Venetoclax Medicine 03 June 2025 Extended indication Venetoclax in combination with ibrutinib for second line or later treatment of relapsed/refractory Mantle cell lymphoma in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Venetoclax Domain Hematology Reason of inclusion Indication extension IND Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Venetoclax in combination with ibrutinib for second line or later treatment of relapsed/refractory Mantle cell lymphoma 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 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2025 Expected Registration June 2026 Orphan drug Yes 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 De fase 3 Sympatico studie is gepubliceerd. Venetoclax+ibrutnib versus ibrutinib+placebo. Een gevonden mediane progressievrije overleving van 32 versus 22 maanden, mediane algehele overleving 45 versus 39 maanden. Hieruit blijkt een significante- progressievrije overleving en algehele overleving voor de venetoclax arm. Duration of treatment Frequency of administration Dosage per administration References NCT03112174 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 Additional remarks Incidentie betreft in totaal 221 patiënten in 2023 voor Mantle Cell Lymphoma (MCL). 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 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