Insurance companies place heavy barriers on access to PCSK9 inhibitors

A $14,000 price tag isn’t the only thing standing between cardiac patients and cholesterol-lowering PCSK9 inhibitors anymore—access to the drugs could be further blocked by insurance companies, according to a study published in Circulation: Cardiovascular Quality and Outcomes this week.

PCSK9 inhibitors are relatively recent additions to the cardiovascular care market but have been effective in lowering cholesterol levels in patients who are less responsive to traditional treatment, like statins, lead author Jalpa A. Doshi, PhD, and colleagues wrote. These individuals suffer from either familial hypercholesterolemia (FH) or atherosclerotic cardiovascular disease (ASCVD), and can inject the medication to protect against heart attack and stroke.

But PCSK9 inhibitors can cost a patient $5,000 per year out-of-pocket, according to JAMA Cardiology, with retail costs skyrocketing to more than $14,000. Insurance companies can help, but Doshi and co-authors’ research suggests extensive prior authorization could be roadblocking that option.

“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,” Doshi said in a University of Pennsylvania release. “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 researchers analyzed data that spanned 3,872 insurance plans in the commercial, health insurance exchange, Medicare and Medicaid sectors, according to the study. They found that between 82 percent and 97 percent of Americans were enrolled in insurance plans that would require prior authorization to receive PCSK9s.

Authorization could include anything from heavy paperwork to medical records to hard-to-locate documents, the authors wrote. On average, clinicians were required to meet 3 to 11 more demands for PCSK9 requests than other medications, and patients are still seeing a high rejection rate for the drugs.

“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,” 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.”