Republican senators slam proposed accelerated approval payment reforms
Republican senators are speaking out against a proposed test model in which drugmakers would effectively make less for drugs approved via the FDA’s accelerated approval.
The test program, dubbed the Accelerating Clinical Evidence Model, was announced last month as a way to incentivize quicker confirmatory trials and “reduce Medicare spending on drugs that have no confirmed clinical benefit.” HHS Secretary Xavier Becerra directed CMS to begin consultation with the FDA on the model this year.
However, 18 Republican senators urged Becerra and CMS Administrator Chiquita Brooks-LaSure not to pursue the model in a letter on Wednesday.
“By bringing groundbreaking therapies to patients years before these products could otherwise reach the market, the FDA’s Accelerated Approval Program (AAP) has saved countless lives while upholding strong safeguards and standards,” they wrote. “The Accelerating Clinical Evidence Model recently announced by the Biden Administration, unfortunately, risks undermining or even reversing this trend, triggering access gaps for seniors, as well as imposing cuts on frontline providers.”
In an October report, HHS’ inspector general said that Medicare and Medicaid spent more than $18 billion from 2018 to 2021 for therapies with incomplete confirmatory trials past their original planned completion dates.
“Given the increasing number of AAP approvals, some experts are concerned the number of past-due trials may continue to increase,” the report states. Congress and President Joe Biden recently signed off on new authority for the FDA to begin requiring confirmatory trials prior to an approval.
Last month, a CMS spokesperson told Endpoints News that the agency is “still exploring the specific approaches to payment adjustments in the Accelerating Clinical Evidence Model, and any approach will be developed in close coordination with the Food and Drug Administration.”
While HHS’ report claimed that any adjustments would be made “in a manner that attempts to avoid penalizing physicians or beneficiaries for choosing (or avoiding) an accelerated approval treatment,” the senators argued on Wednesday that certain confirmatory trials may still take years to complete in difficult diseases such as Alzheimer’s or some cancers.
“Punitive treatment of products that opt for accelerated approval sends a precarious signal to patients, providers, payers, and the public that CMS lacks confidence in this life-saving pathway,” they wrote.