Version 5

Belzutifan

Medicine

Extended indication WELIREG is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or
Therapeutic value No estimate possible yet
Total cost € 343,275,000.00
Registration phase Registered

Product

Active substance Belzutifan
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Kidney cancer
Extended indication WELIREG is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies.
Proprietary name Welireg
Manufacturer MSD
Portfolio holder MSD
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Mode of action: HIF-2α inhibitor

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date December 2023
Expected Registration February 2025
Orphan drug No
Registration phase Registered
Medicine sluice Included in the sluice
Additional remarks Positieve CHMP opinie december 2024. In januari 2025 advies tot sluisplaatsing gegeven. Belzutifan voldoet bij deze indicaties aan het sluiscriterium dat het €20 miljoen of meer per jaar kost om dit geneesmiddel in heel Nederland te gebruiken bij een of meer nieuwe indicaties.

Therapeutic value

Current treatment options Everolimus
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation Uit de resultaten bleek na een mediane duur van 18,4 maanden (range, 9.4-31.7) de PFS en overall survival beter waren in de belzutifan arm vergeleken met de everolimus arm. overall survival was 21,9% voor de belzutifan arm, vergeleken met 3,5% in de everolimus arm, waarbij de belzutifan overall survival toe nam tot 22,7%. Er was geen statistisch significant effect in overall survival tussen de twee groepen, met 21 versus 17,2 maanden (HR 0,88).
References Albiges L. Belzutifan versus everolimus in participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC): Randomized open-label phase III LITESPARK-005 study.

Expected patient volume per year

Patient volume < 995

Market share is generally not included unless otherwise stated.
References NKR2021
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 € < 345,000.00

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 Drugs.com
Additional remarks In de Verenigde Staten kost belzutifan $31,243 voor 90 tabletten, wat neerkomt op een maand verbruik. Per jaar zou dat omgerekend ongeveer €345.000 kosten. De kosten in Europa zullen waarschijnlijk lager uitvallen.

Potential total cost per year

Total cost € 343,275,000.00

Off label use

Off label use No

Indication extension

Indication extensions No

Other information