Would you be first in line for the new Alzheimer’s drug?

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I have a question for you. (Please answer at the bottom.) IF you had mild Alzheimer’s Disease, would you want to try a new medication Aduhelm (aducananabab)? As I get older, this is no longer a hypothetical question. It hits closer and closer to home as some of my friends are starting to develop signs of the disease. The disease is so common that some people get the disease when they have only one risk factor: aging.

What is Aduhelm?

Aduhelm is a recently approved drug for the treatment of Mild Cognitive Impairment and mild Alzheimer’s Disease. It is an antibody that stimulates the immune system to destroy amyloid plaque in the brain. Amyloid has long been felt to be a major cause of Alzheimer’s Disease.

How “good” is Aduhelm?

There is controversy about whether Aduhelm is an effective medication.

In 2019 several trials were stopped because the data did not show any clinical impact on the disease.

But when more data became available, one of two studies showed positive results. In that study, patients who received the higher dose of Aduhelm had a slower rate of decline.

In addition, there is strong evidence that Aduhelm results in less amyloid plaque in the brain.

Aduhelm is definitely not a cure.

It will not reverse decline in brain function. It will not stop Alzheimer’s Disease from progressing. Aduhelm reminds me of other drugs that have been used for Alzheimer’s Disease. It might slow the rate of decline. Some patients and families have told me that these other drugs were “useless” because the disease still progressed. Other families were glad that the drugs helped keep “Mom with us as long as possible”.

Is there anything “bad” about Aduhelm?

More than one third of patients receiving the high dose of Aduhelm had abnormal brain scans.

Abnormalities included some edema (swelling) and some very small areas of bleeding. These patients did not have any symptoms 75% of the time. However, 25% developed symptoms such as headache, confusion, dizziness, or nausea.

Overall, serious side effects occurred in over ten percent of patients. However, serious side effects were equally common in patients on placebo and in patients on Aduhelm. Some patients dropped out of the study because of Aduhelm side effects. There were major side effects, including seizure, in a small number of patients.

Aduhelm cannot be taken by mouth. It is given by one-hour infusion every four weeks.There is no clarity about how long the medication should be given. Once the mediation is started, no one can say for sure whether the medication is having a positive impact or not. Some institutions or health plans may decide to discontinue the medication when the Alzheimer’s has progressed to a more severe stage.

An MRI needs to be done at baseline and periodically after that.

Aduhelm is expensive.

The cost of the drug is $56,000 per patient per year. There are additional costs for the infusion, imaging of the brain and for visits to specialists. Insurance coverage will vary but the drug is very likely to be costly to many patients.

Who can get Aduhelm?

80% of patients in the clinical trials had Mild Cognitive Impairment due to Alzheimer’s Disease (“pre-Alzheimer’s”). 20% had mild Alzheimer’s Disease. The FDA has approved the medication for use in patients at these stages of the disease.

Most patients with Alzheimer’s Disease do not meet criteria for the medication because they have more severe stages of the disease.

Aduhelm is not currently available in most places across the United States. Many institutions are now preparing policies and procedures for use of the drug. Consultation by a specialist is very likely to be a requirement. Insurance companies and Medicare have not yet produced coverage policies.

Aduhelm can be used concurrently with other medications that are used for Alzheimer’s Disease.

Some thoughts:

Aduhelm has been FDA approved but many experts disagreed with the approval. The FDA is requiring a Phase IV study, but patients will be able to receive the drug without being in the study. The Phase IV study will collect more data about the safety and efficacy of the drug. 6000 patients will be enrolled over 4 years and results will be collected for the following 5 years. As a result, final data will be collected in 9 years. The Phase IV study is likely to provide a clearer picture of the long-term impact of the drug. It will be interesting to see if the impact is greater or less over many years.

There is good evidence that Aduhelm results in fewer plaques. One area of interest might be the use of Aduhelm in the preclinical stages of Alzheimer’s Disease. At that stage plaques are forming but there is no evidence of cognitive problems. Other studies using other drugs are doing this type of research.

Other drugs using similar mechanisms of actions are likely to be approved over time. This may result in lower cost of medications such as Aduhelm in the future.

More than 150 clinical trials of multiple investigational drugs have failed to result in a positive impact on Alzheimer’s Disease. Most of these studies focused on decreasing amyloid plaque. Many newer drug trials are not focusing on amyloid.

Addendum
 
Two Congressional committees have raised concerns about the FDA approval process for Aduhelm and are investigating further.  Some major medical centers have decided not to offer Aduhelm. The Department of Veterans Affairs has decided not  to have the drug on its formulary.

