BOSTON, January 26, 2018– The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of emicizumab (Hemlibra®, Genentech, Inc.). Emicizumab was approved by the FDA in November of 2017 for prevention of bleeding in adults and children who have hemophilia A with coagulation factor VIII inhibitors. Factor VIII is the clotting protein that is deficient in those with hemophilia A, and inhibitors interfere with the factor replacement therapy that would typically be used to treat the condition.
ICER is committed to engaging with all stakeholders in a thorough and transparent manner. Prior to conducting this review, ICER spoke with key patient groups, clinical experts, and manufacturers, and accepted public comments 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.
Submit a Public Comment: The Draft Evidence Report and Draft Voting Questions are now open to public comment until February 23rd at 5 PM ET. 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 March 15, 2018. All comments and ICER’s response to comments will be posted publicly along with the revised Evidence Report.
Register for the Public Meeting: The Evidence Report will be the subject of a public meeting of the New England Comparative Effectiveness Public Advisory Council on March 29, 2018 in Cambridge, MA. During the meeting, the independent council will vote on key questions raised in the report, and an expert policy roundtable will discuss recommendations to apply the evidence to policy and practice.
Register now to attend the meeting in person, or register to watch the live webcast.
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 PM ET on February 23, 2018. 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.