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.
Medicine details
- Medicine name:
- sotatercept (Winrevair)
- SMC ID:
- SMC2831
- Indication:
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.
- Pharmaceutical company
- Merck Sharp & Dohme Ltd
- BNF chapter
- Cardiovascular system
- Submission type
- Full
- Status
- Not recommended
- Date advice published
- 09 February 2026