–Open Input now being accepted on both topics; Both reviews to be subject to public deliberation at upcoming CTAF meeting–
BOSTON, November 9, 2017 – The Institute for Clinical and Economic Review(ICER) will assess the comparative clinical effectiveness and value of erenumab (Amgen/Novartis) for prevention of migraine headaches. The FDA’s decision on whether to approve erenumab is expected in May of 2018.
In addition, ICER will conduct an update to its 2016 report on therapies for plaque psoriasis. ICER plans to review new evidence that has emerged on the previously reviewed therapies, as well as evidence on recently-approved guselkumab (Tremfya™, Janssen/Johnson & Johnson) and on tildrakizumab (Sun Pharma), which is currently under review by the FDA with an expected decision in March of 2018.
Both reports will be publicly discussed during a meeting of the California Technology Assessment Forum in June of 2018, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s reports.
An Open Input period begins today, and comments on both topics will be accepted from all interested stakeholders until November 30, 2017 at 5 PM ET. This period is intended to allow stakeholders to share key information relevant to the development of the evidence reports. 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 more information about the Open Input period, visit ICER’s website. ICER’s Manufacturer Engagement Guide and Patient 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. For the psoriasis condition update, ICER will be most interested to learn how new evidence and emerging therapies have affected the treatment landscape since the 2016 review.
There are no page limits to Open Input submissions, and input received will be incorporated throughout report development. All input can be emailed to email@example.com and must be received by 5 PM ET on November 30, 2017 to be considered.
Draft Scoping Documents, which will provide more detail on ICER’s proposed scope, will be available on or about December 4, 2017 for both reviews. These will be open to public comment for three weeks.
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.