OBJECTIVES: The objective of this study is to conduct a cost-effectiveness analysis for the FARAPULSE™ Pulsed Field Ablation (PFA) system in comparison to thermal ablation medical devices in patients with paroxysmal atrial fibrillation (AF).

METHODS: The economic analysis was conducted from the Social Security Institution (SGK) perspective for a period of 10 years. The analysis considered direct costs and life years gained. All of the clinical data included in the Markov model were obtained from studies in the literature. The economic data of the study (costs of medicine, medical device, stroke, hospitalization) were calculated according to SGK.

RESULTS: The average 10-year direct cost per patient was found to be TRY71,012.81 for the FARAPULSE™ and TRY47,113.07 for thermal ablation. The life years gained were 9.55 years and 9.26 years, respectively. According to the calculations, the survival rates were calculated to be approximately 83% for the thermal ablation method and approximately 90% for FARAPULSE™, and it was found that FARAPULSE™ gave patients 0.29 life years. The calculated incremental cost-effectiveness ratio (ICER) for FARAPULSE™ compared to thermal ablation was TRY83,821.87. The gross domestic product per capita (GDP) for Turkiye in 2022 was reported as TRY176,589. Considering the GDP for 2022 as the threshold value, the ICER value (TRY83,821.87) was below the GDP per capita, indicating that the FARAPULSE™ method is cost-effective.

CONCLUSIONS: The cost-effectiveness analysis, taking into account the clinical benefit, additional life years gained, and the perspective of the SGK, demonstrates that the FARAPULSE™ PFA system provides economic and societal benefits in the reimbursement coverage for patients with paroxysmal atrial fibrillation in Turkiye.