Zalunfiban Medicine 04 June 2024 Extended indication Treat ST-Elevated Myocardial Infarction. Therapeutic value No estimate possible yet Total cost € 3,300,000.00 Registration phase Clinical trials Product Active substance Zalunfiban Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other medication for cardiovascular diseases Extended indication Treat ST-Elevated Myocardial Infarction. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Celecor Portfolio holder Mechanism of action Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date 2026 Expected Registration January 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Anticoagulants (eg, unfractionated heparin, enoxaparin, bivalirudin) Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor (eg, clopidogrel, prasugrel, ticagrelor. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Dit gaat om een enkele percutane interventie toediening. In de Celebrate studie wordt het getest on top of standard care (dus al dapt). Een voordeel zou minder trombusvorming zijn. In tegenstelling tot dit middel geeft bijvoorbeeld tirofiban (intraveneus beschikbaar) risico op trombocytopenie. Duration of treatment Frequency of administration Dosage per administration 0,110mg/kg References NCT04825743 (CELEBRATE) Additional remarks Expected patient volume per year Patient volume 11,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) https://www.hartstichting.nl/hart-en-vaatziekten/cijfers-hart-en-vaatziekten; (2) https://www.hartenvaatcijfers.nl/jaarcijfers/jaarcijfers-coronairlijden-a608f#h4; Additional remarks In Nederland zijn er circa 32.000 acute hartinfarcten per jaar.(1). Primaire PCI bij STEMI is komt voor bij circa 30% van de patiënten. Het geschatte aantal is daardoor circa 11.000 per jaar (2). Expected cost per patient per year Cost € 300.00 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 medicijnkosten.nl Additional remarks Er is nog geen prijsinformatie beschikbaar. Mogelijk is de prijs vergelijkbaar met 250mg poeder voor injectie/infusieoplossing bivalirudin: kosten rond de €300. Potential total cost per year Total cost € 3,300,000.00 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