– February 23, 2023 
Jeff Myers, Catalyst’s Senior Vice President, Market Access & Reimbursement Strategies, comments on the pricing models recently announced by CMS. Mr. Myers “says cell and gene therapy manufacturers may be skeptical of putting so much power in CMS’ hands when it comes to OBAs” (outcomes-based arrangements), the article states.
Under the new Cell and Gene Therapy Access Model, CMS would negotiate pricing, access, and outcome agreements with manufacturers for participating states. “Having CMS determine the outcomes for OBAs while simultaneously being the arbiter of market access and payment terms seems like a very bad idea,” he says.
“Instead, he suggests that CMS should allow private firms to work with states to help them manage the challenges associated with setting up multistate, outcomes-based contracts with manufacturers,” the article notes. “But Myers tells AIS Health that given the structure of the IRA [Inflation Reduction Act], which casts HHS as a central authority in setting certain drug prices in Medicare, he doesn’t have much hope that the Biden Administration will consider a public-private hybrid approach like what he is advocating.”
“‘I think it’s clear that both the administration and the agency [CMS] believe that adjusting drug prices has to be done in a top-down fashion,’ he says.”
Mr. Myers also comments on CMS’ new Accelerating Clinical Evidence Model, which would “reprice” payments for drugs approved under the Accelerated Approval pathway. CMS has said the new model would “encourage timely confirmatory trial completion” under Accelerated Approval. “Myers says he agrees that a solution is needed to incentivize manufacturers to ‘fulfill their requirement'” to complete the trials to confirm benefit. “However, Myers point out that drug manufacturers could respond to the possibility of their products’ prices being adjusted downward – as the Accelerating Clinical Evidence Model would do for therapies that fail to prove a clinical benefit – by setting higher list prices in the first place.”
See also Jeff Myers’ recent blog post on the pricing models.
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