COST EFFECTIVENESS OF PERCUTANEOUS CLOSURE OF A PATENT FORAMEN OVALE TO REDUCE THE RISK OF RECURRENT ISCHEMIC STROKE IN PATIENTS WHO HAVE HAD A CRYPTOGENIC STROKE DUE TO A PRESUMED PARADOXICAL EMBOLISM IN THE UNITED STATES

• Published in: Value in health Vol. 20; no. 5; p. A8
• Main Authors: Tirschwell, D, Marks, D, Macdonald, L, Smalling, R, Carroll, JD, Gu, NY, Koullick, M, Saver, F, Thaler, D
• Format: Journal Article
• Language: English
• Published: Lawrenceville Elsevier Science Ltd 01.05.2017
• Subjects: Clinical outcomes; Clinical research; Clinical trials; Confidence intervals; Cost analysis; Embolism; Followup; Health care expenditures; Ischemia; Middle age; Monte Carlo simulation; Quality adjusted life years; Recurrent; Risk assessment; Risk reduction; Robustness; Sensitivity analysis; Stroke; Willingness to pay; United States > US
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2017.05.005

OBJECTIVES: FDA has recently approved a first percutaneous patent foramen ovale (PFO) occluder indicated for transcatheter closure of a PFO to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism. The objective of this study was to evaluate the cost-effectiveness of this therapy compared with medical therapy in the US. METHODS: A Markov cohort model consisted of 4 health states (stable state, post mild and moderate acute recurrent stroke state, and death) was developed to simulate the projected clinical and economic outcomes based on US payer perspective. Event rates were extracted from a randomized clinical trial (RESPECT) with a median 5.9 years follow-up. Health utilities and direct medical costs were obtained from the published sources. One-way, probabilistic sensitivity and scenario analyses were performed to assess the robustness of the model. Monte Carlo simulations were used to estimate the 95% confidence intervals (CI) of the modeled outcomes. The model took a lifetime horizon, discounted at 3% and reported in 2016 dollars. RESULTS: Compared with medical therapy alone and using the commonly accepted willingness-to-pay (WTP) threshold of $50,000, PFO closure reached the cost-effectiveness in less than 3 years (year 2.684). The cost-effectiveness ratios (ICERs) at year 3, 6 (the median trial followup) and 10 were: $44,335 (95%CI: $35,295-$54,803), $20,996 (95%C1: $16,139-$26,487) and $12,110 (95% CI: $8,824-$15,737), respectively, per each quality-adjusted life-year (QALY) gained. Cost-effectiveness acceptability curve indicated 85.3% probability that the ICERs would be lower than the WTP threshold at year 3 and 100% after year 3. Sensitivity analyses showed that the model was robust. CONCLUSIONS: In carefully selected young to middle-aged patients with PFO and history of a cryptogenic ischemic stroke, percutaneous PFO closure therapy is cost-effective in the long term compared to medical therapy alone in the context of US healthcare system.