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bluebird bio, Inc. (NASDAQ:BLUE) ("bluebird bio") today announced it has signed its first Medicaid outcomes-based agreement for LYFGENIA™ (lovotibeglogene autotemcel, also known as lovo-cel) with the state of Michigan. LYFGENIA is a one-time gene therapy approved for the treatment of patients 12 years of age and older with sickle cell disease and a history of vaso-occlusive events (VOEs). Approximately 50 percent of individuals living with sickle cell disease in the U.S. are insured by Medicaid.
"Our commercial approach is built on the principle that people with sickle cell disease insured through Medicaid deserve the same timely access to gene therapy as patients with other forms of insurance," said Tom Klima, chief commercial & operating officer, bluebird bio. "We are extremely pleased to have reached this agreement with Michigan Medicaid and with the momentum behind our reimbursement negotiations across the board just months following approval, which underscores payers' shared commitment to equitable access and understanding of the value that LYFGENIA can bring to people living with sickle cell disease, their caregivers, and the healthcare system."
bluebird is an established leader in developing and implementing innovative, value-based contracting approaches. The Company has designed outcomes-based contract options unique to LYFGENIA that offer payers meaningful risk sharing tied to VOE-related hospitalizations—a claims-based metric that is directly correlated with clinical benefit and aligned with study endpoints in the LYFGENIA clinical development program—with patients followed for three years. bluebird's outcomes-based contract offering for State Medicaid Agencies was designed with direct input from government payers to specifically address the challenges they face in adapting to provide access to one-time, transformative treatments, and reflects the Company's unmatched experience delivering gene therapies in the commercial setting.
bluebird is in ongoing discussions with more than 15 Medicaid agencies representing 80 percent of Medicaid-insured individuals in the U.S. Additionally, bluebird has signed multiple outcomes-based agreements for LYFGENIA with national commercial payer organizations representing dozens of downstream plans and covering approximately 200 million U.S. lives.
bluebird is also engaged with the Center for Medicare and Medicaid Innovation (CMMI) on its Cell and Gene Therapy Access Demonstration Model, which is anticipated to start in 2025.
About LYFGENIA™ (lovotibeglogene autotemcel) or lovo-cel
LYFGENIA is a one-time ex-vivo lentiviral vector gene therapy approved for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events (VOEs). LYFGENIA works by adding a functional β-globin gene to patients' own hematopoietic (blood) stem cells (HSCs). Durable production of adult hemoglobin with anti-sickling properties (HbAT87Q) is possible following successful engraftment. HbAT87Q has a similar oxygen-binding affinity to wild-type HbA, limits sickling of red blood cells and has the potential to reduce and VOEs.
The Phase 1/2 HGB-206 study of LYFGENIA is complete and the Phase 3 HGB-210 study evaluating LYFGENIA is ongoing. bluebird bio is also conducting a long-term safety and efficacy follow-up study (LTF-307) for patients with sickle cell disease who have been treated with LYFGENIA in bluebird bio-sponsored clinical studies.
Posted In: BLUE
