Philadelphia—If pharmacists are able to fill surprisingly few prescriptions for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, a new report might help explain why.

The study published in Circulation: Cardiovascular Quality and Outcomes found significant administrative burden in the prior-authorization requirements for the new class of medications for patients with high cholesterol that increases their risk for heart attack or stroke.

Researchers from the Perelman School of Medicine at the University of Pennsylvania point out that the requirements are coming from both public and private insurers across the country. The self-injected medications were approved by the FDA in 2015 for patients with familial hypercholesterolemia (FH) and those with atherosclerotic cardiovascular disease (ASCVD) who have high cholesterol despite receiving statins and other traditional treatments.

“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,” explained lead author Jalpa A. Doshi, PhD, a professor of General Internal Medicine. “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.”

For the study, researchers analyzed data from a proprietary database containing information on prior-authorization policies covering more than 275 million Americans, i.e., 95% of those with prescription coverage. Reviewing data from 3,872 plans in the commercial, health insurance exchange, Medicare, and Medicaid segments, the study found that between 82% and 97% of Americans were enrolled in plans requiring prior authorization for PCSK9 inhibitors.  

Furthermore, in many of those plans, clinicians had to submit medical records instead of filling out a form, which is the more common approach. Also required were patient histories that might have been hard to obtain if patients had switched physicians in the past, the researchers note.

“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 coauthor Michael Parmacek, MD, chair of Medicine at the Perelman School of Medicine at the University of Pennsylvania. In fact, researchers found some payors required confirmation of the FH diagnosis through genetic testing, which is not a standard test in clinical practice and typically not covered by insurance.

The study also found that prior-authorization criteria for PCSK9 inhibitors was much more burdensome than that for ezetimibe and liraglutide, two other medications that would be prescribed by the same types of physicians and also were more expensive than alternative treatment options. Compared to those drugs, prescribers had three to 11 times the number of required items to be filled out on the prior-authorization form for PCSK9s and more frequent demands to justify responses to individual items with medical-record submissions, authors report.
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