Treatment for patients with idiopathic pulmonary arterial hypertension (iPAH) and pulmonary arterial hypertension (PAH) can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under section 100 of the National Health Act 1953 using the following agents:
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Ambrisentan is available for the treatment of:
- World Health Organization (WHO) Functional Class III or IV iPAH or anorexigen-induced PAH or heritable PAH , and
- WHO Functional Class III or IV PAH secondary to connective tissue disease
- WHO Functional Class III or IV iPAH or anorexigen-induced PAH or heritable PAH WHO Functional Class III or IV PAH secondary to connective tissue disease, and
- WHO Functional Class III or IV PAH associated with a congenital systemic-to-pulmonary shunt, including Eisenmenger's physiology
- WHO Functional Class IV iPAH or anorexigen-induced PAH or heritable PAH
- WHO Functional Class IV PAH secondary to connective tissue disease
- WHO Functional Class III iPAH or anorexigen-induced PAH or heritable PAH where the patient has previously failed treatment with a PBS-subsidised PAH agent, and
- WHO Functional Class III PAH secondary to connective tissue disease where the patient has previously failed treatment with a PBS-subsidised PAH agent
- WHO Functional Class IV iPAH or anorexigen-induced PAH or heritable PAH
- WHO Functional Class IV PAH secondary to connective tissue disease
- WHO Functional Class III iPAH or anorexigen-induced PAH or heritable PAH where the patient has previously failed treatment with a PBS-subsidised PAH agent
- WHO Functional Class III PAH secondary to connective tissue disease where the patient has previously failed treatment with a PBS-subsidised PAH agent, and
- WHO Functional Class III or IV drug-induced PAH
- WHO Functional Class III or IV iPAH or anorexigen-induced PAH or heritable PAH
- WHO Functional Class III or IV PAH secondary to connective tissue disease, and
- WHO Functional Class III or IV PAH associated with congenital systemic-to-pulmonary shunt including Eisenmenger's physiology
- WHO Functional Class III or IV iPAH or anorexigen-induced PAH or heritable PAH
- WHO Functional Class III or IV PAH secondary to connective tissue disease, and
- WHO III or IV PAH associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology)
- WHO Functional Class III iPAH or anorexigen-induced PAH or heritable PAH, and
- WHO Functional Class III PAH secondary to connective tissue disease
- WHO Functional Class III iPAH or anorexigen-induced PAH or heritable PAH, and
- WHO Functional Class III PAH secondary to connective tissue disease
Section 100 arrangements
These items are available to a patient attending:
These items are available to a patient attending:
- an approved private hospital
- a public participating hospital, or
- a public hospital
- day admitted patient
- non admitted patient, or
- patient on discharge
Patient eligibility
Patients must meet the relevant criteria in the restrictions and be eligible for the PBS.
The Schedule of Pharmaceutical Benefits on the PBS website outlines the full list of restrictions for PAH agents.
These 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 that predicted.
Patients must meet the relevant criteria in the restrictions and be eligible for the PBS.
The Schedule of Pharmaceutical Benefits on the PBS website outlines the full list of restrictions for PAH agents.
These 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 that predicted.
Interchangeability
Interchangeability between PAH agents is defined in the Schedule of Pharmaceutical Benefits on the PBS website.
Application
sAll patients (excluding applications for balance of supply) must be assessed by a physician at a PAH designated hospital.
Interchangeability between PAH agents is defined in the Schedule of Pharmaceutical Benefits on the PBS website.
Application
sAll patients (excluding applications for balance of supply) must be assessed by a physician at a PAH designated hospital.
Initial treatment
Make all initial applications for authority approval to prescribe PAH agents for the treatment of iPAH or PAH in writing and:
Applications for riociguat must include at least 1 written authority prescription for up to 6 months of therapy.
Make all initial applications for authority approval to prescribe PAH agents for the treatment of iPAH or PAH in writing and:
- upload through Health Professional Online Services (HPOS), or
- post to the PBS Complex Drugs Programs address
- authority prescription form(s), and
- Pulmonary arterial hypertension Initial authority application Supporting information form (PB070)
Applications for riociguat must include at least 1 written authority prescription for up to 6 months of therapy.
Grandfathered patients for riociguat
Make initial applications for patients who began treatment with riociguat for iPAH or PAH before 1 February 2017 as an initial Grandfather application.
For Grandfathered patients lodge the Pulmonary arterial hypertension - riociguat Initial grandfather PBS authority application form (PB201).
Make initial applications for patients who began treatment with riociguat for iPAH or PAH before 1 February 2017 as an initial Grandfather application.
For Grandfathered patients lodge the Pulmonary arterial hypertension - riociguat Initial grandfather PBS authority application form (PB201).
Continuing treatment
Make all first applications for continuing authority approval to prescribe PAH agents for the treatment of iPAH and PAH in writing and:
The patient must show stability or improvement of condition relative to the baseline assessment. Subsequent applications for continuing treatment, and applications for balance of supply, can be made by calling the PBS Complex Drugs Programs enquiry line.
Make all first applications for continuing authority approval to prescribe PAH agents for the treatment of iPAH and PAH in writing and:
- upload through HPOS, or
- post to the PBS Complex Drugs Programs address
- authority prescription form(s), and
- Pulmonary arterial hypertension Continuing authority application Supporting information form (PB071)
The patient must show stability or improvement of condition relative to the baseline assessment. Subsequent applications for continuing treatment, and applications for balance of supply, can be made by calling the PBS Complex Drugs Programs enquiry line.
Change of treatment
Patients can change to an alternate PAH agent at any time, once an authority for initial treatment with the first PBS subsidised PAH agent is approved. Patients do not have to re-qualify for treatment with the alternate agent, irrespective of the severity of their disease at the time the application to swap therapy is submitted, as long as they meet the alternate agent restriction criteria. No new baseline measurements are needed.
A set of new baseline results may be provided with applications for patients who have not shown stability or improvement of iPAH or PAH relative to the baseline result, and who want to change to an alternative agent for which they are eligible.
Applications can be made for change approvals for:
Patients can change to an alternate PAH agent at any time, once an authority for initial treatment with the first PBS subsidised PAH agent is approved. Patients do not have to re-qualify for treatment with the alternate agent, irrespective of the severity of their disease at the time the application to swap therapy is submitted, as long as they meet the alternate agent restriction criteria. No new baseline measurements are needed.
A set of new baseline results may be provided with applications for patients who have not shown stability or improvement of iPAH or PAH relative to the baseline result, and who want to change to an alternative agent for which they are eligible.
Applications can be made for change approvals for:
- bosentan monohydrate - must include 2 written authority prescription forms-1 for the first month of initiation therapy and another for the remaining 5 months of that therapy
- riociguat - must include required written authority prescription forms, or
- other listed PAH agents - must include an authority prescription form for up to 6 months of therapy
Stopping treatment
Prescribers with patients who want to temporarily stop treatment with a PAH agent must submit a Pulmonary arterial hypertension Continuing authority application Supporting information form (PB071) for their current treatment to demonstrate response.
Send the completed form to the PBS Complex Drugs Programs enquiry line so it can be included in the patient's treatment history.
Phone approval will be granted only for patients stopping treatment with bosentan, to provide sufficient supply to allow gradual dose reduction over a period of 1 month. To do so you can contact the PBS Complex Drugs Programs enquiry line.
Prescribers with patients who want to temporarily stop treatment with a PAH agent must submit a Pulmonary arterial hypertension Continuing authority application Supporting information form (PB071) for their current treatment to demonstrate response.
Send the completed form to the PBS Complex Drugs Programs enquiry line so it can be included in the patient's treatment history.
Phone approval will be granted only for patients stopping treatment with bosentan, to provide sufficient supply to allow gradual dose reduction over a period of 1 month. To do so you can contact the PBS Complex Drugs Programs enquiry line.
Further information
For more information call the PBS Complex Drugs Programs enquiry line.
For more information call the PBS Complex Drugs Programs enquiry line.
PBS Mediation Report
As of May 2018 - Here
As of May 2018 - Here