ICER Releases Update Due to New Evidence About PCSK9 Inhibitor Effectiveness

On Wednesday, the Institute for Clinical and Economic Review (ICER) added a “New Evidence Update” to the 2015 review of the comparative clinical effectiveness and value of PCSK9 inhibitors for management of high cholesterol.

The first part of the update, which is now available, discusses new information about the comparative clinical effectiveness of evolocumab resulting from the new evidence discovered during the Further Cardiovascular Outcomes Research (FOURIER) trial. The FOURIER trial participants included 27,563 patients with atherosclerotic cardiovascular disease (ASCVD) whose low-density lipoprotein cholesterol levels had not met the target amount of 70mg/dL. The participants were then randomly selected to receive evolocumab or identical placebo injections.

Prior to the update, ICER’s 2015 review found the clinical benefit of PSCK9 inhibitors to be inconclusive; however, the FOURIER trial results revealed that evolocumab combined with statins is effective for decreasing cardiovascular events. The evidence points to risk reductions for all outcomes with years of statin therapy. Despite this reduction, no significant decrease in mortality rates of cardiovascular disease was discovered.

“At the time of our initial report on PCSK9 inhibitors, the ability of these drugs to dramatically lower cholesterol levels was obvious,” said Steven D. Pearson, MD, MSc, president of ICER. “What remained unknown, and what was obviously of greatest importance to patients and clinicians, was the extent to which the lower cholesterol levels would ultimately help prevent strokes, heart attacks, and premature death."

ICER also plans to release an economic analysis update based on the FOURIER trial evidence and data that will involve a lower value-based price point for evolocumab. Prior to the new data, ICER had priced PCSK9 treatment at an annual price of $5404 to $7735.

"With data now available on these patient-centered outcomes from an important study of one of the two available drugs, and with insurers and others in the process of revisiting earlier coverage and pricing decisions, we felt it would be helpful to provide an update that summarizes our view of the implications of the new evidence for judgments of comparative clinical effectiveness,” noted Pearson. “We plan to release a second part of this update containing revised cost-effectiveness analyses and corresponding value-based price benchmarks in the near future."

ICER assures that studies will continue to be performed and analyzed in order to further investigate the effectiveness of the inhibitor alirocumab, which may lead to newly discovered evidence that can be applied to all PCSK9 inhibitors.