Belzutifan Medicine 04 December 2025 Extended indication Belzutifan In combination with pembrolizumab, for the adjuvant treatment of adult patients with clear cell renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Therapeutic value Total cost € 9,651,400.00 Registration phase Registration application pending Product Active substance Belzutifan Domain Oncology Reason of inclusion Indication extension IND Main indication Kidney cancer Extended indication Belzutifan In combination with pembrolizumab, for the adjuvant treatment of adult patients with clear cell renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Current proprietary name Already available biosimilars / generics Proprietary name Welireg Manufacturer MSD Portfolio holder MSD Mechanism of action Other, see general comments 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 Normal trajectory Particularity Indication extension ATMP No Submission date February 2026 Expected Registration September 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks NCT05239728 Therapeutic value Current treatment options Pembrolizumab monotherapie Therapeutic value Substantiation Er zijn nog geen resultaten bekend. Duration of treatment Frequency of administration 1 times a day Dosage per administration 120 mg References NCT05239728 Additional remarks Expected patient volume per year Patient volume 22 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: Gipdatabank Additional remarks Er werd in 2024 adujvant pembrolizumab monotherapie aan 22 patiënten met heldercellig RCC gegeven(1). Expected cost per patient per year Cost € 438,700.00 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 Additional remarks Er is nog geen Nederlandse prijs bekend. Gebaseerd op de prijs in de VS zou één jaar behandeling met belzutifan omgerekend € 438.791 per patiënt per jaar zijn. Dit is exclusief de kosten voor pembrolizumab. Potential total cost per year Total cost € 9,651,400.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks