bluebird bio’s Lovo-Cel Will be Covered Under Outcomes-Based Agreement With Michigan Medicaid

bluebird bio has established an outcomes-based agreement with Michigan Medicaid for the coverage of lovotibeglogene autotemcel (lovo-cel, marketed as Lyfgenia), an FDA-approved ex-vivo lentiviral vector-based gene therapy indicated for patients with sickle cell disease (SCD) who aged 12 years or older and have a history of vaso-occlusive events (VOEs).¹

bluebird bio stated that it has previously set outcomes-based agreements with a number of commercial insurance companies that collectively cover 200 million Americans and that it is working on additional agreements with more than 15 more Medicaid agencies. The company noted that the aforementioned Medicaid agencies cover 80% of people with Medicaid in the United States and that in total 50% of people with SCD in the US are covered by Medicaid.

Bluebird’s outcomes-based contract options for lovo-cel utilize VOE-related hospitalizations as a metric for risk sharing, with patients followed for 3 years posttreatment. Notably, the FDA’s approval of lovo-cel, which occurred on December 8, 2023, was based on results from 36 patients treated in the phase 1/2 HGB-206 clinical trial (NCT02140554) and 2 patients treated in the phase 3 HGB-210 clinical trial (NCT04293185).² Both of these trials utilized the same primary end point: complete resolution of VOEs between 6 and 18 months after infusion. At that time, 88% (n = 28) of the 32 included patients achieved this milestone.

According to an article published in The Lancet on December 16, 2023, lovo-cel carries a price tag of $3.1 million in the US.³ Bluebird has stated that because lovo-cel is a 1-time treatment expected to have a transformative impact on disease it poses unique issues for government payers.¹ The company noted it has utilized their input with the intent of addressing these difficulties.

“Our commercial approach is built on the principle that people with SCD insured through Medicaid deserve the same timely access to gene therapy as patients with other forms of insurance,” Tom Klima, BA, the chief commercial and operating officer of bluebird bio, said in a statement.¹ “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 payers’ shared commitment to equitable access and understanding of the value that Lyfgenia can bring to people living with SCD, their caregivers, and the healthcare system.”

Lovo-cel consists of autologous CD34+ hematopoietic stem cells collected by plerixafor mobilization and apheresis, transduced with BB305 lentiviral vector encoding the human beta-A-T87Q globin gene.² It was approved on the same day that Vertex and CRISPR Pharmaceuticals' exagamglogene autotemcel (exa-cel; Casgevy), a CRISPR-based gene-edited cell therapy, was approved by the FDA for a similar SCD indication.

In January 2024, Blue Cross Blue Shield became the first health insurance company in the US to agree to provide coverage for the 2 aforementioned SCD gene therapies.⁴ Although priced lower than lovo-cel, exa-cel's cost in the US is still in the range of millions of dollars at $2.2 million.

“In 2023 bluebird cemented our status as a gene therapy leader, securing our third FDA approval in under 2 years and establishing a commercial footprint that will support growth in the coming year and beyond,” Andrew Obenshain, MBA, BA, the chief executive officer of bluebird bio, said in a January 2024 statement.⁵ “In 2024 we are leveraging our validated commercial strategy to accelerate the launch of Lyfgenia and drive continued strong uptake for Zynteglo. We are extremely pleased with the indicators of demand from both patients and providers in the weeks following FDA approval of Lyfgenia and are focused on using our real-world experience to support timely and equitable access and deliver a positive treatment experience.”

REFERENCES
1. bluebird bio announces first outcomes-based agreement with medicaid for sickle cell disease gene therapy. News release. bluebird bio, Inc. March 11, 2024. Accessed March 14, 2024. https://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-announces-first-outcomes-based-agreement-medicaid
2. FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease. News release. FDA. December 8, 2023. Accessed March 14, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease
3. The Lancet. The promise of genetic therapies in sickle cell disease. The Lancet. 2023;402(10419):2265. doi: https://doi.org/10.1016/S0140-6736(23)02797-6
4. Blue Cross Insurers Will Be First To Cover New Sickle Cell Gene Therapies. News article. KFF health News. January 22, 2024. Accessed March 14, 2024. https://kffhealthnews.org/morning-breakout/blue-cross-insurers-will-be-first-to-cover-new-sickle-cell-gene-therapies/
5. bluebird bio provides update on commercial launch progress, program milestones, and 2024 financial outlook. News release. bluebird bio, Inc. January 8, 2024. Accessed March 14, 2024. https://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-provides-update-commercial-launch-progress-0