Seniors and their families will likely be excited when they learn that the newest drug treatment for Alzheimer’s, Aduhelm, received FDA accelerated approval in the summer of 2021. But, will Medicare cover the new drug for Alzheimer’s and if so, what will be the aduhelm price to consumers?
Reviews of the clinical trials of Aduhelm indicate that the drug will best benefit Alzheimer’s patients who are in the early stages of the disease.
Key Article Takeaways
Moreover, the Centers for Medicare and Medicaid Services (CMS) recently announced that Medicare will cover the cost of Aduhelm along with other monoclonal antibodies that target amyloid, the plaque that causes Alzheimer’s once the drugs receive FDA approval.
However, the New York Times announced “In Reversal, F.D.A. calls for limits on who gets Alzheimer’s Drug, meaning that the drug is approved only for patients with mild thinking or memory problems.
There is a catch, however. Medicare will only approve coverage for Aduhelm treatments for patients who are participating in clinical trials that have been approved by the FDA.
What is Aduhelm?
Aduhelm (Aducanumab) is a new drug that is taken once per month through an IV infusion. It is recommended for patients in the early stage of Alzheimer’s and targets the plaques that can build up in the brain and cause symptoms like:
- Memory loss that disturbs everyday living
- Issues with planning and problem solving
- Challenges with completing regular tasks
- Confusion about location or time of day
- Difficulty with understanding visual images and geographical relationships
- Challenges with speaking and writing
- Misplacing items and the inability to retrace one’s steps
- Impaired judgment and decision making
- Reluctance to go to work or attend social activities
- Mood swings and personality changes
Although Aduhelm has proven that it can attack the underlying cause of Alzheimer’s, it is not a cure for Alzheimer’s disease. Aduhelm is not capable of reversing the progression in patients who have already developed symptoms of the disease.
According to the National Council on Aging (ncoa.org), “Aduhelm has been shown to break down the amyloid plaques described above but has yet to show clinically significant slowing of cognitive decline, such as memory loss, wandering/getting lost, trouble handling money and paying bills, repeating questions, taking longer to complete normal daily tasks, and personality and behavior changes.
How much does Aduhelm Cost?
When Biogen, the makers of Aduhelm first announced its availability, the company announced that a maintenance dose of the drug would be $56,000 per year but the company has since substantially reduced the cost to $28,000 for patients paying out-of-pocket.
However, patients who are insured under individual health insurance or Medicare will pay significantly less. But, in addition to the cost of the drug, patients will be required to undergo a PET scan and MRI in order for a patient’s physician to prescribe the drug.
It’s important to note once again, however, that Medicare Part B will only cover the cost of the Aduhelm treatment for patients who are involved with clinical studies and who have been diagnosed with a mild form of cognitive impairment and/or early-stage dementia.
Will Medicare Cover Aduhelm Treatments?
As of this writing, the Centers for Medicare and Medicaid Services (CMS) which oversees Medicare and Medicaid, has announced that Medicare Part B will cover a beneficiary’s treatment of Aduhelm as long as the patient is enrolled in a Medicare-approved clinical trial and that the disease has been diagnosed to be in its early stage.
The CMS announcement was met with little applause and much scorn since there are at least 1.5 million Americans with early-stage Alzheimer’s disease. With the restrictions implemented by CMS, Medicare Part B will likely only help a fraction of individuals suffering from Alzheimer’s symptoms.
The CMS announcement was also met with displeasure since qualifying beneficiaries amount to only a few thousand early-stage Alzheimer’s patients.
How Can I Join an Alzheimer’s Clinical Trial Approved by Medicare?
If you are not in a position to pay for Aduhelm out-of-pocket, you can get Medicare Part B to cover most of the cost of the treatment by joining a clinical trial approved by Medicare.
To find out if a trial is being conducted near you, you can visit Alzheimers.gov to get the nearest location of an approved clinical trial.
Unless you meet the qualifications specified in CMS’s approval announcement and guidelines, your only other option would be to pay for your Aduhelm prescription out-of-pocket.
It’s interesting to note that CMS received over 10,000 comments on its website which were primarily emotional pleas from Alzheimer’s patients and their families along with many medical practitioners.
Many called CMS’s decision discriminatory because many Alzheimer’s patients are not living in urban areas and as such, do not have access to clinical trials.
Was the Medicare Part B Premium Increase to Cover Alzheimer’s Drugs?
Many healthcare professionals are speculating that the 2022 increase in Medicare Part B was Medicare’s way of covering the eventual costs of Aduhelm and other monoclonal antibodies that target amyloid, the plaque that causes Alzheimer’s disease.
Certainly, the increase in Medicare Part B premiums for 2022 over 2021 is the largest in the last 10 years. However, one could speculate that the considerable increase may be Medicare’s strategy to offset its cost for Covid 19 in 2020 and 2021.
If either of these theories can hold water, it means that the entire senior population is subsidizing those who have been treated for Covid and who may be treated for Alzheimer’s with a $28,000 per year price tag.
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Will Medicare Supplement Plans (Medigap) Cover the New Drug for Alzheimer’s?
Since Medicare Supplement plans act as an extension of Original Medicare Part A and Part B. Unless a patient is qualified for Part B coverage, a Medicare Supplement plan will not offer coverage, If however, a patient does qualify for Aduhelm coverage, then your Medicare Supplement plan will cover the new drug for Alzheimer’s – Aduhelm.
Having a Medicare Part D prescription drug plan will not cover Aduhelm since the drug is administered in an IV and therefore not considered a retail prescription.
The Bottom Line
There’s no doubt that the pharmaceutical industry wants and needs to find a treatment for Alzheimer’s. Let’s face it, they have about 6 million people in the U.S. alone waiting for some form of breakthrough.
Certainly, it may be too early to know if Aduhelm is an answer since it was rushed through the approval process, but Medicare would not have given the green light for coverage, even with significant restrictions, without believing that this drug has promise.
Frequently Asked Questions
According to Bloomberg Law, “The standard monthly premium for Medicare outpatient, or “Part B,” coverage went from $148.50 in 2021 to $170.10 this year, in part to shore up contingency reserves in case the program began to cover Aduhelm. The costly drug was first priced at $56,000 a year, but has since been lowered to $28,000.”
Medical News Today is reporting side effects caused by Aduhelm as:
reduced or blurred vision
Although the FDA has only placed a few limitations on who should take Aduhelm, Dr. Stephen P. Salloway, a site principal investigator for trials of the drug stated that “people should not be given the drug if they have had a macro-hemorrhage in the brain; more than five micro-hemorrhages; a significant stroke; or “unstable medical conditions that could interfere with treatment.”
Aduhelm is given intravenously by infusion during a one-hour setting monthly for an indefinite period of time.
No. This medication is not a cure and will not reverse any damage already caused by Alzheimer’s. It is considered a disease-modifying drug that should slow the progression of Alzheimer’s.
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