Nivolumab Medicine 08 June 2021 Extended indication Extension of indication for Opdivo to include adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) who are at high risk of recurrence after undergoing radical resection of MIUC. Therapeutic value No estimate possible yet Total cost € 20,000,000.00 Registration phase Registration application pending Product Active substance Nivolumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication Extension of indication for Opdivo to include adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) who are at high risk of recurrence after undergoing radical resection of MIUC. Current proprietary name Already available biosimilars / generics Proprietary name 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 March 2021 Expected Registration May 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 In totaal kregen er 353 patiënten nivolumab toegediend en 356 placebo. De mediane ziekte-vrije overleving in the intention-to-treat populatie was 20,8 maanden. HR < 0,7, voorlopig positief advies. De verwachting is dat de PASKWILL-criteria gehaald zullen worden. Duration of treatment Frequency of administration Dosage per administration References NEJM 2021 juni; 2102-2114; (NCT02632409) Additional remarks Expected patient volume per year Patient volume < 400 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Leliveld-Kors, A. (2014). Urothelial Cell Carcinoma: Patterns of care and contemporary urography. [S.n.]. (record atezolizumab) Additional remarks Jaarlijks zijn er 1.700-1.800 patiënten met de diagnose spierinvasief blaaskanker. Hiervan zijn er 1.100-1.200 met de diagnose T2-T4a, N0, M0 (spierinvasief, niet gevorderd). Hiervan zal ongeveer een derde cystecomie ondergaan (400). Van deze patiënten zal een deel mogelijk in aanmerking komen voor behandeling met nivolumab. 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 € 20,000,000.00 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