Pembrolizumab Medicine 13 December 2018 Extended indication Keytruda, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults. Therapeutic value No judgement Total cost € 11,250,000.00 Registration phase Registered and reimbursed Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Kidney cancer Extended indication Keytruda, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults. Current proprietary name Already available biosimilars / generics Proprietary name Keytruda Manufacturer MSD 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 Anti-PD-1 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date January 2019 Expected Registration September 2019 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie juli 2019. Positief advies CieBOM: https://www.nvmo.org/bom/eerstelijns-combinatiebehandeling-met-pembrolizumab-en-axitinib-bij-het-gemetastaseerd-heldercellig-niercelcarcinoom/?meta Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200 mg References SmPC Additional remarks Maximaal 2 jaar behandeling Expected patient volume per year Patient volume 150 - 300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Zinnige Zorg verbetersignalement: Dure oncolytica. ZIN 2017; Lam et al. World J Urol 2005;23(3):202-212. Additional remarks De incidentie RCC is ongeveer 2.300 patiënten (NKR), hiervan heeft ongeveer 85% heldercellig RCC (N=1956) (Zinnige Zorg verbetersignalement: Dure oncolytica). Ongeveer 42% (N=825) heeft op moment van diagnose of in een later stadium (met/zonder nefrectomie) stage IIIb/IV RCC (Lam et al. 2005). De prognose van de patiënten bepaalt de behandelkeuze. Het marktaandeel zal afhangen van de nog onbekende therapeutisch waarde van dit middel ten opzichte van de huidige standaard therapieën en de nieuw te registreren (PD(L)1 combinatie therapieën. Uiteindelijke inschatting: zo'n 150-300 patiënten. 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 Voor alle indicatie van pembrolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met juni 2020). AIP per november 2017: €2.624,38 per injectieflacon 25 mg/mg flacon 4 ml (oplossing). Inschatting: in lijn met andere indicaties. Potential total cost per year Total cost € 11,250,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Fabrikant Additional remarks Indication extension Indication extensions Yes Indication extensions Indicatieuitbreidingen worden weergegeven in de Horizonscan (Maagkanker, Hoofd- en halskanker, huidkanker, Longkanker, etc.) References Fabrikant en Horizonscan Additional remarks Other information Additional remarks