Dostarlimab Medicine 03 December 2024 Extended indication Extension of indication for JEMPERLI to include, in combination with carboplatin and paclitaxel, the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. Therapeutic value Possible added value for a subgroup Total cost Registration phase Registered Product Active substance Dostarlimab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Extension of indication for JEMPERLI to include, in combination with carboplatin and paclitaxel, the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. Current proprietary name Already available biosimilars / generics Proprietary name Jemperli Manufacturer GSK Portfolio holder GSK Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Concentrate for solution for infusion Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date May 2024 Expected Registration February 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Out of the sluice Additional remarks In april 2026 is er een financieel arrangement afgesloten voor dostarlimab tot en met 31 december 2026 voor de huidige en alle toekomstige indicaties. Therapeutic value Current treatment options Therapeutic value Possible added value for a subgroup This assessment does not indicate any potential inclusion in the package. Substantiation De RUBY studie is gepubliceerd en hierop is een positief cieBOM advies uitgebracht voor zowel de dMMR (MSI) als de pMMR groep, al is het effect in de eerste groep waarschijnlijk dragend voor de ITT uitkomst. Er is vergoeding voor (alleen) de d-MMR populatie (is uit de sluis). Duration of treatment Frequency of administration Dosage per administration References NCT03981796 (RUBY) Additional remarks Expected patient volume per year Patient volume < 320 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) NKR 2021 (2) Huijgens AN, Mertens HJ. Factors predicting recurrent endometrial cancer. Facts Views Vis Obgyn. 2013;5(3):179-86. PMID: 24753943; PMCID: PMC3987371. (3) https://www.annalsofoncology.org/action/showPdf?pii=S0923-7534%2822%2901207-8. Additional remarks 1. Er waren in 2021 in totaal 2.221 patiënten met een endometriumcarcinoom. 2. De verdeling van het aantal patiënten per FIGO stadium is 80,9% voor stadium 1, 4,8% stadium 2, 11,5% stadium 3 en 2,9% stadium 4. 3. Patiënten met een gevorderd stadium van endometriumcarcinoom (stadium 3 en 4) komen in aanmerking voor systemische therapie. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks