must have been assessed by a physician with expertise in the management of PAH; AND
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

C11044

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.
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

C11064

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; AND
Patient must have been assessed by a physician with expertise in the management of PAH; AND
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

C11229

Pulmonary arterial hypertension (PAH)
Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised 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').
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 authority application for selexipag must be approved prior to the authority application for this agent.
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.
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

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

Eltrombopag

C11199

Severe thrombocytopenia
Second or subsequent Continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND
Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
Patient must be aged 18 years or older.
For the purpose of this restriction, a continuing response to treatment with drug is defined as:
(a) use of rescue medication (corticosteroids or immunoglobulins) on no more than one occasion during the most recent 24 week period of PBS-subsidised treatment with this drug
AND either of the following:
(b) a platelet count greater than or equal to 50,000 million per L
OR
(c) a platelet count greater than 30,000 million per L and which is double the baseline platelet count.
The platelet count must be no more than 4 weeks old at the time of application.

Compliance with Authority Required procedures

C11202

Severe thrombocytopenia
Initial treatment 1 - New patient
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have had a splenectomy; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy following the splenectomy; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy following the splenectomy; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
Patient must be aged 18 years or older.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of initial application;
(a) a platelet count of less than or equal to 20,000 million per L; OR
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.
Where intolerance to treatment with corticosteroid and immunoglobulin therapy developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form,
(2) a completed Idiopathic Thrombocytopenic Purpura Initial PBS Authority Application - Supporting Information Form,
(3) details of a platelet count supporting the diagnosis of ITP.
The platelet count must be no more than 4 weeks old at the time of application.
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.
Patients will be able to trial either eltrombopag or romiplostim within the initial 24 weeks treatment period. Where a patient has started initial treatment with one of the two agents, change of therapy to the alternative agent may be authorised under the Balance of supply or change of therapy restriction to complete up to 24 weeks initial treatment. Patients who fail to demonstrate a response to treatment with eltrombopag and/or romiplostim after completion of 24 weeks initial therapy will not be eligible to receive further PBS-subsidised treatment with either of these drugs.

Compliance with Written Authority Required procedures

C11244

Severe thrombocytopenia
Balance of supply or change of therapy within 24 weeks initial treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 restriction to complete 24 weeks treatment; OR
Patient must be swapping therapy from romiplostim to this drug for this condition within the initial 24 weeks of treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Second and subsequent Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Patient must be aged 18 years or older.
Patients will be able to trial either eltrombopag or romiplostim within the initial 24 weeks treatment period. Where a patient has started initial treatment with one of the two agents, change of therapy to the alternative agent may be authorised under the Balance of supply or change of therapy restriction to complete up to 24 weeks initial treatment. Patients who fail to demonstrate a response to treatment with eltrombopag and/or romiplostim after completion of 24 weeks initial therapy will not be eligible to receive further PBS-subsidised treatment with either of these drugs.

Compliance with Authority Required procedures

C11262

Severe thrombocytopenia
Initial treatment 2 - New patient
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must not have had a splenectomy; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy at a dose equivalent to 0.5-2 mg/kg/day of prednisone for at least 4-6 weeks; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND
Patient must be unsuitable for splenectomy due to medical reasons; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
Patient must be aged 18 years or older.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of initial application;
(a) a platelet count of less than or equal to 20,000 million per L; OR
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.
Where intolerance to treatment with corticosteroid and immunoglobulin therapy developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form,
(2) a completed Idiopathic Thrombocytopenic Purpura Initial PBS Authority Application - Supporting Information Form,
(3) details of a platelet count supporting the diagnosis of ITP, and
(4) details of the reason of medical contraindication for surgery and date of assessment.
The platelet count must be no more than 4 weeks old at the time of application.
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.
Patients will be able to trial either eltrombopag or romiplostim within the initial 24 weeks treatment period. Where a patient has started initial treatment with one of the two agents, change of therapy to the alternative agent may be authorised under the Balance of supply or change of therapy restriction to complete up to 24 weeks initial treatment. Patients who fail to demonstrate a response to treatment with eltrombopag and/or romiplostim after completion of 24 weeks initial therapy will not be eligible to receive further PBS-subsidised treatment with either of these drugs.

