Extended indication Stage III or IV non mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (collectively
Therapeutic value No estimate possible yet
Total cost 29,790,000.00
Registration phase Clinical trials

Product

Active substance Dostarlimab
Domain Oncology
Reason of inclusion Indication extension
Main indication Ovarian cancer
Extended indication Stage III or IV non mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (collectively referred to as "ovarian cancer")
Proprietary name Jemperli
Manufacturer GSK
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2024
Expected Registration October 2025
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Combination therapy with niraparib (Zejula).

Therapeutic value

Current treatment options De behandeling van het hoog stadium ovariumcarcinoom bestaat uit de combinatie van chirurgie en chemotherapie. Primaire debulking gevolgd door chemotherapie is momenteel de standaard behandeling.
Therapeutic value No estimate possible yet
Substantiation Voor PD-L1 is er over het algemeen veel concurrentie. Het is nog de vraag of deze behandeling een meerwaarde zal hebben.
References NCT03651206

Expected patient volume per year

Patient volume

< 662

Market share is generally not included unless otherwise stated.

References NKR2021; Weiderpass and Tyczynski. Mol Diagn Ther. 2015 Dec;19(6):351-64; expertopinie; HARRISON. Mucinous ovarian cancer. International journal of gynecological cancer : official journal of the International Gynecological Cancer Society.
Additional remarks In 2021 waren er 1.130 diagnoses epitheliaal ovariumcarcinoom, 142 diagnoses extraovarieel ovariumcarcinoom en 69 diagnoses tubacarcinoom. In totaal zijn dit 1.341 patiënten. Hiervan heeft 47% stadium III (630) en 26% stadium IV (348), wat samen 978 patiënten betreft. Van deze groep hebben 735 patiënten (75%) een hooggradige vorm van ovariumcarcinoom. Van de patiënten met epitheliaal ovariumcarcinoom heeft 90% de non mucinous variant. Dit betekent dat er mogelijk maximaal 662 patiënten in aanmerking zullen komen voor deze behandeling.

Expected cost per patient per year

Cost 30,000.00 - 60,000.00
References G-standaard The costs of dostarlimab (Jemperli) are currently not (yet) known. A better estimation of costs can be provided when the lock procedure for Jemperli monotherapy is done.
Additional remarks The cost of niraparib are similar to the costs of olaparib.

Potential total cost per year

Total cost

29,790,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References adisinsight
Additional remarks Geen nieuwe indicatie-uitbreidingen buiten de indicaties in de Horizonscan Geneesmiddelen.

Other information

There is currently no futher information available.