Pembrolizumab Medicine 07 December 2021 Extended indication Extension of indication to include the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, Stage IIC or stage III melanoma and to include the treatment of adolescents aged 12 years and older with advanced melanoma for Keytruda Therapeutic value No estimate possible yet Total cost € 92,340,000.00 Registration phase Positive CHMP opinion Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Skin cancer Extended indication Extension of indication to include the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, Stage IIC or stage III melanoma and to include the treatment of adolescents aged 12 years and older with advanced melanoma for Keytruda 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 August 2021 Expected Registration July 2022 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie mei 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 Keynote 716 studie loopt nog door tot oktober 2022. Resultaten of informatie betreffende de plaatsbepaling zijn nog niet bekend. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200 mg References NCT03553836 (Keynote 716) Additional remarks Treatment up to 2 years. Expected patient volume per year Patient volume < 1,026 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL Additional remarks Incidentie IKNL: 1.026 patiënten, stadium 2, met melanoom van de huid in 2018. 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 x 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 € 92,340,000.00 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.