Sotatercept Medicine 04 December 2025 Extended indication Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III, and IV (see section 5.1). Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Sotatercept Domain Lung diseases Reason of inclusion Indication extension IND Main indication Lung diseases other Extended indication Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III, and IV (see section 5.1). Current proprietary name Already available biosimilars / generics Proprietary name Winrevair Manufacturer MSD Portfolio holder Mechanism of action Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Indicatieuitbreiding naar WHO Functional Class IV. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New medicine with Priority Medicines (PRIME) ATMP No Submission date June 2025 Expected Registration January 2026 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in december 2025. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 0,7mg/kg References NCT04896008 (ZENITH) Additional remarks Sotatercept start met een dosering van 0,3mg/kg en een streefdosis van 0,7mg/kg subcutaan (SC). Toegediend elke 21 dagen, plus PAH-therapie als achtergrondbehandeling. Expected patient volume per year Patient volume < 700 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Longfonds; Miller DP et al., Chest (2012) – “The REVEAL Registry” Humbert M et al., Circulation (2006) Additional remarks In Nederland zijn er ongeveer 800 mensen met de diagnose PAH. Ongeveer 90-95% hebben klasse II, III, of IV. Expected cost per patient per year Cost References www.drugs.com Additional remarks Er zijn nog geen gegevens bekend over de verwachte kosten in Nederland. In Amerika is 1 flacon van 45mg of 60mg gelijk aan $14.951,17. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks