– Document open to public comment until May 2, 2018; Report expected to review lanadelumab (Shire), and C1 inhibitors Haegarda® (CSL Behring), Cinryze® (Shire), and Ruconest® (Pharming) –
BOSTON, April 12, 2018 – The Institute for Clinical and Economic Review (ICER) has posted a Draft Scoping Document outlining a planned review of 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 scoping document will be open to public comment until 5pm ET on May 2, 2018.
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 2018, and three C1 inhibitors (Haegarda®, CSL Behring; Cinryze®, Shire; and Ruconest®, Pharming). The report will be subject to deliberation during a public meeting of the California Technology Assessment Forum (CTAF), one of ICER’s three independent evidence appraisal committees, in October of 2018. ICER is also speaking with key stakeholders, including clinical experts, patients, and drug manufacturers, on an ongoing basis to gain additional insight into living with hereditary angioedema and to enrich the evidence available from clinical trials.
All interested stakeholders are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered.
Comments can be submitted by email to email@example.com and must be received by May 2nd at 5pm ET. All comments submitted must meet ICER’s formatting specifications.
ICER’s Patient Participation Guide and Manufacturer Engagement Guide provide additional guidance for submitting public comments, including suggestions for what types of information may be most useful.
In addition to comments on the scope, ICER also welcomes submissions from stakeholders on examples of low-value care practices within this clinical area. These submissions will inform a report section focused on strategies to reduce waste and preserve resources for high-value, potentially higher cost treatments. More information is available in the scoping document.
Following the public comment period, a revised scoping document will be posted on or about May 10, 2018.
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.