Aduhelm was approved by the Food and Drug Administration (FDA) in early June as a treatment for Alzheimer’s disease, and it is the first new medication to be approved in 18 years.
However, there has been controversy surrounding this approval. Many Aduhelm-related articles have focused on its cost and side effects in addition to concerns over its effectiveness.
Aduhelm is expected to improve the quality of life for residents under their care in assisted living and memory care facilities. Nevertheless, providers admit there are more questions than answers following the announcement:
- Will it be effective for residents who have advanced stages of Alzheimer’s?
- How much will the treatment cost for residents of an assisted living facility?
- Is the drug going to complicate the monitoring of residents and put them at risk for liability concerns?
- If a large-scale study is not proving to be effective, might approve of the drug be revoked?
Dan Williams, Seasons Living President, and COO said assisted living, and memory care operators are doing their due diligence to provide residents and their families with as much information as possible about Aduhelm once it becomes widely available.
Williams acknowledged that his initial reaction to the FDA announcement was positive, but as more information about Aduhelm’s ability to get tested became available, his optimism cooled.
The Approval Process is Controversial
Aduhelm has been the subject of controversy in large part because of how the FDA approved it.
For filling an unmet medical need, the agency utilized its accelerated approval program, which allows drug companies to request fast-track approval designation at any time during the development of a drug. The FDA approved a total of 53 drugs under this program in 2020.
As part of the program’s guidelines, drug companies must still conduct phase 4 confirmatory trials to confirm the outcome of the anticipated study. When these studies show a drug provides a clinical benefit, formal approval is granted by the FDA. If the FDA can’t prove this, it has regulatory procedures that could result in the medication being taken off the market.
Aduhelm is an infusion treatment that combats the buildup of beta-amyloid plaque, which is known to damage brain cell communication and hasten cognitive decline in Alzheimer’s patients. Biogen was ordered to conduct a post-approval study to determine whether the drug benefits Alzheimer’s patients, as the FDA considered the drug “reasonably likely” to provide benefits.
A panel of 11 independent experts for the FDA is concerned with the drug’s effectiveness, but the FDA’s approval runs counter to the panel’s concerns. Aduhelm was rejected for use by 10 of the 11-panel members in November because there was insufficient evidence to support substantial benefits.
The FDA approved the product, resulting in three members of the advisory panel resigning in protest.
Aduhelm’s approval, according to elderly neurologists with experience treating Alzheimer’s patients, will make existing therapies like galantamine which is an oral medication approved by the FDA in 2003 be less desirable. Sam Gandy, a neurologist, writing on Stat News, noted that cutting beta-amyloid plaque is not enough to treat Alzheimer’s. A founding and current director of the Mount Sinai Center for Cognitive Health and NFL Neurological Care, he has more than 30 years of experience in neurology.
Medication Management Partners’ clinical pharmacist Mimoza Metarapi shares critics’ concerns. As a pharmacy partner for assisted living communities, memory care facilities, and behavioral health clinics throughout the country, iDrive provides medication management and is committed to providing medication safety.
It is necessary to acknowledge that Aduhelm is best marginally beneficial for people in care for Alzheimer’s.
Despite its approval, Metarapi is looking forward to post-approval trials that will test the drug’s effectiveness.
Even so, a large number of physicians express interest in prescribing the treatment for their patients. Jeffreyeries Global Financial Services recently surveyed 50 neurologists and psychiatrists specializing in Alzheimer’s patient treatment. They found that 35% would be interested in prescribing the drug during the early phases of Alzheimer’s disease.
Concerns Regarding Costs
Biogen would profit financially from the development of Aduhelm since there are approximately 6.2 million Americans with the disease.
As soon as the drug becomes widely available, analysts estimate peak sales of up to $10 billion. An Aduhelm treatment could cost up to $56,000 per patient per year, according to Biogen.
However, it raises concerns that the treatment would not be affordable for people with middle- and low incomes. According to an Alzheimer’s Association statement from June 12, the list price of Aduhelm is “simply unacceptable” and that such a high price will increase accessibility barriers for the drug.
According to Kristen Clifford, chief program officer for the Alzheimer’s Association, Biogen is publicly urged to lower the price tag.
In general, observers believe that Medicare Part B and Part D coverage will cover Alzheimer’s treatments. However, Metarapi points out that this is not guaranteed with treatments that receive accelerated approval.
The cost of Aduhelm would place significant strain on Medicare Part B and Part D budgets. In April, the Kaiser Family Foundation reported that Part B of Medicare spent an estimated $37 billion on pharmaceuticals in 2019, while Part D plans spend about $90 billion on prescription drugs.
Aduhelm is estimated to generate $69.4 million alone in pharmaceutical revenue if 20% of diagnosed Alzheimer’s patients in the U.S. were treated with it.
As a result of unabated costs, insurance premiums will undoubtedly increase, especially for seniors.
Aduhelm can also cause headaches and an increased risk of falling, as well as bleeding in or on the brain’s surface. The patients should be monitored for side effects, including having expensive MRIs to check for bleeding, as part of the treatment regimen. Senior living providers will face additional risks and costs as a result of this change. For patients, this will increase their costs and co-pays.
There is also no indication yet, as assisted living providers monitor for symptoms in front of insurance companies, what impact Aduhelm therapy will have on general liability insurance premiums.
Williams stated that Seasons would provide Aduhelm treatment only at the residents’ request. Since this treatment requires intravenous infusions, residents must travel to another facility to have it.
As a result of the uncertainties surrounding Aduhelm, he is having second thoughts.
As providers gather information about Aduhelm, Lewis McCoy, COO at Anthem Memory Care, said residents and their families could make an informed decision.
The FDA has approved Aduhelm for patients with Alzheimer’s. Yet, Mr. Sorn believes the benefits of eliminating the barriers to treatment outweigh the risks, leading to a more extensive focus on other treatments.
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