in the absence of a submission from the holder of the marketing authorisation:
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) IV.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result, we cannot recommend its use within NHSScotland.
SMC has previously accepted sotatercept (Winrevair®) for restricted use 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 (SMC2923). This advice remains valid.
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Medicine details
- Medicine name:
- sotatercept (Winrevair)
- SMC ID:
- SMC2973
- Indication:
In combination with other pulmonary arterial hypertension (PAH) therapies for the treatment of PAH in adult patients with WHO Functional Class (FC) IV.
- Pharmaceutical company
- Merck Sharp & Dohme Ltd
- BNF chapter
- Cardiovascular system
- Submission type
- Non submission
- Status
- Not recommended
- Date advice published
- 07 September 2026