News Briefs: ICER Says Evidence for Beti-Cel Demonstrates Net Health Benefit
The Institute for Clinical and Economic Review (ICER) unanimously determined that evidence for bluebird bio, Inc.’s betibeglogene autotemcel gene therapy “is adequate to demonstrate that the net health benefit of beti-cel is superior to that of standard clinical management,” it said in a final evidence report published July 19. “Given the high costs of standard care, cost-effectiveness modeling finds beti-cel meets commonly accepted value thresholds at an anticipated price of $2.1 million — if that price is subject to an 80% payback for treatment failure,” stated ICER in a press release. The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) unanimously voted in June in support of approval for the treatment of people with beta thalassemia who require regular red blood cell transfusions. The FDA is expected to make a decision on the application by Aug. 19.