25 September 2013

HEREDITARY ANGIOEDEMA: : Differential diagnosis non-itchy swelling.

www.HAEi.org HAE International MARBURG, GERMANY — 23 February 2013 - CSL Behring announced the results of a cost-effectiveness analysis showing that on-demand treatment of hereditary angioedema (HAE) attacks with Berinert®, C1 Esterase Inhibitor (Human), provides cost savings to payers when compared with the use of two other therapies approved in the U.S. for the acute treatment of HAE. The data were presented at the 2013 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The cost study, which compared Berinert to Firazyr® and Kalbitor™, analyzed differential dosing and administration costs indirectly using current, publically available prices. Results were weighted by typical re-dosing frequencies. The study included no head-to-head comparison of product efficacy or safety. “On-demand treatment options for acute swelling attacks of HAE differ widely in the doses administered per patient and price per administration, weighted partially by the need for re-dosing,” said Timothy J. Craig, D.O., Professor of Medicine and Pediatrics at Penn State University in Hershey, Pennsylvania, and one of the study’s investigators. “These factors significantly impact the overall cost of therapy. Our first-ever analysis of the differential costs to resolve HAE attacks found Berinert to be the least costly of these treatments, reflecting its minimal re-dosing frequency as the therapy is prescribed based on each individual’s weight.” Estimates for re-dosing frequencies for the HAE treatments were based on clinical trial data for all three Food and Drug Administration-approved products. The re-dosing frequency for Berinert (studied in the I.M.P.A.C.T. 1 and I.M.P.A.C.T. 2 trials) was 1 percent, while Firazyr® (FAST-1, FAST-2 and FAST-3) was 7 percent and Kalbitor™ (EDEMA1, EDEMA3 and EDEMA4) was 20 percent. Berinert is dosed based on weight, ranging from two to five vials (500 IU each) for patients weighing 50 to 150 kg. Berinert was the least costly on-demand treatment option for HAE in a typical patient with 75 kg per body weight needing three vials per treatment episode. Per attack, Berinert was estimated to save patients $79.29 to $4,659 compared to Firazyr® and $2,628 to $7,208 compared to Kalbitor™. Berinert is approved for on-demand treatment of acute abdominal, facial or laryngeal attacks of HAE in adults and adolescents, and is approved for patient self-administration after proper training by a healthcare professional.