Here Comes the First Alzheimer’s Treatment in 20 years. But Will Medicare Cover It?

February 21, 2022
New Jersey.com
By Tony Dearing

Every day in this country, an estimated 1,000 people progress from moderate Alzheimer’s dementia to the final and most severe stage of the disease.

That’s a grim statistic in its own right.

But the gravity of it becomes even greater at a time when the federal government must decide whether it will give Alzheimer’s patients access to a controversial new drug that has the potential to slow the progression of their decline.

Should this new drug, Aduhelm, be covered by Medicare? Do we have — at long last — the breakthrough treatment for Alzheimer’s that we’ve been waiting more than two decades for? Or was its recent approval by the Food and Drug Administration a mistake, driven more by public pressure than by scientific proof?

The debate has become fierce, putting the nation’s leading Alzheimer’s experts at odds.

Dr. Dennis Selkoe, professor of neurology at Harvard, says evidence shows Aduhelm and three similar drugs still being studied “robustly clear” amyloid plaque from the brain, which he says is associated with the slowing of cognitive decline in typical Alzheimer’s patients.

Selkoe says this group of drugs is “the closest medicine has come to a disease-modifying approach” for Alzheimer’s dementia.

“That is why (Aduhelm) was given accelerated approval by the FDA based on its strong biomarker result and modest clinical benefit in some patients that should increase with time,” he says.

Dr. Brienne Miner, assistant professor of geriatric medicine at Yale, looks at the same evidence and comes to the opposite conclusion.

“I am deeply troubled by the pressure to use an unproven and potentially dangerous treatment in our patients, many of whom are desperate to try anything that might give them hope,” she says. “I am also saddened to think about the many other, much more beneficial ways we could use the resources that will be sucked up by (Aduhelm) to really help people and families with Alzheimer’s.”

In a lively discussion on the website AlzForum involving some of the country’s most renowned experts on the disease, opinion is running about two to one in favor of a proposal that would tightly limit Medicare coverage for Aduhelm. Many of the quotations in this column come from that forum or from expert opinion posted on the Medicare site.

As a journalist who writes a column about brain health and dementia, I understand the widespread skepticism this drug has engendered. But as the cacophony of criticism gets louder, I hope it does not drown out other voices that also need to be heard.

I’m talking about the voices of respected neurologists who have tested this drug in clinical trials and say they’ve seen patients benefit from it.

And above all, I’m talking about those who have the most at stake here: the 6.2 million people in this country who have Alzheimer’s and the family members who care for them.

I’m talking about people like Jeff Borghoff, a 57-year-old Alzheimer’s patient in South Jersey who has been taking Aduhelm for several years through a clinical trial.

Last summer, he told me he’s convinced the drug helped significantly slow the progression of his dementia.

“For myself and my family, it’s been a success,” Borghoff said. “It’s been five years, and I think statistically speaking when a person is diagnosed with Alzheimer’s at my age, the trajectory (of decline) is rather quick. But I still function cognitively very well. Some of my (test) scores have increased over the years.”

Borghoff was among the many people whose hopes were crushed when drugmaker Biogen declared in March 2019 that it was shutting down further research on Aduhelm because results showed it to be ineffective. But a stunning reversal came six months later. Biogen announced that after further review of the study data, it found a small group of patients who received a higher dose toward the end of the clinical trial who seemed to benefit.

Based on that, Biogen took Aduhelm to the FDA and received conditional approval for patients with mild cognitive impairment or early stage Alzheimer’s. The authorization was based on evidence it reduced beta amyloid plaque in the brain, which the FDA deemed “reasonably likely” to slow the progression of the disease.

That decision has been pilloried ever since, and one brouhaha has led to another. Now that the drug is FDA-approved, the next controversy becomes: Should it be covered by Medicare?

That question has huge implications.

An estimated 1 million Alzheimer’s patients could be eligible to get this drug under Medicare if it’s covered and if their doctors are willing to prescribe it to them.

Usually, Medicare coverage of an FDA-endorsed drug is nearly automatic. But the Centers for Medicare and Medicaid Services (CMS), which decides what does and doesn’t get covered, is balking at this one.

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