Pembrolizumab Medicine 07 December 2021 Extended indication Keytruda as monotherapy is indicated for the treatment of the following MSI‑H or dMMR tumours in adults with: unresectable or metastatic colorectal cancer after previous fluoropyrimidine‑based combination therapy; advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation; unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. Therapeutic value No estimate possible yet Total cost € 15,390,000.00 Registration phase Registered Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Keytruda as monotherapy is indicated for the treatment of the following MSI‑H or dMMR tumours in adults with: unresectable or metastatic colorectal cancer after previous fluoropyrimidine‑based combination therapy; advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation; unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. 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 Infusion fluid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date July 2021 Expected Registration April 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Registratie verkregen in april 2022 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De response rate was 34,3% (95% CI, 28.3% to 40.8%). Mediane progressie-vrije survival was 4,1 maanden (95% CI, 2,4 to 4,9 maanden) en mediane overall survival was 23,5 maanden. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200 mg References NCT02563002; NCT02628067 Additional remarks Treatment duration approximately 2 years. Expected patient volume per year Patient volume < 171 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Bonneville et al. JCO Precis Oncol. 2017 Additional remarks mCRC valt niet onder deze beoordeling; pembrolizumab heeft hier een formele eerstelijns indicatie. Voor de overige indicaties worden er jaarlijks in Nederland 2.286 patiënten gediagnosticeerd met stadium IV. Gemiddeld komt MSI-H voor bij ongeveer 4% van alle tumoren. Dit komt neer op 171 patiënten van bovenstaand volume. Per subtype zal dit percentage echter variëren. 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 G-standaard Additional remarks AIP per november 2017: €2.624,38 per injectieflacon 25mg/ml, flacon 4ml (oplossing). Uitgaande van een behandeling van 1x per 3 weken 200mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar. Voor pembrolizumab is een financieel arrangement van toepassing tot 1 januari 2024. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk. Potential total cost per year Total cost € 15,390,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks