PCSK9 Inhibitors Have High Prior Authorization Rejection Rate

Less than half of patients with heart disease receive insurer approval for a newer class of cholesterol-lowering drug, according to a study published by Circulation. These findings may indicate that many patients who would benefit from PCSK9 inhibitors are not receiving access to the treatment.

PCSK9 inhibitors have been shown to reduce low-density lipoprotein cholesterol up to 60% and significantly lower the risk of cardiovascular events, including heart attacks and strokes. Despite their benefits, PCSK9 inhibitors cost an average of $14,300 per year, making their use subject to prior authorization, according to the authors.

The cost of the new class of heart disease drugs has caused it to be a controversial topic of conversation, with some experts wondering whether the cost is in line with the benefits.

Insurers use prior authorization and other methods to control costs. These methods also ensure that the right patients are taking the right medications, especially if the drugs are expensive, according to the study authors.

Included in the study were pharmacy claims and electronic medical records (EMRs) for 9357 patients who were prescribed PCSK9 inhibitors between July 2015 and August 2016. Approximately 60% of patients had a history of atherosclerotic cardiovascular disease.

The authors discovered that only 47% of patients who were prescribed the drug received insurance approval, leaving 53% of patients without access to the treatment, according to the study.

“With the controversy surrounding whether or not these drugs were cost effective, we were anticipating that there might be some reluctance by insurance companies to cover these medications,” said senior author Robert Yeh, MD. “However, we were surprised by the very high rate of rejection, even when prescribed to patients with known atherosclerotic cardiovascular disease, very high LDL levels and those who were intolerant of statins, for example.”

The authors discovered that prior authorization approval largely depended on the type of insurance a patient had. Interestingly, privately insured patients had the lowest approval rate, while Medicare had the highest approval rate, according to the study.

“Whether or not we can agree on the cost-effectiveness of these drugs, I believe most would agree that one’s access to medications should be driven primarily by the strength of the indications for the prescription as opposed to what drug plan you happen to carry,” Dr Yeh said.

Patients whose prior authorization requests are rejected may have to seek another treatment option or pay for PCSK9 inhibitors out of pocket, which may be too costly for many.

“Approximately 1 out of 3 patients who had their prescription approved did not purchase or receive the medication,” said first author Gregory Hess, MD, MBA, MSc. “Those patients who didn’t purchase their medication had an out-of-pocket cost that was twice as high as those who did purchase it.”

It is known that patients who have to pay high out of pocket costs for the drugs may be less likely to start therapy or remain adherent to the regimen in order to save money, which can threaten outcomes.

The authors suggest that standardized prescribing guidelines may result in more patients receiving access to the drugs.

“Better education for providers prescribing these medications and more uniform guidelines by insurers about what will and will not be covered are necessary to reduce the amount of administrative waste that is created to reject prescriptions for new medications,” Dr Yeh said.