— Public comment period now open until September 23, 2020; Requests to make oral comment during public meeting also being accepted —
BOSTON, August 26, 2020 – The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of treatments for hemophilia A; this assessment includes valoctocogene roxaparvovec (Roctavian™, BioMarin Pharmaceutical) and emicizumab (Hemlibra®, Genentech). ICER is proceeding with this assessment despite the complete response letter that BioMarin Pharmaeutical recently received from the FDA. This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.
Submit a Public Comment
The Draft Evidence Report and Draft Voting Questions are now open to public comment until 5 PM ET on September 23, 2020. 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 October 16, 2020. All comments and ICER’s response to comments will be posted publicly along with the Evidence Report.
Register for the Virtual Public Meeting
The Evidence Report will be the subject of a virtual public meeting of the New England CEPAC. During the meeting, the independent council will vote on key questions raised in the report. Registration for the virtual public meeting is now open.
Register to Make an Oral Comment
During the virtual 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 September 23, 2020. 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.