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Cost-Effectiveness of Alirocumab: A Just-in-Time Analysis Based on the ODYSSEY Outcomes Trial
Dhruv S Kazi1, Joanne Penko2, Pamela G Coxson2
1Beth Israel Deaconess Medical Center, Boston, Massachusetts (D.S.K.).
Insights
Alirocumab, an advanced cholesterol-lowering drug, is not cost-effective for post-acute coronary syndrome patients compared to ezetimibe. Significant price reductions are needed for alirocumab to be considered cost-effective.
Area of Science:
- Cardiovascular Medicine
- Health Economics
- Pharmacoeconomics
Background:
- The ODYSSEY Outcomes trial demonstrated that adding alirocumab to statin therapy reduced major adverse cardiovascular events in patients with recent acute coronary syndrome (ACS).
- This study aimed to evaluate the cost-effectiveness of alirocumab in the U.S. healthcare system for ACS patients.
Purpose of the Study:
- To determine the cost-effectiveness of alirocumab compared to ezetimibe as an add-on therapy to statins for U.S. adults following a myocardial infarction (MI).
Main Methods:
- A decision analysis using the Cardiovascular Disease Policy Model was employed.
- Data from the ODYSSEY Outcomes trial and U.S. population health data were integrated.
- The primary outcome measure was the incremental cost-effectiveness ratio (ICER) expressed in 2018 U.S. dollars per quality-adjusted life-year (QALY) gained.
Main Results:
- Adding ezetimibe to statin therapy resulted in an ICER of $81,000 per QALY gained.
- Adding alirocumab to statin therapy had a significantly higher ICER of $308,000 per QALY gained.
- Replacing ezetimibe with alirocumab in statin-treated patients was estimated to cost $997,000 per QALY gained.
Conclusions:
- Alirocumab is not cost-effective at its original price when compared to ezetimibe for ACS patients.
- A substantial price reduction, from $14,560 to $1,974 annually, is required for alirocumab to be cost-effective relative to ezetimibe.
- Independent cost-effectiveness analyses are crucial for informing clinical and policy decisions regarding new cardiovascular drugs.
Background:
The ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial included participants with a recent acute coronary syndrome. Compared with participants receiving statins alone, those receiving a statin plus alirocumab had lower rates of a composite outcome including myocardial infarction (MI), stroke, and death.
Objective:
To determine the cost-effectiveness of alirocumab in these circumstances.
Design:
Decision analysis using the Cardiovascular Disease Policy Model.
Data Sources:
Data sources representative of the United States combined with data from the ODYSSEY Outcomes trial.
Target Population:
U.S. adults with a recent first MI and a baseline low-density lipoprotein cholesterol level of 1.81 mmol/L (70 mg/dL) or greater.
Time Horizon:
Lifetime.
Perspective:
U.S. health system.
Intervention:
Alirocumab or ezetimibe added to statin therapy.
Outcome Measures:
Incremental cost-effectiveness ratio in 2018 U.S. dollars per quality-adjusted life-year (QALY) gained.
Results Of Base-Case Analysis:
Compared with a statin alone, the addition of ezetimibe cost $81 000 (95% uncertainty interval [UI], $51 000 to $215 000) per QALY. Compared with a statin alone, the addition of alirocumab cost $308 000 (UI, $197 000 to $678 000) per QALY. Compared with the combination of statin and ezetimibe, replacing ezetimibe with alirocumab cost $997 000 (UI, $254 000 to dominated) per QALY.
Results Of Sensitivity Analysis:
The price of alirocumab would have to decrease from its original cost of $14 560 to $1974 annually to be cost-effective relative to ezetimibe.
Limitation:
Effectiveness estimates were based on a single randomized trial with a median follow-up of 2.8 years and should not be extrapolated to patients with stable coronary heart disease.
Conclusion:
The price of alirocumab would have to be reduced considerably to be cost-effective. Because substantial reductions already have occurred, we believe that timely, independent cost-effectiveness analyses can inform clinical and policy discussions of new drugs as they enter the market.
Primary Funding Source:
University of California, San Francisco, and Institute for Clinical and Economic Review.
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