Abstract
To assess the cost-effectiveness of pembrolizumab versus carboplatin plus gemcitabine in patients with locally advanced or metastatic urothelial cancer, who are not eligible for cisplatin-containing chemotherapy. A three-state partition survival model was developed with a 20-year time horizon and a weekly cycle. KEYNOTE-052, phase II single arm clinical trial informed the clinical efficacy and adverse events parameters of pembrolizumab in the model. Overall survival (OS) was extrapolated using a piece-wise approach, utilising Kaplan-Meier data until week 32 and using a log-normal distribution for the remainder of the time horizon. A network meta-analysis, enabled through the use of a simulated treatment comparison (STC), provided comparative effectiveness estimates of pembrolizumab versus carboplatin plus gemcitabine as time-varying hazard ratios (HRs). Quality-adjusted life years (QALYs) were estimated using utilities derived from EQ-5D data collected in KEYNOTE-052. Resource use and unit costs were applied from a NHS perspective. Probabilistic-, deterministic-, and scenario- analyses were performed to assess model uncertainty. The model demonstrated that pembrolizumab increases the life expectancy of patients by 1.39 years, corresponding to 1.04 additional QALYs. The base case incremental cost-effectiveness ratio (ICER) is £35,016 (confidential discount included). Model results are sensitive to the following assumptions: comparative effectiveness HR for pembrolizumab vs. carboplatin plus gemcitabine, extrapolation of overall survival data, and the utility estimates used. The results of this cost-effectiveness analysis demonstrated that pembrolizumab is a cost-effective choice compared to carboplatin plus gemcitabine when considering a willingness to pay threshold of £50,000 per QALY, as per NICE end-of-life criteria.
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