The Committee Leaders Are Conducting an Ongoing Investigation into Aduhelm’s Controversial Approval Process Amid Concerns Over the Treatment’s Safety, Efficacy, and Cost Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) and Oversight and Reform Committee Chairwoman Carolyn B. Maloney (D-NY) wrote to Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure today in support of the agency’s proposed National Coverage Determination (NCD) decision memo limiting Medicare coverage of Biogen’s controversial Alzheimer’s treatment, Aduhelm, to patients enrolled in qualifying clinical trials.
The Committee Chairs, who are conducting an ongoing investigation into the approval of Aduhelm, also voiced support for a reevaluation of the Medicare Part B Premiums based on the NCD and a change in the medication’s price.
“We applaud the agency for striking a balance between the need for Alzheimer’s patients to access treatment with the need to gather more evidence on the treatment’s safety and efficacy through clinical trials,” the Committee Chairs wrote in their letter to Administrator Brooks-LaSure.
“Since receiving accelerated approval from the U.S. Food and Drug Administration (FDA) in June 2021, Aduhelm’s approval process and its imbalance of benefit to risk have been met with concern from the scientific and medical communities.”
The two Committee Chairs noted that FDA’s approval of Aduhelm has sparked a wave of new drug candidates seeking a similar path to accelerated approval. While noting the importance of maintaining the integrity of FDA’s drug approval process, the Committee Chairs also commended CMS for recognizing that its coverage determination will have far-reaching implications for millions of patients for years to come.
“This determination will allow certain Alzheimer’s patients access to Aduhelm while providing the opportunity to gain more evidence on the drug’s efficacy and safety,” the Committee Chairs wrote.
“Any broader coverage determination before there is clarity on Aduhelm’s approval process and findings from the myriad ongoing investigations may put the health of millions of Alzheimer’s patients on the line and the financial stability of the nation’s health insurance program for American seniors at risk.”
Pallone and Maloney also expressed their strong support for Health and Human Services Secretary Xavier Becerra’s recent request that CMS reevaluate Medicare Part B monthly premiums for 2022, a large part of which has been attributed to the originally set $56,000 per year launch price of Aduhelm.
In December, Biogen announced that it would reduce the price of Aduhelm by approximately 50 percent, to $28,200 per year.
“Given Biogen’s decision to nearly halve Aduhelm’s price since CMS calculated the 2022 Medicare Part B premium, evidence of limited uptake of the drug, and the proposed NCD, we strongly support Secretary Becerra’s January 10, 2022, order for CMS to reassess the premium, and we encourage the agency to do so expeditiously,” the Committee Chairs continued.
The Committee Chairs wrote to Administrator Brooks-LaSure amid their ongoing investigation into FDA’s controversial approval of Aduhelm.
The investigation focuses on concerns over the treatment’s safety and efficacy as well as potentially inappropriate communication and coordination between the regulatory agency and the pharmaceutical company.
“This process is currently under investigation by our respective Committees, as well as the Department of Health and Human Services’ Office of the Inspector General,” the Committee Chairs wrote. “FDA and Biogen continue to cooperate with the Committees’ investigation.
However, serious questions and concerns remain surrounding the approval process for Aduhelm. Our Committees will continue to diligently and aggressively investigate Aduhelm’s approval process.”
Read the full comment letter to CMS HERE.
