SOMERVILLE, Mass. - bluebird bio, Inc. (NASDAQ:BLUE), a biotechnology company specializing in gene therapies, announced today an outcomes-based agreement with Michigan Medicaid for its gene therapy product LYFGENIA™ (lovotibeglogene autotemcel), designed to treat sickle cell disease in patients 12 years and older with a history of vaso-occlusive events (VOEs). This marks the company's first Medicaid agreement for LYFGENIA™, a one-time treatment approved to alleviate the complications of this genetic disorder.
Tom Klima, bluebird bio's chief commercial & operating officer, emphasized the importance of this agreement for Medicaid-insured individuals with sickle cell disease, stating that it reflects a commitment to equitable access and acknowledges the therapy's potential benefits. The contract includes provisions for shared financial risk based on the therapy's performance, specifically its impact on VOE-related hospitalizations, over a three-year period.
bluebird bio has crafted its Medicaid contract options with input from government payers, aiming to address the challenges of providing access to transformative, one-time treatments. The company is actively negotiating with over 15 Medicaid agencies, which represent 80 percent of the Medicaid-insured U.S. population. In addition, bluebird has established multiple outcomes-based agreements with national commercial payers, extending coverage to approximately 200 million American lives.
LYFGENIA™ works by adding a functional β-globin gene to a patient's own blood stem cells, which can result in the production of adult hemoglobin that limits red blood cell sickling and potentially reduces VOEs. The therapy has completed a Phase 1/2 study and is currently undergoing a Phase 3 trial, with a long-term follow-up study also in progress.
As with any medical treatment, LYFGENIA™ comes with potential risks, including hematologic malignancy. Patients who receive the therapy are advised to undergo lifelong monitoring for such malignancies. The therapy has not been studied in patients with more than two α-globin gene deletions.
The announcement of this agreement with Michigan Medicaid is part of bluebird bio's ongoing efforts to partner with healthcare payers, including discussions with the Center for Medicare and Medicaid Innovation (CMMI) for a model anticipated to launch in 2025. The company continues to focus on gene therapies for severe genetic diseases, leveraging its experience in bringing these therapies from clinical studies to commercial availability.
This news is based on a press release statement from bluebird bio, Inc.
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