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 health 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, 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 (control arm of the EORTC-30994 study), assuming functional cure from year 5. CheckMate-274 trial data also informed survival estimations from the LR 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.