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Cost and Patency Rate Targets for the Development of Endovascular Devices to Treat Femoropopliteal Arterial Disease¹

¹ From the Program for the Assessment of Radiological Technology (ART Program), Departments of Radiology (G.S.R.M., M.G.M.H.) and Epidemiology and Biostatistics (M.G.M.H.), Erasmus University Medical Center Rotterdam, Rm EE21-40a, Dr. Molewaterplein 50, 3015 GE Rotterdam, the Netherlands; and the Department of Health Policy and Management, Harvard School of Public Health, Boston, Mass (M.G.M.H.). Received January 10, 2000; revision requested March 4; revision received April 25; accepted June 1. Address correspondence to M.G.M.H. (e-mail: hunink@epib.fgg.eur.nl).

PURPOSE: To determine the criteria that would make use of an endovascular device cost-effective compared with bypass surgery and percutaneous transluminal angioplasty in the treatment of femoropopliteal arterial disease.

MATERIALS AND METHODS: A decision model was developed to compare treatment with the use of a hypothetical endovascular device with established therapies. Cost-effectiveness from the perspective of the health care system was considered. Outcome measures were lifetime costs and quality-adjusted life-years. With the use of net health benefit calculations and threshold analysis, combinations of costs and patency rates were determined that would make the device cost-effective compared with established therapies. In subgroup and sensitivity analyses, the effect on decision-making of sex, age, indication, lesion type, procedural risk, and society’s willingness to pay for incremental gain in health were explored.

RESULTS: Use of a device that costs $3,000 would be cost-effective compared with bypass surgery for critical ischemia if the 5-year patency rate is 29%–46%. Use of the same device would be cost-effective compared with angioplasty for disabling claudication and stenosis if the 5-year patency rate is 69%–86%.

CONCLUSION: The target combinations of costs and patency rates found in this study are probably attainable, and further development of such endovascular devices seems warranted.

Index terms: Arteries, extremities, 92.721 • Arteries, grafts and prostheses, 92.1268 • Arteriosclerosis, 92.721 • Cost-effectiveness • Interventional procedures, comparative studies, 92.126, 92.128 • Technology assessment

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