Nivolumab Medicine 08 June 2021 Extended indication Extension of indication in combination with ipilimumab to include treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) for combination treatment with Opdivo and Yervoy; Therapeutic value No estimate possible yet Total cost € 6,350,000.00 Registration phase Registered Product Active substance Nivolumab Domain Oncology Reason of inclusion Indication extension IND Main indication Colon cancer Extended indication Extension of indication in combination with ipilimumab to include treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) for combination treatment with Opdivo and Yervoy; Current proprietary name Already available biosimilars / generics Proprietary name Opdivo Manufacturer BMS Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date December 2020 Expected Registration June 2021 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in mei 2021. Voor nivolumab is er een financieel arrangement afgesloten met het Ministerie van VWS (lopend tot 1 januari 2024). Het verlengde financieel arrangement voor nivolumab heeft mede betrekking op alle (toekomstige) bewezen effectieve indicaties van nivolumab. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment loopt de fase 3 studie nog. De fase 2 data is gepubliceerd in 2018. Hierin werd geconcludeerd dat nivolumab plus ipilimumab mogelijk effectiever is dan monotherapie. Duration of treatment Frequency of administration 2 times every 2 weeks Dosage per administration 3mg/kg References J Clin Oncol 2018 Mar 10;36(8):773-779; NCT02060188 Additional remarks Expected patient volume per year Patient volume 127 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2018; Poynter et al. Cancer Epidemiol Biomarkers Prev. 2008 Nov;17(11):3208-15.; Zhaohui Jin. Prognostic and Predictive Values of Mismatch Repair Deficiency in Non-Metastatic Colorectal Cancer. Cancers 2021. Additional remarks In 2018 waren er 1.929 patiënten met een coloncarcinoom en 622 patiënten met een rectum carcinoom in stadium 4. Dit zijn in totaal 2.551 patiënten. Er wordt verwacht dat ongeveer 5% hiervan in aanmerking zal komen voor behandeling. Dit betekent dat er naar verwachting 127 patiënten per jaar behandeld zullen worden. Expected cost per patient per year Cost € 40,000.00 - 60,000.00 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 G-standaard Additional remarks Nivolumab 10mg/ml flacon, 4 ml (40mg): €405,03; Nivolumab 10mg/ml flacon, 10ml (100mg): €1.012,56; Nivolumab 10mg/ml flacon, 24ml (240mg): €2.430,15; Z-index, 1 april 2021, exclusief btw. Prijs is ingeschat in lijn met andere indicaties. Voor alle indicatie van nivolumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis lopend tot 1 januari 2024. Potential total cost per year Total cost € 6,350,000.00 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