Pulmonary arterial hypertension (PAH) Program in Pharmaceutical Benefits Schedule (PBS) 012-18051131

PAH is a condition causing blood flow obstruction through the lungs.

Listing dates for monotherapy:

• bosentan - 1 March 2004
• iloprost - 1 April 2005
• epoprostenol - 1 August 2006
• sildenafil - March 2007
• ambrisentan - 1 December 2009
• tadalafil - 1 April 2012
• macitentan - 1 September 2014
• riociguat - 1 February 2017

Listing dates for dual therapy:

• bosentan - 1 October 2020
• macitentan - 1 October 2020
• sildenafil - 1 October 2020
• tadalafil - 1 October 2020
• ambrisentan - 1 December 2020
• epoprostenol - 1 March 2021
• iloprost - 1 March 2021

Listing dates for triple therapy:

• ambrisentan - 1 February 2021
• bosentan - 1 February 2021
• macitentan - 1 February 2021
• selexipag - 1 February 2021
• sildenafil - 1 February 2021
• tadalafil - 1 February 2021
• epoprostenol - 1 December 2022
• iloprost - 1 December 2022

See Written Authority Required Drugs for more details.

Assessment tests

Details for the following tests should be provided with an initial monotherapy or dual therapy application, where available:

• RHC composite assessment, and
• ECHO composite assessment, and
• 6 Minute Walk Test (6MWT)

The following drug classes relevant for PAH:

• Endothelin receptor antagonist (ERA) - ambrisentan, bosentan, macitentan
• Phosphodiesterase-5 inhibitor (PDE-5i) - sildenafil, tadalafil
• Prostanoid - epoprostenol, iloprost

Monotherapy - refers to treatment with a single PAH agent from this list:

• ambrisentan with WHO Functional Class II, III or IV PAH
• bosentan with WHO Functional Class II, III or IV PAH
• epoprostenol with WHO Functional Class IV PAH
• iloprost with WHO Functional Class III drug and toxins induced PAH, or WHO Functional Class IV PAH
• macitentan with WHO Functional Class II, III or IV PAH
• riociguat with WHO Functional Class III or IV PAH
• sildenafil with WHO Functional Class II or III PAH
• tadalafil with WHO Functional Class II or III PAH

Dual Therapy (excluding selexipag) - refers to treatment with a combination of PAH agents in patients with WHO Functional Class III or IV PAH. For the purposes of PBS subsidy, dual therapy consists of either:

• one ERA and one 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 in patients with WHO Functional Class III or IV PAH. For the purposes of PBS subsidy, triple therapy consists of:

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

Triple Therapy (including selexipag) - refers to treatment with a combination of PAH agents with WHO Functional Class III or IV PAH. For the purposes of PBS subsidy, triple therapy is the combined use of:

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

Transfer enquiries about prescription arrangements to PBS Complex Drugs Programs, and choose the option relevant to the condition treated.