— Public comment period extended through November 8, 2019; Public meeting now to take place on December 9, 2019 in Oakland, CA —
BOSTON, October 11, 2019 – The Institute for Clinical and Economic Review (ICER) today released an updated Draft Evidence Report assessing the comparative clinical effectiveness and value of treatments for rheumatoid arthritis (RA).
After initially publishing an earlier version of this Draft Evidence Report on September 26, 2019, ICER’s internal reviewers identified the need to reevaluate some of the assumptions and calculations in the report to better align our economic modeling with how patients transition between these therapies in the real world. In our updated model, patients that are failed by first-line treatment now transition to a market basket of targeted immune modulators, instead of palliative care. Also, because clinical differentiation between these therapies is uncertain over time, we will now analyze their cost-effectiveness in the first year of use, instead of over a patient’s lifetime.
With this new update, the public comment period on this draft report has been extended until 5 p.m. ET on November 8, 2019. Based on stakeholder feedback, ICER may revise key assumptions and findings for its Evidence Report, which will be published on November 26, 2019. The Evidence Report will be subject to deliberation during a public meeting of the California Technology Assessment Forum (CTAF), one of ICER’s three independent evidence appraisal committees, on December 9, 2019.
ICER is committed to engaging with all stakeholders in a thorough and transparent manner. During this review, ICER has spoken with patients, clinical experts, insurers, and manufacturers. Public comments were also accepted on a Draft Scoping Document. The current draft report incorporates input received from patients, clinicians, and other stakeholders during each of these opportunities for engagement.
ICER conducted economic analyses on the hēRo3 modeling platform to assess the long-term cost-effectiveness of these therapies. Consistent with our model transparency program, ICER is able to use the hēRo3 platform to securely share the economic model with manufacturers to better inform their public comments on this draft report.
Submit a Public Comment
The Draft Evidence Report and Draft Voting Questions are now open to public comment until 5 p.m. ET on November 8, 2019. All stakeholders are invited to submit formal comments by email to email@example.com. Guidelines for submitting public comments, including formatting specifications, are available on ICER’s website. ICER’s Manufacturer Engagement Guide and Patient Participation Guide provide additional detail on what types of information may be most informative to the report.
ICER will review all comments and incorporate any necessary changes in the Evidence Report and Revised Voting Questions that will be posted on or about November 26, 2019. All comments and ICER’s response to comments will be posted publicly along with the Evidence Report.
Register for the Public Meeting
The Evidence Report will be the subject of a public meeting of the CTAF on December 9, 2019 in Oakland, CA. During the meeting, the independent council will vote on key questions raised in the report. Registration for the public meeting and live webcast is now open.
Register to Make an Oral Comment
During the public meeting, there will be a limited amount of time available for interested stakeholders to make an oral comment on the report. Requests to submit oral comments must be emailed to firstname.lastname@example.org by 5 p.m. ET on November 8, 2019. Individuals who wish to deliver oral comments must separately register to attend the meeting. For more information about registering for oral comment, please visit our website.
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.