What’s new: The CMS Innovation Center is broadening the framework of the Cell and Gene Therapy (CGT) Access Model beyond sickle cell disease to invite manufacturers of other cell and gene therapies to apply to the model following positive initial results from the first model evaluation report.
Why it matters: The broadened model would make life-changing therapies more affordable to state Medicaid programs, giving more patients access to treatments they need to live healthier lives.
What to expect: In the coming months, CMS will release a Request for Applications for manufacturers to allow for negotiations for outcomes-based agreements to start more quickly—whether right after FDA approval or licensure of a therapy or for therapies already approved—and to broaden the model's scope beyond sickle cell disease.
The big picture: The Administration is dedicated to convening partners across the health care system to address affordability so patients can get critical care. This model has shown strong state buy-in and clear advantages to CMS-led negotiation over a fragmented, state-by-state approach to negotiations.
Additional details: In the voluntary CGT Access Model, CMS negotiates outcomes-based agreements with manufacturers on behalf of state Medicaid programs. Initial evaluation results indicated CMS-led negotiations (focused on the model’s treatment of sickle cell disease) eased administrative burden, giving state Medicaid programs greater negotiating leverage by pooling beneficiaries.
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