CMS Decision to Limit Coverage of Alzheimer’s Treatment Takes Center Stage

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WASHINGTON — A House panel scheduled to kick the tires on roughly 20 different health care-related bills on Thursday spent time considering the Food and Drug Administration’s decision to grant accelerated approval to the first disease-modifying treatment for Alzheimer’s disease and the Centers for Medicare and Medicaid Services’ subsequent decision to restrict coverage for the drug to patients participating in clinical trials.

At the very heart of the debate is Aduhelm, developed by Biogen, the first FDA-approved treatment to address a likely cause of Alzheimer’s — the accumulation of a toxic protein that is believed to ravage neurons and cause dementia.

“Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research when the agency announced its decision in June 2021. 

“As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation,” she said in a statement included in the FDA release.

The agency went on to describe Aduhelm as “a first-of-its-kind” treatment for a debilitating disease that affects 6.2 million Americans — a number that Alzheimer’s Association research predicts will rise to an estimated 14 million by 2060, with minority populations being affected the most.

Not only is it the first new treatment approved to treat Alzheimer’s in nearly two decades, it is also the first therapy that targets the fundamental pathophysiology of the disease.

In November, however, CMS waded in, announcing as part of its preliminary National Coverage Determination that it would only cover Aduhelm and similar treatments for patients participating in randomized clinical trials supported by CMS or the National Institutes of Health.

It based its decision on its belief that the FDA’s Accelerated Approval Process left gaps in the evidence that Aduhelm is a “reasonable and necessary” treatment for Alzheimer’s disease. Also of concern was the potential impact the price of the medicine — at that point it cost $56,000 a year for a maintenance treatment — would have on Medicare spending.

To gird against additional spending, CMS last fall announced a 14.5% hike in the Medicare Part B premium for 2022, attributing about half the premium increase — the average premium would go from $148.50 in 2021 to $170.10 in 2022 — to the need for additional revenues to cover higher projected Part B spending, specifically for Aduhelm.

In the meantime, Biogen has cut the price of Aduhelm by about half, bringing it down to $28,200, and Health and Human Services Secretary Xavier Becerra directed CMS to reassess the monthly Medicare Part B premium for 2022 in light of Biogen’s announcement. 

But even before those developments many analysts and lawmakers said CMS’ proposed premium increase was driven by an unrealistic scenario. In practice, they said, Aduhelm would be used by a relatively small number of Alzheimer’s patients.

Critics of the proposed CMS decision contend the process by which Medicare premiums were raised was based on highly unlikely and inflated projections that may warrant additional scrutiny and oversight by Congress.

The decision regarding who is covered to get the new drug and how much it will cost all Medicare recipients is scheduled to be finalized by April 11.

While Medicare coverage lags are not unusual, a range of stakeholders have criticized CMS’ proposed decision, accusing the agency of second-guessing the FDA’s assessments of Aduhelm’s safety and effectiveness, and overstepping its statutory authority — namely setting a clinical trial standard that conflicts with those set by the FDA.

CMS has also been criticized for applying its proposed decision to an entire class of FDA-approved products, called anti-amyloid monoclonal antibody treatments, rather than just Aduhelm.

As the Energy and Commerce Subcommittee on Health hearing got underway, policymakers and stakeholders continued to engage with CMS on these issues, one congressional staffer telling The Well News there’s still hope the agency’s final coverage decision will differ from its proposed decision, as was the case for CAR T-cell therapy, a method of engineering immune cells from a patient’s own blood to treat cancer.

Meanwhile several lawmakers are calling for better coordination between the FDA and CMS, continuing an effort that long predates the current administration and this debate.

One of these is Sen. Mike Crapo, R-Idaho, who has introduced a bill called the Lower Costs, More Cures Act. Along with including many provisions related to reducing prescription drug costs, the bill includes provisions derived from the bipartisan NOVEL Act, which would increase transparency and efficiency in CMS’ Medicare coverage decisions.

Other provisions of Crapo’s bill lay out steps to strengthen collaboration and coordination between the FDA and CMS.

Earlier this week, a Crapo staffer confirmed he has actively engaged, and continues to engage, CMS on its proposed coverage decision, working to ensure the agency has considered the implications and nuances of all aspects of its proposed decision.

In the end, the staffer said, “we hope … the final coverage determination reflects serious engagement with all credible issues, concerns, and inquiries submitted by stakeholders and policymakers.”

This article was produced in partnership with and paid for by BIO, the Biotechnology Innovation Organization.