Pembrolizumab Medicine 08 December 2020 Extended indication Adjuvant treatment in monotherapy of adults with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Therapeutic value No estimate possible yet Total cost € 48,600,000.00 Registration phase Registration application pending Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Kidney cancer Extended indication Adjuvant treatment in monotherapy of adults with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 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 July 2021 Expected Registration February 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Dit jaar te verwachten survival data in september. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200mg References SMPC Keytruda, NCT03142334. Additional remarks Bij monotherapie eenmaal in de 6 weken 400mg mogelijk; tot maximaal 1 jaar behandeling. Expected patient volume per year Patient volume < 540 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Op basis van de inclusiecriteria van de Keynote-564, komen er jaarlijks maximaal 540 patiënten voor deze behandeling in aanmerking. 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 € 48,600,000.00 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