Presentation (CTI)

OBJECTIVES: Out-licensing of Chinese-origin oncology assets to global markets is rising, but how they fare in European health technology assessment (HTA) is less well characterised. We examined NICE appraisals of Chinese-origin oncology treatments as a descriptive case series. Origin was defined as the location of molecule discovery and early and pivotal development, regardless of the current licensee.
METHODS: We included Chinese-origin oncology treatments with completed NICE single technology appraisals (STAs). Two technologies across 5 indications qualified: fruquintinib (third-line metastatic colorectal cancer) and zanubrutinib (Waldenström's macroglobulinaemia (WM), chronic lymphocytic leukaemia [CLL], marginal zone and mantle cell lymphoma). Other identified Chinese-origin assets STA were either in progress or terminated. For each complete STA, we recorded the pivotal trial design and comparator, indirect comparisons, cost-effectiveness results, and the draft and final decisions.
RESULTS: All five indications were recommended with subgroup restrictions in some. Trial designs included a placebo-controlled randomised trial, head-to-head randomised trials, and single-arm trials. All five carried a confidential discount (patient access scheme (PAS)), and indirect comparison generated relative treatment effects versus UK comparators. Fruquintinib was recommended only after an initial negative draft decision, when the company revised the price and the economic model with no change to the trial evidence. Zanubrutinib in WM was recommended in a restricted population after the company revised price and the model following the first committee meeting. NICE criticised the clinical evidence, citing comparators not relevant to UK practice, immature survival data, and reliance on uncertain indirect comparisons.
CONCLUSIONS: Positive recommendations were frequently reached, or limited to subgroups, on the basis of price and the economic case rather than new clinical evidence. These observations suggest value in assessing HTA-readiness at licensing, particularly comparator relevance, cost-effectiveness, and pricing. The EU Joint Clinical Assessment may sharpen the comparator question, since evidence must address multiple comparators (PICOs) across member states.