A recent investigation by the Family Heart Foundation, a nonprofit focused on research and advocacy for inherited lipid disorders, has brought to light the ongoing challenges in accessing a crucial cholesterol-lowering medication, despite significant medical and economic efforts to improve its reach.
The medication in question, PCSK9 inhibitors (PCSK9i), is designed to lower low-density lipoprotein cholesterol (LDL-C), a key factor in cardiovascular risk, particularly for those at high risk of heart attacks and strokes.
The study, published in Circulation: Cardiovascular Quality and Outcomes, underscores a persistent issue: even after efforts to enhance the prescription of PCSK9i—through label expansion, conclusive outcomes trials, a substantial price drop, and the establishment of clinical guidelines—insurance plan rejections remain unusually high.
This situation persists despite the potential of PCSK9i to significantly reduce cardiac events in high-risk patients.
Between 2017 and early 2019, developments aimed at increasing the use of PCSK9i included a 60% price reduction and evidence from large-scale studies showing their effectiveness in reducing heart attacks and strokes.
Moreover, the 2018 ACC/AHA Multi-society Guidelines on the Management of Blood Cholesterol highlighted PCSK9i as a recommended treatment for patients who do not achieve low enough LDL-C levels with statins alone.
However, the research indicates that these measures have not sufficiently overcome barriers to access. During the period from 2019 to 2021, there were only 470,018 new prescriptions for PCSK9i, a modest increase from the 238,704 prescriptions recorded between 2015 and 2018.
Additionally, the rejection rate by insurance plans stood at 30.95%, significantly higher than for other cardiometabolic therapies, which range from 3.53% to 14.61%.
The implications of these findings are profound. A previous study by the Family Heart Foundation in 2019 demonstrated that patients whose PCSK9i prescriptions were either rejected by insurance or not filled experienced a higher rate of cardiovascular events within a year compared to those who received their medication.
Diane E. MacDougall, Vice President of Science and Research at the Family Heart Foundation and co-author of the current study, emphasized the severe consequences of these access issues.
Patients eligible for PCSK9i face a heightened risk of heart attacks and other cardiovascular incidents due to the barriers in obtaining prescribed medications.
The ongoing struggle to access PCSK9i highlights a critical gap in healthcare delivery for patients with high cholesterol at risk of cardiovascular disease.
Despite clear guidelines and proven benefits, the financial and bureaucratic hurdles in obtaining these life-saving medications underscore the need for systemic changes to ensure that high-risk patients can benefit from advanced treatment options.
The study calls for a concerted effort among healthcare providers, insurance companies, and policymakers to address these challenges and improve access to vital treatments.
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The research findings can be found in Circulation: Cardiovascular Quality and Outcomes.
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