Version 3

Belzutifan

Medicine

Extended indication In combination with lenvatinib for treatment of advanced or metastatic clear cell renal cell carcinoma.
Therapeutic value No estimate possible yet
Total cost € 339,195,500.00
Registration phase Registration application pending

Product

Active substance Belzutifan
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Kidney cancer
Extended indication In combination with lenvatinib for treatment of advanced or metastatic clear cell renal cell carcinoma.
Manufacturer MSD
Portfolio holder MSD
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks MoA: Endothelial PAS domain-containing protein 1 inhibitors.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date February 2026
Expected Registration September 2026
Orphan drug No
Registration phase Registration application pending
Medicine sluice Broadly excluded

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation Het geneesmiddel wordt onderzocht in een tweedelijnsstudie na eerdere behandeling met anti PD-1/L1. In Nederland wordt vaak eerstelijns ipilumab/nivolumab ingezet.
Frequency of administration 1 times a day
Dosage per administration 120mg
References NCT04586231; Motzer RJ, Schmidinger M, Eto M, Suarez C, Figlin R, Liu Y, Perini R, Zhang Y, Heng DY. LITESPARK-011: belzutifan plus lenvatinib vs cabozantinib in advanced renal cell carcinoma after anti-PD-1/PD-L1 therapy. Future Oncol. 2023 Jan;19(2):113-121. doi: 10.2217/fon-2022-0802. Epub 2023 Feb 8. PMID: 36752726.

Expected patient volume per year

Patient volume < 995

Market share is generally not included unless otherwise stated.
References IKNL 2021
Additional remarks In 2021 werden er 411 diagnoses stadium 3 en 584 diagnoses stadium 4 gesteld (1). In totaal zijn dit 995 diagnoses stadium 3 en 4.

Expected cost per patient per year

Cost € < 340,900.00

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 Drugs.com
Additional remarks De prijsstelling in Nederland is nog niet bekend. De prijs in de Verenigde Staten is $330,61 per 40mg. Uitgaande van 120mg per dag zou dat voor een heel jaar behandelen maximaal uitkomen op minder dan €340.950. De behandelduur is echter nog niet bekend.

Potential total cost per year

Total cost € 339,195,500.00

Off label use

Indication extension

Indication extensions No
References Adis Insight
Additional remarks Geen andere fase 3 studies

Other information