OBJECTIVES

: Patent Foramen Ovale (PFO) is a congenital defect that constitutes a hole between the right and left upper chambers of the heart. It may contribute to the risk of ischemic stroke so the closure is considered as a secondary prevention in patients who had a cryptogenic stroke. The objective of this study is to examine cost effectiveness of PFO closure in the context of Korean healthcare system.

METHODS

: A Markov model consisting of 4 health states (stable, post-minor recurrent stroke, post-moderate recurrent stroke, death) similar to Tirschwell et al. (HTAi 2017) was developed to assess cost effectiveness in patients selected for PFO closure based on RESPECT trial extended follow-up. The intervention cost and medication costs were obtained from the current fee schedule, drug prices, and statistical yearbook in the National Health Insurance (NHI). Severity distribution of recurrent stroke was set by expert opinion. Using these data, a cost effectiveness analyses of (1) PFO closure with antiplatelet therapy (intervention) versus (2) medical therapy alone (control) was assessed at 20 years post the intervention. Univariate sensitivity analyses and probabilistic sensitivity analysis (PSA) were performed.

RESULTS

: The analysis showed that the intervention has 3.2 million KRW more cost with 1.2 higher utility which corresponds to an ICER of 2.7 million KRW per QALY which is below the implicit Korean threshold of 25 million KRW. A sensitivity analysis on time horizon showed that discounted ICER reach the threshold in 4 years, i.e. net monetary benefit of intervention exceeds control in 4 years. The PSA result showed acceptability of intervention at the threshold was 96.4% compared to control.

CONCLUSIONS

: Though there might be uncertainties from foreign modeling, the current study suggests a careful selection of patients with cryptogenic stroke history and application of PFO closure may benefit the patients and the public payer in Korea.