- •Bempedoic acid required insurance approval or cost mitigation in 94.5% of cases
- •Bempedoic acid reduced LDL-C by 20.3%-36.7%, with wide inter-individual variability
- •Hyper- and hypo-responder phenotypes were present in 25% and 14% of patients
- •Drug discontinuations were common, occurring in 35.9% of patients
- •The most common TEAEs were musculoskeletal
Lipid management for prevention and treatment of cardiovascular disease remains insufficient for many with currently available therapies.
Evaluate real-world use of bempedoic acid.
Retrospective study of patients in our Center for Preventive Cardiology who were prescribed bempedoic acid between February 2020 and July 2021. Patients were managed according to clinical standards of care, with lipid assessments at months ≤3, 6, and 12 post-bempedoic acid initiation.
Seventy-three patients were prescribed bempedoic acid, with 64 initiating therapy. The majority had atherosclerosis (89%), familial hypercholesterolemia (64%), and statin intolerance (74%), with baseline low-density lipoprotein cholesterol (LDL-C) 120 mg/dL. Prior authorization requests and appeals of denials were required in 90% and 19% of cases, respectively. Cost-mitigating strategies reduced median monthly drug costs from $432 pre-insurance approval to $80 post-insurance approval, to $10 after financial assistance intervention. Bempedoic acid reduced LDL-C by -36.7%, -31%, and -20.3% at ≤3, 6, and 12, respectively, with >20% achieving LDL-C <70 mg/dL. There was substantial inter-individual heterogeneity in LDL-C lowering. We observed high rates of drug discontinuation (35.9%), mostly related to treatment-emergent adverse events (TEAEs) (32.8%), primarily musculoskeletal complaints. Use of reduced dose bempedoic acid (<180 mg) was associated similar LDL-C lowering but TEAE and drug discontinuation were still common.
Real-world use of bempedoic acid was limited by insurance and cost barriers requiring substantial post-prescription interventions. In patients at heightened risk for atherosclerotic events and statin intolerance, bempedoic acid was associated with clinically meaningful LDL-C lowering, but high rates of TEAEs and drug discontinuations.
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Published online: December 03, 2021
Accepted: November 27, 2021
Received in revised form: November 3, 2021
Received: September 8, 2021
© 2021 National Lipid Association. Published by Elsevier Inc. All rights reserved.