A microsimulation model-based analyses suggests that the health benefits associated with the 10-year atherosclerotic cardiovascular disease risk threshold of 7.5 percent or higher used in the 2013 ACC-AHA cholesterol guidelines are worth the additional costs required to achieve these health gains, and that a more lenient threshold might also be cost-effective, according to a study in the July 14 issue of JAMA.
In November 2013 the American College of Cardiology and the American Heart Association (ACC/AHA) released new recommendations to guide statin treatment initiation for the primary prevention of cardiovascular disease. These guidelines established 4 categories for statin treatment eligibility for adults 40 to 75 years of age, including 10-year atherosclerotic cardiovascular disease (ASCVD) risk of 7.5 percent or higher. It has been estimated that based on the new ASCVD risk threshold that 8.2 million additional adults in the U.S. would be recommended for statin treatment compared with previous recommendations. This expansion of statin treatment eligibility has been controversial, with some critics arguing that the guidelines substantially overestimate risk, and when taken in conjunction with more lenient treatment thresholds, millions of adults in the U.S. would be exposed to unnecessary statin treatment costs and risks, according to background information in the article.
Ankur Pandya, Ph.D., of the Harvard T.H. Chan School of Public Health, Boston, and colleagues performed a cost-effectiveness analysis of the ACC/AHA cholesterol treatment guidelines. With use of a microsimulation model, hypothetical individuals from a representative U.S. population 40 to 75 years of age received statin treatment, experienced ASCVD events, and died from ASCVD-related or non-ASCVD-related causes based on ASCVD natural history and statin treatment parameters. Data sources for model parameters included National Health and Nutrition Examination Surveys, large clinical trials and meta-analyses for statin benefits and treatment, and other published sources.
The researchers found that the current ASCVD threshold of 7.5 percent or higher, which was estimated to be associated with 48 percent of adults treated with statins, had an incremental cost-effectiveness ratio (ICER) of $37,000/quality-adjusted life-year (QALY) compared with a 10 percent or higher threshold. More lenient ASCVD thresholds of 4.0 percent or higher (61 percent of adults treated) and 3.0 percent or higher (67 percent of adults treated) had ICERs of $81,000/QALY and $140,000/QALY, respectively.
Shifting from the 7.5 percent or higher threshold to 3.0 percent or higher to 4.0 percent or higher was associated with an estimated additional 125,000 to 160,000 CVD events averted.
The optimal ASCVD threshold was sensitive to patient preferences for taking a pill daily, changes to statin price, and the risk of statin-induced diabetes.
"The decision to initiate statin treatment for adults without CVD should ultimately be informed by both evidence-based policies and patient preferences," the authors write.
(doi:10.1001/jama.2015.6822; Available pre-embargo to the media at http://media.
Editor's Note: This work is supported by a grant to the Harvard School of Public Health from the National Heart, Lung, and Blood Institute (Dr. Gaziano). Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.
Please Note: A podcast interview on this study will be available at JAMA.com at the embargo time.
Editorial: Cholesterol Lowering in 2015
"Based on available evidence, including the 2 reports in this issue of JAMA, answers to the questions of in whom and how regarding cholesterol lowering are now more clear than they were just 18 months ago," write Philip Greenland, M.D., of the Northwestern University Feinberg School of Medicine, Chicago, and Senior Editor, JAMA, and Michael S. Lauer, M.D., of the National Heart, Lung, and Blood Institute, Bethesda, Md., in an accompanying editorial.
"Available evidence indicates that statins are both effective and cost-effective for primary prevention even among low-risk individuals. Although lifestyle interventions must be employed across all segments of the population, for many people a statin drug will also be required to minimize risk. Where to set the treatment threshold and how to determine the individual's level of risk are also becoming progressively clarified."
"There is no longer any question as to whether to offer treatment with statins for patients for primary prevention, and there should now be fewer questions about how to treat and in whom. Rather, the next phase of research should be directed at better ways of applying lifestyle and drug treatments to the millions, and possibly billions, worldwide who could potentially benefit from a cost-effective approach to primary prevention of ASCVD."
(doi:10.1001/jama.2015.7434; Available pre-embargo to the media at http://media.
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.