Key result
PFO closure proves cost-effective vs medical therapy in cryptogenic stroke at ~$29,000 per QALY.
Why the study?
While PFO closure has been shown to be cost-effective outside Japan, no studies had evaluated its cost-effectiveness from the perspective of a Japanese healthcare payer.
Is patent foramen ovale closure cost-effective compared with medical therapy alone in Japanese patients aged ≤60 years with cryptogenic stroke?
Is patent foramen ovale closure cost-effective compared with medical therapy alone in Japanese patients aged ≤60 years with cryptogenic stroke?
Patent foramen ovale closure is cost-effective compared to medical therapy alone for Japanese patients aged ≤60 years with cryptogenic stroke, with an ICER of $29,208 per QALY gained.
May support PFO closure decisions in eligible Japanese patients; leaves open generalizability to other populations and systems.
BACKGROUND: Closure of a patent foramen ovale reduces the risk of recurrent stroke compared with medical therapy alone in young patients with cryptogenic strokes revealed by randomized control trials. Some cost-effectiveness analyses outside Japan have shown that patent foramen ovale closure is cost-effective, but no studies have examined cost-effectiveness in Japan. The objective of this study is to assess cost-effectiveness, from the perspective of a Japanese healthcare payer, of patent foramen ovale closure versus medical therapy alone for patients with patent foramen ovale related to cryptogenic strokes. METHODS: A cost-effectiveness study was conducted by developing a decision tree and a Markov model. Probabilities and a 5.9-year time horizon followed the RESPECT study. Utilities and costs were based upon published studies and assumptions. All assumptions were assessed by experts, including a cardiologist and a statistical expert. The target population comprised patients with cryptogenic stroke and patent foramen ovale, aged 60 years or younger. The model was discounted at 2.0% and its cycle was one month. A willingness-to-pay threshold is set at $50,000 / quality-adjusted life years (QALYs). Incremental cost-effectiveness ratio was evaluated. Then one-way sensitivity analyses as deterministic sensitivity analysis, and probabilistic sensitivity analyses were performed to assess data robustness. RESULTS: Incremental quality-adjusted life years, incremental costs, and incremental cost-effectiveness ratio were 0.464, $13,562, and $29,208 per QALY gained, respectively. One-way sensitivity analysis showed that the stable state utility score difference between patent foramen ovale closure and medical therapy had the largest impact on incremental cost-effectiveness ratio. Patent foramen ovale closure is cost-effective at a stable state utility score difference of >0.051, compared with medical therapy. Probabilistic sensitivity analyses demonstrated that patent foramen ovale closure was 50.3% cost-effective. CONCLUSIONS: Patent foramen ovale closure was cost-effective compared with medical therapy for Japanese patients with cryptogenic stroke who were ≤60 years.
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Shijoh et al. (2022) studied Cryptogenic stroke with patent foramen ovale (n=980). Patent foramen ovale (PFO) closure vs. Medical therapy alone was evaluated on Incremental cost-effectiveness ratio (ICER) (ICER $29,208/QALY). Patent foramen ovale closure was cost-effective compared with medical therapy for Japanese patients aged ≤60 years with cryptogenic stroke, yielding an ICER of $29,208 per QALY gained.
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