Pembrolizumab Medicine 13 December 2018 Extended indication Extension of indication to include first line treatment of advanced or metastatic renal cell carcinoma (RCC) as combination therapy of pembrolizumab together with axitinib. Therapeutic value No judgement Total cost € 11,250,000.00 Registration phase Registration application pending Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Kidney cancer Extended indication Extension of indication to include first line treatment of advanced or metastatic renal cell carcinoma (RCC) as combination therapy of pembrolizumab together with axitinib. 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 Registration application pending Reimbursement Medicine sluice Additional remarks In combinatie met axitinib. 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 Expected patient volume per year Patient volume 150 - 300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; NKR; Zinnige Zorg verbetersignalement: Dure oncolytica. ZIN 2017; Lam et al. World J Urol 2005;23(3):202-212; Motzer et al. J Clin Oncol. 1999 Aug;17(8):2530-40; Additional remarks De incidentie RCC is ongeveer 2.300 patienten (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. Aannemelijk is dat deze behandeling met name gebruikt zal worden voor patiënten met een goede of intermediaire prognose (78%; N=644) (Motzer et al. 1999). Het marktaandeel zal afhangen van de nog onbekende therapeutisch waarde t.ov. de huidige standaard therapieën en de nieuw te registreren PD(L)1 combinatie therapieën. 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 eind 2019). AIP per nov 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 Indicatie-uitbreidingen worden weergegeven in de Horizonscan (Maagkanker, Hoofd- en halskanker, huidkanker, Longkanker, etc.) References Fabrikant Additional remarks Other information Additional remarks