Pembrolizumab Medicine 08 December 2020 Extended indication Extension of indication to include pembrolizumab in combination with lenvatinib for the treatment of advanced endometrial carcinoma in adults who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. Therapeutic value No estimate possible yet Total cost € 4,050,000.00 Registration phase Positive CHMP opinion Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Extension of indication to include pembrolizumab in combination with lenvatinib for the treatment of advanced endometrial carcinoma in adults who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. 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 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 March 2021 Expected Registration January 2022 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie ontvangen oktober 2021. Therapeutic value Current treatment options Chemotherapie Therapeutic value No estimate possible yet 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 20mg eens per 3 weken. Expected patient volume per year Patient volume 40 - 50 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 209 gevallen een carcinoom in stadium 3 en in 189 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 40 tot 80 patiënten in aanmerking komen voor deze behandeling. De uiteindelijke inschatting van experts is dat er 40 tot 50 patiënten in aanmerking zullen 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 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. 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 € 4,050,000.00 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. References Fabrikant. Additional remarks Other information Additional remarks