Pembrolizumab Medicine 13 December 2018 Extended indication 2/3L Triple negative metastatic breast cancer Therapeutic value No judgement yet Total cost € 16,250,000.00 Registration phase Withdrawn Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication 2/3L Triple negative metastatic breast cancer 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trajectory Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks Mogelijk met een PD-L1 expressie marker. KEYNOTE-119 heeft primaire eindpunt niet gehaald. Therapeutic value Current treatment options Therapeutic value No judgement 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 SmPC Additional remarks Expected patient volume per year Patient volume 250 - 400 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2016, expert opinie Additional remarks In totaal 1.687 diagnoses mammacarcinoom HR-, HER-, waarvan 134 diagnoses stadium 4. Er komen in de loop van de ziekte veel meer patienten in stadium IV; de meest vrouwen ontvangen uiteindelijk een tweede (en ws ook wel derde) van behandeling. Schatting experts: 250-400. Expected cost per patient per year Cost € 40,000.00 - 60,000.00 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 Voor alle indicatie van pembrolizumab geldt een financieel arrangement dat is voortgekomen uit de onderhandelingen in de sluis (lopend tot eind 2019). AIP per nov 2017: €2.624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). Inschatting: in lijn met andere indicaties. Potential total cost per year Total cost € 16,250,000.00 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, etc.) References Fabrikant Additional remarks Other information Additional remarks