Disitamab Vedotin Medicine 04 June 2026 Extended indication Disitamab vedotin in combination with pembrolizumab for first line treatment of locally advanced or metastatic HER2-expressing (IHC 1+ and greater) Urothelial carcinoma in adults and elderly. Therapeutic value No estimate possible yet Total cost € 238,000.00 Registration phase Clinical trials Product Active substance Disitamab Vedotin Domain Oncology Reason of inclusion New medicine (specialité) Main indication Bladder cancer Extended indication Disitamab vedotin in combination with pembrolizumab for first line treatment of locally advanced or metastatic HER2-expressing (IHC 1+ and greater) Urothelial carcinoma in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Pfizer Portfolio holder Pfizer Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: HER2 inhibitor Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP Submission date September 2026 Expected Registration October 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De studie resultaten zijn nog niet bekend. Duration of treatment Frequency of administration Dosage per administration References SGNDV-001 trial (NCT05911295) Additional remarks Expected patient volume per year Patient volume 1 - 12 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: IKNL2022; 2: HER2 expression in urothelial carcinoma, a systematic literature review. Scherrer et al, 2022; Additional remarks Volgens IKNL waren er in 2022 11 patiënten met stadium III en 10 patiënten met stadium IV urotheelcelcarcinoom. 6,7% tot 56,3% van de UC patienten hebben de HER2 vorm(2). Expected cost per patient per year Cost € 34,000.00 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. References Additional remarks Kosten op basis van IHSI-inschatting, afgeleid van de mediane kosten van dezelfde ATC-klasse (L01FD - HER2 remmers) geneesmiddelen in Nederland. Potential total cost per year Total cost € 238,000.00 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