– Review will be subject of October CTAF meeting; Open Input now being accepted until April 9th –
BOSTON, March 23, 2018 – The Institute for Clinical and Economic Review(ICER) today announced plans to assess the comparative clinical effectiveness and value of therapies for hereditary angioedema, a rare condition characterized by attacks of deep tissue swelling within the skin and/or mucosa. The report is set to be reviewed during an October 2018 public meeting of the California Technology Assessment Forum, one of ICER’s three independent evidence appraisal committees.
ICER’s report is expected to focus on four therapies for the prevention of hereditary angioedema attacks: lanadelumab (Shire), which is currently under review by the FDA with an approval decision expected in August of 2018, and three C1 esterase inhibitors (Haegarda®, CSL Behring; Cinryze®, Shire; and Ruconest®, Pharming). This list is tentative and subject to change.
An Open Input period begins today and is intended to allow stakeholders to share key information relevant to the development of the evidence report. Comments will be accepted from all interested stakeholders on until 5 PM ET on April 9, 2018. 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 treatment for this condition.
ICER’s Manufacturer Engagement Guide, Patient Participation Guide, and Patient Guide to Open Input provide additional information for manufacturers and patient groups, including an explanation of what types of information may be most informative.
There are no page limits to Open Input submissions, and input received will be incorporated throughout report development. All input can be emailed to publiccomments@icer.org and must be received by 5 PM ET on April 9, 2018 to be considered.
A draft scoping document for the review will be available on or about April 12, 2018 and will provide more detail on ICER’s planned analyses. The scoping document will be open to public comment for three weeks.
ICER’s website provides a timeline of key posting dates and public comment periods.
About ICER
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.