Venetoclax Medicine 03 June 2025 Extended indication Newly diagnosed high-risk myelodysplastic syndrome in adults and elderly. Therapeutic value No estimate possible yet Total cost € 14,310,000.00 Registration phase Clinical trials Product Active substance Venetoclax Domain Hematology Reason of inclusion Indication extension IND Main indication AML / MDS Extended indication Newly diagnosed high-risk myelodysplastic syndrome in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Venclyxto Manufacturer Abbvie Portfolio holder Abbvie Mechanism of action Bcl-2 inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Apoptosis stimulant; proto-oncogene protein c-bcl-2 inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2025 Expected Registration June 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van inschatting fabrikant. 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 Dosage per administration References NCT04401748 (VERONA) Additional remarks Expected patient volume per year Patient volume < 477 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021; NCT04401748 Additional remarks In 2021 waren er in totaal 953 MDS diagnoses. Alleen hoog risico MDS patiënten komen hiervoor in aanmerking (IPSS-R intermediair, hoog of zeer hoog). Dit zijn ongeveer de helft van alle diagnoses (477). Expected cost per patient per year Cost € 20,000.00 - 40,000.00 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 GIPdatabank Additional remarks Op basis van declaratiedata zal de prijs ergens tussen de 20.000 en 40.000 komen te liggen. Potential total cost per year Total cost € 14,310,000.00 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