Cost-Effectiveness of Statin Therapy for Primary Prevention in a Low-Cost Statin Era

Study Questions:

Are expanded statin prescribing strategies using low-cost generics cost-effective for primary prevention?

Methods:

Expanded statin prescribing strategies were simulated with a coronary heart disease (CHD) policy model. The CHD policy model is an established computer simulation, Markov state-transition model of CHD incidence, prevalence, mortality, and costs in the US population >35 years of age. The model simulates development of CHD and associated events in the US population stratified by age, sex, diastolic blood pressure, smoking status, high-density lipoprotein cholesterol, low-density lipoprotein (LDL) cholesterol, diabetes mellitus, and use of statin therapy. Statin efficacy was modeled via a reduction in LDL cholesterol, an approach that closely replicates the reduction in coronary events with statins and approximates the cost-effectiveness ratios of individual trials when their outcomes data are used. Costs and quality-adjusted life-years (QALYs) were discounted at 3% per year. The model created assumed that a low-intensity statin intervention would reduce LDL by 27%, which translates into an 8-34% relative risk reduction depending on age. Side effect rates were derived from systematic reviews of statin trials. Costs of hospitalization for acute kidney failure (from rhabdomyolysis) and liver failure were derived from the Healthcare Cost and Utilization Project.

Results:

Based on an estimated statin cost of $4 dollars per month, treatment thresholds of LDL cholesterol >160 mg/dl for low-risk persons (0-1 risk factor), >130 mg/dl for moderate-risk persons (≥2 risk factors and 10-year risk >10%), and >100 mg/dl for moderately high-risk persons (≥2 risk factors and 10-year risk >10%) would reduce annual health care costs by $430 million compared with Adult Treatment Panel III guidelines. Lowering thresholds to >130 mg/dl for persons with zero risk factors and >100 mg/dl for persons with one risk factor and treating all moderate- and moderately high-risk persons regardless of LDL cholesterol would provide additional health benefits for $9,900 per QALY. These findings were insensitive to most adverse effect assumptions (including statin-associated diabetes mellitus), but were sensitive to large reductions in the efficacy of statins or to a long-term disutility burden for which a patient would trade 30-80 days of life to avoid 30 years of statins.

Conclusions:

The authors concluded that low-cost statins are cost-effective for most persons with even modestly elevated cholesterol or any CHD risk factors if they do not mind taking a pill daily. Adverse effects are unlikely to outweigh benefits in any subgroup in which statins are found to be efficacious.

Perspective:

This is an interesting study, which adds to the debate about prescribing and paying for lipid-lowering therapies such as statins among patients with modestly elevated cholesterol. Whether such studies can or should impact prevention guidelines remains unclear.

Keywords: Liver Failure, Cost-Benefit Analysis, Risk Reduction Behavior, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Acute Kidney Injury, Drugs, Generic, Coronary Disease, Risk Factors, Blood Pressure, Hypercholesterolemia, Cost of Illness, Smoking, Primary Prevention, Rhabdomyolysis, Prevalence, Cholesterol, Cardiovascular Diseases, Hospitalization, Diabetes Mellitus


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