Lawmakers press Becerra over FDA, CMS 'disconnect' on Biogen's Aduhelm coverage decision

Lawmakers on both sides of the aisle called for Department of Health and Human Services (HHS) Secretary Xavier Becerra to explain why the Centers for Medicare & Medicaid Services (CMS) only granted narrow Medicare coverage for Biogen's Alzheimer’s disease drug Aduhelm.

Members of the House Energy and Commerce Committee voice criticism during a budget hearing Wednesday, with some saying CMS is adding more red tape and is hindering access to the treatment given accelerated approval by the Food and Drug Administration (FDA) last year.

“There seems to be a disconnect,” said Rep. Nanette Barragan, D-California. “We are saying the FDA can say something is safe, but CMS will decide whether it is reasonable and necessary. That to me says that FDA can’t judge clinical data, but CMS can.”

Barragan said she was worried about access to the Alzheimer’s treatment, which treats amyloid plaques in the brain. CMS granted narrow Medicare coverage to the entire class of drugs, but only for patients in qualifying clinical trials.

“People who can pay for it will get it. People under the [Medicare] program won’t,” she said. “This decision should be between a patient and a doctor. I am so disappointed.”

She added that this is the first time Medicare has not covered a drug approved under the FDA’s accelerated approval process, which grants faster approvals to products that address unmet medical needs.

Rep. Gus Bilirakis, R-Florida, told Becerra the agency appears to be adding more red tape for patients, highlighting that CMS also pulled a controversial Trump-era rule that narrowed coverage determinations for breakthrough medical devices. 

“Why do you seem so intent on adding an additional layer of red tape around your agencies?” Bilirakis asked Becerra.

The HHS secretary said the missions of both the FDA and the CMS are different as the agencies have “distinct authorities and distinct missions. 

“FDA is the agency in charge of telling us if a particular new drug is safe or effective,” Becerra said. “It is CMS’ responsibility [to determine] if the treatment is reasonable or necessary for treatment of an illness or injury. We cannot confuse what FDA’s mission and role is with that of the CMS. That is why you have distinct decision-making.”

Becerra noted that the heads of CMS and FDA issued a joint statement earlier this month that addressed the criticism. 

The agency leaders said while FDA can make decisions based on a careful evaluation of the available data, CMS can also conduct its own review to determine whether the product is “reasonable and necessary” for those in the Medicare population.

FDA decided to approve the drug despite misgivings from the agency's advisers over its efficacy. Some larger insurers have been waiting for Medicare's decision on coverage to decide how to proceed with their own decisions, with questions over the high price tag and effectiveness hanging over the drug.

The lawmakers’ questions illustrate lingering disappointment along both sides of the aisle on CMS’ decision on Aduhelm, which was approved to treat mild cognitive impairment associated with Alzheimer’s. CMS made its coverage determination despite a massive opposition campaign from the pharmaceutical industry and patient advocacy groups.