Bluebird bio’s Lyfgenia launch progresses with 2nd major outcomes-based coverage deal

Despite competitive pressure from a buzzy CRISPR therapy, bluebird bio keeps striding forward with its sickle cell disease gene therapy Lyfgenia.

The Massachusetts biotech has signed a second outcomes-based reimbursement agreement for Lyfgenia, according to a securities filing. The deal pushes Lyfgenia’s coverage range to nearly 200 million people in the U.S., up from the previous 100 million when bluebird signed the first agreement three weeks ago.

Bluebird pulled off the feat within a month of winning FDA approval for Lyfgenia in SCD patients who have a history of the painful blood flow blockade episodes known as vaso-occlusive events. And it comes despite the company pricing Lyfgenia at a wholesale acquisition cost that’s about 40% higher than Vertex and CRISPR Therapeutics’ rival gene therapy Casgevy.

Under these outcomes-based agreements, bluebird is offering a discount if a patient is hospitalized because of vaso-occlusion events within three years after treatment. In addition to commercial payers, bluebird has said it’s offering contracting options to state Medicaid agencies as well.

The two therapies have shown similar efficacy in keeping vaso-occlusion at bay. But analysts hold different opinions about which company may be more successful when it comes to their marketing promotion efforts.

Although the FDA approved Lyfgenia and Casgevy at the same time, bluebird got a head start on its launch preparations. Bluebird had already been selling Zynteglo, a twin med to Lyfgenia for beta thalassemia, since fall 2022, and it has built a network of qualified treatment centers, which Casgevy can’t match at the moment.

But a William Blair team previously pointed to Vertex’s “extensive commercial experience” built on a successful cystic fibrosis franchise as a threat to bluebird.

Following Lyfgenia’s approval and a surprise lack of an FDA priority review voucher, bluebird in December launched a $150 million public offering to support commercialization. Although the dilutive capital raise could alleviate a near-term cash constraint, “the pathway to cash flow breakeven is still murky in absence of truly remarkable launch acceleration,” Leerink Partners analysts wrote in a December note.

Lyfgenia’s black-box warning and higher list price could be challenges in its competition with Casgevy, the Leerink team said.

Bluebird will provide an update on Lyfgenia’s launch progress at the upcoming J.P. Morgan Healthcare Conference on Tuesday.

PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.

Related News

Related Services