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FDA Approves First Alzheimer's Drug Since 2003

Have you heard the news? The Food & Drug Administration (FDA) has approved a new drug called Aduhelm (or aducanumab) to combat the onset of Alzheimer’s disease. This is the first drug to receive an approval of any form for Alzheimer’s since 2003.

Alzheimer’s is one of the most debilitating and deadly diseases facing Americans. It was the sixth leading cause of death in the U.S. prior to the pandemic. The availability of a new drug to fight it is exciting news, but there is some controversy surrounding the drug and its approval. So, let’s take a closer look at Aduhelm, its FDA approval, and why it’s controversial.

Facts, figures, and quotes can be found in the FDA’s press release, prescribing information, or on Aduhelm’s approval, unless cited elsewhere.

What Does Aduhelm Claim to Do?

The results of trials for Aduhelm have been extremely promising, making it the first treatment that’s shown signs of actually slowing the disease’s progression. These signs are positive because of the novel approach this treatment takes toward combatting Alzheimer’s disease. Should Aduhelm prove to be effective at slowing down the progression of Alzheimer’s, it could answer questions for a disease we still don’t know a ton about and pave the way for other treatment options. So, how does it work?

Aduhelm is given through an intravenous (IV) infusion and targets beta-amyloid plaque in the brain, which is a sign of Alzheimer’s disease. It’s believed that beta-amyloid plaque can be toxic to the brain and, as it collects between neurons, disrupts cell function in the brain. Though more research is needed on this to determine the exact ties between Alzheimer’s and the plaques, these studies are done to better understand the relationship, not confirm it.

It’s a promising new option for the millions of Americans diagnosed with Alzheimer’s and their families.

Getting back to Aduhelm, the drug is a protein that acts as an antibody to the beta-amyloid plaques, reducing the number of them in the brain, and potentially, slowing the onset of Alzheimer’s disease. It’s important to remember that Aduhelm only purports to slow the progression of the disease. It isn’t a cure, and it can’t reverse any damage that has already been done. Despite that, it’s a promising new option for the millions of Americans diagnosed with Alzheimer’s and their families.

Is the Approval of Aduhelm a Done Deal?

The FDA has reserved the right to rescind Aduhelm’s conditional approval in the future, and it’s also requiring another large Phase IV trial to fully determine the benefits of the drug. The results of this new trial could either confirm the approval of this exciting new drug or take its developers back to square one.

Would Medicare Cover It?

Considering 72 percent of Alzheimer’s patients are 75 and older, thus squarely in Medicare-age, the question of whether Medicare will cover the new drug or not is an important one, especially considering its cost. The annual cost of Aduhelm is around $56,000 per patient. Keep in mind, that is the list price, which is the cost if you didn’t have insurance. It’s not known for sure if Medicare will cover the drug entirely or even at all. Medicare could enact a coverage determination to cover only part of the treatment or not cover it at all if the program decides that the clinical data doesn’t support coverage.

It’s yet not known for sure if Medicare will cover the drug entirely or even at all.

If Aduhelm is covered by Medicare, it could be covered under Medicare Part B, since it is likely to be administered in an outpatient setting by IV infusion. This would leave you with two out-of-pocket costs. Coverage would start once you hit your Part B deductible, which is $203 in 2021, and would include a 20-percent coinsurance. Medicare Part C plans can also attempt to negotiate with the drug’s manufacturer, Biogen, for lower prices and offer additional coverage, though this will vary from plan to plan. Luckily, Medicare does cover other facets of dementia care also, so you’ll receive assistance for the many aspects of treatment and care.

What’s the Controversy?

Of course, Aduhelm’s FDA approval has not been without controversy, which is why the FDA has only given a conditional approval. There are actually three controversial subjects that have been touched on with Aduhelm that must be addressed.

You probably guessed the first — the price. Biogen has been under fire recently for the $56,000 price tag placed on the drug, though Biogen’s CEO, Michel Vounatsos, maintains the pricing is fair. This is despite the drug being priced $31,000 to $46,000 more than what earlier expectations predicted. With the majority of the likely users of Aduhelm being on Medicare, this cost will likely fall on the Medicare program itself, causing concerns for both the long-term viability of the popular program and for the taxpayers that fund it. That’s a lot of risk for a drug that has had mixed results for effectiveness in studies, which brings us to the next controversial subject.

A number of independent groups and doctors cast serious doubt on the effectiveness of Aduhelm in slowing the onset of Alzheimer’s.

It may be surprising, since the FDA approved the drug, but there are a lot of questions about just how effective Aduhelm is, explaining why the FDA is ordering another large trial. In fact, a number of independent groups and doctors cast serious doubt on the effectiveness of Aduhelm in slowing the onset of Alzheimer’s. Even the FDA’s own advisory panel declined to endorse the treatment. Biogen itself lost faith in Aduhelm at one point, ceasing both of its ongoing trials in 2019 when their data revealed the drug likely wasn’t beneficial. They ultimately restarted trials after further data in one of the trials showed success.

And lastly, there are reports of some serious side effects like brain swelling and microhemorrhage in the brain, and the theory of beta-amyloid plaque causing Alzheimer’s has not been yet proven. When you consider all of these points, you can understand why there are worries about the approval of the drug, even if it’s conditional upon another large trial.

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Ultimately, a lot hinges on the final trial that has been ordered by the FDA. As part of the approval press release, the FDA stated that lack of treatments and drugs fulfilling the need of those with Alzheimer’s was the main reason for this approval. This has drawn criticism from some in the medical field who have noted that, while unmet need is an important contextual factor for approval, it is by no means the most important and shouldn’t be the defining reason. Alternatively, patient advocate groups like the Alzheimer’s Association believe that new treatments can reinvigorate a field, leading to even better treatments down the road.

So, while there are certainly valid and major concerns facing Aduhelm, a positive Phase IV trial could alleviate some, though not all, of the associated worries. Regardless, at the very least, this approval could signal a promising new direction for Alzheimer’s research, even if Aduhelm is only a stepping stone in the journey toward treating Alzheimer’s disease.

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