Extended indication

Advanced renal cell carcinoma

Therapeutic value

No estimate possible yet

Total cost

343,275,000.00

Registration phase

Registration application pending

Product

Active substance

Belzutifan

Domain

Oncology

Reason of inclusion

New medicine (specialité)

Main indication

Kidney cancer

Extended indication

Advanced renal cell carcinoma

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

January 2025

Registration phase

Registration application pending

Therapeutic value

Current treatment options

Everolimus

Therapeutic value

No estimate possible yet

Substantiation

Nog geen publicatie. Uit de resultaten bleek na een mediane duur van 18,4 maanden (range, 9.4-31.7) de PFS en ORR beter waren in de belzutifan arm vergeleken met de everolimus arm. ORR was 21,9% voor de belzutifan arm, vergeleken met 3,5% in de everolimus arm, waarbij de belzutifan ORR toe nam tot 22,7%. Er was geen statistisch significant effect in OS tussen de twee groepen, met 21 vs 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 III en 584 diagnoses stadium IV gesteld (1). In totaal zijn dit 995 diagnoses stadium III/IV.

Expected cost per patient per year

Cost

< 345,000.00

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

Potential total cost per year

Total cost

343,275,000.00

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

Off label use

No

Indication extension

Indication extension

No

Other information

There is currently no futher information available.