Bluebird snags more outcomes-based coverage for its $3M+ sickle cell gene therapy

The announcement brings the cumulative total of covered lives for the therapy known as Lyfgenia to approximately 200 million people, suggesting that the biotech has locked up broad coverage from major insurers after facing doubts about its commercial strategy.

The first outcomes-based agreement, announced in an SEC filing on Dec. 14, came with another unnamed organization covering approximately 100 million lives in the US. Bluebird also said it is in advanced discussions with a number of the nation’s other large commercial payers and more than 15 Medicaid agencies collectively representing 80% of individuals with sickle cell disease in the US.

The company added in the SEC filing last month that including its two other therapies, it anticipates 85 to 105 patients starting treatment this year. Along with Lyfgenia, that includes Zynteglo, its gene therapy for the treatment of beta thalassemia, and Skysona, its gene therapy to treat boys with early, active cerebral adrenoleukodystrophy.

Bluebird had previously stressed that its outcomes-based contract options offer payers meaningful risk sharing tied to a claims-based metric for sickle cell — costly hospitalizations for vaso-occlusive events — with patients followed for three years.

The moves to shore up coverage come after the company’s stock declined by about 40% on the day the therapy won FDA approval as it was priced $900,000 more than Vertex and CRISPR’s competing sickle cell therapy known as Casgevy, approved on the same day.

Vertex currently has nine authorized treatment centers in the US, according to a website for the treatment. Bluebird, which has invested heavily in building out infrastructure for its products, has more: 18 qualified treatment centers according to its website, but 27 accepting patients, according to a bluebird spokesperson. The full network for bluebird is supposed to be up and running by the end of the first quarter of this year.

Beyond the higher price, bluebird had counted on the FDA granting a priority review voucher when it approved Lyfgenia to treat sickle cell. In fact, the biotech was so confident that it announced in October that Novartis had already agreed to buy the PRV for $103 million. But in the end, it didn’t get one, and Vertex did, with bluebird instead tapping two different sources to bring in up to $250 million.

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