ambrisentan (Volibris)

Following a full submission

ambrisentan (Volibris®) is accepted for restricted use within NHS Scotland for the treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity.Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.

Data suggest that ambrisentan has a benefit/risk ratio comparable to other endothelin receptor antagonists. Non-inferiority has not been formally demonstrated as ambrisentan is an orphan drug with limited clinical evidence. Where an endothelin receptor antagonist is indicated, ambrisentan provides an alternative.

It is restricted to initiation and prescribing by specialists in the Scottish Pulmonary Vascular Unit or similar specialists.