Belzutifan

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	April 2025
Orphan drug	No
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 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 III en 584 diagnoses stadium IV gesteld (1). In totaal zijn dit 995 diagnoses stadium III/IV.

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 Verenigde Staten kost belzutifan $31,243voor 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 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.

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.