Bluebird bio inks first Medicaid coverage agreement for sickle cell gene therapy, signing on with Michigan

Bluebird bio has secured its first Medicaid outcomes-based agreement for its sickle cell disease gene therapy Lyfgenia (lovo-cel), signing on with the state of Michigan.

It is the first in a series of deals the Massachusetts-based gene therapy company hopes to make as it is in discussion with more than 15 other agencies that represent 80% of Medicaid-insured people in the U.S., bluebird said. Roughly half of the people in the U.S. with sickle cell disease are covered by Medicaid.

The company already has inked several outcomes-based reimbursement deals for Lyfgenia with national commercial payer organizations representing plans that cover roughly 200 million in the U.S. Its first commercial deal came less than a week after the company scored an FDA approval for its treatment in December. That agreement was with a program that covers more than 100 million people in the U.S.

“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,” Tom Klima, bluebird’s chief commercial and operating officer, said in a release.

The outcomes-based framework offered by bluebird tracks treatment results for three years and provides rebates if a patient is hospitalized because of a painful episode of vaso-occlusion.

To avoid such events—when blood flow is restricted and muscles are deprived of oxygen—patients are often resigned to a lifetime of periodic and costly blood transfusions. While use of Lyfgenia comes with risks typical of other gene therapies, a single dose can be curative, which helps explain its prohibitive cost of $3.1 million and why elaborate coverage deals are necessary.

Vertex and CRISPR placed a $2.2 million price tag on their sickle cell disease gene therapy Casgevy (exa-cel), which created more buzz upon its FDA approval—that came on the same day—because it is the first medicine using the revolutionary CRISPR gene editing system, which won its creators a Nobel Prize in 2020.

Two months ago, Vertex reported that it had signed an agreement with Synergie Medication Collective, a contracting organization affiliated with companies covering approximately 100 million people in the U.S. to provide access to Casgevy.