Rothwell B, Sheikh K, Knight C, Kamgar F, Jain R, Mamtani R, Kurt M, Poretta T, Broughton E, Teitsson S. Cost-utility of Nivolumab versus observation for the adjuvant treatment of Urothelial Carcinoma (UC) for patients who are at high-risk of recurrence: a United States (US) payer perspective. Poster presented at the ISPOR 2022 Conference; May 15, 2022. Washington, DC. [abstract] Value Health. 2022 Jun;.


OBJECTIVES: To estimate, from a US payer perspective, the cost-utility of adjuvant treatment of UC after radical resection with nivolumab versus observation using data with 11 months’ minimum follow-up from the Phase 3 CheckMate-274 trial and survival estimates from the published literature.

METHODS: A four-state semi-Markov model consisting of disease-free (DF), local recurrence (LR), distant recurrence (DR), and death states was developed to evaluate discounted total costs and quality-adjusted life-years (QALYs) over a 30-year time horizon. The annual discount rate on costs and outcomes was 3%. The model included costs of drug acquisition, administration, monitoring, subsequent therapies, adverse events, routine disease management, and end-of-life care. Transitions from the DF state were estimated using patient-level survival data for first recurrence events from CheckMate-274 and the published literature in adjuvant treatment of UC (EORTC 30994), assuming functional cure from year 5. Trial data also informed survival estimations from the LR health state. The DR state was modelled as an absorbing state, entrance to which was associated with one-off costs and QALYs estimated via adjusted survival data from the published literature for metastatic UC. Health-state utilities were derived from CheckMate-274 EQ-5D-3L data. The primary outcome of the analysis was the incremental cost-utility ratio (ICUR).

RESULTS: Nivolumab was associated with 1.03 incremental QALYs and $89,866 incremental costs, producing an ICUR of $87,079/QALY. Key drivers of cost-effectiveness included annual discount rate and utility values in DF state. Nivolumab had a 91% and 100% probability of being cost-effective at willingness-to-pay thresholds of $100,000/QALY and $150,000/QALY, respectively. The impact of alternative approaches to estimating transitions from the DF state, health-state utilities, and subsequent treatment distribution were explored, and cost-effectiveness conclusions remained robust.

CONCLUSION: Nivolumab is estimated to be a life-extending and cost-effective adjuvant treatment option compared with observation for UC in the US.

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