A Cost-Benefit Analysis of Lipid Standardization in the United States

Introduction By improving lipid standardization, the Centers for Disease Control and Prevention's (CDC's) Lipid Standardization Program and Cholesterol Reference Method Laboratory Network have contributed to the marked reduction in heart disease mortality that has occurred since 1980. The fundamental activities of the programs are to define reference methods and maintain reference materials for total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. These programs have established an accuracy-based reference which allows results to be compared across different labs and over time, which is necessary when conducting multicenter clinical trials. No previous study has estimated the benefit of these lipid standardization programs.

Methods We developed a logic model that shows how the inputs, activities and participants of the lipid standardization programs produce short-term outcomes including standardizing results from trials and improving accuracy of clinical testing. These in turn lead to 5 medium-term outcomes including the development of practice patterns, increased cholesterol awareness, improved diet and exercise, improvements in prescription drugs, and higher diagnosis rates which all contribute towards improvements in cardiovascular mortality and morbidity (the long-term outcomes). We calculated the benefits of improvements in these long-term outcomes by multiplying a willingness to pay per lifeyear value by the previously estimated life-years gained from statin treatments and total cholesterol reduction observed between 1980 and 2000.

To estimate the benefits of the lipid standardization programs, we polled thirteen cardiovascular disease experts including four members of the National Association of Chronic Disease Director's, Cardiovascular Biomarker Standardization Steering Committee to provide an estimate of the share of cardiovascular disease mortality improvements attributable to the standardization programs. The median estimate was 5%, but there was a wide range of estimates (from 2%–3% to more than 50%). We also considered more conservative estimates of 1.0% and 0.5%.

Results With 5% of the cholesterol-related benefits attributable to the programs and a $113,000 value per life-year, the benefits attributable to the programs equaled $7.6 billion. With more conservative assumptions (0.5% of cholesterol-related benefits attributable to the programs and a $50,000 value per life-year), the benefits attributable to the programs equaled $338 million.

Conclusion In 2007, the CDC lipid standardization programs cost $1.7 million. Thus, our estimates suggest that the benefits of CDC's lipid standardization programs greatly exceed their costs.