Prior Authorization May Reduce Patient Access to PCSK9 Inhibitors

Prior authorization requirements implemented by public and private insurers have resulted in a significant administrative burden on physicians prescribing PCSK9 inhibitors for patients with high cholesterol, according to a new study published by Circulation: Cardiovascular Quality and Outcomes.

PCSK9 inhibitors are typically prescribed to patients with familial hypercholesterolemia (FH) and those with atherosclerotic cardiovascular disease (ASCVD) whose cholesterol levels remain high despite treatment.

“As innovative yet often expensive new drugs come on the market to treat serious and/or chronic medical conditions, insurers have turned to policies aimed at ensuring appropriate use in order to manage costs,” said lead author Jalpa A. Doshi, PhD. “Prior authorization—which requires a prescriber to demonstrate that a prescription is medically necessary for the patient before it is approved by the insurer–has been used for many years and is a fairly common strategy, but we found that the burden of the requirements for PCSK9 inhibitors were so high that they raise real concerns about access barriers.”

The authors investigated information from a database that included prior authorization policies for more than 95% of Americans with prescription drug coverage. Between 82% and 97% of Americans were enrolled in private or public health insurance plans that require prior authorization for PCSK9 inhibitors.

Many health plans required physicians to submit medical records and provide documentation regarding patient history that may not be available if patients have changed physicians, according to the study.

“Of particular concern was that patients with FH, where the need for PCSK9 inhibitors is more straightforward, faced the same cumbersome requirements as did patients with ASCVD,” said researcher Michael Parmacek, MD.

Additionally, insurers required genetic testing to confirm FH diagnosis. These tests are typically not covered by insurance and are not standard procedure, according to the study.

The authors said that requiring genetic tests could place a financial burden on patients, in addition to high out-of-pocket costs for PCSK9 inhibitors.

The investigators then compared prior authorization guidelines for PCSK9 inhibitors to 2 other alternative treatments that are prescribed by the same physicians and have similar characteristics.

The comparison indicated that prior authorization for PCSK9 inhibitors was more stringent compared with the other drugs. PCSK9 inhibitors required 3 to 11 times the number of items for prior authorization and more frequently required justification for individual items with medical records, according to the study.

Previous studies have found that PCSK9 inhibitors have a high rate of rejection. The authors of the current study said their findings may underscore some contributing factors.

“More paperwork means more risk of errors or omissions, and the forms weren’t consistent across insurance plans, so it’s also juggling multiple sets of requirements and appeals when initial requests are rejected,” Dr Doshi said. “This places particular burden on physicians in smaller practices without dedicated staff or resources to assist and could take time away from patient care. It raises the question of whether patients seen by physicians with greater administrative capacity, rather than those with the greatest medical need, are more likely to receive approval.”

The long-term efficacy and cost-effectiveness of PCSK9 inhibitors is still being evaluated, which may add to the reasons why they have numerous prior authorization requirements, according to the authors of the current study.

“It remains to be seen how payers will respond to additional evidence, and whether they will modify the prior authorization requirements,” said researcher Daniel Rader, MD. “While the concerns over the budget impact of prescribing PCSK9 inhibitors are certainly valid, there ultimately needs to be a balance between appropriate pre-approval requirements and ensuring those most in need have access to treatment.”