Alzheimer Medication and Treatment

## 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.

: https://www.sfgate.com/news/article/norwalk-hospital-alzheimers-care-new-drug-18201267.php

: https://news.yahoo.com/analysis-alzheimers-drug-breakthrough-big-140333077.html

: https://www.nejm.org/doi/full/10.1056/NEJMoa2100708

: https://www.nytimes.com/2023/07/07/health/alzheimers-drug-lecanemab.html

: https://www.cnn.com/2023/07/17/health/second-alzheimers-drug-to-slow-disease-may-be-approved-this-year/index.html

: https://jamanetwork.com/journals/jama/article-abstract/2783810