Tebentafusp Medicine 04 December 2025 Extended indication Tebentafusp in combination with pembrolizumab for second line or later treatment of stage III or IV unresectable HLA-A*02:01 positive non-ocular Melanoma in adults and elderly who have progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a BRAF kinase inhibitor. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Tebentafusp Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Tebentafusp in combination with pembrolizumab for second line or later treatment of stage III or IV unresectable HLA-A*02:01 positive non-ocular Melanoma in adults and elderly who have progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a BRAF kinase inhibitor. Current proprietary name Already available biosimilars / generics Proprietary name KIMMTRAK Manufacturer Immunocore Portfolio holder Mechanism of action Immunostimulation Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date March 2027 Expected Registration October 2027 Orphan drug Yes 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 Er zijn nog geen resultaten bekend. Duration of treatment Frequency of administration Dosage per administration References NCT05549297 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 (1). Carvajal et al; B J Opthalmol; Vol 101, Issue 1, 2017 (2). Kai Cai et al; Human Immunology Vol 62, Issue 9, 2001 (3). Expertopinie (4). Additional remarks De Nederlandse Kanker Registratie (NKR) becijfert dat in 2021, 217 patiënten uveamelanoom hebben gekregen. Ongeveer 50% van de uveamelanoom patiënten ontwikkelt op termijn metastasen. Er van uitgaande dat dit door de jaren heen gelijk is, kan worden gesteld dat op jaarbasis 109 patiënten metastaten ontwikkelt (2). Expected cost per patient per year Cost References Additional remarks De behandelkosten per patiënt komen neer op €12.431 per flacon. Totale kosten per patiënt per jaar zijn afhankelijk van de dosering en behandelduur. Potential total cost per year Total cost 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