Michigan is First Medicaid Program to Offer Lyfgenia for Sickle Cell

Michigan is the first state to sign an outcomes-based agreement for Lyfgenia (lovotibeglogene autotemcel) for patients with sickle cell disease who are in the state’s Medicaid program.

Developed by bluebird bio, Lyfgenia is a one-time gene therapy that is designed to add functional copies of a modified form of the β-globin gene into a patient’s own blood stem cells, enabling the body to produce its own hemoglobin. The FDA approved Lyfgenia in December 2023.

Sickle cell disease is a group of inherited blood disorders affecting about 100,000 people in the United States. The disease is caused by mutations in a gene that encodes a key component of hemoglobin, the oxygen carrying molecule in blood. It can lead to painful symptoms and chronic hospitalizations and can reduce life expectancy. Treatment involves regular transfusions.

Lyfgenia has a wholesale acquisition cost of $3.1 million. Bluebird executives said this price recognizes the value the therapy may deliver. Frequent vaso-occlusive events average between $4.0 and $6.0 million in direct lifetime medical costs, Bluebird said in a press release. A vaso-occlusive crisis occurs when sickled red blood cell block blood flow, resulting in pain.

Company officials said in a press release that the outcomes-based agreement was designed to offer payers risk sharing tied to vaso-occlusive events-related hospitalizations for three years. This is a claims-based metric that bluebird said was correlated with clinical benefit and aligned with study endpoints in the Lyfgenia clinical development program.

Bluebird’s outcomes-based contract for state Medicaid agencies was designed with input from government payers to address the challenges they face in providing access to gene therapies.

Related: Questions Remain about CMS’s Plan for Gene Therapy Access in Medicaid

Bluebird is in ongoing discussions with more than 15 Medicaid agencies representing 80% of Medicaid-insured individuals in the United States. bluebird is also engaged with the Center for Medicare and Medicaid Innovation (CMMI) on its Cell and Gene Therapy Access Demonstration Model, which is anticipated to start in 2025.

Additionally, bluebird has signed multiple outcomes-based agreements for Lyfgenia with national commercial payers representing covering about 200 million U.S. lives. One of these is Synergie Medication Collective, a contracting company formed last year by a group of Blue Cross Blue Shield plans. The collective was formed to engage with manufacturers for access to injected or infused medications, including gene therapies. Collectively, these organizations serve almost 100 million people.

In January, bluebird announced that it anticipates there will be about 85 to 105 patients starts for the therapy across commercial payers.