Majority of PCSK9 inhibitor prescription claims initially rejected

Amgen's data from two studies shows that for appropriate patients in the United States, the majority of prescription claims for PCSK9 inhibitors, such as Repatha (evolocumab), were initially rejected.
One of those two studies, which were presented at the American College of Cardiology 66th Annual Scientific Session (ACC 17), also showed no major differences in the characteristics of patients who were denied versus those who were accepted. Amgen noted that this result suggests a utilization management process not driven by any observable clinical criteria.
"While it is important to ensure that PCSK9 inhibitors are used in appropriate cases, our data suggest that the current approval process is lengthy and highly variable by payer. High initial rejection and slow approval rates may be preventing patients who could truly benefit from getting these drugs," Dr. Ann Marie Navar, assistant professor of medicine at the Duke Clinical Research Institute and lead study investigator, said in a statement. "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."