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Will Medicare Cover Aduhelm, the New $56,000 Alzheimer’s Drug?

Will Medicare Cover Aduhelm, the New $56,000 Alzheimer’s Drug?

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The $56,000 Alzheimer’s drug, Biogen’s Aduhelm, is causing a lot of emotions.

First is excitement—it’s the first Alzheimer’s drug to be approved in over 18 years. Skepticism often follows that excitement as the FDA approved the drug must faster than normal, and against the recommendation of its own advisory panel.

Finally, there’s a good dose of fear as the cost of the drug could wreak havoc on public insurance programs, including Medicare. Here are some answers to questions about Aduhelm and Medicare.

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What is Aduhelm?

Aduhelm (generic name aducanumab), is an innovate medicine, given intravenously, developed to help treat and slow down the progression of Alzheimer’s disease.

Photo source: John Hopkins University, "Insights on FDA's controversial approval of Alzheimer's drug"

Aduhelm is the first drug to attack beta-amyloid plaques, or clumps of a toxic protein believed to destroy neurons in the brain. Many believe the beta-amyloid plaques cause Alzheimer’s disease, so the hope is Aduhelm can slow down or delay the onset of cognitive decline.

Aduhelm is not a cure for Alzheimer’s and does not reverse the progression of the disease.

Is Aduhelm effective?

The verdict is still out on whether Aduhelm is truly effective in slowing down or stopping the progression of Alzheimer’s disease.

Aduhelm attaches itself to beta-amyloid plaques, those clumps of toxic protein thought to cause Alzheimer’s. The body’s response is to get rid of them, which hopefully will stop brain cells from dying and thus slow down the progression of cognitive issues (like memory loss).

A visual of beta-amyloid plaques, clumps of toxic protein thought to cause Alzheimer’s

The important distinction here is Biogen developed Aduhelm to target those clumps of toxic proteinnot to treat Alzheimer’s. There is very little evidence proving that reducing those toxic proteins improves cognitive function.

Biogen's Clinical Trials

Biogen had two clinical trials in 2019, which were stopped as the data showed no benefit to the patients’ cognitive function. However, they conducted a new analysis based on a larger dataset from one of the 2019 trials. That analysis found a subset of patients who received very high doses of the drug and experienced positive cognitive benefits.  

Photo source: Biogen, "Innovation in Alzheimer's"

As soon as Biogen completed that analysis, they submitted the drug for FDA approval. The FDA granted accelerated approval, despite their own advisory panel recommending against it.

Under accelerated approval, Biogen has 9 years to confirm the drugs’ potential benefit in what’s called a “post-approval” study.

Late-Stage Alzheimer's

Biogen has not tested Aduhelm on anyone with late-stage Alzheimer’s disease. The FDA-approved labeling says providers should only start the treatment in patients with mild cognitive impairment.

While there is a lot of uncertainty about the effectiveness of Aduhelm to treat or stop the progression of Alzheimer’s, it is still a very exciting innovation.

Hopefully, this is the first step toward more advancements in Alzheimer’s disease treatment.

How much does Aduhelm cost?

Aduhelm costs $56,000 per year (for 12 total treatments). Providers give the treatment through an IV infusion, which takes about an hour. That infusion is given once a month.

In addition to the cost of the drug, patients need a required PET scan before starting treatment. The PET scan must show the patient has amyloid plaques in their brain to qualify for the drug.  

Also, during clinical trials, about 35% of patients suffered the most common side effect, which is painful brain swelling. To monitor the brain for swelling, providers must do MRI scans before and during treatments.

Does Medicare cover Aduhelm?

As of November 2021, Medicare does not yet cover Aduhelm. The Centers for Medicare & Medicaid Services (CMS) is currently in a National Coverage Determination (NCD) analysis, which takes 6-9 months. This process allows the agency to review and determine whether Medicare should cover the drug.

We should know by early 2022 if Medicare will cover Aduhelm.

The general consensus is Medicare will probably cover Aduhelm, but there may be restrictions on who qualifies based on who would benefit the most from the drug.

Medicare and Aduhelm Costs

If Medicare covers Aduhelm, they would cover it under Medicare Part B. Part B would cover 80% of the drug cost, or $44,800 for a year’s worth of treatment. This would leave 20% of the cost, or $11,200 to the individual.

For those with a Medicare Supplement, your plan would cover that 20% coinsurance in full. Your costs for Aduhelm would be $0 after you meet your Part B deductible, which is $203 in 2021.

For those with Medicare Advantage plans, the exact out-of-pocket cost for Aduhelm would depend on your specific plan. Costs for Aduhelm with a Medicare Advantage plan would likely be much higher than for those with a Medicare Supplement.

This is a prime example of why we are so passionate about Medicare Supplements. If Medicare decides to cover Aduhelm, those with a Medicare Supplement will have $0 in out-of-pocket costs after they meet their small deductible. That offers incredible peace of mind!

Aduhelm and the Future of Medicare

According to the Alzheimer’s Association, over 6 million Americans over age 65 live with Alzheimer’s dementia, as of 2021.

If half a million people were prescribed Aduhelm, total Medicare spending for one year would be about $29 billion. For reference, total Medicare spending for all Part B drugs was $37 billion in 2019.

That $29 billion figure also doesn’t include expensive PET scans and MRIs, which are required for those who are prescribed Aduhelm.

Image source: Cancer.gov, "PET scan"

If Medicare had to shoulder this financial burden, Medicare premiums for everyone would rise. According to some preliminary estimating, if 500,000 people on Medicare were prescribed Aduhelm, Medicare Part B premiums would increase by about $97 per year, or $8 per month.

Medicare Supplement premiums would also likely go up, as these plans would pay for 20% of the treatment cost.

Conclusion

For those who have loved ones dealing with Alzheimer’s, Aduhelm marks an important moment in time. For nearly 20 years, the FDA has approved no new drugs to treat or prevent Alzheimer’s.  

While Aduhelm comes with a shocking price tag and questions about its effectiveness, it is providing hope and a path for the future of Alzheimer’s disease treatment.


References:

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