— Due to delay in regulatory submission, ICER will reinitiate assessment at a future date —
BOSTON, March 3, 2020 – The Institute for Clinical and Economic Review (ICER) announced today that we plan to postpone our ongoing assessment of LentiGlobin (bluebird bio) for the treatment of beta thalassemia. Once a clearer timeframe for the therapy’s FDA review is known, we will reinitiate this assessment and announce an updated timeframe, which will include a new date for our public meeting.
On December 5, 2019, ICER launched our assessment of LentiGlobin, originally intending to conclude the review in August 2020. However, on February 18, 2020, bluebird announced that the company is engaged in discussions with the FDA regarding the requirements and timing of certain information to be provided in the rolling BLA submission; subject to these discussions, bluebird now is planning to complete its submission in the second half of 2020.
We anticipate that this additional time will enable bluebird to provide clinical trial data on a larger population of patients.
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.