Effectiveness and cost-effectiveness of pembrolizumab in persistent, recurrent, or metastatic cervical cancer with PD-L1 CPS 1-10: secondary analysis of KEYNOTE-826 using innovative KMSubtraction

BACKGROUND: To evaluate the effectiveness and cost-effectiveness of pembrolizumab combined with chemotherapy and anti-angiogenesis treatment for PD-L1 CPS 1-10 cervical cancer (CC) patients from the perspective of US healthcare payers. RESEARCH DESIGN AND METHODS: KM curves for the CPS 1-10 subgroup were derived using the KMSubtraction workflow to reconstruct individual patient data, with analysis based on restricted mean survival time. A partitioned survival model (PFS, PD, death) was used for cost-effectiveness analysis, applying a $150,000 per QALY willingness-to-pay threshold. RESULTS: Pembrolizumab plus chemotherapy significantly improved PFS (RMST difference 5.06 months) and OS (RMST difference 5.84 months) versus placebo. The treatment increased QALYs by 1.17 at an additional cost of $297,505,yielding an ICER of 254,262 $/QALY. A threshold analysis indicated that an effective pembrolizumab price of $25.80 per mg would be required for the regimen to meet the $150,000/QALY threshold. Sensitivity analysis identified drug prices, health state utilities, and discount rates as key influencing factors. CONCLUSIONS: Pembrolizumab+chemotherapy significantly improved PFS and OS in PD-L1 CPS 1-10 CC patients, with higher mean RMST than the placebo group. However, it is not cost-effective at current prices, but reducing pembrolizumab's price could improve its cost-effectiveness.