The Centers for Medicare & Medicaid Services has successfully negotiated agreements with two drug manufacturers to participate in the newly created Cell and Gene Therapy Access Model.
Vertex Pharmaceuticals’ drug Casgevy and bluebird bio’s Lyfgenia, both approved by the Food & Drug Administration in December, were selected. Both treat sickle cell disease.
States and U.S. territories in the Medicaid Drug Rebate Program can choose to participate in the voluntary model. Payments will be dealt out depending on whether the drugs improve outcomes for people with Medicaid.
Interested states can begin applying this month and can apply for optional funding by the end of February.
More than 100,000 people have sickle cell disease in the U.S., with approximately more than half enrolled in Medicaid. Sickle cell disease predominantly impacts Black and Hispanic Americans, data from the Centers for Disease Control and Prevention shows, and the life expectancy is around 20 years shorter.
“Cell and gene therapies hold significant potential to improve patient outcomes and transform lives, ultimately reducing long-term health care spending,” said Liz Fowler, deputy administrator and director of the CMS Innovation Center, in a news release. “However, due to the high costs, these therapies can pose challenges to state budgets. This model will afford state Medicaid agencies more budget predictability while helping improve access to these innovative therapies for people with Medicaid with sickle cell disease.”
In February 2023, CMS released its model designed to rein in the cost of gene and cell therapies by collaborating with state Medicaid agencies.
Eleven months later, CMS said to expect sickle cell disease to be one of the first priorities of the model before later expanding to other conditions. That plan was reemphasized Dec. 4.