Boston, Mass., August 11, 2017 – The Institute for Clinical and Economic Review (ICER) will develop a report assessing the comparative clinical effectiveness and value of emicizumab (Genentech/Roche), a monoclonal antibody currently under review by the FDA for prevention of bleeding in patients who have hemophilia A with factor VIII inhibitors. Factor VIII is the clotting protein that is deficient in hemophilia A, and inhibitors interfere with factor replacement therapy. An FDA approval decision is expected in the first quarter of 2018.
An “Open Input” period begins today, and comments on the topic will be accepted from all interested stakeholders until September 6, 2017 at 5 PM ET. The Open Input 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 this new treatment option.For more information about the Open Input period, including further explanation of the types of information that may be most helpful to development of the report, visit ICER’s website. ICER’s Manufacturer Engagement Guide and ICER’s Patient Participation Guide and Patient Guide to Open Input provide additional information for manufacturers and patient groups.
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 September 6, 2017 in order to be considered.
A Draft Scoping Document, which will provide more detail on ICER’s proposed scope for the review, will be available on or about September 11, 2017 and will be open to public comment for three weeks.
The report will be the subject of a March 2018 meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). During the meeting, the independent Council will deliberate and vote on the comparative clinical effectiveness, benefits or disadvantages, and contextual considerations of the therapy. The Council will discuss the implications of the votes for policy and practice with a roundtable including clinical experts and patients to provide guidance to patients, clinicians, insurers, and policymakers in making informed, evidence-based decisions related to use of the therapy.
The key dates for ICER’s review of emicizumab are included below:
- August 11 – September 6, 2017: Open Input opens
- September 11, 2017: Draft Scoping Document Posted
- September 11 – September 29, 2017: Public comment on draft scoping document
- October 10, 2017: Revised Scoping Document Posted
- January 26, 2018: Draft Evidence Report and Voting Questions posted
- January 26- February 23, 2018: Public comment on Draft Evidence Report
- March 15, 2018: Evidence Report Posted
- March 29, 2018: Public Meeting of the New England CEPAC
- On or about April 12, 2018: Final Report posted
More information about the report and meeting will be posted to ICER’s website as it becomes available.
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.