BOSTON, October 24, 2018 – The Institute for Clinical and Economic Review (ICER) today 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 Novartis Pharmaceuticals, declining to approve canakinumab’s expanded indication for atherosclerotic cardiovascular disease.
In June 2018, ICER originally announced its intention to assess canakinumab. With the termination of this assessment, 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.
ICER thanks Jeffrey A. Tice, MD, Professor of Medicine at the University of California San Francisco, for serving as the clinical evidence author; and Dhruv S. Kazi, MD, MSc, MS, Associate Director of the Richard F. and Susan A. Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center in Boston, for leading the development of the cost-effectiveness model.
The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.
ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.