By Marie Rosenthal
Insurance companies are more likely to deny a claim for prescriptions of PCSK9 inhibitors than approve it, according to new research (Circulation 2017 Oct 30. [Epub ahead of print]).
PCSK9 inhibitors, such as evolocumab (Repatha, Amgen) and alirocumab (Praluent, Sanofi-Regeneron), have been shown to reduce low-density lipoprotein by 60% and decrease major cardiac events, but cost much more than other cholesterol-lowering drugs, with an average cost of $14,300 per year. Prescriptions require prior authorization by health insurance companies, but a recent study found that patients are not likely to receive that authorization.
In a nationwide review of the pharmacy claims combined with electronic medical record laboratory test results of 9,357 patients prescribed the drugs between July 2015 and August 2016, 4,397 patients (47%) were approved for PCSK9 inhibitor therapy and 4,960 (53%) were rejected. Of these patients, 60% had a history of atherosclerotic cardiovascular disease and 40% did not.
“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, the director of the Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center, in Boston. “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,” he said.
Researchers also found that the most significant factor associated with approval rates was insurance type, with the lowest approval rates from private insurance and the highest approval from Medicare.
“Just because a drug is indicated does not mean that it should be covered at any cost,” said C. Michael White, PharmD, FCP, FCCP, the department head and a professor of pharmacy practice at the University of Connecticut’s School of Pharmacy, in Storrs. “The cost-effectiveness is related to the number needed to treat to prevent a cardiovascular event. At $14,000 per year, the cost per quality-adjusted life-year [QALY] for PCSK9 inhibitors is astronomically high. Even with a 50% discount to the insurer, the number needed to treat has to be below 30 people to meet a threshold of less than $150,000 per QALY. This is the highest acceptable level of payment per QALY that [has] any support among health economists,” said Dr. White, who was asked to comment on the results (J Am Coll Cardiol 2016;68[22]:2412-2421).
“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,” said Dr. Yeh, who is also an associate professor of medicine at Harvard Medical School, in Boston.
Dr. White agreed with this statement. PCSK9 inhibitors are not indicated for everyone who has a high LDL. “In people without homozygous hypercholesterolemia, only people at very high risk of cardiovascular events or those at high risk with an LDL above 130 mg/dL would meet that number needed to treat threshold for cost-effectiveness,” he explained.
“I would be against not having PCSK9 inhibitors on the formulary but am fully supportive of steering utilization to those patients most likely to benefit and only after assuring that more cost-effective options have been exhausted. In any market-driven environment, there needs to be a dynamic interplay between the seller and the buyer in order to create a sustainable market, and this is just a manifestation of markets working properly,” Dr. White said.
“This analysis only scratches the surface of the criteria that insurers use to control drug spending in the PCSK9 class, but they by and large target therapy to scenarios where statins are not indicated, where statins plus ezetimibe have failed to control marked LDL elevations, and other select factors linked to cost-effectiveness,” he said.
The findings are based on Symphony Health’s HIPAA-compliant patient-level data from all 50 states and all payor types. The study was a retrospective analysis and could not determine whether patients experienced any cardiovascular effects from the denial of claims for these prescriptions.