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Cost-Effectiveness of Bempedoic Acid in High Cardiovascular Risk Patients with Statin Intolerance: An Analysis of the
Stephen J Nicholls1, Kausik K Ray2, A Michael Lincoff3
1Victorian Heart Institute, Monash University, 631 Blackburn Road, Clayton, VIC, 3168, Australia. stephen.nicholls@monash.edu.
Insights
Bempedoic acid significantly reduces major adverse cardiovascular events (MACE) in high-risk patients with hypercholesterolemia and statin intolerance. The drug demonstrates cost-effectiveness, particularly when considering combination therapy or reduced pricing, offering improved cardiovascular risk reduction.
Area of Science:
- Cardiovascular Medicine
- Health Economics
- Pharmacoeconomics
Background:
- The CLEAR Outcomes study demonstrated bempedoic acid's efficacy in reducing major adverse cardiovascular events (MACE) by 13% in high-risk patients with hypercholesterolemia and statin intolerance.
- The cost-effectiveness of bempedoic acid in this specific patient group remained undetermined.
Purpose of the Study:
- To evaluate the cost-effectiveness of bempedoic acid compared to standard of care for reducing cardiovascular risk in patients with hypercholesterolemia and statin intolerance.
- To analyze the economic implications from a US third-party payer perspective over a lifetime horizon.
Main Methods:
- Markov modeling was employed to estimate cost-effectiveness, utilizing individual patient data from the CLEAR Outcomes trial.
- Treatment benefits were extrapolated over a lifetime horizon, with scenario analyses including on-treatment effects, varying drug costs, and the impact of a fixed-dose combination with ezetimibe.
Main Results:
- Bempedoic acid was associated with reduced lifetime MACE (1.58 vs. 1.95 per patient) and improved quality-adjusted life-years (QALYs).
- At list price, the incremental cost-effectiveness ratio (ICER) was $166,830 per QALY, improving to $70,279 per QALY with an on-treatment analysis.
- A 25% price reduction yielded an ICER of $99,993 per QALY, while modeling the fixed-dose combination resulted in an ICER of $40,317 per QALY.
Conclusions:
- Bempedoic acid provides improved lifetime cardiovascular risk reduction compared to standard of care for high-risk patients.
- The drug's use is considered cost-effective at common thresholds, especially when considering combination therapy or price adjustments.
Background:
In the CLEAR Outcomes study, 13,970 high cardiovascular risk patients with hypercholesterolemia and statin intolerance were randomized to treatment with bempedoic acid or standard of care (placebo). Bempedoic acid reduced the risk of major adverse cardiovascular events by 13%. However, the cost-effectiveness of bempedoic acid in this patient population is unknown.
Methods:
Markov modeling estimated cost-effectiveness of bempedoic acid versus standard of care alone to reduce cardiovascular risk from a US third-party payer perspective. Baseline risk was estimated by applying individual patient characteristics from the trial to established risk equations. Treatment benefit was extrapolated over a lifetime horizon using hazard ratios for individual major adverse cardiovascular event (MACE) components from CLEAR Outcomes. Scenario analyses included on-treatment analysis, alternate bempedoic acid costs, and modeling effects of the fixed-dose combination with ezetimibe on low-density lipoprotein cholesterol (LDL-C) reduction and predicted MACE.
Results:
Bempedoic acid was estimated to reduce lifetime MACE (1.58 versus 1.95 per patient) versus standard of care. At list price, bempedoic acid was associated with increased costs (+ $22,600) and improved quality-adjusted life-years (QALYs, + 0.14), resulting in an incremental cost-effectiveness ratio (ICER) of $166,830 per QALY. The on-treatment analysis resulted in an ICER of $70,279 per QALY. Reduction in bempedoic acid price by 25% resulted in lower incremental total costs and an ICER of $99,993 per QALY. Modeling the effects of the fixed-dose combination resulted in an ICER of $40,317 per QALY.
Conclusions:
Use of bempedoic acid offers improved lifetime cardiovascular (CV) risk reduction over standard of care in patients with or at high risk for CV disease (CVD) at common cost-effectiveness thresholds ($150,000 per QALY).
Trial Registration:
ClinicalTrials.gov identifier: NCT02993406 (CLEAR Outcomes study).
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