## Lecanemab: The First FDA-Approved Drug to Slow
Alzheimer's Progression
On July 7, 2023, the US Food and Drug Administration (FDA)
approved lecanemab, a new drug that has been shown to slow the cognitive and
functional decline in patients with early-stage Alzheimer's disease . Lecanemab is
the first drug of its kind to receive FDA approval, marking a historic shift in the
treatment of Alzheimer's disease.
Lecanemab is a monoclonal antibody that targets amyloid, a
protein that accumulates in the brains of people with Alzheimer's disease and forms
sticky plaques that damage neurons. Lecanemab works by binding to amyloid and
clearing it from the brain, reducing its harmful effects.
Lecanemab was developed by Eisai and Biogen, two
pharmaceutical companies based in Japan and the US, respectively. The approval of
lecanemab was based on the results of a large trial involving more than 1,800
patients with early symptomatic Alzheimer's disease . The trial showed that patients
who received lecanemab had a significant slowing of cognitive and functional decline
compared to those who received a placebo over 18 months.
Lecanemab is expected to be available in the US by the end
of 2023. The drug will be administered by intravenous infusion every four weeks at a
specialized infusion center. The cost of lecanemab has not been announced yet, but
it is estimated to be around $56,000 per year .
Medicare will likely cover lecanemab under Part B, which
covers outpatient services such as doctor visits and lab tests. However, Medicare
beneficiaries may still face high out-of-pocket costs for lecanemab, such as
deductibles, coinsurance and copayments. Medicare Part D, which covers prescription
drugs, may also cover some of the costs of lecanemab, depending on the plan.
## Donanemab: Another Potential Drug to Slow Alzheimer's
Progression
Another drug that may soon join lecanemab on the market is
donanemab, developed by Eli Lilly, a US-based pharmaceutical company. Donanemab is
also a monoclonal antibody that targets amyloid in the brain, but it has a different
mechanism of action than lecanemab.
Donanemab was shown in May and in fuller Phase 3 clinical
trial results released at the Alzheimer’s Association International Conference on
July 18, 2023 to delay the disease’s progression . The trial involved more than
1,700 patients with early-stage Alzheimer's disease. The results showed that
patients who received donanemab had 35% slower progression of disease than those who
received placebo over 76 weeks on a measure called the integrated Alzheimer’s
Disease Rating Scale (iADRS), which assesses both cognition and function.
Donanemab was also very effective at eliminating amyloid
from the brain, but the clinical effect was comparatively weak . Moreover, donanemab
did not provide as much benefit to people at later stages of Alzheimer's disease or
those with a common genetic variation called APOE4 that raises the risk of
developing Alzheimer's disease.
Donanemab also has some serious side effects, such as
amyloid-related imaging abnormalities (ARIA), which can cause brain bleeding and
seizures. Around one-quarter of the participants in Eli Lilly’s phase III trial
developed ARIA, and three died of the condition .
Eli Lilly has completed its FDA submission for donanemab,
and expects regulatory action by the end of 2023 . The cost and availability of
donanemab have not been announced yet.
Medicare will likely cover donanemab under Part B as well,
but beneficiaries may face similar out-of-pocket costs as for lecanemab. Medicare
Part D may also help cover some of the costs of donanemab, depending on the plan.
## Other Treatments for Alzheimer's Disease
Besides lecanemab and donanemab, there are other treatments
for Alzheimer's disease that are currently available or in development. These
include:
- Cholinesterase inhibitors and memantine: These are drugs
that are approved by the FDA to treat the symptoms of Alzheimer's disease, such as
memory loss, confusion and agitation. They work by affecting the levels of certain
chemicals in the brain that are involved in communication between neurons.
Cholinesterase inhibitors include donepezil, rivastigmine and galantamine. Memantine
is often used in combination with a cholinesterase inhibitor. These drugs are
covered by Medicare Part D, but beneficiaries may have to pay copayments or
coinsurance depending on the plan.
- Lifestyle interventions: These are non-pharmacological
approaches that aim to improve the quality of life and well-being of people with
Alzheimer's disease and their caregivers. They include physical activity, cognitive
stimulation, social engagement, healthy diet, stress management and sleep hygiene.
These interventions may help delay the onset or progression of Alzheimer's disease,
or reduce the severity of its symptoms. Medicare may cover some of these
interventions under Part B or Part C, such as occupational therapy, nutrition
counseling or wellness programs.
- Clinical trials: These are research studies that test new
drugs or devices for Alzheimer's disease or other conditions. Participating in a
clinical trial may offer access to experimental treatments that are not yet
available to the public, or provide additional care and monitoring. However, there
are also risks and uncertainties involved in clinical trials, such as potential side
effects, unknown effectiveness or eligibility criteria. Medicare may cover some of
the costs of participating in a clinical trial under Part A, B or D, such as
hospital stays, doctor visits or lab tests.
## Conclusion
Alzheimer's disease is a devastating condition that affects
millions of Americans and their families. There is no cure for Alzheimer's disease,
but there are treatments that can help slow down its progression and improve the
quality of life of those affected. The recent approval of lecanemab and the
potential approval of donanemab mark a major breakthrough in the field of
Alzheimer's research and treatment, as they are the first drugs to show a clear
benefit in slowing down the disease. However, these drugs are not without
limitations and challenges, such as high costs, side effects and variable efficacy.
Medicare will likely cover these drugs under Part B, but beneficiaries may still
face high out-of-pocket costs. Medicare Part D may also help cover some of the costs
of these drugs, depending on the plan.
Other treatments for Alzheimer's disease include drugs that
treat the symptoms, lifestyle interventions that improve well-being and clinical
trials that test new therapies. Medicare may cover some of these treatments under
different parts, but beneficiaries may have to pay copayments or coinsurance
depending on the plan.
If you or someone you love has Alzheimer's disease, it is
important to consult with your doctor about the best treatment options for your
situation. You should also review your Medicare coverage and costs for different
treatments, and consider enrolling in a Medicare Supplement plan or a Medicare
Advantage plan that may offer additional benefits or lower out-of-pocket costs.
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https://www.sfgate.com/news/article/norwalk-hospital-alzheimers-care-new-drug-18201267.php
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https://news.yahoo.com/analysis-alzheimers-drug-breakthrough-big-140333077.html
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https://www.nytimes.com/2023/07/07/health/alzheimers-drug-lecanemab.html
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https://www.cnn.com/2023/07/17/health/second-alzheimers-drug-to-slow-disease-may-be-approved-this-year/index.html
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https://jamanetwork.com/journals/jama/article-abstract/2783810
