Pembrolizumab Medicine 13 December 2018 Extended indication Extension of indication for Keytruda in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery of adults with locally advanced, inflammatory, or earlystage triple-negative breast cancer at high-risk of recurrence. Therapeutic value No estimate possible yet Total cost € 156,150,000.00 Registration phase Registration application pending Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Extension of indication for Keytruda in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery of adults with locally advanced, inflammatory, or earlystage triple-negative breast cancer at high-risk of recurrence. 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 Anti-PD-1 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date August 2021 Expected Registration March 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 Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200 mg References NCT02819518 Additional remarks Maximaal 1 jaar behandeling. Nota bene: voor mono en combinatie therapie ook 1 x 400mg per 6 weken mogelijk. Expected patient volume per year Patient volume < 1,735 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR 2018: 1.735 diagnoses mammacarcinoom HR-, HER- waarbij een chirurgische ingreep is gedaan. 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. De behandelduur die voor deze indicatie onderzocht wordt is maximaal 12 maanden. 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 € 156,150,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Fabrikant Additional remarks Indication extension Indication extensions Yes Indication extensions Indicatie uitbreidingen worden weergegeven in de Horizonscan Geneesmiddelen (maagkanker, hoofd- en halskanker, huidkanker, longkanker, nierkanker, et cetera) References Fabrikant Additional remarks Other information Additional remarks