Pembrolizumab Medicine 12 June 2018 Extended indication Keytruda as monotherapy is indicated for the first‑line treatment of metastatic microsatellite instability‑high (MSI‑H) or mismatch repair deficient (dMMR) colorectal cancer in adults. Therapeutic value No estimate possible yet Total cost € 11,430,000.00 Registration phase Registered and reimbursed Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Keytruda as monotherapy is indicated for the first‑line treatment of metastatic microsatellite instability‑high (MSI‑H) or mismatch repair deficient (dMMR) colorectal cancer in adults. 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 Humanised monoclonal IgG4 antibody against the programmed death-1 (PD-1) protein. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date July 2020 Expected Registration January 2021 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positief cieBOM advies in februari 2021. FDA grants Breakthrough Therapy Designation to pembrolizumab for treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer. 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 SmPC; NCT02563002 Additional remarks Toediening op dag 1 van iedere cyclus van 21 dagen. Maximaal 2 jaar behandeling. Nota Bene: voor monotherapie ook 1 x 400mg per 6 weken mogelijk. Expected patient volume per year Patient volume 127 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Poynter et al. Cancer Epidemiol Biomarkers Prev. 2008 Nov;17(11):3208-15. Zhaohui Jin. Prognostic and Predictive Values of Mismatch Repair Deficiency in Non-Metastatic Colorectal Cancer. Cancers 2021. Additional remarks In 2018 waren er 1.929 patiënten met een coloncarcinoom en 622 patiënten met een rectum carcinoom in stadium 4. Dit zijn in totaal 2.551 patiënten. Er wordt verwacht dat ongeveer 5% hiervan in aanmerking zal komen voor behandeling. Dit betekent dat er naar verwachting 127 patiënten per jaar behandeld zullen worden. 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 200 mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar. Potential total cost per year Total cost € 11,430,000.00 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 Indicatieuitbreidingen worden weergegeven in de Horizonscan Geneesmiddelen (maagkanker, hoofd- en halskanker, huidkanker, longkanker, nierkanker, et cetera). References Clinicaltrials.gov; SPS. Additional remarks Other information Additional remarks