sotatercept (Winrevair)

following a resubmission:

sotatercept (Winrevair®) is accepted for restricted 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.

SMC restriction: for use in patients with intermediate-low risk status on the European Society of Cardiology (ESC)/European Respiratory Society (ERS) four-strata risk rating system.

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.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.