Belzutifan

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	339,245,250.00
Registration phase	Clinical trials

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	Peloton
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	2024
Expected Registration	2025
Orphan drug	No
Registration phase	Clinical trials

Therapeutic value

Therapeutic value	No estimate possible yet
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	120 mg
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 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

IKNL 2021

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	< 340,950.00
References	drugs.com
Additional remarks	Amerikaanse prijs is $330.61 per 40 gram. Uitgaande van 120mg per dag zou dat voor een heel jaar behandelen maximaal uitkomen op minder dan €340.950. Behandelduur is echter nog niet bekend.

Potential total cost per year

Total cost	339,245,250.00 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

339,245,250.00

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

There is currently nothing known about off label use.

Indication extension

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

Other information

There is currently no futher information available.