Compliance with Written Authority Required procedures

C11263

Severe thrombocytopenia
First Continuing treatment or Re-initiation of interrupted continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break; OR
Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment; AND
Patient must not have previously received PBS-subsidised continuing treatment with romiplostim for this condition; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
Patient must be aged 18 years or older.
For the purposes of this restriction, a sustained platelet response is defined as:
(a) use of rescue medication (corticosteroids or immunoglobulins) on no more than one occasion during the initial period of PBS-subsidised treatment with this drug,
AND either of the following:
(b) a platelet count greater than or equal to 50,000 million per L on at least four (4) occasions, each at least one week apart;
OR
(c) a platelet count greater than 30,000 million per L and which is double the baseline (pre-treatment) platelet count on at least four (4) occasions, each at least one week apart.
Applications for the First continuing PBS-subsidised treatment or Re-initiation of interrupted PBS-subsidised continuing treatment must be made in writing and must include:
(1) a completed authority prescription form, and
(2) a completed Idiopathic Thrombocytopenic Purpura Continuing PBS Authority Application - Supporting Information Form, and
(3) the most recent platelet count.
The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug.
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.

Compliance with Written Authority Required procedures


 

C11021

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; AND
Patient must have been assessed by a physician with expertise in the management of PAH; AND
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

C11033

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.
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

C11034

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.
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

C11043

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.
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

C11071

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; AND
Patient must have been assessed by a physician with expertise in the management of PAH; AND
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

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

C11229

Pulmonary arterial hypertension (PAH)
Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised 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').
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 authority application for selexipag must be approved prior to the authority application for this agent.
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.
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

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

Romiplostim

C11205

Severe thrombocytopenia
Initial treatment 2 - New patient
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must not have had a splenectomy; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy at a dose equivalent to 0.5-2 mg/kg/day of prednisone for at least 4-6 weeks; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND
Patient must be unsuitable for splenectomy due to medical reasons; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
Patient must be aged 18 years or older.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of initial application;
(a) a platelet count of less than or equal to 20,000 million per L; OR
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.
Where intolerance to treatment with corticosteroid and immunoglobulin therapy developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
At the time of the written authority application, medical practitioners should request the appropriate quantity of vials of appropriate strength to provide sufficient drug for a single treatment at a dose of 1 microgram/kg. Up to 1 repeat may be requested with the initial written application.
Subsequently during the initial period of dose titration, authority applications for a single dose and up to 1 repeat may be requested by telephone. The dose (microgram/kg/week) must be provided at the time of application.
Once a patient's dose has been stable for a period of 4 weeks, authority approvals for sufficient vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) for up to 4 weeks of treatment and up to 4 repeats may be granted, as long as the total period of treatment authorised under this restriction does not exceed 24 weeks.
Authority approval will not be given for doses higher than 10 micrograms/kg/week
The authority application must be made in writing and must include:
(1) a completed authority prescription form,
(2) a completed Idiopathic Thrombocytopenic Purpura Initial PBS Authority Application - Supporting Information Form,
(3) details of a platelet count supporting the diagnosis of ITP, and
(4) details of the reason of medical contraindication for surgery and date of assessment.
The platelet count must be no more than 4 weeks old at the time of application.
Patients will be able to trial either eltrombopag or romiplostim within the initial 24 weeks treatment period. Where a patient has started initial treatment with one of the two agents, change of therapy to the alternative agent may be authorised under the Balance of supply or change of therapy restriction to complete up to 24 weeks initial treatment. Patients who fail to demonstrate a response to treatment with eltrombopag and/or romiplostim after completion of 24 weeks initial therapy will not be eligible to receive further PBS-subsidised treatment with either of these drugs.

Compliance with Written Authority Required procedures
 

C11246

Severe thrombocytopenia
Balance of supply or change of therapy within 24 weeks initial treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 restriction to complete 24 weeks treatment; OR
Patient must be swapping therapy from eltrombopag to this drug for this condition within the initial 24 weeks of treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Second and subsequent Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Patient must be aged 18 years or older.
Patients will be able to trial either eltrombopag or romiplostim within the initial 24 weeks treatment period. Where a patient has started initial treatment with one of the two agents, change of therapy to the alternative agent may be authorised under the Balance of supply or change of therapy restriction to complete up to 24 weeks initial treatment. Patients who fail to demonstrate a response to treatment with eltrombopag and/or romiplostim after completion of 24 weeks initial therapy will not be eligible to receive further PBS-subsidised treatment with either of these drugs.

