Less than one-third of patients prescribed a PCSK9 inhibitor during the first year they were available on the market actually received the medication – due to low insurance approval rates and patient abandonment reported a study recently published in JAMA Cardiology.

The high cost of PCSK9 inhibitors has led to strict prior authorization practices and high copays, resulting in reduced patient access to the drugs in clinical practice. This study, authored by Ann Marie Navar, MD, PhD, et al., determined the proportion of patients prescribed PCSK9 inhibitors who ultimately received therapy and factors associated with approval and dispensing during the first year after PCSK9 inhibitor approval in the U.S.

New PCSK9 inhibitor prescriptions were evaluated from August 1, 2015 through July 31, 2016. The first transaction date for a patient’s PCSK9 inhibitor prescription was considered the prescribing date. Approval rates during the first 24 hours, ultimate approval and dispense rates were evaluated. The proportion of dispensed versus abandoned prescriptions by percentile of copay was also assessed.

Data for a total of 45,029 patients were analyzed. During the first day after a prescription was submitted, 79.2 percent were rejected and 20.8 percent were approved. Among the rejected prescriptions, 73.5 percent were appealed or resubmitted, of which 45.4 percent were approved, leading to a final approval rate of 47.2 percent. Among patients who received approval, 34.7 percent never picked up their medication. Ultimately, 30.9 percent of the patients prescribed a PCSK9 inhibitor received therapy. The median time between initial submission and approval was 3.9 days, with 5 percent of patients waiting ≥87 days for approval.

Factors associated with prescription approval included older age, male gender, atherosclerotic disease, government versus commercial insurance and use of a specialty versus retail pharmacy. Prescriptions written by a cardiologist were more likely to be approved than those written by a general practitioner (odds ratio, 1.42). LDL-C level and statin use did not affect approval rates.

Prescription approval also varied significantly by pharmacy benefit manager (PBM). In the study, it was possible to correctly discriminate ultimate approval in 72 percent of cases based on patient age, sex, pharmacy type, prescriber type, payor and PBM (C statistic, 0.721). The inclusion of laboratory, medication and diagnoses data only increased model prediction to a C-statistic of 0.737.

The rate of prescription dispensing dropped from 92.6 percent among patients with $0 copay to 20-25 percent among those with ≥$350 copays. Copay alone was highly predictive of whether a patient would fill their prescription (C statistic, 0.86). Female gender, patients with government insurance, use of a specialty pharmacy, and increased time to approval were also associated with lower dispensing rates.

The authors write that one of the strongest factors associated with approval rates was the specific payor and PBM, which is likely because of differences in both criteria for approval and the process itself. “Even after navigating the approval process, nearly one-third of patients did not pick up their medication, which was mostly explained by out-of-pocket cost,” the authors write. 

Keywords: Hydroxymethylglutaryl-CoA Reductase Inhibitors, General Practitioners, Refusal to Treat, Odds Ratio, Health Expenditures, Pharmacy, Pharmaceutical Services, Government

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