Belzutifan Medicine 06 June 2023 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 € 307,877,850.00 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 Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Peloton Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks MoA: Endothelial PAS domain-containing protein 1 inhibitors Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2024 Expected Registration 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het geneesmiddel wordt onderzocht in een tweedelijnsstudie na eerdere behandeling met anti PD-1/L1. In Nederland wordt vaak eerstelijns ipilumab/nivolumab ingezet. Duration of treatment Frequency of administration 1 times a day Dosage per administration 120 mg References NCT04586231 Additional remarks Expected patient volume per year Patient volume < 903 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL Additional remarks In 2020 werden er 374 diagnoses stadium III en 529 diagnoses stadium IV gesteld (1). In totaal zijn dit 903 diagnoses stadium III/IV. Expected cost per patient per year Cost € < 340,950.00 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 Amerikaanse prijs is $330.61 per 40 gram. uitgaande van 120 mg per dag zou dat voor een heel jaar behandelen maximaal uitkomen op minder dan 340.950 euro. Behandelduur is echter nog niet bekend. Potential total cost per year Total cost € 307,877,850.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Adis Insight Additional remarks Geen andere fase 3 studies Other information Additional remarks