Institute for Clinical and Economic Review to Assess Canakinumab for Atherosclerosis

— Review will be subject of January Midwest CEPAC meeting —

— Open Input now being accepted until July 5th 

 

BOSTON, June 18, 2018 — The Institute for Clinical and Economic Review (ICER) today announced plans to develop a report assessing the comparative clinical effectiveness and value of canakinumab (Novartis) for cardiovascular risk reduction in people with atherosclerosis. The report is set to be reviewed during a January 2019 public meeting of the Midwest Comparative Effectiveness Public Advisory Council, one of ICER’s three independent evidence appraisal committees.

Canakinumab was originally approved by the FDA in 2009 and is marketed for various rare inflammatory disorders; it is currently under review for a new indication in atherosclerosis.An Open Input period begins today and is intended to allow stakeholders to share key information relevant to the development of the evidence report. Comments will be accepted from all interested stakeholders on either topic until 5 PM ET on July 5, 2018. During this time, ICER will also contact key patient groups and clinical experts to gain further insights on the patient perspective and clinical context of treatment for these conditions.

For more information about the Open Input period, visit ICER’s website. ICER’s Manufacturer Engagement GuidePatient Participation Guide, and Patient Guide to Open Input provide additional information for manufacturers and patient groups, including an explanation of what types of information may be most informative.

There are no page limits to Open Input submissions, and input received will be incorporated throughout report development. All input can be emailed to publiccomments@icer-review.org and must be received by 5 PM ET on July 5, 2018 to be considered.A draft scoping document for the review will be available on or about July 10, 2018 and will provide more detail on ICER’s planned analyses. The documents will be open to public comment for three weeks.

ICER’s website provides a timeline of key posting dates and public comment periods for the review.

About ICER

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.