New Alzheimer’s Drug, Aduhelm, Approved by the FDA

For decades, scientists and medical researchers have searched for a cure for Alzheimer’s to no avail. Most approved drugs for use in Alzheimer’s sufferers are intended to combat symptoms of this degenerative and deadly disease.

In addition, technologies have been developed to help protect Alzheimer’s patients from harm that could result from the negative side effects of the disease, such as memory loss, anxiety, confusion, and agitation. Solutions like Accutech’s wander management system, ResidentGuard, help protect patients from the dangers of wandering brought about by Alzheimer’s dementia. But to this date, no miracle pill has been found that can cure the disease altogether.

The FDA’s Decision

However, on June 7, 2021, the Food and Drug Administration (FDA) approved a new drug developed by Biogen that will be marketed publicly as Aduhelm (FDA.gov). This drug is approved through the Accelerated Approval pathway, a fast approval process used for drugs that could help with terminal or seriously life-threatening diseases or illnesses.

Aduhelm is not a cure for Alzheimer’s, but the drug is meant to slow the progression of the disease by targeting protein plaque buildup in the brain thought to be related to the destructive path that Alzheimer’s takes through the brain.

The ray of hope that Aduhelm provides patients could have significant implications for the medical community, those suffering with Alzheimer’s, and family members of Alzheimer’s sufferers.

Questions About the Efficacy of Aduhelm

The FDA cleared the drug for sale and distribution even though studies have shown little effectiveness in the drug’s ability to combat Alzheimer’s disease. The FDA has a panel of experts that offer advice related to the development of drugs and the approval of drugs for the marketplace. Although the panel advised the FDA against approving the drug—and several panel experts actually quit over the FDA’s decision to move forward with approval—the drug was ultimately approved.

Why did the FDA approve a drug thought to have little impact on slowing the progression of Alzheimer’s disease?

• One set of data showed improvement (a slowing of the disease’s progression) in patients who were given high doses of the drug over patients who were not administered as much of the drug.
• The FDA asserted that it is “reasonably likely” that the drug will at least help Alzheimer’s patients somewhat and will certainly not harm them.
• Further studies and research will continue related to Aduhelm’s usefulness as a potential treatment for Alzheimer’s, but the FDA’s decision to allow patients to have access to this drug could offer some small hope to the hopeless.

The High Cost of Aduhelm: Is it Reasonably Priced?

Controversy about the pricing of Aduhelm began swirling immediately due to a high price tag for a drug with seemingly insignificant effectiveness. If this drug does little to help Alzheimer’s patients, is it worth the $56,000/year price tag?

Some are worrying about the pricing of an ineffective drug hitting the market because it could set a precedent for other companies to create drugs with little to no usefulness that could not only result in false hope but could also raise drug prices and cause other harm to the pharmaceutical and medical industries.

Charging a high price for hope—a drug with extremely low efficacy—could bring about a large number of other drugs that do little to nothing to improve serious diseases. Could patients lose faith in drugs and medical experts altogether if ineffective drugs flood the marketplace?

The Costs of Patient Care

Conversely, caring for Alzheimer’s patients is expensive. Alzheimer’s patients require special care that includes protective measures like security systems designed to avert patient wandering, caregivers, care facilities, and other services related to caring for Alzheimer’s patients who cannot care for themselves.

The already high cost of drugs needed to treat seniors and the symptoms of Alzheimer’s coupled with the necessary expense of caregiving measures could make a drug that just might help seem like a worthwhile Hail Mary investment.

Alzheimer’s patient care cost considerations:

1. In-home or facility care expenses
2. Cost of drugs needed to treat the symptoms of Alzheimer’s
3. Expense of security equipment to secure a home or senior care center
4. Transportation costs
5. Income loss due to a family member’s need to care for a senior

Again, in comparison to the expenses of caring for Alzheimer’s sufferers, the pricing of Aduhelm seems almost reasonable. Additionally, those who stand to benefit from an effective Alzheimer’s treatment will likely believe the results are worth the cost.

Perhaps We Could Give Aduhelm a Shot

Alzheimer’s patients are not complaining about the release of this new drug. It provides them with a chance to fight this disease, and most people will take a chance over no chance, even if the efficacy seems low.

Many medical experts and biotech scientists have come to the consensus that the drug could be pulled from the market at a later time if it’s proven ineffective at treating Alzheimer’s. Some suggest the drug should be used as an option for terminal patients looking for an experimental option that offers some hope to patients and family members. If the drug proves to be effective during additional studies, it’s really a win for everyone.