Sotatercept Medicine 04 December 2025 Extended indication Extension of indication to include in combination with other pulmonary arterial hypertension (PAH) therapies treatment of adult patients with PAH World Health Organisation Functional Class IV. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Sotatercept Domain Lung diseases Reason of inclusion Indication extension IND Main indication Lung diseases other Extended indication Extension of indication to include in combination with other pulmonary arterial hypertension (PAH) therapies treatment of adult patients with PAH World Health Organisation Functional Class IV. Current proprietary name Already available biosimilars / generics Proprietary name Winrevair Manufacturer MSD Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks 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 April 2026 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 80 - 120 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: Longfonds; 2: Risk assessment, prognosis and guideline implementation in pulmonary arterial hypertension Athénaïs Boucly. 2017. Additional remarks In Nederland zijn er ongeveer 800 mensen met de diagnose PAH (1). In studies van PAH in andere landen wordt vaak gemeld dat ongeveer 10-15% van de patiënten bij diagnose in WHO Functional Class IV is (2). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks