Cost-effectiveness of intensive atorvastatin treatment in high-risk patients compared with usual care in a postgeneric statin market: economic analysis of the Aggressive Lipid-lowering Initiation Abates New Cardiac Events (ALLIANCE) study.

BACKGROUND: Intensive lipid-lowering therapy reduces cardiovascular (CV) event rates more than moderate therapy. Currently available generic statins cost less but provide less risk reduction.

OBJECTIVE: Our goal was to calculate the incremental cost-effectiveness ratio (ICER) comparing an intensive atorvastatin-based regimen versus usual care, defined as prevalent statin therapy used at the time of the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) study-a trial of usual community practice that was conducted among patients enrolled in managed-care plans.

METHODS: A 7-year cost model incorporated patient-level CV event rates and mortality data from the ALLIANCE study. To address the managed-care perspective, costs for clinical end points were estimated from administrative claims data for equivalent events. Direct medical costs included drugs, acute events, and a maximum of 36 months of follow-up costs. Average wholesale pricing was used for drug costs. Differences in patient copayments were incorporated and a 3 % discount factor was applied. Scenario analyses explored 3- and 5-year time frames, varying discount rates, drug costs, and copayment assumptions.

RESULTS: The baseline ICER using all events examined in the ALLIANCE study and a 7-year time frame was US $10,344 (year-2007 value) per event avoided. Over 7 years, the number needed to treat to avoid a clinical end point was 11 patients. Using a realworld economic model that considered atorvastatin becoming generic in 3 years, starting patients on branded and converting them to generic atorvastatin would be a cost-saving strategy compared with current generic statin use.

CONCLUSIONS: Intensive lipid-lowering using atorvastatin increased prescription drug costs of treating CV disease patients but reduced CV events. Medical cost offsets associated with reduced events, based on data from the ALLIANCE study, resulted in ICERs within accepted cost-effectiveness ranges comparing atorvastatin with a generic statin. Atorvastatin-based regimens produced cost savings from a managed-care perspective when the anticipated impact of the generic availability of atorvastatin was modeled.