WASHINGTON, DC—Amgen presented new data from two studies showing how the majority of prescription claims for PCSK9 inhibitors like Repatha (evolocumab) are initially rejected for patients in the United States. One of the two studies further revealed no major differences in patient characteristics for those who were approved and denied, suggesting an inconsistent utilization management process. Full findings from the two studies were presented at the ACC.17 Scientific Session.
Study researchers evaluated 45,029 new PCSK9 inhibitor prescription claims in one retrospective study. They reported that 79.2% were initially rejected across commercial and Medicare plans, of which 52.8% were ultimately rejected. Also, the authors found 34.7% of prescriptions were unfilled by the patient.
The rate of rejection differed based on prescribing provider and payer (P<0.001). Over 70% of prescription claims submitted to commercials payers were ultimately rejected and 40% of claims submitted to government payers were ultimately rejected. The authors noted that their analysis did not examine patient characteristics of those denied and approved.
Data from a second retrospective study evaluated 44,234 new PCSK9 inhibitor prescription claims and found that 83% of claims were initially rejected with 57% being ultimately rejected. The rate of final rejection was higher in commercially insured patients vs. Medicare patients (69.5% vs. 42.3%). No major differences in baseline statin use, statin intensity, ezetimibe use or history of co-medication use (including antiplatelets) were found between approved and denied patients.
“This study highlights the need to better investigate the impact of policies around drug access on the utilization of novel therapies, including pricing, payments and reimbursement, and the approval process,” said Ann Marie Navar, MD, PhD, assistant professor of medicine at the Duke Clinical Research Institute and lead study investigator.
Lead study investigator, Seth Baum, MD, president of the American Society for Preventive Cardiology added, “The similarities in clinical profiles between accepted and rejected patients suggest concerning inconsistencies in the approval-rejection process.”
Repatha, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, is approved as adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C); and as adjunct to other LDL-lowering therapies (eg, statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.
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