PCSK9 inhibitor access barriers—issues and recommendations: Improving the access process for patients, clinicians and payers
Open accessAbstract
The proprotein convertase subtilisin/kexin type 9 inhibitors or monoclonal antibodies likely represent the greatest advance in lipid management in 30 years. In 2015 the US Food and Drug Administration approved both alirocumab and evolocumab for high‐risk patients with familial hypercholesterolemia (FH) and clinical atherosclerotic cardiovascular disease requiring additional lowering of low‐density lipoprotein cholesterol. Though many lipid specialists, cardiovascular disease prevention experts, endocrinologists, and others prescribed the drugs on label, they found their directives denied 80% to 90% of the time. The high frequency of denials prompted the American Society for Preventive Cardiology (ASPC), to gather multiple stakeholder organizations including the American College of Cardiology, National Lipid Association, American Association of Clinical Endocrinologists (AACE), and FH Foundation for 2 town hall meetings to identify access issues and implement viable solutions. This article reviews findings recognized and solutions suggested by experts during these discussions. The article is a product of the ASPC, along with each author writing as an individual and endorsed by the AACE.
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The better implementation and persistence in European populations compared with the United States is likely attributable to health care system accessibility, cost-sharing structures, study design, and medication monitoring practices.
“likely attributable to health care system accessibility, cost-sharing structures, study design, and medication monitoring practices.119, 120, 121, 122, 123”
From Adherence to PCSK9 Inhibitors in Clinical Practice (2026) · cites this paper as [120]
The Step therapy section (page unavailable) links formulary costs and restrictions to diminished medication access and nonadherence, supporting the general access-and-cost rationale. It does not compare implementation or persistence in European and US populations, or address cost-sharing structures, study design, or medication monitoring as explanations for such a difference. (LLM, conf=0.82)
Experimental — accuracy not yet measuredU.S. health insurers implement restrictive measures such as prior authorization, step therapy, and complex appeals processes if initial coverage for PCSK9 inhibitors is denied.
“U.S. health insurers implement restrictive measures such as prior authorization, step therapy, and complex appeals processes, if initial coverage for PCSK9 inhibitors is denied.120”
From Adherence to PCSK9 Inhibitors in Clinical Practice (2026) · cites this paper as [120]
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- Authors
- Baum, S. J., Toth, P. P., Underberg, J. A., Jellinger, P., Ross, J., & Wilemon, K.
- Affiliations
- Florida Atlantic University (US)
- Johns Hopkins University (US)
- NYU Langone Health (US)
- University of Miami (US)
- University of Pennsylvania Health System (US)
- The Familial Hypercholesterolemia Foundation Pasadena California
- Corresponding author
- Baum, Seth J.
- Venue
- Clinical Cardiology
- Publisher
- Wiley
- Published
- 2017-03-22
- Volume
- 40
- Issue
- 4
- Pages
- 243-254
- ISSN
- 0160-9289 (ISSN-L)
- 1932-8737
- PMC
- PMC5412679
- OpenAlex
- W2600369610
- Cited by
- 88
- References
- 58
- Citations by year
- 2026: 7 · 2025: 4 · 2024: 7 · 2023: 5 · 2022: 7 · 2021: 13 · 2020: 12 · 2019: 15 · 2018: 8 · 2017: 10
- FWCI
- 2.61
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Clinical Cardiology (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Amgen and Sanofi/Regeneron
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
- Keywords
- PCSK9 inhibitors, alirocumab, evolocumab, access barriers, insurance coverage, familial hypercholesterolemia, LDL cholesterol lowering, atherosclerotic cardiovascular disease, lipid control
- MeSH terms
- Proprotein Convertase 9, PCSK9 Inhibitors, Antibodies, Monoclonal, Cost-Benefit Analysis, Humans, Hypercholesterolemia, Drug Costs, Practice Guidelines as Topic, Indole Alkaloids, Antibodies, Monoclonal, Humanized
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