ICER has released the clinical portion of its New Evidence Update. The value analysis portion is expected to be released the week of September 5, 2017

Update will incorporate new data on outcomes for patients with atherosclerotic cardiovascular disease released during the March 17th American College of Cardiology conference

With important new clinical evidence now available, the Institute for Clinical and Economic Review (ICER) has begun a “New Evidence Update” to its 2015 review of the comparative clinical effectiveness and value of PCSK9 inhibitors alirocumab (Praluent®, Sanofi/Regeneron) and evolocumab (Repatha®, Amgen). The ICER update will assess newly-released data on the clinical efficacy of evolocumab in patients with atherosclerotic cardiovascular disease (ASCVD), but these trial results will not include data with which to update previous assessments of evidence for patients with familial hypercholesterolemia or those who are intolerant to statins.  The New Evidence Update will include a re-calculation of the ICER value-based price benchmark for evolocumab. ICER will also be reaching out to the clinical and patient community to gain additional insights on the importance of the new data from these perspectives. The New Evidence Update will be released within eight weeks.

“PCSK9 inhibitors have the potential to be an important option for many patients for whom other treatments are not appropriate or have been ineffective,” stated Steven D. Pearson, MD, MSc, ICER’s President. “New evidence released today will trigger reconsideration of the comparative clinical effectiveness and value of these drugs by patients, clinicians, insurers, and policymakers.  Given the substantial patient populations for which these drugs may be prescribed, we will rapidly produce a brief report assessing the new evidence, putting it in context with the findings of our previous assessment, and updating the calculation of a value-based price benchmark that aligns with the demonstrated clinical benefit to patients.  We hope this new evidence update will help ensure that our PCSK9 inhibitor assessment remains a useful source of information to inform clinical practice and policy decisions.”

Amgen announced that in a clinical trial, evolocumab met its primary endpoint of risk reduction for cardiovascular events in patients with ASCVD. The new data were unveiled during the March 17, 2017 American College of Cardiology conference and provide information on the ability of PCSK9 inhibitors to affect clinical endpoints.

ICER’s initial report reviewing PCSK9 inhibitors, along with votes on evidence by the independent New England Comparative Effectiveness Public Advisory Council, concluded that evidence was not sufficient to show that the drugs provided a net health benefit for patients with cardiovascular disease who cannot take statins, or who take statins but have not reached a suitable cholesterol level. The report’s conclusion was based largely on the uncertainty surrounding the use of surrogate endpoints in earlier clinical trials, which showed that PCSK9 inhibitors were effective in lowering LDL-C levels but did not provide clear evidence that lower LDL-C resulted in a reduced risk for cardiovascular events. ICER found that evidence did suggest a net health benefit for patients with familial hypercholesterolemia, due to increased risk factors associated with the condition.

ICER’s New Evidence Update will be available in mid-May of 2017. The update will incorporate the newly released data, including updated economic analyses and value-based price benchmarks. The update will be available here when available.