Update: ICER’s report on RA will now be the subject of a New England CEPAC meeting scheduled for March 23, 2017. The timeline has been revised accordingly. For the current timeline and meeting details, please see the meeting page.
July 11, 2016 – The Institute for Clinical and Economic Review (ICER) will develop a report assessing the comparative clinical effectiveness and value of new and emerging drug therapies for treatment of rheumatoid arthritis (RA). The report may also assess therapies for treatment of psoriatic arthritis (PSA); the decision of whether to include PSA will be made based on feedback received during the scoping period for the report.
Beginning with this review and effective for all future reviews, ICER will be instituting an “Open Input” period. This period begins immediately, with the announcement of the topic, and will last for three weeks. The Open Input period is intended to allow all stakeholders to share key information as ICER is developing the Draft Scoping Document. During this time, ICER will also be contacting key patient groups and clinical experts to gain further insights on the topic.
During the Open Input period, all stakeholders, including patient groups, clinicians, and manufacturers, are invited to submit commentary on a broad range of issues, including but not limited to:
- Important patient-relevant and patient-centered outcomes, especially those not adequately captured in the clinical trial data
- Key publications from clinical trials
- Other benefits and disadvantages (e.g. more convenient delivery method, significant public health benefit, potential to reduce disparities, etc.)
- Key research needs
- Contextual considerations
- Any other input deemed relevant and critical to a comprehensive understanding of the evidence base
There are no page limits to Open Input submissions. Input received will be used to inform the development of the Draft Scoping Document, which, in turn will serve as the foundation for a Final Scoping Document and ultimately an Evidence Report. All input can be emailed to firstname.lastname@example.org and must be received by 5PM on Monday, August 1st in order to be considered.
Please note the new Open Input period will not apply to ICER reviews that are already in progress, including non-small cell lung cancer, psoriasis, and multiple sclerosis. More information on ICER’s engagement process can be found on our website.
ICER’s review of RA and PSA will be the subject of a January 2017 meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC). During the meeting, the independent Council will deliberate and vote on the comparative clinical effectiveness and value of the treatments included in the review. The Council will discuss the implications of the votes for policy and practice with a roundtable of experts in the field to provide guidance to patients, clinicians, insurers, and policymakers confronted with decisions on how best to manage the condition under review.
Key dates for the development of the report, including formal opportunities for stakeholder engagement, are as follows:
- Open Input Period: July 11- August 1
- Draft Scoping Document posted: August 1
- Public comment on Draft Scoping Document: August 1- August 22
- Final Scoping Document posted: August 29
- Draft Evidence Report and Draft Voting Questions Posted: November 14
- Public Comment on Draft Evidence Report and Draft Voting Questions: November 14-December 13
- Evidence Report and Revised Voting Questions Posted: January 4
- Public Meeting of the Midwest CEPAC: January 19
- Final Report Posted: January 25
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.