PBS eases restrictions on PAH medicines to include WHO FC II patients

PBS access criteria for Pulmonary Arterial Hypertension (PAH) medicines have been eased to allow the use of ERA or PDE-5 inhibitor monotherapy in patients with WHO Functional Class (FC) II symptoms.

From 1 May 2020 PAH patients with WHO FC II symptoms will be able to access PBS-subsidised monotherapy with endothelin receptor antagonist (ERA) medicines (ambrisentan, bosentan and macitentan) or PDE-5 inhibitor medicines (sildenafil and tadalafil).

New patients require a written authority and must meet initial PBS restriction criteria of Right Heart Catheter (RHC) composite assessment, ECHO composite assessment or 6 Minute Walk Test (6MWT).

However, patients who will not be required to demonstrate a response to initial PBS-subsidised treatment to access continued monotherapy, and continuing prescriptions will be available by telephone authority. The new initial access criteria have also removed the need for a trial of vasodilator therapy and

In a statement the PBS said the changes are being introduced as a result of the the Post-Market Review of PAH medicines that recommended PBS criteria be aligned with clinical guidelines.

In November 2019 the Pharmaceutical Benefits Advisory Committee (PBAC) said it had accepted proposals from the from the Pulmonary Hypertension Society of Australia and New Zealand for dual combination use of ERA and PDE-5 inhibitor medicines for patients with WHO functional class (FC) III/IV PAH symptoms.

The PBAC noted the clinical evidence presented in the Post Market Report supported dual combination therapy when a PDE-5i is added to a prostanoid (epoprostenol or iloprost) compared with monotherapy with a prostanoid.

The Committee made a recommendation for PBS subsidy combination therapy with a prostanoid and sildenafil (or tadalafil at a comparable price) as second line treatment for patients with WHO FC III symptoms and first line treatment for patients with WHO FC IV symptoms.

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