Sotatercept Medicine 07 December 2022 Extended indication Treatment of Pulmonary Arterial Hypertension Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Sotatercept Domain Lung diseases Reason of inclusion New medicine (specialité) Main indication Lung diseases other Extended indication Treatment of Pulmonary Arterial Hypertension Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MSD Portfolio holder MSD 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 Unknown Particularity New medicine with Priority Medicines (PRIME) ATMP No Submission date October 2023 Expected Registration November 2024 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks In oktober 2022 heeft de fabrikant bekend gemaakt dat de primaire eindpunten van de STELLAR studie zijn gehaald. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de fase 2 studie werden er resultaten gevonden op de 60 minuten looptest. De resultaten uit de fase 3 studie worden nog afgewacht. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 0,7 mg/kg References NCT04576988 (STELLAR) Additional remarks Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy. Expected patient volume per year Patient volume 255 - 884 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References ntvg.nl Additional remarks De prevalentie van PAH in Nederland is ongeveer 15-52 per 1 miljoen inwoners. 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 No Indication extensions References fabrikant Additional remarks Other information Additional remarks