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Alzheimer’s Drug Coverage Plan Spurs Call for Becerra to Step In (1)

Jan. 27, 2022, 8:22 PMUpdated: Jan. 27, 2022, 9:41 PM

An Alzheimer’s patient advocacy group is urging the Biden administration to allow broader coverage of Biogen’s Aduhelm, the latest call for action in an ongoing debate over who should be able to access the controversial drug.

FDA approval of a drug usually leads to Medicare coverage. But the extraordinary circumstances surrounding Aduhelm’s path through the agency, along with the sheer scope and costs related to the drug, prompted the administration to propose limiting coverage to patients enrolled in clinical trials. Advocacy groups say that threatens access to minorities and other groups that are typically underrepresented in drug studies.

“This is a huge unmet need in our society, causing massive social and economic consequences, both to the government and to American families, and to not have Medicare cover any of the first generation of Alzheimer’s drugs is simply intolerable,” George Vradenburg, chairman and co-founder of UsAgainstAlzheimer’s, said in an interview Thursday.

UsAgainstAlzheimer’s sent a letter to Health and Human Services Secretary Xavier Becerra urging him to direct the Medicare agency to reconsider the limited coverage proposal. Biogen has the only approved drug of its type, but companies such as Roche and Eli Lilly & Co. have similar products in development.

The letter marks the latest effort by patient advocates and some drug industry groups that have decried Medicare’s preliminary decision as a setback for patients. Nearly 5.8 million Americans had Alzheimer’s in 2020, and that number is expected to triple in 2060, according to the Centers for Disease Control and Prevention.

But consumer groups like Public Citizen say the Centers for Medicare & Medicaid Services made the right call on a drug that’s been mired in controversy since even before the Food and Drug Administration approved it June 7.

The FDA decided Aduhelm’s ability to remove a protein called amyloid, which forms plaques between neurons and disrupts cell function, was sufficient for an accelerated approval, contingent on results from a future study. That decision went against the advice of its own scientific advisory panel, which questioned the evidence, and prompted several advisers to quit in the wake of the approval.

“I just wasn’t at all surprised that this is what CMS did,” given the controversy behind the FDA’s decision, said Holley Thames Lutz, a Dentons attorney who focuses on Medicare coverage and reimbursement counseling. “Just because FDA says it’s approved doesn’t mean Medicare is going to pay for it.”

Biogen initially set its drug at $56,000 a year but later cut that cost in half after Becerra ordered a review of Medicare premium hikes tied to the drug. The CMS will announce its final coverage decision by April 11.

The HHS said in an email that Becerra’s instruction to reassess premiums for 2022 based on Aduhelm’s price drop is separate from and unrelated to CMS’s proposed coverage determination, which is still in the public comment stage. The department further noted the FDA and CMS are separate agencies with distinct authorities and missions, and with their own distinct legal processes.

Battle of Authorities

Vradenburg said the Medicare decision is causing a battle between the authorities of two HHS agencies that Becerra needs to resolve as secretary.

A former senior HHS official said some at the FDA feel the decision is undermining the authority of their agency because drug regulators determined the drug was safe and effective.

It’s also atypical that the Medicare agency is pushing for randomized clinical trials instead of relying on observational studies, the official said. “They’re in essence signaling to the marketplace that they want a study done that they feel probably that the FDA should have done in the first place.”

The proposed payment decision offers a window into how Medicare will cover future drugs in Aduhelm’s class, Rachel E. Sachs, an FDA and health law scholar at Washington University in St. Louis, said.

“There are clearly implications for other monoclonal antibodies directed at removing amyloid,” Sachs said. “CMS is recognizing that some of these other products will be going through the FDA or are already moving through the FDA review process. And for those products, CMS wants to make clear that showing a clinical benefit will be needed to obtain Medicare reimbursement.”

But she said the decision might not apply to all products, depending on how the FDA acts in the future.

“If FDA chooses to behave differently going forward, this could well be an isolated [national coverage decision] and issues don’t go further than this,” Sachs said. “If FDA continues down the path of looking to use unvalidated, surrogate endpoints in the accelerated approval process, then we could see CMS start to push back more strongly for coverage of some of these products.”

Accelerated Approval

Vradenburg said he’s heard concerns from the cancer and rare disease communities that the Medicare decision will put the FDA’s accelerated approval mechanism at risk.

The accelerated approval program allows earlier approval of drugs that treat serious conditions and fill an unmet medical need. To speed the review process, the approvals can be based on surrogate endpoints, or factors like tumor shrinkage that signal a treatment works but don’t show direct clinical benefit the way criteria like an overall survival rate does.

About 85% of accelerated approvals are for cancer therapies, and the FDA’s cancer chief Richard Pazdur has said he feels the program is under attack. But he’s noted out of more than 155 accelerated approvals over the past 20 years, only about 10 of these indications have been removed from the market.

Lutz said the proposed coverage limits don’t signal that surrogate endpoints are a no-go since the concerns are specific to Aduhelm’s approval. “This particular drug and study had its own factors,” she said. “There was enough there for them to look at the FDA process to say,’ I’m not sure the FDA was so sure. And so I’m going to study it on my own.’”

Drug companies must show their treatments are safe and effective for the FDA to approve them. But the CMS’s standard for coverage decisions is reasonable and necessary, which is easier to demonstrate when there’s a clear clinical benefit. “It’s easier to pay for something that says, ‘You take this drug and your blood pressure goes down, not you take this drug and you stop creating some enzyme,’” Lutz said.

If FDA approval stemmed from data showing clearer clinical benefits, instead of relying on questionable surrogate endpoints and didn’t have the controversy, the Medicare agency likely would have covered the drug more fully, she said.

(Updated to include an HHS statement in the 10th paragraph.)

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloombergindustry.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com

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