Alzheimer’s drug plan prompts Becerra to step in (1)

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Alzheimer’s patient advocacy group urges Biden administration to allow broader coverage of biogenic Aduhelm, the latest call to 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 journey with the agency, as well as the drug’s scope and costs, prompted the administration to propose limiting coverage to patients enrolled in clinical trials. Advocacy groups say this threatens access to minorities and other groups that are typically underrepresented in drug studies.

“This is a huge unmet need in our society, with massive social and economic consequences, both for the government and for American families, and the fact that Medicare does not cover any first-generation drugs against Alzheimer’s disease is simply intolerable,” said George Vradenburg, president. and co-founder of UsAgainstAlzheimer’s, said in an interview Thursday.

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

The letter marks the latest effort by patient advocates and some pharmaceutical industry groups who have decried Medicare’s preliminary ruling as a setback for patients. Nearly 5.8 million Americans had Alzheimer’s disease in 2020, and that number is expected to triple by 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 choice on a drug that has been mired in controversy since even before the Food and Drug Administration approved it on June 7.

The FDA decided that Aduhelm’s ability to clear a protein called amyloid, which forms plaques between neurons and disrupts cell function, was sufficient for expedited approval, pending the results of a future study. The move went against the advice of its own scientific advisory committee, which questioned the evidence, and prompted several advisers to resign following the approval.

“I just wasn’t surprised at all that this was 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 advice. “Just because the FDA says it’s approved doesn’t mean Medicare is going to pay for it.”

Biogen initially pegged 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.

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

Battle of authorities

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

A former senior HHS official said some at the FDA felt the decision undermined their agency’s authority 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 basically signaling to the market that they want a study done, which they probably think 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, said Rachel E. Sachs, an FDA and health law specialist at the University of Washington in St. Louis.

“There are clearly implications for other monoclonal antibodies aimed at removing amyloid,” Sachs said. “CMS recognizes that some of these other products will go through the FDA or are already going through the FDA review process. And for those products, CMS wants to clarify that demonstration of clinical benefit will be required to obtain Medicare reimbursement.

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

“If the FDA chooses to behave differently in the future, this may well be an isolated case. [national coverage decision] and the problems go no further than that,” Sachs said. “If the FDA continues to seek to use unvalidated surrogate endpoints in the expedited approval process, we could see CMS begin to push back coverage for some of these products more heavily.”

Accelerated approval

Vradenburg said he heard concerns from the cancer and rare disease communities that Medicare’s decision would jeopardize the FDA’s fast-track approval mechanism.

The Accelerated Approval Program enables earlier approval of drugs that treat serious conditions and address an unmet medical need. To expedite the review process, approvals may be based on surrogate endpoints or factors such as tumor shrinkage that signal a treatment is working but do not show direct clinical benefit as criteria such as than an overall survival rate.

About 85% of fast-track approvals are for cancer therapies, and FDA cancer chief Richard Pazdur said he senses that the program is under attack. But he noted that of more than 155 fast-track approvals over the past 20 years, only about 10 of those indications have been taken off the market.

Lutz said the proposed coverage limits do not signal that surrogate parameters are prohibited, as the concerns are specific to Aduhelm’s endorsement. “This drug and this particular study had their own factors,” she said. “There was enough that they looked at the FDA process to say, ‘I’m not sure the FDA is so sure. And so I will study it by myself.

Pharmaceutical companies must show that their treatments are safe and effective for the FDA to approve them. But the CMS standard for coverage decisions is reasonable and necessary, which is easier to demonstrate when there is 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 an enzyme,'” Lutz said.

If the FDA approval came from data showing clearer clinical benefits, instead of relying on dubious surrogate endpoints and had no controversy, Medicare would likely have covered the drug more fully, she said.

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