ICER to Assess Upadacitinib and Other Treatments for Rheumatoid Arthritis

–Open Input now being accepted; Review will be subject to public deliberation at upcoming CTAF meeting–

BOSTON, March 26, 2019 – The Institute for Clinical and Economic Review (ICER) will conduct an update to its 2017 assessment on therapies for rheumatoid arthritis, including new evidence on upadacitinib (AbbVie), which is currently under review by the FDA with an expected decision around August 2019.

The assessment will be publicly discussed during a meeting of the California Technology Assessment Forum in October of 2019, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.

An Open Input period begins today, and comments will be accepted from all interested stakeholders until April 8, 2019 at 5 PM ET. This period is intended to allow stakeholders to share key information relevant to the development of the evidence report. 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. ICER will be most interested to learn how new evidence and emerging therapies have affected the treatment landscape since the 2017 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 publiccomments@icer-review.org and must be received by 5 PM ET on April 8, 2019 to be considered.

The Draft Scoping Document, which will provide more detail on ICER’s proposed scope, will be available on or about April 11, 2019. This draft document will be open to public comment for three weeks.

Timelines of the key dates are available here.

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.