Compliance with Authority Required procedures
 

C11266

Severe thrombocytopenia
Initial treatment 1 - New patient
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have had a splenectomy; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy following the splenectomy; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy following the splenectomy; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
Patient must be aged 18 years or older.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of initial application;
(a) a platelet count of less than or equal to 20,000 million per L; OR
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.
Where intolerance to treatment with corticosteroid and immunoglobulin therapy developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
At the time of the written authority application, medical practitioners should request the appropriate quantity of vials of appropriate strength to provide sufficient drug for a single treatment at a dose of 1 microgram/kg. Up to 1 repeat may be requested with the initial written application.
Subsequently during the initial period of dose titration, authority applications for a single dose and up to 1 repeat may be requested by telephone. The dose (microgram/kg/week) must be provided at the time of application.
Once a patient's dose has been stable for a period of 4 weeks, authority approvals for sufficient vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) for up to 4 weeks of treatment and up to 4 repeats may be granted, as long as the total period of treatment authorised under this restriction does not exceed 24 weeks.
Authority approval will not be given for doses higher than 10 micrograms/kg/week
The authority application must be made in writing and must include:
(1) a completed authority prescription form,
(2) a completed Idiopathic Thrombocytopenic Purpura Initial PBS Authority Application - Supporting Information Form,
(3) details of a platelet count supporting the diagnosis of ITP.
The platelet count must be no more than 4 weeks old at the time of application.
Patients will be able to trial either eltrombopag or romiplostim within the initial 24 weeks treatment period. Where a patient has started initial treatment with one of the two agents, change of therapy to the alternative agent may be authorised under the Balance of supply or change of therapy restriction to complete up to 24 weeks initial treatment. Patients who fail to demonstrate a response to treatment with eltrombopag and/or romiplostim after completion of 24 weeks initial therapy will not be eligible to receive further PBS-subsidised treatment with either of these drugs.

Compliance with Written Authority Required procedures
 

C11267

Severe thrombocytopenia
First Continuing treatment or Re-initiation of interrupted continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break; OR
Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment; AND
Patient must not have previously received PBS-subsidised continuing treatment with eltrombopag for this condition; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
Patient must be aged 18 years or older.
For the purposes of this restriction, a sustained platelet response is defined as:
(a) use of rescue medication (corticosteroids or immunoglobulins) on no more than one occasion during the initial period of PBS-subsidised treatment with this drug,
AND either of the following:
(b) a platelet count greater than or equal to 50,000 million per L on at least four (4) occasions, each at least one week apart;
OR
(c) a platelet count greater than 30,000 million per L and which is double the baseline (pre-treatment) platelet count on at least four (4) occasions, each at least one week apart.
The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.
Authority approval will not be given for doses higher than 10 micrograms/kg/week
Applications for the First continuing PBS-subsidised treatment or Re-initiation of interrupted PBS-subsidised continuing treatment must be made in writing and must include:
(1) a completed authority prescription form, and
(2) a completed Idiopathic Thrombocytopenic Purpura Continuing PBS Authority Application - Supporting Information Form, and
(3) the most recent platelet count.
The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug.

Compliance with Written Authority Required procedures
 

C11289

Severe thrombocytopenia
Second or Subsequent Continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND
Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
Patient must be aged 18 years or older.
For the purpose of this restriction, a continuing response to treatment with drug is defined as:
(a) use of rescue medication (corticosteroids or immunoglobulins) on no more than one occasion during the most recent 24 week period of PBS-subsidised treatment with this drug
AND either of the following:
(b) a platelet count greater than or equal to 50,000 million per L
OR
(c) a platelet count greater than 30,000 million per L and which is double the baseline platelet count.
The platelet count must be no more than 4 weeks old at the time of application.
The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.
Authority approval will not be given for doses higher than 10 micrograms/kg/week

Compliance with Authority Required procedures
 

Selexipag

C11193

P11193

Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received PBS-subsidised treatment with this drug for this condition; 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.
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.

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, tadalfil, 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, tadalfil, 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, tadalfil, 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

C10998

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.
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

C11012

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.
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

C11020

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.
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

C11032

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; AND
Patient must have been assessed by a physician with expertise in the management of PAH; AND
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

C11045

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; AND
Patient must have been assessed by a physician with expertise in the management of PAH; AND
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

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

C11229

Pulmonary arterial hypertension (PAH)
Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised 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').
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 authority application for selexipag must be approved prior to the authority application for this agent.
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.
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

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

C10998

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.
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
 

C11012

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.
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
 

C11020

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.
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
 

C11032

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; AND
Patient must have been assessed by a physician with expertise in the management of PAH; AND
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
 

C11045

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; AND
Patient must have been assessed by a physician with expertise in the management of PAH; AND
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
 

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

C11229

Pulmonary arterial hypertension (PAH)
Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised 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').
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 authority application for selexipag must be approved prior to the authority application for this agent.
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.
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

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