Pembrolizumab Medicine 08 December 2020 Extended indication Advanced Endometrial Cancer (2L+) in combination with lenvatinib. Therapeutic value No judgement Total cost € 900,000.00 Registration phase Clinical trials Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Advanced Endometrial Cancer (2L+) in combination with lenvatinib. 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 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 Fabrikant verwacht indiening in 2021 en registratie in het tweede kwartaal van 2022. Therapeutic value Current treatment options Chemotherapie Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Maximal 2 year / years Frequency of administration 1 times every 3 weeks Dosage per administration 200 mg References KEYNOTE-775 (NCT03517449). Additional remarks Lenvatinib 20 mg een per 3 weken. Expected patient volume per year Patient volume < 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Follow-up after primary therapy for endometrial cancer: a systematic review. Fung-Kee-Fung. Gynecol Oncol. 2006 Jun;101(3):520-9. Epub 2006 Mar 23.; Sorbe B, Juresta C, Ahlin C. Natural history of recurrences in endometrial carcinoma. Oncol Lett. 2014;8(4):1800–1806. doi:10.3892/ol.2014.2362. Additional remarks Er waren in 2018 in totaal 1.931 patiënten met een endometriumcarcinoom. Daarvan betrof het in 177 gevallen een carcinoom van stadium 4. De recurrence rate voor endometrium carcinoom bedraagt ongeveer 10%-20%. Dit zou betekenen dat er in de tweede lijn of later mogelijk minder dan 10 patiënten in aanmerking komen voor deze behandeling. 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 Voor alle indicatie van pembrolizumab geldt een financieel arrangement dat is voortgekomen uit de onderhandelingen in de sluis. AIP per november 2017: €2.624,38 per injectieflacon 25MG/ML FL 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. Potential total cost per year Total cost € 900,000.00 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. References Fabrikant. Additional remarks Other information Additional remarks