Does Medicare Cover Aduhelm, the New Alzheimer’s Drug?
The expensive new 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 much faster than normal, and against the recommendation of its own advisory panel.
Finally, there was a good dose of fear as the cost of the drug started out at $56,000, later cut in half by Biogen to $28,200. Would Medicare approve this drug? If so, what would it mean for Medicare premiums?
So many changes have taken place since Aduhelm was approved by the FDA, including Medicare’s coverage decision. Here’s what you need to know about Medicare and Aduhelm.
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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.
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).
The important distinction here is Biogen developed Aduhelm to target those clumps of toxic protein—not 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.
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.
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?
When Aduhelm was first released, the price tag was $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.
However, on December 20, 2021, Biogen announced they were cutting the price tag in half to $28,200.
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?
Medicare released its coverage decision for Aduhelm on April 7, 2022. Prior to this, the Centers for Medicare & Medicaid Services (CMS) underwent 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.
After a lengthy and careful review, CMS decided that Medicare would cover the drug, but only if the person is enrolled in an approval clinical trial.
Medicare and Aduhelm Costs
Medicare covers Aduhelm under Medicare Part B. Part B covers 80% of the drug cost, or $22,560 for a year’s worth of treatment. This would leave 20% of the cost, or $5,640 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 $233 in 2022.
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 annual deductible. That offers incredible peace of mind!
Aduhelm and the Future of Medicare
CMS raised the Medicare Part B premium to $170.10 in 2022, the highest increase in Medicare’s history. The reason for this premium hike was partly due to the anticipation of Aduhelm, which is very expensive:
“Potential Aduhelm costs resulted in roughly half of the 2022 premium increase.” (CMS)
At the time the Part B premium for 2022 was decided, no one knew if Medicare would cover the drug, and Biogen had not yet slashed the price in half.
Now that we know Medicare will only approve Aduhelm if an individual is in an approved clinical trial – and the cost of the drug is half of what was expected – many are calling for a Part B premium reduction.
While CMS has not made any announcements about reducing the 2022 Part B premium, they have been reexamining the current premium and are suggesting it be lowered in 2023 (CMS):
“CMS recommends incorporating the savings realized from the difference between assumed and actual Part B spending into the 2023 Part B premium determination.”
Medicare enrollees may see some premium savings in 2023!
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.
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