Amgen declared that data from two new studies suggest barriers to access for PCSK9 inhibitors

Amgen revealed that data from two new studies suggest barriers to access for PCSK9 inhibitors and the potential consequences of barring access for PCSK9 inhibitors and the potential consequences of denying coverage for high-risk patients.

The studies will be presented at the American College of Cardiology’s 67th Annual Scientific Session.

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.

Seth Baum, M.D., president of the American Society for Preventive Cardiology and lead study investigator said “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 , “Predicted  Cardiovascular Risk Using Common Utilization Management Criteria for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors in Commercially Insured Patients With Atherosclerotic Cardiovascular Disease” that exhibited 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.

Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. said “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.”

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.

This retrospective cohort study analysed data from the QuintilesIMS Formulary Impact Analyzer (FIA) database across 3,472 patients requesting access to Repatha or Praluent (alirocumab) from January 2016 to December 2016. The mean patient age was 58 years; 56 percent were male and 44 percent were female.

Using the International Classification of Diseases, Volume 9 and 10 (ICD-9 and ICD-10) and Current Procedural Terminology (CPT) billing codes, researchers estimated baseline acute CV event rates (defined as heart attack, stroke, hospitalization for unstable angina, and coronary revascularizations) in the six months following a final decision on PCSK9 inhibitor reimbursement and access requests.