Pembrolizumab Medicine 13 December 2018 Extended indication KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early‑stage triple‑negative breast cancer at high risk of recurrence. Therapeutic value Possible added value Total cost € 156,150,000.00 Registration phase Registered Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early‑stage triple‑negative breast cancer at high risk of recurrence. Current proprietary name Already available biosimilars / generics Proprietary name Keytruda Manufacturer MSD Portfolio holder MSD 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 August 2021 Expected Registration May 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie verkregen in april 2022. Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation NEJM 2020 februari met resultaten pathologische responsen en toxiciteit. PFS na eerste interim analyse (15,5 maanden) lijkt beter in pembrolizumab groep dan enkel neoadjuvante chemotherapie. 3 jaar follow up en HR <0.7 bij PFS zal tot voorlopige goedkeuring CieBOM leiden. 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 2018 (1); Additional remarks In 2018 waren er 1.735 diagnoses van 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