Amgen (AMGN) announced data from two new studies exploring barriers to access for PCSK9 inhibitors


New Analyses Show Payer Utilization Management Criteria Deny Access To PCSK9 Inhibitors For Patients At The Highest Risk For Subsequent Cardiovascular Events

The first study, “Cardiovascular Risk in Patients Denied Access to PCSK9i Therapy,” (Abstract #1129-408) found only 35 percent of 3,472 commercially insured and Medicare patients requesting access to a PSCK9 inhibitor were approved by their health plan in 2016. Among the 65 percent of patients who were denied access, the rate of acute cardiovascular (CV) events was higher than the rate in the overall patient population requesting a PCSK9 inhibitor. Acute CV events were defined as heart attack, ischemic stroke, hospitalization for unstable angina or coronary revascularizations.

“Based on the rejection and event rates observed in the 2016 data, we estimate that among appropriate patients prescribed PCSK9 inhibitors, over 110,000 acute cardiovascular events could have occurred in patients rejected access to a PCSK9 inhibitor,” said Seth Baum, M.D., president of the American Society for Preventive Cardiology and lead study investigator. “A particular concern is that, among patients who are at an increased risk of subsequent acute cardiovascular events, two out of three were denied access to a PCSK9 inhibitor in 2016.”

Another study presented, “Predicting Cardiovascular Risk Using Common Utilization Management Criteria for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors in Commercially Insured Patients With Atherosclerotic Cardiovascular Disease,” (Abstract #1129-409) showed  commercial payer utilization management criteria fail to prioritize patients at the highest risk for CV events. Researchers evaluated data from 2012 to 2013 among 5,276 commercially insured patients with atherosclerotic CV disease. They found that the stringent utilization management criteria used by commercial payers that may delay or deny appropriate treatment for uncontrolled low-density lipoprotein cholesterol (LDL-C) do not identify patients at the greatest risk for further heart attacks, strokes or with the greatest need for coronary revascularizations.

According to 2017 data from Symphony Health, approximately 70 percent of commercial patients prescribed Repatha® (evolocumab) have their prescriptions denied by their insurance provider.1

“These data further highlight what we have seen for the past two years and the need for improved access to medications like Repatha that reduce life-changing events, such as heart attacks and strokes, among high-risk cardiovascular patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Clinical data and experience tell us those at highest risk for further cardiovascular events benefit the most from intensive LDL-cholesterol lowering with a PCSK9 inhibitor, like Repatha. We are in active discussions with payers to align on clinically grounded, utilization management policies with the goal of best serving the needs of appropriate patients and ensuring access to Repatha.”

Cardiovascular Risk in Patients Denied Access to PCSK9i Therapy (Abstract #1129-408)

An estimated 65 percent of patients requesting PCSK9 inhibitors were denied access and 35 percent were approved. The baseline rate of acute CV events over a six-month follow-up period in patients rejected for a PCSK9 inhibitor was numerically higher (7.29 per 100 patient years), compared to the overall rate of 6.73 per 100 patient years in the patients requesting PCSK9 inhibitors. At the 2016 rejection and event rates, the data suggest that if all appropriate patients were prescribed PCSK9 inhibitors, over 110,000 acute CV events would occur in patients inappropriately rejected.


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