BRIEF—ICER drops assessment of canakinumab for atherosclerosis

The US Institute for Clinical and Economic Review (ICER) yesterday announced that it will not proceed with its comparative clinical effectiveness and value assessment of canakinumab.

This decision is the result of the Food and Drug Administration recently issuing a Complete Response Letter to Swiss pharma giant Novartis, declining to approve canakinumab’s expanded indication for atherosclerotic cardiovascular disease.

Canakinumab, marketed by Novartis under than brand name Ilaris, was originally approved by the FDA in 2009 and is indicated for various rare inflammatory disorders

In June 2018, the ICER originally  announced its intention to assess canakinumab.

With the termination of this assessment, the ICER is also canceling the February 2019 public meeting of the California Technology Assessment Forum (CTAF), which was scheduled to review ICER’s evidence report and develop recommendations for how stakeholders could apply the evidence on canakinumab to improve the quality and value of cardiovascular health care.