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 5 p.m. EST May 2.
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 , 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 firstname.lastname@example.org and must be received by 5 p.m. EST May 2. All comments submitted must meet ICER’s formatting specifications.
To read more on ICER’s latest Draft Scoping Document, and how to submit your comments, click here.