Pembrolizumab Medicine 08 December 2020 Extended indication Locally Advanced Head and Neck Squamous Cell Carcinoma With Chemoradiation. Therapeutic value No estimate possible yet Total cost € 33,750,000.00 Registration phase Clinical trials Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Head and neck cancer Extended indication Locally Advanced Head and Neck Squamous Cell Carcinoma With Chemoradiation. 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 Unknown Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Eindpunten van de studie niet gehaald. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment loopt de Keystone-421 studie nog. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200mg References SMPC KEYTRUDA; NCT03040999 Additional remarks - tot maximaal 1 jaar behandeling. Expected patient volume per year Patient volume < 375 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR, expertopinie Additional remarks Er zijn in totaal 2.855 met SCC van het hoofd-halsgebied. 375 hiervan hebben stadium III. 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 € 33,750,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Indicatie uitbreidingen worden weergegeven in de Horizonscan Geneesmiddelen. References Fabrikant Additional remarks Other information Additional remarks