Sotatercept powder and solvent for solution for injection (Winrevair®)

Summary

The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows:

ADVICE: following a full submission sotatercept (Winrevair®) is not recommended for use within NHSScotland.

Indication under review: in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with WHO Functional Class (FC) II to III, to improve exercise capacity.

In a phase III study of patients with PAH with WHO FC II or III who were receiving stable background therapy, sotatercept significantly improved exercise capacity, measured by the 6-minute walk test, compared with placebo.

The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC.

The submitting company has indicated their intention to make a resubmission.