Bluebird Bio has signed its first outcomes-based Medicaid agreement for its sickle-cell disease (SCD) gene therapy Lyfgenia with the state of Michigan.
While Bluebird has already signed agreements with several national commercial payer organizations, the firm noted in a statement that approximately 50% of people in the U.S. living with SCD are insured by Medicaid. Bluebird is currently in discussion with 15 other Medicaid agencies, representing 80% of Medicaid-insured people in the U.S.
Lyfgenia (lovotibeglogene autotemcel) is a one-time cell-based gene therapy that uses a lentiviral vector for genetic modification. It was approved in December by the U.S. Food and Drug Administration (FDA) for the treatment of patients 12 years of age and older with SCD and a history of vaso-occlusive events (VOEs) at the same time that the CRISPR-based SCD treatment Casgevy was approved. Lyfgenia and Casgevy are the first such effective approved SCD therapies.
Lyfgenia can be curative in a single dose; however, at $3.1 million, the treatment is cost-prohibitive. At the FDA advisory committee meeting held for Casgevy in October, concern over access to these treatments for all SCD patients was stressed.
"[B]luebird’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," the company said in its statement.
The outcomes-based contract being offered to agencies by Bluebird tracks patients for three years and will provide rebates if a patient is hospitalized due to a VOE.
VOEs, in which blood flow is restricted and muscles are deprived of oxygen, are often debilitating and may lead to life-threatening disabilities and early death. Their treatment involves periodic blood transfusions.
"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 and operating officer of Bluebird Bio.
