Alirocumab was cost effective at a price up to $6,319 per year at the $100,000 willingness to pay threshold, based on an economic analysis of patients in the recently released ODYSSEY OUTCOMES study. These findings were presented Nov. 10 as part of AHA 2018 in Chicago, IL.

The large multi-center ODYSSEY OUTCOMES trial involved 18,924 patients with elevated LDL-C despite a background of high-intensity or maximally tolerated statin therapy who had experienced an acute coronary syndrome within one to 12 months prior. Patients were randomly assigned to either alirocumab (70 mg) subcutaneously or matching placebo every two weeks.

As part of the cost-effectiveness analysis, researchers used diagnosis-related group cost based on Medicare and adjusted for commercial rates to account for patients <65 years of age. Cost was also applied to cardiovascular death and recurrent non-fatal events including myocardial infarction, ischemic stroke, coronary revascularization and unstable angina requiring hospitalization. Follow-up costs after acute events were not included in the analysis. Additionally, researchers extrapolated long-term survival probability, health-related quality of life and treatment in the overall intention-to-treat (ITT) population, as well as in two separate subgroups (patients with LDL-C ≥100 mg/dL at baseline and patients with LDL-C <100 mg/dL at baseline).

Results, which were presented by Deepak L. Bhatt, MD, MPH, FACC, found that the higher the baseline LDL-C in patients, the higher the value of alirocumab appeared to be. At any level of willingness to pay, cost-effectiveness is greater in patients with baseline LDL-C values ≥100 mg/dL relative to the overall ITT population, Bhatt said. Similarly, at any level of willingness to pay, cost-effectiveness was lower in patients with baseline LDL-C values <100 mg/dL relative to the overall ITT population. Bhatt also noted the findings suggest alirocumab may offer good value in patients with a history of ACS and LDL-C ≥100 mg/dL despite maximally tolerated statin therapy based on both absolute clinical benefit and cost-effectiveness.

Limitations of the study included the use of modeling to assess all-cause mortality not prespecified hierarchical testing of secondary endpoints. Additionally, the study used U.S.-only costs vs. country-specific costs. "Factors other than high LDL-C, such as diabetes, may identify additional patients for whom treatment with alirocumab has favorable cost-effectiveness," Bhatt adds.

Keywords: AHA18, AHA Annual Scientific Sessions, Hypercholesterolemia, Aged, Cholesterol, LDL

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