Caution About a New Alzheimer’s Drug

by Anita Schnee, Attorney at Law

The federal Food and Drug Administration has approved a new drug for those suffering from early-stage or mild Alzheimer’s. This sounds like good news for the millions at risk for this dread disease. However, CMS, the federal agency in charge of Medicare and Medicaid, has provisionally announced that it will not pay for that treatment unless the patient receives it in an experimental setting. That CMS decision would effectively put the drug out of reach of just about everybody for now, because treatment costs in the five figures per year. The manufacturer recently slashed the price to half of what it once was, but it still runs around $28,200 per year.

The drug, known as Aduhelm or aducanumab, is a monoclonal antibody. Monoclonal antibodies are molecules, manufactured in a laboratory, that assist the immune system. In the Alzheimer’s context, they work by attaching themselves to the plaque patches on the brain that are thought to cause the illness. The antibodies stimulate the immune system to get rid of the plaque and, it is hoped, to prevent brain cells from dying.

However, a significant number of those receiving the drug experienced potentially serious side effects including brain swelling or bleeding. The manufacturer’s research claims that these effects were largely harmless. Regardless, though, that risk would require careful monitoring with brain imaging, which adds to the expense beyond the cost of the drug itself. What’s more, the treatment requires IV infusion once a month, so it’s not as simple as taking a pill and, again, that wrinkle increases the cost and difficulties still more. Once on this drug, patients might need to continue taking it for the rest of their lives.

Due to these concerns, many hospitals, including the Cleveland Clinic, Johns Hopkins Hospital, and Massachusetts General in Boston, will not be providing the drug.

Likewise, a committee of independent experts who advise FDA recommended that the drug not be approved. A similar body in the European Union reached the same conclusion, as did the Canadians. The Blue Cross Blue Shield Association concluded that the drug should not be found “reasonable and necessary” because of “numerous safety risks and uncertain clinical benefits.” The American Academy of Neurology objected to charging Medicare patients “thousands of dollars of out-of-pocket costs for a drug with substantial risks and without proven clinical benefit.” Indeed, Medicare recipients are already paying, regardless whether they are receiving the drug. CMS administrators have attributed a significant portion of the 2022 increase in Medicare Part B premiums to Aduhelm’s approval.

Despite these objections, FDA granted the manufacturer, Biogen, “provisional approval” to show that Aduhelm actually does work. The provisional approval process, which itself is controversial, is designed to speed the progress of promising new drugs to the market. After the drugs are released, manufacturers are supposed to provide proof that those drugs actually improve health. Biogen presently plans to begin patient screening in May 2022, as part of what’s known as “Phase 4 confirmatory trials.” The company projects that those studies will be completed in around four years. If those studies do not show actual clinical benefit at that point, FDA could remove the drug from the market.

There is another generic drug called Donepezil (pronounced duh-NEH-puhzl), available for decades by now, that has been shown to be effective on Alzheimer’s symptoms.

Disagreement between FDA and CMS over a drug is highly unusual. Three members of the FDA advisory panel resigned after FDA approved the drug contrary to the panel’s recommendation. The final CMS decision about Medicare coverage is expected in April.

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Anita Schnee

Anita Schnee

Anita Schnee has been a lawyer for around thirty years, half of those in Fayetteville. She has served as judicial law clerk in the state and federal systems, taught legal research and writing at the University of Arkansas Law School, and is now pleased to assist the Estate & Elder Law Planning Center on issues affecting elders and the disabled.
Anita Schnee

Anita Schnee

Anita Schnee has been a lawyer for around thirty years, half of those in Fayetteville. She has served as judicial law clerk in the state and federal systems, taught legal research and writing at the University of Arkansas Law School, and is now pleased to assist the Estate & Elder Law Planning Center on issues affecting elders and the disabled.
This blog does not provide legal advice. Please consult us for specific guidance. Rights to this article are shared only with users who are part of the Eldercounsel organization. For an attorney in your state, please click here.

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