OBJECTIVES: In 2020, the World Health Assembly announced a global comprehensive plan to eliminate cervical cancer, involving vaccination, screening, and treatment-rate targets. Pembrolizumab in combination with - paclitaxel, cisplatin, carboplatin, and bevacizumab - is reimbursed for first-line treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS>=1) based on the results of KEYNOTE-826 trial. The present study aims to assess cost-effectiveness of Pembrolizumab plus SoC versus SoC alone in Greece in this setting.

METHODS: A semi-Markov State Transition model with three health states (progression-free, progressed disease and death) was adapted to Greece, adopting payer’s perspective with a 40 years’ time-horizon. Clinical, safety and quality of life data were drawn from KEYNOTE-826 trial (22 months follow-up data). Primary outcomes were patients’ life years gained (LYg), quality-adjusted life years (QALYs), total costs and incremental cost-effectiveness ratios (ICER) per QALY. Both costs and QALYs were discounted at 3.0% per annum. Α one-way sensitivity analysis (OWSA) was undertaken to examine the most influential parameters on the results and a probabilistic sensitivity analysis (PSA) was conducted to account for uncertainty in the model.

RESULTS: The model showed that, over a lifetime horizon, total average cost per patient with pembrolizumab plus SoC was estimated at €157,368 whereas the cost of SoC alone was €73,360. Pembrolizumab with SoC was more effective than SoC providing 6.104 LYs versus 2.991 LYg which translated into 3.412 and 1.799 QALYs respectively; overall incremental LYG were 3.113 and the incremental QALYs were 1.613. The ICER was estimated at €52,081/QALY which is below the national cost-effectiveness threshold for Greece(3x GDP capita, €52,770/QALY). The OWSA and PSA results confirmed the robustness of the model.

CONCLUSIONS: The present modeling study suggests that pembrolizumab in combination with SoC is a cost-effective intervention compared to SoC that improves health outcomes and the efficient allocation of resources in Greece.