Pembrolizumab Medicine 13 December 2018 Extended indication Tripple Negative Breast Cancer - Neoadjuvant and adjuvant. Therapeutic value No judgement Total cost € 135,990,000.00 Registration phase Clinical trials Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Tripple Negative Breast Cancer - Neoadjuvant and adjuvant. 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 Intravenous drip 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 2021 Expected Registration February 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks De fabrikant verwacht registratie in het eerste kwartaal van 2022. Therapeutic value Current treatment options Therapeutic value No judgement 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. NB: voor monotherapie ook 1 x 400 mg per 6 weken mogelijk. Expected patient volume per year Patient volume < 1,511 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR 2016: 1.511 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 FL 4ML (oplossing). Uitgaande van een behandeling van 1 x per 3 weken 200 mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar. Potential total cost per year Total cost € 135,990,000.00 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 (Maagkanker, Hoofd- en halskanker, huidkanker, Longkanker, Nierkanker, et cetera) References Fabrikant Additional remarks Other information Additional remarks