OBJECTIVES:

Statins are prescribed for primary cardiovascular disease (CVD) prevention based on absolute risk of CVD over 10 years (AR). Individuals with lower AR but high LDL cholesterol may experience the same 10-year absolute CVD risk reduction (ARR) from statin therapy as those with higher AR but moderate LDL. This study aimed to estimate the cost-effectiveness of ARR-based statin treatment incremental to AR-based treatment.

METHODS:

A microsimulation version of the CVD Policy Model, a decision-analytic state-transition model, was employed. The model estimated health and cost outcomes for a cohort of CVD-free individuals, accounting for outcomes and costs associated with statin treatment and CVD events. Individual demographic and risk factor profiles were randomly drawn from U.S. National Health and Nutrition Examination Surveys 1999-2010, producing a cohort of 50,000 CVD-free individuals (50% women) who were simulated from ages 40-80 years.

Moderate-intensity statin therapy was simulated first for those with AR≥7.5% (standard of care) and was then extended to those with ARR≥2.3% (the minimum ARR at the 7.5% AR threshold). ARR was assigned using a formula that accounted for LDL and AR was assigned using the 2013 U.S. Pooled Cohorts CVD Risk Score. Effectiveness was quantified in quality-adjusted life years (QALYs), costs were quantified in 2017 $U.S., and both were discounted at an annual rate of 3%. The primary outcome was the incremental cost-effectiveness ratio (ICER).

RESULTS:

Incremental to treating all AR≥7.5%, adding treatment of remaining ARR≥2.3% yielded an ICER of $15,783/QALY. Treating remaining ARR≥2.3% would prevent 1,223 lifetime CVD events in the cohort. Women benefited most (68% of 1,245 QALYs gained). In scenario analyses, results were sensitive to treatment adherence (ICER: Dominant-$52,598/QALY) and efficacy (ICER: $4,984-70,628/QALY) inputs.

CONCLUSIONS:

Statin treatment based on ARR is cost-effective and would yield significant lifetime health gains in U.S. adults. Women would gain most from ARR-based statin treatment when AR<7.5%.