Pulmonary hypertension - arterial

Please note: You’ll get an immediate assessment when you request PBS authorities online.

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 pulmonary arterial hypertension.

When the term 'PAH agent' appears it refers to:

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

For the PBS subsidy:

Dual Therapy (excluding selexipag) - refers to treatment with a combination of PAH agents for patients with WHO Functional Class III or IV PAH and consists of either:

• one endothelin receptor antagonist (ERA) and one phosphodiesterase-5 inhibitor (PDE-5i)
• one ERA and one prostanoid
• one PDE-5i and one prostanoid.

Triple Therapy (excluding selexipag) - refers to treatment with a combination of PAH agents for patients with WHO Functional Class III or IV PAH and consists of:

• one ERA, one PDE-5i and one prostanoid.

Triple Therapy (including selexipag) - refers to treatment with a combination of PAH agents for patients with WHO Functional Class III or IV PAH and consists of:

• the combined use of selexipag, an ERA and a PDE-5i
• the combined use of selexipag and either an ERA or a PDE-5i, in cases where a patient cannot receive all 3 agents for clinical reasons.

Approved ERAs for dual and triple therapies are:

• ambrisentan
• bosentan
• macitentan.

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

• sildenafil
• tadalafil.

Approved prostanoids for dual and triple therapies 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

PAH agents are only PBS-subsidised for non-admitted patients, day admitted patients, or patients on discharge who are attending:

• an approved private hospital
• a public hospital.

PAH agents aren’t PBS-subsidised for public 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 be treated by and the authority application completed by a physician with expertise in the management of PAH.

Authority applications

Applying for initial monotherapy treatment

Applications for initial authority approval to prescribe PBS-subsidised PAH agents to treat PAH as monotherapy can be made either in:

• real time using the Online PBS Authorities system
• writing and use HPOS Form upload
• writing and mail to PBS Complex Drugs Programs.

All written applications must include:

• details of the proposed prescription or prescriptions
• the completed pulmonary arterial hypertension - initial monotherapy authority application form
• relevant attachments.

Applying for initial dual or triple therapy treatment (excluding selexipag)

Applications for initial authority approval to prescribe PBS-subsidised PAH agents to treat PAH as dual or triple therapy (excluding selexipag) in a previously untreated patient can be made either in:

• real time using the Online PBS Authorities system
• writing and use HPOS Form upload
• writing and mail to PBS Complex Drugs Programs.

All written applications must include:

• details of the proposed prescription or prescriptions
• the completed pulmonary arterial hypertension - initial dual or triple therapy authority application form
• relevant attachments.

Applying to transition to dual or triple therapy, change or continuing treatment (excluding selexipag)

Applications can be made for patients that are:

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

These applications can be made either:

• in real time using the Online PBS Authorities system
• by calling the PBS Complex Drugs Programs enquiry line.

Applying for initial triple therapy treatment (including selexipag)

Applications for PBS-subsidised triple therapy with selexipag 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:

• in real time using the Online PBS Authorities system
• by calling the PBS Complex Drugs Programs enquiry line.

More information

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