Tebentafusp in Metastatic Uveal Melanoma: A Market Access and Value Evidence Strategy

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Publication Date

7-14-2026

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Presentation: 20:35

Abstract

Tebentafusp, a first-in-class ImmTAC bispecific therapy, is the only systemic treatment demonstrated to improve overall survival in metastatic uveal melanoma (mUM), a rare cancer for which no prior therapy showed survival benefit; however, global health technology assessment (HTA) bodies have reached inconsistent reimbursement decisions despite reviewing identical clinical evidence. This capstone characterizes the existing evidence base for tebentafusp, identifies the specific evidence gaps driving HTA divergence, and proposes a value evidence strategy to address them. A structured literature review of PubMed, EMBASE, and HTA grey literature (NICE, SMC, CADTH) identified 33 peer-reviewed articles and 8 grey literature documents; findings were synthesized into a comparative HTA decision analysis and a gap-prioritization framework, informing a targeted value evidence strategy including two fully specified study designs. The pivotal IMCgp100-202 trial demonstrated an overall survival hazard ratio of 0.51 (median OS 21.7 vs 16.0 months), yet minimal progression-free survival difference and no quality-of-life benefit complicated economic modeling. NICE approved tebentafusp (TA1027) using formal expert elicitation and end-of-life pricing flexibility; SMC rejected it (SMC2746) despite accepting clinical benefit; CADTH conditionally recommended it only with substantial price reduction. This divergence traced to a single finding: 92% of modeled cost-effectiveness benefit derives from survival extrapolated beyond observed trial data. Three priority evidence gaps were identified: long-term survival extrapolation, absent quality-of-life differentiation, and unpublished real-world cost data. A real-world overall survival registry study and a U.S.-focused budget impact analysis, alongside three supporting studies, represent an actionable strategy for reducing the specific uncertainties currently limiting consistent global reimbursement for tebentafusp.

Language

English

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