macitentan (Opsumit)

following a full submission:

macitentan (Opsumit®) is accepted for restricted use within NHS Scotland.

Indication under review: as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension in adult patients of World Health Organisation Functional Class II to III.

SMC restriction: to initiation and prescribing by specialists in the Scottish Pulmonary Vascular Unit or similar specialists.

In a pivotal phase lll study in patients with pulmonary arterial hypertension, macitentan significantly increased the time to a first event related to morbidity or mortality from any cause compared with placebo.  The effect was maintained for up to two years.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of macitentan. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.