NEW YORK – The UK's National Institute for Health and Care Excellence (NICE) on Tuesday recommended Immunocore's Kimmtrak (tebentafusp) as a treatment for patients in England with HLA-A*02:01-positive unresectable or metastatic uveal melanoma.
NICE's final draft guidance, which now makes Kimmtrak available through England's National Health Service, reverses the institute's initial refusal to recommend the treatment in 2023. The positive recommendation follows an appeal from Immunocore and a committee meeting in September 2024.
The list price for a 200 micrograms/1 milliliter vial of Kimmtrak is £10,114 ($12,822.28). However, in a statement, NICE said that its updated recommendation factored in an "improved commercial offer" from Immunocore, which the parties are keeping confidential.
According to NICE, just over 100 people with advanced uveal melanoma will be eligible for Kimmtrak, a T-cell receptor bispecific antibody therapy given as once-weekly infusions. Because there is no standard treatment for this specific disease, patients often receive treatments approved for cutaneous melanoma, such as immune checkpoint inhibitors or chemotherapy.
NICE based its recommendation in part on a Phase III clinical trial, in which patients receiving Kimmtrak lived a median 21.7 months, versus 16 months with immune checkpoint inhibitors or chemo.
The US Food and Drug Administration approved Kimmtrak for the same indication in early 2022. After that, the European Commission followed suit, as did the UK's Medicines and Healthcare Products Regulatory Agency, Australia's Therapeutic Goods Administration, and Health Canada.