Pembrolizumab Medicine 07 December 2021 Extended indication 1L treatment with pembrolizumab for advanced melanoma, in combination with lenvatinib. Therapeutic value No estimate possible yet Total cost € 69,750,000.00 Registration phase No registration expected Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Skin cancer Extended indication 1L treatment with pembrolizumab for advanced melanoma, in combination with lenvatinib. 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 2023 Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Fabrikant geeft aan dat deze indicatieuitbreiding niet meer wordt verwacht: https://www.merck.com/news/merck-and-eisai-provide-update-on-phase-3-trials-of-keytruda-pembrolizumab-plus-lenvima-lenvatinib-in-certain-patients-with-advanced-melanoma-leap-003-and-metastatic-colorectal-cance/ Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration pembrolizumab 200 mg (1 maal per 3 weken) + lenvatinib 20 mg (1 maal per dag) References NCT03820986 Additional remarks Participants receive pembrolizumab 200mg via intravenous infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20mg via oral capsule daily for up to at least 2 years. Expected patient volume per year Patient volume < 775 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Melanoom van de huid betreft 6.746 patiënten in 2020, hiervan zijn er 687 patiënten met stadium 3 en 88 patiënten met stadium 4 (maximaal 775 patiënten die in aanmerking komen voor deze behandeling.) 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 1 maal 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 € 69,750,000.00 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 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.