Extended indication Dostarlimab in combination with carboplatin-paclitaxel followed by maintenance dostarlimab plus niraparib for treatment of recurrent or primary advanc
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Dostarlimab
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Oncology other
Extended indication Dostarlimab in combination with carboplatin-paclitaxel followed by maintenance dostarlimab plus niraparib for treatment of recurrent or primary advanced Endometrial cancer in adults and elderly.
Proprietary name Jemperli
Manufacturer GSK
Portfolio holder GSK
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Infusion fluid
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Submission date June 2026
Expected Registration December 2026
Registration phase Clinical trials
Additional remarks Tijdslijn op basis van IHSI-inschatting.

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

Substantiation De studieresultaten zijn nog niet bekend.
References NCT03981796 (RUBY)

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

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.
Additional remarks Er waren in 2021 in totaal 2.221 patiënten met een endometriumcarcinoom. 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. Patiënten met een gevorderd stadium van endometriumcarcinoom (stadium 3 en 4) komen in aanmerking voor systemische therapie.

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). De lijstprijs per 100mg capsule niraparib (Zejula) is €92,43 (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

Off label use

Indication extension

Other information