Aficamten Medicine 05 December 2023 Extended indication Symptomatic obstructive hypertrophic cardiomyopathy Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Aficamten Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other medication for cardiovascular diseases Extended indication Symptomatic obstructive hypertrophic cardiomyopathy Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Cytokinetics Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2024 Expected Registration 2025 Orphan drug No Registration phase Clinical trials 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 a day Dosage per administration 5 - 20 mg References NCT06081894 Additional remarks Daily oral dose of 5mg, 10mg, 15mg or 20mg of aficamten Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 17,500.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References G-standaard november 2023 Additional remarks Verwachting is dat de prijs per patiënt vergelijkbaar zal zijn met concurrent mavacamten. Kosten van mavacamten zijn ingeschat op €17.500 per patiënt per jaar. 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