Despite Progress, Access to PCSK9 Inhibitors Remains Subpar Among US Patients

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A recent study is calling attention to issues in access to effective cholesterol-lowering medications for patients in the US.

An analysis of anonymized data from the Family Heart Database recorded between 2015 and 2021, results of the study indicate use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors among high-risk patients remain low in part because of high insurance rejection rates associated with the class relative to other similar therapies for cardiovascular and metabolic disease.¹

“The results from this new Family Heart Foundation study suggest that patients still experience substantial challenges getting the PCSK9i that have been prescribed for them by their medical team, despite guidelines recommending their use and extensive evidence documenting their role in LDL-C reduction and the prevention of heart attack or stroke," said study investigator Diane E. MacDougall, MS, vice president of Science and Research at the Family Heart Foundation.² “As a result, eligible patients remain at higher risk of heart attacks and other major cardiovascular events as demonstrated by the 2019 study.”

In 2015, cardiology witnessed history when the FDA approved alirocumab (Praluent) as the first PCSK9 inhibitor. A class that has since demonstrated its ability to induce significant LDL-C reductions in a multitude of trials, a 2017 label expansion to include reducing event risk and to reduce LDL-C in primary hypercholesterolemia left the class poised to make a significant impact on population level health.^1,3

Still, as MacDougall explains, uptake of the class has been suboptimal despite the benefits of use. In 2019, MacDougall and colleagues published a study suggesting those whose prescription was rejected by insurance plans or abandoned experienced significantly more myocardial infarction, strokes, and other cardiovascular events within 12 months.^1,3

In the current study, investigators hoped to evaluate how expanded guideline recommendations, indications, and price reductions may have influenced uptake and access to PCSK9 inhibitors in the US. With this in mind, investigators designed a retrospective cohort study of adults prescribed a PCSK9 inhibitor between July 2015 and December 2021 from the Family Heart Database, which is comprised of US health care claims data and represents more than half of the US census.¹

For the purpose of analysis, patients’ coverage for new PCSK9 inhibitor prescriptions were paid (covered by insurer; retrieved by individual), rejected (rejected by the insurer); or abandoned (covered by insurer; not retrieved). Investigators pointed out initial and durable coverage was assessed across 2 time periods, defined as 2015 to 2018 and 2019 to 2021.¹

Investigators defined initial coverage statusas use during the first 90 days and durable, paid coverage as having received ≥168 days of paid PCSK9i medication within any 12-month period, which is considered adequate therapy to potentially affect ASCVD events. Investigators also pointed out initial coverage of apixaban, sacubitril/valsartan, dapagliflozin, empagliflozin, and liraglutide served as a frame of reference.¹

Upon analysis, investigators found 238,704 patients were newly prescribed a PCSK9i from 2015 to 2018 and 470,018 patients were newly prescribed from 2019 to 2021. Analysis of demographic information from these cohorts revealed both were similar, with approximately 50% being female, 60% identifying as White, 7% identifying as Black, 5% identifying as Hispanic, and 28% to 29% as unknown ethnicity.¹

Overall, number of patients with paid prescriptions in the first 90 days rose 2.7-fold from 85,215 (2015–2018) to 234,703 (2019–2021) . When accounting for rejections by insurance plans and abandonments, the paid prescription rate for PCSK9 inhibitor coverage was substantially lower (35.7% to 49.93%) during the study period than those for other guideline-recommended cardiometabolic therapies (68.49% to 84.45%).¹

Further analysis revealed prescriptions for PCSK9 inhibitors were rejected 30.95% of the time, which was more than double any of the reference therapies included in the study (3.53% to 14.61%). Investigators highlighted prior authorization requirements (97% vs 44%) and provider intervention (100% versus 50% to 54%) were more common for PCSK9 inhibitors than for other guideline-indicated agents.¹

Investigators noted clinicians should consider the limitations of their study, such as potential misclassification or other biases in administrative claims data, when interpreting results.¹

References:

1. _{^{MacDougall DE, Baum SJ, Ahmed CD, McGowan MP, Wilemon KA. Trends in Patient Access to and Utilization of Prescribed PCSK9 Inhibitors in a Large US Claims Database From 2015 to 2021. Circ Cardiovasc Qual Outcomes. 2024;17(2):e009988. doi:10.1161/CIRCOUTCOMES.123.009988}}
2. _{^{Life saving medicine still being denied. Family Heart Foundation. February 21, 2024. Accessed March 13, 2024. https://familyheart.org/research-pcsk9i-still-being-denied.}}
3. _{^{Myers KD, Farboodi N, Mwamburi M, et al. Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes. Circ Cardiovasc Qual Outcomes. 2019;12(8):e005404. doi:10.1161/CIRCOUTCOMES.118.005404}}