NICE Recommends Tebentafusp Reimbursement for HLA-A*02:01+ Uveal Melanoma

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The United Kingdom’s (UK) National Institute for Health and Care Excellence (NICE) has recommended funding for tebentafusp-tebn (Kimmtrak) through England’s National Health Service (NHS) for eligible patients with HLA-A*02:01–positive unresectable or metastatic uveal melanoma.¹

This recommendation is consistent with the marketing authorization for tebentafusp and reverses the initial negative recommendation made by NICE in May 2023. At that time, NICE acknowledged that tebentafusp met the criteria for a life-extending treatment and was likely to improve survival.² However, the organization justified the decision by citing uncertainties in the most likely cost-effectiveness estimates, noting they exceeded acceptable thresholds for NHS resource allocation for end-of-life treatments.

A panel was subsequently convened on October 20, 2023, to consider appeals to NICE’s final draft guidance to the NHS submitted by the drug developer, Immunocore, and 2 patient groups, Melanoma Focus and Ocular Melanoma UK.3 The decision was successfully appealed by the drug’s developer, Immunocore, in December 2023.¹

“I am delighted for patients and their families that NICE has now recommended tebentafusp as a treatment option for HLA-A*02:01–positive metastatic or unresectable uveal melanoma,” Paul Nathan, MBBS, PhD, MRCP, consultant medical oncologist at Mount Vernon Cancer Centre, UK, stated in a news release. “Access to the first therapy that improves survival for this rare and threatening disease marks a major step forward. There remains much work to be done to build upon this advance so that we can further improve outcomes for all patients."

Tebentafusp monotherapy is approved for the management of HLA-A*02:01–positive unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the UK. Treatment with the agent is funded in England as of December 3, 2024.

“Today is a landmark day for the uveal melanoma community, with NICE’s recommendation of the first treatment to prolong survival in HLA-A*02:01–positive adults with metastatic or unresectable uveal melanoma,” Susanna Daniels, chief executive officer of Melanoma Focus, added in the news release., “Uveal melanoma is a very rare form of melanoma which requires different clinical management. The option to prescribe tebentafusp is a step change for patients and their families, and we continue to support the process so that there is reimbursement for the therapy across the UK for all eligible patients.”

The NICE assessments were primarily informed by findings from the phase 3 IMCgp100-202 trial (NCT03070392).⁴ The open-label, randomized, controlled, single-arm trial evaluated tebentafusp vs investigator’s choice of pembrolizumab (Keytruda), ipilimumab (Yervoy), or dacarbazine in the first-line treatment of HLA-A*02:01–positive patients with advanced uveal melanoma (n = 378). Results from IMCgp100-202 supported the use of tebentafusp primarily as a first-line treatment, but potential clinical benefit of tebentafusp as a second-line option was also demonstrated.

In response to the Evidence Review Group’s (ERG) questions, Immunocore clarified that tebentafusp was positioned as a first-line treatment and that second-line use would likely be limited to patients already receiving advanced uveal melanoma therapies at the time of NICE’s recommendation. Ultimately, the committee concluded that tebentafusp would primarily be utilized as a first-line treatment for advanced uveal melanoma, consistent with the IMCgp100-202 trial findings. They also concluded that results from the IMCgp100-202 trial were generalizable to NHS practice for patients with HLA-A*02:01–positive advanced uveal melanoma.

"The recommendation of tebentafusp by NICE is a groundbreaking moment for individuals with metastatic uveal melanoma. For the first time, HLA-A*02:01–positive patients with this condition will have access to an effective treatment, which offers new hope in the fight against this rare cancer,” Jo Gumbs, chief executive officer and founder of Ocular Melanoma UK, added in a news release.¹ “We are especially proud to have represented our patient community in the appraisal process. This recommendation highlights the power of collaboration between patients, advocates, and medical experts. We remain committed to advancing care and support for people with ocular melanoma and thank everyone who has contributed to this monumental milestone.”

References

1. Immunocore announces reimbursement agreement in England for Kimmtrak for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma. News Release. Immunocore. December 3, 2024. Accessed December 4, 2024. https://www.immunocore.com/investors/news/press-releases/detail/102/immunocore-announces-reimbursement-agreement-in-england-for-kimmtrak-for-the-treatment-of-hla-a02-01-positive-adults-with-unresectable-or-metastatic-uveal-melanoma
2. Final appraisal document: tebentafusp for treating advanced uveal melanoma. NICE. July 2023. Accessed December 4, 2024. https://www.nice.org.uk/guidance/gid-ta10428/documents/final-appraisal-determination-document
3. Project documents: Tebentafusp for treating advanced (unresectable or metastatic) uveal melanoma [ID1441]. NICE. Accessed December 4, 2024. https://www.nice.org.uk/guidance/indevelopment/gid-ta10428/documents
4. Final draft guidance: tebentafusp for treating advanced uveal melanoma. NICE. November 2024. Accessed December 4, 2024. https://www.nice.org.uk/guidance/gid-ta10428/documents/674