Pembrolizumab Medicine 03 June 2025 Extended indication Pembrolizumab in combination with Bacillus Calmette-Guerin for adjuvant treatment of high risk non-muscle invasive bladder cancer in adults and elderly who have undergone cystoscopy/TURBT and are BCG-naive. Therapeutic value No estimate possible yet Total cost € 431,182,500.00 Registration phase Clinical trials Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication Pembrolizumab in combination with Bacillus Calmette-Guerin for adjuvant treatment of high risk non-muscle invasive bladder cancer in adults and elderly who have undergone cystoscopy/TURBT and are BCG-naive. 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 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date 2026 Expected Registration May 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Out of the sluice Additional remarks Voor alle indicaties van pembrolizumab geldt een financieel arrangement tot 1 januari 2027. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten gepubliceerd. Duration of treatment Frequency of administration 1 times every 6 weeks Dosage per administration 400mg References NCT03711032 (KEYNOTE-676) Additional remarks Expected patient volume per year Patient volume < 4,775 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2022 (1); IKNL. 2025 (2). Additional remarks In 2022 kregen 6.821 mensen de diagnose blaaskanker (1). Hiervan is ongeveer 70% hoog risico, niet-spierinvasief (CIS, T1, Ta) (n=4.775) (2). Een deel hiervan ondergaat TURBT en komt in aanmerking voor deze indicatieuitbreiding. Expected cost per patient per year Cost € < 90,300.00 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 Additional remarks Voor pembrolizumab is een financieel arrangement van toepassing tot 1 januari 2027. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk. AIP per juni 2026: €2.624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). Uitgaande van een behandeling van 1 x per 3 weken 200 mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar. Inschatting: in lijn met andere indicaties. Potential total cost per year Total cost € 431,182,500.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks