One of the approaches that CMS has is the Cell and Gene Therapy (CGT) Access Model. This model involves CMS negotiating outcomes-based agreements (OBAs) with manufacturers at the federal level, including pricing terms and outcomes to be evaluated. States can then choose to participate in the contract terms negotiated by CMS or negotiate on their own terms. This model is hoped to increase purchasing power, leading to lower prices or more negotiated rebates. Manufacturers aim to expedite access for patients and reduce transaction costs by negotiating with fewer than 50 State Medicaid Agencies. CMS will support states in implementing, monitoring, reconciling, and evaluating the financial and clinical outcomes outlined in OBAs.
What CGTs are planned for inclusion in the CGT Access model and their costs?
Two CGTs for treating sickle cell disease are planned for inclusion. “Casgevy” from Vertex Pharmaceuticals and CRISPR Therapeutics has a list price of $2.2 million per patient, while “Lyfgenia” from bluebird bio is listed at $3.1 million per patient.
What rebates could State Medicaid Agencies receive under the CGT Access Model?
Rebates include the standard Medicaid Drug Rebate Program (MDRP) rebate (Medicaid best price), additional guaranteed and volume rebates, as well as future rebates based on patient and population outcomes.
When would the rebates be paid?
Rebate timing depends on the type of rebate, with some paid immediately after treatment and others that come into effect at the end of the year or years after treatment administration.
How does the process look like from the patient perspective?
The CGT Access Model: Overview for States presentation provides a helpful timeline.
If a state chooses to participate in the model, can it negotiate additional discounts or terms?
If a state participates, it must enter into an agreement with the manufacturer reflecting the terms negotiated by CMS, although some limited state-to-state variation may be permitted.
What do states need to do to participate in the CGT Access Model?
Requirements include executing value-based purchasing supplemental rebate agreements (VBP SRAs) with manufacturers, pursuing state plan amendments, establishing a standardized access policy for included gene therapies, etc.
What legislation created the CGT Access Model?
The model was developed in response to President Biden’s Executive Order 14087, “Lowering Prescription Drug Costs for Americans.”
How can I learn more?
Additional information can be found on the CMS CGT Access Model webpage.
