Version 5

Belzutifan

Medicine

Extended indication WELIREG is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised r
Therapeutic value No estimate possible yet
Total cost € 4,485,000.00
Registration phase Registered

Product

Active substance Belzutifan
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication WELIREG is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.
Proprietary name Welireg
Manufacturer MSD
Portfolio holder MSD
Mechanism of action Other
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
Reimbursement Reimbursement request pending
Medicine sluice Included in the sluice
Additional remarks Positieve CHMP opinie december 2024. Zorginstituut Nederland beoordeelt of belzutifan (Welireg®) vergoed kan worden. In juli of augustus 2026 wordt het advies verwacht.

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation De behandeling van deze kleine groep patiënten lijkt op de behandeling van andere patiënten met een gemetastaseerd nier carcinoom. Verdere resultaten worden nog afgewacht.

Expected patient volume per year

Patient volume 10 - 15

Market share is generally not included unless otherwise stated.
Additional remarks based on clinical VHL experts input

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 € 4,485,000.00

Off label use

Off label use No

Indication extension

Other information