Bluebird’s Zynteglo Approval Kicks Off Commercial Operations
Beta-Thalassemia Gene Therapy’s List Price Is $2.8m
Bluebird bio’s Tom Klima told Scrip launch preparations are well under way, including negotiations with payers on outcomes-based reimbursement agreements.
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The $3m gene therapy for the rare disease cerebral adrenoleukodystrophy marks bluebird’s second approval in just under a month.
San Rocco, whose potential rival gene therapy for thalassemia is in preclinical development, had wanted FDA to delay approval of bluebird’s BLA until resolution of a patent case and a ‘careful investigation’ of Zynteglo’s risks.
Outcomes and disease progression could be clear cut, lending the rare disease treatment to innovative contracting. But the amount of money at stake is likely to complicate things.