Your thoughts:

If you or a loved one developed mild problems indicative of Alzheimer’s Disease, would you
Vote

 

With Aloha,

PS: Here's a pdf with more Aducanumab (Aduhelm™) Information

Posted in Alzheimer's, Caregiving, Dr. Warren, Geriatrics with Aloha and tagged , .

9 Comments

  1. My understanding is Aduhelm was by approved under the accelerated approval pathway, which provides patients with a serious disease earlier access to drugs when there is an expectation of clinical benefit despite some uncertainty about the clinical benefit.

    Aducanumab comes with a hefty price tag. Biogen says the wholesale cost of treatment with aducanumab, which requires an infusion once every four weeks, is about $4,312 per infusion, making the annual cost around $56,000 for a high dose.

    On those two points, safety & cost, we probably wouldn’t use Aduhelm, if I needed, today. Perhaps we’d think differently in the future, if the potential side effects and cost make it safe, affordable and helpful. Science evolves as we learn, adjust and improve.

    We’ll hope we never have to make that decision, but if we do, we’ll work closely with our trusted professionals and each other (my wife & I) as we gather as much info as we can to make the best decisions and plans to age with dignity and the love of each other til death do us part.

    That’s my two cents with change.

    • Thanks Rick,
      The price tag for Aduhelm is extremely high. In addition, Alzheimer’s Disease is very common and Aduhelm efficacy is uncertain. These issues have raised major red flags. The FDA gave accelerated approval but also included a mandate for the phase 4 study. The FDA has the right to rescind approval if the phase 4 study does not show positive results. It will be interesting to see whether any positive impact increases or disappears. It will challenging to recruit enough people for the study since many people will not want to receive placebo.
      It will also be interesting to see how CMS responds. CMS is in a position to determine coverage,irrespective of FDA drug approval.
      Dr. Warren

  2. Based on the information you provided about Aduhelm, one would be grasping at straws in the wind to give that drug a try. Also, based on the information provided, I brlieve one would be irresponsible to try the drug. The benefits are slight at best and the odds of negative reactions are high, far from insignificant.

  3. Aloha

    You ask a very interesting question. Would I take Aduhelm? I don’t know. Would I be in denial during the first stages of Alzheimer? “Oh, no, it is just once in a while that I forget. It is part of growing old. Thee is nothing wrong with me.”

    Would my family notice it early on and encourage me to see someone? Perhaps not. Most elderly live independently or with their spouse. I notice that when I point out to some individuals about their forgetfulness, or a topic that we just discussed and they are asking a question like we never talked about it, they don’t think that there is anything wrong and will not even mention it to their physician.

    Does Aduhelm only work with those with Alzheimer’s or is it effective with other types of dementia, such as FTD? FTD starts early on – 50, 60’s and if not properly diagnosed, it could for years without being diagnosed properly.

    Is the drug effective in the middle stages or just in the early stages? Of course, earlier is better. But it is better late than never?

    At the age of 77, do I forget? Yes, but is it because I am overworked and underpaid. Might be. Will I recognize in the next 5 to 10 years, that I am forgetting dates, appointments, where I put things, where I am going, etc.

    Anyway, this is from top of my head. Hope all is going well with you. Love your topics.

    My Mahalo

  4. I envision a research project in which we offer to people with mild cognitive dysfunction and proven amyloid deposits two choices, with very good information about each: (1) $100,000 per year cash, paid out monthly, tax free and not counted in figuring out public benefits (like Medicaid), to use however you wish, for every year until you die, which is about the total costs of aducanumab and its tests, infusions, and side-effects, with all usual care, or (2) aducanumab for as long as you can tolerate it and its attendant burdens, along with usual care.

    My bet is that most people, well-informed, would take the cash. What do others think?

  5. Before reading the information you provided about Aduhelm, my answer would have been that I would ask two or three doctors and trust/evaluate their opinions.

    I believe that people doing their own homework on very technical issues and arriving at a correct solution is the style these days but not necessarily a good way to make decisions. I believe much more in trusting an expert that I respect.

    After reading the information, my Lord, apparently 10-30% of the people tested had negative reactions. How do you approve a drug like that?

  6. Hi Joanne,
    Wow, a completely different way of thinking about “why do we spend so much money on treating diseases?”
    I would definitely lean towards suggesting to patients that they take the money and use it for what really matters to the patient.

    I look forward to your thoughts about making care for seniors what it should be!!

    Let’s discuss your book:
    MediCaring Communities: Getting What We Want and Need in Frail Old Age at an Affordable Cost –  at http://medicaring.org/book

    Dr. Warren

  8. Pingback: My Auntie says “Why Didn’t You” Over and Over – Geriatrics with Aloha

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