NEW YORK – Bluebird Bio has inked its first outcomes-based contracting agreement with a state Medicaid agency for the sickle cell disease gene therapy Lyfgenia (lovotibeglogene autotemcel), the firm said on Monday.
Somerville, Massachusetts-based Bluebird's Lyfgenia was one of two sickle cell gene therapies approved by the US Food and Drug Administration in December, representing the first time the agency has greenlighted such treatments for the disease. Both came with sky-high price tags, with Lyfgenia's list price clocking in at $3.1 million.
Bluebird's latest contracting deal is with the state of Michigan, with which the firm has struck a risk-sharing agreement that ties payment to whether sickle cell patients on Lyfgenia experience painful episodes known as vaso-occlusive events and end up in the hospital. In the deal, patients' vaso-occlusive events will be tracked through medical claims for three years.
At the American Society of Hematology's annual meeting in December, Bluebird shared data on 34 patients who had at least four vaso-occlusive events in the two years prior to starting Lyfgenia treatment in the clinical trial. Of these patients, nearly 90 percent reported complete resolution of such events six to 18 months after getting a single infusion of the gene therapy.
Bluebird, in setting the $3.1 million wholesale acquisition cost for Lyfgenia, considered that, on average, patients with frequent vaso-occlusive events incur between $4 million and $6 million in direct lifetime medical costs. Still, the company has priced the treatment above the $1.35 million and $2.05 million range that the Institute for Clinical and Economic Review, a nonprofit that conducts independent value assessments of healthcare interventions, has deemed cost-effective.
Bluebird said the outcomes-based offering is designed to address challenges payors face covering one-time, potentially curative treatments, especially since half of the around 100,000 patients living in the US with sickle cell disease have Medicaid coverage.
"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 payors' 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," Tom Klima, chief commercial and operating officer at Bluebird, said in a statement.
Bluebird said it is having discussions about outcomes-based contracts for Lyfgenia with more than 15 state agencies that cover 80 percent of the Medicaid-insured population in the US. The firm is also talking with the Centers for Medicare & Medicaid Services' innovation center about including outcomes-based pricing negotiations for Lyfgenia within a cell and gene therapy access demonstration model the agency hopes to launch next year.