New cell and gene therapies promise to revolutionize care for patients with genetic diseases.Many of these diseases affect children in and around One in three U.S. children enrolled in Medicaid or the Children’s Health Insurance Program (CHIP)Challenges for Government: Cell and gene therapies are potentially breakthrough treatments, but they are costly and, due to the (relatively) short duration of clinical trials, long-term clinical benefit is often uncertain.
One solution to this problem is outcome-based contracts. Under outcomes-based contracts, payers pay only when cell and gene therapies are effective.
To help state Medicaid agencies implement the protocol, CMS’ Innovation Center is considering implementing cell and gene therapy access models. CMS describes the program as follows:
Cell and Gene Therapy Access Models: Cell and gene therapies are an emerging area of new drug development with enormous potential, but the cost of these therapies can run as high as $1 million. Under this model, state Medicaid agencies would assign CMS to coordinate and manage outcome-based multistate agreements with manufacturers for certain cell and gene therapies. As new treatments become available, this will help Medicaid beneficiaries access potentially life-changing, high-cost specialty medicines for conditions like sickle cell disease and cancer.
One benefit for cell and gene therapy manufacturers is that CMS can coordinate a single outcomes-based contract instead of negotiating individually with 50 different state Medicaid agencies.
some other summaries Drug Affordability and Accessibility Model listed below.