The Institute for Clinical and Economic Review (ICER) on Friday 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, 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 began Friday 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 until 5 p.m. April 9.
During that 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.