Dostarlimab Medicine 04 June 2026 Extended indication Dostarlimab monotherapy for first line treatment of stage ii/iii, locally advanced mismatch repair deficient (dMMR) / microsatellite instability-high (MSI-H) Rectal cancer in adults and elderly. Therapeutic value Total cost € 2,295,000.00 Registration phase Clinical trials Product Active substance Dostarlimab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Dostarlimab monotherapy for first line treatment of stage ii/iii, locally advanced mismatch repair deficient (dMMR) / microsatellite instability-high (MSI-H) Rectal cancer in adults and elderly. 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 Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP Submission date February 2027 Expected Registration September 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value Substantiation MSI‑H/dMMR is een kansrijke indicatie gezien de sterke effecten van PD‑1/PD‑L1‑remmers in dit tumortype. De AZUR‑1‑studie met dostarlimab loopt nog door tot november 2026, waardoor resultaten nog ontbreken. Eerder fase II‑onderzoek toont positieve uitkomsten. Duration of treatment Frequency of administration Dosage per administration References NCT05723562 (AZUR-1); https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2024.42.17_suppl.LBA3512 Additional remarks Expected patient volume per year Patient volume 48 - 53 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: IKNL2022; 2: Incidence and Outcomes of Patients With Mismatch Repair Deficient Rectal Cancer Operated in 2016: A Nationwide Cohort From The Netherlands Eline G. M. van Geffen Additional remarks Er zijn jaarlijks 470 stadium II en 1239 stadium III patiënten met een rectumcarcinoom in Nederland. In een cohortanalyse van Nederlandse patiënten bleek dat ongeveer 2,8-3,1 % van de rectale tumoren dMMR (mismatch repair deficient) zijn wanneer MMR-status werd getest. Dit betekent dat er ongeveer 48 tot 53 patiënten per jaar in aanmerking komen. Expected cost per patient per year Cost € 45,000.00 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 medicijnkosten.nl; IHSI Additional remarks De lijstprijs voor één 10ml flacon dostarlimab (Jemperli) (50mg/ml) is €3.710 (exclusief BTW). Op basis van IHSI-inschatting, afgeleid van de mediane kosten van dezelfde ATC-klasse (L01FF - PDL1 remmers) geneesmiddelen in Nederland, komen de kosten per patiënt per jaar uit op ongeveer €45.000. Potential total cost per year Total cost € 2,295,000.00 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