Pulmonary hypertension - arterial

The PBS subsidises a range of medicines for patients with pulmonary arterial hypertension (PAH).

Patient eligibility

The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with PAH agents as monotherapy, dual therapy or triple therapy under the National Health Act 1953, section 100 for patients with PAH.

Where the term PAH agent appears it refers to:

  • ambrisentan
  • bosentan monohydrate
  • epoprostenol sodium
  • iloprost trometamol
  • macitentan
  • riociguat
  • sildenafil citrate
  • tadalafil
  • selexipag.

Dual therapy and triple therapy treatments are only subsidised for specific combinations of the above PAH agents.

For the purposes of PBS subsidy:

  • dual therapy requires the combined use of an approved phosphodiesterase-5 inhibitor (PDE-5i) with either an approved endothelin receptor antagonist (ERA), or an approved prostanoid.
  • triple therapy requires the combined use of selexipag, an approved ERA and an approved PDE-5i. Where a patient cannot be treated with an ERA or a PDE-5i for clinical reasons, dual therapy with either an ERA or a PDE-5i in combination with selexipag may be approved in lieu of triple therapy.

Approved PDE-5i’s for dual and triple therapies are:

  • sildenafil citrate
  • tadalafil.

Approved ERAs for dual and triple therapies are:

  • ambrisentan
  • bosentan monohydrate
  • macitentan.

Approved prostanoids for dual therapy are:

  • epoprostenol
  • iloprost.

Patients must be eligible for the PBS and meet the relevant restriction criteria.

The Schedule of Pharmaceutical Benefits on the PBS website outlines the restrictions for prescribing PAH agents.

Section 100 arrangements

These items are only PBS subsidised for day admitted patients, non-admitted patients, or patients on discharge who are attending either:

  • an approved private hospital
  • a public participating hospital
  • a public hospital.

These items aren’t PBS subsidised for hospital in-patients. You must include the hospital name and provider number on the authority application form.

Treatment specifics

To be eligible for PBS subsidised treatment with a PAH agent (or agents), patients must have been treated by and the medication prescribed by a physician with expertise in the management of PAH.

Prostanoids are not PBS subsidised for triple therapy treatment. A patient commencing dual therapy treatment with a PDE-5i in combination with a prostanoid, must either:

  • have WHO Functional Class IV
  • have previously received PBS subsidised PAH treatment with a PAH agent as monotherapy or dual therapy treatment.

Authority applications

Applying for initial monotherapy treatment

Apply for initial authority approval to prescribe PBS subsidised PAH agents to treat PAH as monotherapy in writing and either:

All written applications must include the completed:

Applying for initial dual therapy treatment

Apply for initial authority approval to prescribe PBS subsidised PAH agents to treat PAH as dual therapy in writing and either:

All written applications must include the completed:

Applying for initial grandfather dual therapy treatment

For patients who received non-PBS subsidised dual therapy PAH treatment with a combination of 2 approved PAH agents before:

  • 1 October 2020 for dual therapy including an approved PDE-5i in combination with bosentan or macitentan
  • 1 December 2020 for dual therapy including an approved PDE-5i in combination with ambrisentan
  • 1 March 2021, for dual therapy including an approved PDE-5i in combination with an approved prostanoid.

Apply for grandfather authority approval in writing and either:

All written applications must include the completed:

Applying to transition to dual therapy, change or continuing treatment

Applications can be made for patients that are:

  • transitioning to dual therapy after receiving PBS subsidised monotherapy treatment
  • changing PAH agents after receiving prior PBS subsidised monotherapy or dual therapy treatment
  • continuing PBS subsidised treatment with the current PAH agent (or agents).

These applications can be made either:

Applying for triple therapy treatment

Applications for authority approval to prescribe PBS subsidised PAH agents as triple therapy to treat PAH can be made for patients that:

  • are transitioning to triple therapy after receiving dual therapy with at least one prior PBS subsidised PAH agent
  • are transitioning to triple therapy after receiving PBS subsidised dual therapy
  • have received non-PBS subsidised triple therapy with a combination of approved PAH agents prior to 1 March 2021
  • are changing PAH agents after receiving prior PBS subsidised triple therapy treatment
  • continuing PBS subsidised triple therapy treatment with the current PAH agents

Applications for PBS subsidised triple therapy must be sought in a specific order. A patient cannot receive an authority approval for either an ERA or a PDE-5i as triple therapy until the authority application for selexipag has been approved.

These applications can be made either:

Further information

Call the PBS Complex Drugs Programs enquiry line for further information.

Page last updated: 1 March 2021