Pembrolizumab Medicine 07 June 2022 Extended indication KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy. Therapeutic value Possible added value Total cost Registration phase Registered Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Keytruda Manufacturer MSD Portfolio holder Mechanism of action Unknown 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 Unknown ATMP No Submission date March 2022 Expected Registration October 2023 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in september 2023. Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation De verwachting is dat op basis van de resultaten uit de studie de paskwil criteria net aan gehaald zullen worden. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Longkanker Nederland factsheet 2019; Heineman et al. 2016; DICA jaarrapportage - DLSA 2015; PALGA/IKNL. Pakketadvies ADAURA: ZIN Pakketadvies osimertinib (Tagrisso®) bij niet-kleincellige longkanker (NSCLC) 2021. Additional remarks In 2019 waren er 9.929 patiënten met niet-kleincellig longcarcinoom (NKR 2019), waarvan 19%, 8%, en 11% met pathologisch stadium I, II, en IIIA (Longkanker Nederland factsheet 2019). Totaal ondergaan 1.193 patiënten in stadium IB-IIIA een resectie (NKR 2017, Heineman et al. 2016). 90% van de resecties in Nederland is een R0 resectie (1.073 patiënten) (DICA jaarrapportage - DLSA 2015). 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 een maal per drie weken 200mg voor twaalf maanden zou dat gaan om maximaal €90.000 per patiënt per jaar. De behandelduur die voor deze indicatie onderzocht wordt is maximaal 12 maanden. 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. Potential total cost per year Total cost 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