Pulmonary arterial hypertension

The PBS subsidises a range of medicines for patients with primary pulmonary and pulmonary arterial hypertension.

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:

  • ambrisentan
  • bosentan monohydrate
  • epoprostenol sodium
  • iloprost trometamol
  • macitentan
  • sildenafil citrate, and
  • tadalafil

Ambrisentan is available for the treatment of:

  • World Health Organization (WHO) Functional Class III or IV iPAH or anorexigen-induced PAH or hereditable PAH , and
  • WHO Functional Class III or IV PAH secondary to connective tissue disease

Bosentan monohydrate is available for the treatment of:

  • WHO Functional Class III or IV iPAH or anorexigen-induced PAH or hereditable 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

Epoprostenol sodium is available for the treatment of:

  • WHO Functional Class IV iPAH or anorexigen-induced PAH or hereditable PAH
  • WHO Functional Class IV PAH secondary to connective tissue disease
  • WHO Functional Class III iPAH or anorexigen-induced PAH or hereditable 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

Iloprost trometamol is available for the treatment of:

  • WHO Functional Class IV iPAH or anorexigen-induced PAH or hereditable PAH
  • WHO Functional Class IV PAH secondary to connective tissue disease
  • WHO Functional Class III iPAH or anorexigen-induced PAH or hereditable 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

Macitentan is available for the treatment of:

  • WHO Functional Class III or IV iPAH or anorexigen-induced PAH or hereditable 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

Riociguat is available for the treatment of:

  • WHO Functional Class III or IV iPAH or anorexigen-induced PAH or hereditable 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)

Sildenafil citrate is available for the treatment of:

  • WHO Functional Class III iPAH or anorexigen-induced PAH or hereditable PAH, and
  • WHO Functional Class III PAH secondary to connective tissue disease

Tadalafil is available under the PBS as an 'authority required' item for the treatment of:

  • WHO Functional Class III iPAH or anorexigen-induced PAH or hereditable PAH, and
  • WHO Functional Class III PAH secondary to connective tissue disease

Section 100 arrangements

These items are available to a patient attending:

  • an approved private hospital
  • a public participating hospital, or
  • a public hospital

and is a:

  • day admitted patient
  • non admitted patient, or
  • patient on discharge

You must include the hospital provider number on the application form.

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.

Interchangeability

Interchangeability between PAH agents is defined in the Schedule of Pharmaceutical Benefits on the PBS website.

Applications

All 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:

All applications must include a completed:

Applications for bosentan monohydrate must include 2 written authority prescriptions—1 for the first month of initiation therapy and another for the remaining 5 months of that therapy.

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).

Continuing treatment

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

All applications must include a completed:

The authority prescription may be for up to 6 months of therapy.

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:

  • 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.

Further information

For more information call the PBS Complex Drugs Programs enquiry line.

Page last updated: 27 August 2017