bluebird bio, Inc., a pioneer in the biotechnology industry, has announced the U.S. commercial infrastructure for LYFGENIA (lovotibeglogene autotemcel, also known as lovo-cel), an FDA-approved gene therapy for patients 12 years and older with sickle cell disease and a history of vaso-occlusive events (VOEs). The launch of LYFGENIA, leveraging bluebird’s experience in delivering ex vivo gene therapies in the U.S., includes outcomes-based contract offerings for payers and a personalized patient support program.

Tom Klima, Chief Commercial & Operating Officer at bluebird bio, emphasized the company’s commitment to ensuring timely and equitable access to this vital gene therapy. As an established leader in commercial gene therapy, bluebird aims to work collaboratively with healthcare providers and payers to make LYFGENIA widely accessible, particularly to communities in need of advanced treatment options.

Clinical studies of LYFGENIA have shown its potential as a curative therapy for Dr. Shantel Herbert-Mageesickle cell disease through the durable production of anti-sickling adult hemoglobin (HbAT87Q) and the resolution of VOEs. Recognizing the immense value and long-term impact of this therapy, bluebird has set the wholesale acquisition cost at $3.1 million in the U.S.

The burden of sickle cell disease is profound, affecting every aspect of patients’ lives. Beyond VOEs, patients face risks of organ damage, diminished quality of life, and early mortality. Financially, the disease imposes significant costs on healthcare systems and affects patients’ earnings potential.

To facilitate access, bluebird has designed outcomes-based contract options for LYFGENIA, offering payers risk-sharing tied to VOE-related hospitalizations and operational ease for state Medicaid agencies. These innovative contracts aim to balance the immediate drug costs with potential long-term health expenditure savings.

Dr. Shantel Herbert-Magee, Chief Medical Director of Louisiana Medicaid, highlighted the game-changing nature of this gene therapy for Medicaid programs, focusing on providing access to advanced therapies for disadvantaged and underinsured populations.

As part of its commercial strategy, bluebird is engaged in discussions with the nation’s largest commercial payers and over 15 Medicaid agencies, representing a significant portion of the U.S. population with sickle cell disease.

LYFGENIA’s approval introduces a one-time lentiviral vector gene therapy that adds a functional β-globin gene to patients’ hematopoietic stem cells, potentially reducing or eliminating VOEs. Its ongoing clinical studies further solidify its position as a promising treatment for sickle cell disease.

bluebird bio’s launch of LYFGENIA represents a significant advancement in the treatment of sickle cell disease and underscores the company’s dedication to delivering innovative, life-changing therapies to patients in need.

  bluebird bio, Dr. Shantel Herbert-Magee, gene therapy, LYFGENIA, Sickle Cell Disease, Tom Klima, USA