Dostarlimab Medicine 10 June 2020 Extended indication Jemperli is indicated as monotherapy for the Treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum‑containing regimen. Therapeutic value No estimate possible yet Total cost € 1,215,000.00 Registration phase Registered Product Active substance Dostarlimab Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Jemperli is indicated as monotherapy for the Treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum‑containing regimen. Current proprietary name Already available biosimilars / generics Proprietary name Jemperli Manufacturer GSK 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 Accelerated assessment Particularity Unknown ATMP Unknown Submission date March 2020 Expected Registration April 2021 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in februari 2021. Therapeutic value Current treatment options In de tweede lijn wordt voor immunotherapie bijvoorbeeld Megestrol of Medroxyproges-teron acetaat (MPA) toegediend. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Fase 1-2 Garnet trial SGO annual meeting 2019 ORR rond 50%, maar nog geen andere studies gepubliceerd. Combinatie studie loopt. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 500 mg tot 1000 mg References NCT02715284. Additional remarks 500mg per 3 weken voor de eerste 4 cycli gevolgd door 1.000mg iedere 6 weken. De fabrikant geeft aan dat de GARNET studie een fase 1-2 studie is. Expected patient volume per year Patient volume 18 - 35 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 2015 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 18-35 patiënten mogelijk in aanmerking komen voor deze behandeling. Expected cost per patient per year Cost € 30,000.00 - 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 De kosten zullen waarschijnlijk vergelijkbaar zijn met de PD-L1 remmer olaparib. Potential total cost per year Total cost € 1,215,000.00 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 Fallopiantube, ovarian and peritoneal cancer. References Clinicaltrials.gov. Additional remarks Op dit moment lopen er meerdere fase 3 studies naar boven genoemde indicaties. Other information Additional remarks