Venetoclax Medicine 12 June 2019 Extended indication Extension of the indication to include treatment with Venclyxto in combination with an anti‐CD20 antibody (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Therapeutic value No judgement Total cost € 45,300,000.00 Registration phase Registration application pending Product Active substance Venetoclax Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication CLL Extended indication Extension of the indication to include treatment with Venclyxto in combination with an anti‐CD20 antibody (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Current proprietary name Already available biosimilars / generics Proprietary name Venclyxto Manufacturer Abbvie Portfolio holder Mechanism of action Bcl-2 inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Bcl-2 remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date July 2019 Expected Registration May 2020 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Venetoclax is in de sluis geplaatst. Therapeutic value Current treatment options Chloorambucil+anti-CD20 (bv obinutuzumab) of ibrutinib. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 10.5 month / months Frequency of administration Dosage per administration References Fabrikant Additional remarks Expected patient volume per year Patient volume < 600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Geschat wordt dat er jaarlijks zo'n 600 patiënten in de 1e lijn behandeld worden. Deze patiënten komen dan in aanmerking voor venetoclax (maximum). Expected cost per patient per year Cost € 73,000.00 - 78,000.00 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 Medicijnkosten.nl; SmPC venetoclax Additional remarks Op basis van SmPC en AIP zijn de kosten €73.000,00-€78.000,00 per jaar. Venetoclax is in de sluis geplaatst om te komen tot een financieel arrangement. Potential total cost per year Total cost € 45,300,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Mantle-cell lymphoma; Multiple myeloma (lopende fase III studies) References AdisInsight Additional remarks Other information Additional remarks