October 09, 2019
Patients who were prescribed but denied insurance coverage for PCSK9 (proprotein convertase subtilisin kexin 9) inhibitors had a significantly higher rate of cardiovascular events compared with patients whose prescriptions were covered, according to a study published online in the journal Circulation: Cardiovascular Quality and Outcomes.
“Atherosclerotic cardiovascular disease remains a major cause of death and disability, especially for high-risk familial hypercholesterolemia individuals. PCSK9 inhibitors reduce low-density lipoprotein cholesterol levels and cardiovascular event rates,” researchers wrote. “However, PCSK9 inhibitor prescriptions are rejected at high rates by payers, and use is often delayed or eventually abandoned as a treatment option.”
Researchers compared real-world outcomes for 139,036 adults prescribed PCSK9 inhibitors between August 2015 and December 2017. For the analysis, patients were separated into three groups: those whose prescriptions were paid, rejected, or abandoned. In cases of abandonment, the payer approved the PCSK9 prescription, but the patient did not collect or refill it—likely due to high out-of-pocket costs.
In an analysis in which “paid” was defined as 168 or more days of paid PCSK9 inhibitors within a year, hazard ratios for cardiovascular events were 1.10 for patients with rejected prescriptions and 1.12 for patients with abandoned prescriptions compared with patients whose prescriptions were paid, researchers reported.
In a stricter analysis where “paid” was defined as 338 or more days of paid PCSK9 inhibitors within a year, hazard ratios were 1.16 for patients with rejected prescriptions and 1.21 for patients with abandoned prescriptions compared with patients with paid prescriptions.
Higher rates of insurance rejection for PCSK9 inhibitors occurred with women, racial minorities, and patients with lower incomes, the study found.
“Appropriately identifying and characterizing barriers to PCSK9 inhibitor access, and developing approaches to overcome them, will reduce the clinical and economic burden for patients who are likely to benefit from PCSK9 inhibition,” researchers concluded, “and likely result in more cost-effective policies for payers.”
Myers KD, Farboodi N, Mwamburi M, et al. Effect of access to prescribed PCSK9 inhibitors on cardiovascular outcomes. Circulation. 2019;12(8):e005404.