Pembrolizumab Medicine 04 December 2025 Extended indication Pembrolizumab in combination with definitive chemoradiotherapy for first line treatment of oesophageal carcinoma in adults and elderly who are ineligible for curative surgery. Therapeutic value Total cost € 27,360,000.00 Registration phase Clinical trials Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Pembrolizumab in combination with definitive chemoradiotherapy for first line treatment of oesophageal carcinoma in adults and elderly who are ineligible for curative surgery. 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 Concentrate for solution for injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date May 2027 Expected Registration 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 Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT04210115 (KEYNOTE-975) Additional remarks Expected patient volume per year Patient volume 304 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://iknl.nl/rapport-slokdarm-en-maagkanker-2024/slokdarmkanker Additional remarks 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 € 27,360,000.00 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