Allogenic immunomodulatory progenitor cells Medicine 09 January 2018 Extended indication End-stage heart failure in patients with coronary artery congenital malformation - adjunctive therapy in patients requiring coronary artery bypass graft Therapeutic value No judgement Total cost Registration phase Unknown Product Active substance Allogenic immunomodulatory progenitor cells Domain Cardiovascular diseases Reason of inclusion Main indication Heart failure Extended indication End-stage heart failure in patients with coronary artery congenital malformation - adjunctive therapy in patients requiring coronary artery bypass graft Current proprietary name Already available biosimilars / generics Proprietary name Heartcel Manufacturer Cell Therapy Portfolio holder Mechanism of action Unknown Route of administration Intracardiac Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References van der Bom et al., 2012; www.volksgezondheidenzorg.info Additional remarks De prevalentie van het aantal personen met een aangeboren hartafwijking is in internationaal vergelijkend onderzoek (van der Bom et al., 2012) voor Nederland geschat op 32 per 10.000 volwassenen. Dat komt neer op ongeveer 42.200 volwassenen (> 18 jaar). Daarbij moeten ongeveer 18 x 1.250 = 22.500 gevallen bij jongeren (0-18 jr) worden opgeteld. De totale schatting komt dan op rond 65.000 Nederlanders met een aangeboren hartafwijking. Het genoemde onderzoek gaf aan dat er binnen deze groep sprake is van 5% zeer ernstige, 36% matig ernstige en 58% lichtere hartafwijkingen. Expected cost per patient per year Cost References Additional remarks Meerkosten 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