The Institute for Clinical and Economic Review (ICER) will develop a report assessing the comparative clinical effectiveness and value of emicizumab, from Swiss pharma giant Roche (ROG: SIX) and its subsidiary Genentech.
Emicizumab is a monoclonal antibody currently under review by the Food and Drug Administration for the prevention of bleeding in patients who have hemophilia A with factor VIII inhibitors. An FDA approval of the drug 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. 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.
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