WASHINGTON – During the first year that the lipid-lowering PCSK9 inhibitors were on the U.S. market, 2015-2016, fewer than half the patients prescribed the drug had it covered through their health insurance, based on an analysis of prescriptions written for more than 45,000 patients.

On top of that, about a third of patients with health insurance that eventually agreed to cover the notoriously expensive PCSK (proprotein convertase subtilisin–kexin type) 9 inhibitors failed to actually collect their medication, possibly because of a sizable copay, which meant that, in total, fewer than a third of U.S. patients prescribed these drugs actually began using them, Ann Marie Navar, MD, said at the annual meeting of the American College of Cardiology.

The findings highlight not only the obstacles patients recently faced getting these pricey drugs, which cost roughly $14,000/year based on their list price, but also show “a disconnect between providers’ intent in prescribing these drugs and what patients actually get,” noted Dr. Navar, a cardiologist at Duke University in Durham, N.C. Now that the highly anticipated results from a large clinical outcomes study, FOURIER (N Engl J Med. 2017 Mar 17. doi: 10.1056/NEJMoa1615664), proved that the potent lipid-lowering effects of PCSK9 inhibitors can reduce cardiovascular disease events, Dr. Navar wondered whether coverage barriers will recede.

The recent PCSK9-inhibitor experience highlighting the frequent preauthorization roadblocks and denied coverage that providers and patients must navigate is “one of the dirty little secrets of American medicine,” commented Mariell Jessup, MD, a discussant for the study and professor of medicine at the University of Pennsylvania in Philadelphia.

Dr. Navar countered that these problems may be a secret for many Americans “but it’s not a secret for providers. We know the problems patients have getting drugs covered through the prior authorization process.”

The study she ran focused on the outcomes of prescriptions written for any PCSK9 inhibitor starting in August 2015, immediately after the first agent from this class received Food and Drug Administration marketing approval in July of that year. (A second PCSK9 inhibitor received FDA marketing approval in August 2015.) She collected data through the end of July 2016 from Symphony Health, a health care data company that had prescription coverage information for this period that included roughly 90% of U.S. retail pharmacy business, 70% of specialty pharmacy business, and 60% of mail-order pharmacy business.

Symphony Health’s records included 45,029 U.S. patients who received a first-time PCSK9-inhibitor prescription during the 12 months studied. Just over half were prescriptions exclusively covered by government-funded insurance (with 90% of these covered through Medicaid), 40% exclusively by a commercial insurer, and the balance subject to dual coverage. Nearly half the prescriptions were written by cardiologists, 37% by primary care physicians, and most of the remaining 15% came from endocrinologists.

Among these prescriptions, 79% received an initial rejection. Following appeals, 53% were rejected and 47% covered. Among the more than 21,000 prescriptions approved for coverage, 13,892 (31% of the 45,029) were actually received by patients, Dr. Navar reported.

During the first several months following availability of the PCSK9 inhibitors, the number of new prescriptions steadily rose until a plateau occurred by about April 2016 of about 6,000 new prescriptions written per month. During each of the 12 months examined, the proportion of prescriptions denied coverage remained roughly constant, suggesting that clinicians developed no insights over time into how to better the prospect for ultimate insurance coverage.

In a multivariate analysis certain aspects of the prescribing and coverage process linked with significantly better rates of patients actually receiving the PCSK9 inhibitor. Prescriptions filled at mail-order pharmacies were over fourfold more likely to be received by patients than those filled at retail pharmacies. Prescriptions written by cardiologists were 80% more likely to be received than those written by primary care physicians; those written by endocrinologists were 30% more likely to be filled. Patients who relied exclusively on a government insurance plan had a threefold greater filling rate than those who exclusively had commercial insurance, and patients with both government and commercial insurance had a fourfold greater rate of receiving their prescription, compared with commercial-only patients. Patients who used a manufacturer’s coupon to help reduce the cost of their prescription had a 17-fold higher rate of receiving the drug, compared with patients who did not use a coupon.

A final set of findings underscored the great variability in the approval process that patients encountered. Among the 13,892 prescriptions that were actually dispensed, 45% were dispensed within 1 day of when the prescription was written, but the median time for dispensing wasn’t reached until the tenth day, and for a quarter of the dispenses the lag from writing the prescription to getting it into patients’ hands was greater than 1 month. Rates of coverage denials also varied widely depending on the specific commercial insurers involved and the specific pharmacy benefit manager. Among the top 10 commercial insurers included in the data set, the rate of coverage denial ranged from 33% to 78%.

This variability suggested that many denials were not simply because of clinical factors. Some commercial insurers “introduce vigorous and sometimes burdensome prior authorization procedures,” Dr. Navar said.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

Coverage denials plague U.S. PCSK9-inhibitor prescriptions