The New FDA Approved Alzheimer’s Drug Aduhelm and Occupational Therapy Practice

Closeup of IV drip chamber

Aduhelm Controversy

A headline showed up in my feed about how medicare may potentially cover the cost of the $56,000 annual controversial drug for Alzheimer’s, Aduhelm. This drug has created a lot of controversy as the FDA has approved it despite weak evidence for its efficacy and fierce criticism in the medical and research world. This is also after the passing of the ‘Right-to-try’ Act that was signed by President Trump that allows terminally ill patients ‘access’ to experimental drugs, e.g., only in Phase I that have not received FDA approval.

This could be a very deep rabbit hole you can do down if you are interested in the subject of Alzheimer’s, beta-amyloid hypothesis, the FDA being potentially investigated for foul play, and the ethics of the Right-to-try Act.

My Thoughts

I have mixed feelings about the FDA approval of Aduhelm. In the midst of the pandemic and with the emergency authorized use of the COVID-19 vaccines, I think the last thing we need is more controversy for the FDA. What I still have faith in is science, research, statistics, and the people in our healthcare system working on the frontlines. We will find out very soon how effective this drug is and as cruel as a disease that Alzheimer’s is, I hope it does not give patients and their families false hope and waste their money. Patients could end up worse off after this receiving this drug. I also hope this does not set science and our community back 10-20-30 years. Public perception of science and medicine is not very good these days with COVID-19.

What occupational therapy practitioners should know

  • Aduhelm is made by Biogen
  • It targets amyloid plaques
    • “Amyloid-beta is normally present in the brain as a single protein or monomer. However, it aggregates into clumps in Alzheimer’s disease. Researchers think that these clumps are toxic to brain cells, killing them. Aduhelm is an antibody that targets amyloid-beta…Through this interaction, Aduhelm could reduce the number of amyloid plaques present in the brain, potentially slowing neurodegeneration and disease progression.”

  • There is no consensus in the neurology community whether the beta-amyloid hypothesis is the right direction for potentially curing Alzheimer’s.
  • The initial pricing of the drug is $56,000/year.
  • Aduhelm is to be administered at a maintenance dose of 10 mg/kg, given as an intravenous infusion over about one hour every four weeks.
  • Aduhelm has been known to cause allergic reactions and ARIA-E (fluid accumulation in the brain), which should be monitored in treated patients.
  • Aduhelm was approved for all stages of Alzheimer’s, despite data only including early-stage Alzheimer’s.

Thinking Points

  • Should Medicare be paying for this? How about Medicaid?
  • Will additional trials be conducted? What will be the inclusion/exclusion criteria? How long will these take (all the while the drug is being sold and provided on the market)?
  • What other side effects will be discovered?
  • What are the benefits and risks then?
  • Is this ethical if it does not work and is only giving patients and families false hope?
  • What system is in place to provide this intervention (route=IV fusion)? Will training be required?
  • Is the price justified?
  • How will this affect the FDA and the public’s perception of it?
  • Who should get access to this drug?
  • How will informed consent go? (Potential side effect = brain swelling!)
  • Will doctors be put in a tough position when families ‘demand’ this drug?
  • What is the role of occupational therapy during and after the administration of this drug? Will OT services be covered by insurance?
  • Will this set a precedence for the FDA and similar outcomes from research trials?
  • Placebo effect??? Causation?
  • What happens when patients get worse, e.g, QoL?
  • If patients do get better, what will their QoL be? What will OT’s role be?
  • When should OT discontinue services?
  • How can OT be involved with future research trials?
  • Would it be just better to divert money into palliative care, caregiver assistance, training, respite care, or something else – or at least offer it as an option for late-stage Alzheimer’s with a poor prognosis?
  • Will this be provided in-hospital or on an outpatient basis?
  • Will patients be allowed to mobilize while receiving the infusion? If not, how long after?
  • Will some co-morbidities exclude this drug, e.g., TBI, increased ICP, some cancers?
  • How ‘early’ is early-stage Alzheimer’s to be eligible for this drug?
  • What are potential precautions and contraindications? (Brain swelling as a side effect, probably ALOC)?
  • Will we need to re-assess and screen cognition, e.g., memory, very frequently with rapid tools, e.g., BIMS, A&O, MoCA, etc.?

Until next time.

References

Alzheimer’s News Today. (n.d.). Aduhelm (Aducanumab). Retrieved from https://alzheimersnewstoday.com/aducanumab/