Venetoclax Medicine 07 June 2022 Extended indication Patients With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma 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 Multiple Myeloma Extended indication Patients With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma 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 Unknown Particularity Unknown ATMP Unknown Submission date 2023 Expected Registration 2024 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks fase 3 studies 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 References NCT03539744 Additional remarks Expected patient volume per year Patient volume < 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expert opinie; What Multiple Myeloma With t(11;14) Should Be Classified Into in Novel Agent Era: Standard or Intermediate Risk? Wen Gao. 2020. Additional remarks Deze behandeling is specifiek voor patiënten met een 11-14 mutatie. Dit komt voor bij 16-24% van de populatie, uiteindelijk is de inschatting om die reden dat niet meer dan 50 patiënten voor deze behandeling in aanmerking zullen komen. Expected cost per patient per year Cost References Additional remarks De lijstprijs in de G-standaard is €5.798,58, de prijs per tablet is dus €51,77. Met vier tabletten per dag komen de kosten per maand uit op €6.212,76. 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