Pembrolizumab Medicine 04 December 2025 Extended indication Keytruda, in combination with chemoradiotherapy, is indicated for the treatment of adults with muscle-invasive bladder cancer (MIBC) who choose bladder preservation. Therapeutic value No estimate possible yet Total cost € 12,870,000.00 Registration phase Clinical trials Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication Keytruda, in combination with chemoradiotherapy, is indicated for the treatment of adults with muscle-invasive bladder cancer (MIBC) who choose bladder preservation. Current proprietary name Already available biosimilars / generics Proprietary name Keytruda Manufacturer MSD Portfolio holder MSD Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Infusion fluid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date April 2027 Expected Registration November 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. Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Radicale cystectomie of blaassparende therapie met chemoradiotherapie (bijvoorbeeld met mitomycine/5-FU of capecitabine). Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De KEYNOTE-992 studie is gesloten voor accrual, maar er zijn nog geen resultaten bekend. Duration of treatment Average 1 year / years Frequency of administration 1 times every 3 weeks Dosage per administration 200mg intraveneus elke drie weken. References NCT04241185 (KEYNOTE-992) Additional remarks Expected patient volume per year Patient volume 130 - 156 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL 2023 (1); van Hoogstraten et al. Bladder Cancer. 2022 (2). Additional remarks In Nederland worden jaarlijks ongeveer 1.000 tot 1.200 nieuwe gevallen van spierinvasieve blaaskanker (MIBC) gediagnosticeerd (1). Ongeveer 13% hiervan ondergaat een chemoradiatie (2). Expected cost per patient per year Cost € < 90,000.00 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 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 € 12,870,000.00 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