Alzheimer's disease is a devastating neurodegenerative condition that gradually progresses, causing a decline in cognitive abilities, memory loss, confusion, changes in behavior, and difficulties with daily tasks. As the disease advances, individuals may struggle to recognize loved ones or even perform basic self-care tasks.
An estimated 6.7 million Americans are living with Alzheimer’s Dementia. By 2050, the number of people with Alzheimer's and dementia is projected to reach 12.7 million
Current Alzheimer's disease treatments primarily manage symptoms and enhance the quality of life but do not address the underlying disease progression. There is an urgent need for novel treatments that can target the underlying causes of Alzheimer's and potentially slow or halt its progression and one promising solution on the horizon is Leqembi.
In the CareTalk episode, “FDA Approves Leqembi: What You Should Know.”, hosts, John Driscoll and David Williams discuss Leqembi and its possible effect on the millions of people living with Alzheimer’s.
What is Leqembi?
Leqembi is a groundbreaking treatment specifically developed for individuals in the early stages of Alzheimer's disease. It targets two specific groups: those with mild cognitive impairment (MCI) due to Alzheimer's disease and those experiencing mild Alzheimer's dementia.
MCI due to Alzheimer's disease refers to a stage where individuals may exhibit mild symptoms such as occasional forgetfulness and mild confusion. However, these symptoms do not significantly interfere with their daily lives.
Mild Alzheimer's dementia represents a progression of the disease, where individuals face challenges with tasks they previously handled easily. This can include difficulties in managing bills and completing familiar activities.
Leqembi received initial approval from the FDA in January 2023 under the Accelerated Approval Pathway. This approval was based on its demonstrated ability to slow the progression of Alzheimer's disease, even though its impact on cognitive function had not yet been proven. In July 2023, the FDA granted Leqembi traditional approval, considering both its effectiveness in slowing disease progression and improving cognitive function.
“It has regular approval for early-stage Alzheimer's. It had received accelerated approval at the start of the year. Now it has just a regular approval. It's made by EAI, which is a Japanese pharma company in partnership with Biogen.”- David (CareTalk)
How Does Leqembi Work?
Leqembi (lecanemab-irmb) is a monoclonal antibody designed to specifically target amyloid beta, a protein believed to play a role in the development of Alzheimer's disease. In individuals with Alzheimer's, amyloid beta plaques accumulate in the brain, leading to damage to nerve cells and cognitive decline. Leqembi works by binding to amyloid beta and facilitating its removal from the brain.
The administration of Leqembi involves injecting it into the bloodstream. Once in the brain, the antibody selectively attaches itself to the amyloid beta plaques. By doing so, Leqembi aids in the clearance of these plaques from the brain. This reduction in amyloid beta plaques may contribute to slowing the progression of Alzheimer's disease.
Leqembi is administered through a monthly infusion that typically takes about one hour. It is important to note that there can be side effects associated with Leqembi treatment. Common side effects include infusion-related reactions, headaches, and amyloid-related imaging abnormalities (ARIA). ARIA is a condition that can cause brain swelling and inflammation.
Leqembi vs. Aduhelm
Leqembi and Aduhelm are two monoclonal antibodies that target amyloid beta, a protein associated with Alzheimer's disease. However, there are notable differences between these drugs.
In terms of FDA approval, Leqembi has received both accelerated and traditional approvals. It has demonstrated the ability to slow disease progression and improve cognitive function. Aduhelm, on the other hand, has only received accelerated approval, showing effectiveness in reducing amyloid-beta plaques but lacking evidence of impact on disease progression or cognitive function.
Cost-wise, Leqembi is significantly more affordable than Aduhelm. Leqembi's lower cost is attributed to its approval under the Accelerated Approval Pathway, which focused on disease progression, while Aduhelm's approval centered around plaque reduction in the brain.
In targeting amyloid beta, Leqembi acts on an earlier stage of the protein, while Aduhelm targets a later stage. Both drugs have potential side effects, such as infusion-related reactions, headaches, and amyloid-related imaging abnormalities (ARIA). However, ARIA is more commonly associated with Aduhelm than with Leqembi.
Regarding Medicare coverage, Leqembi is covered for individuals enrolled in clinical trials or meeting specific criteria, such as having an early Alzheimer's diagnosis and the presence of a certain level of amyloid beta. In contrast, Medicare does not provide coverage for Aduhelm, except for individuals enrolled in clinical trials. The Centers for Medicare & Medicaid Services (CMS) determined that the evidence supporting Aduhelm's effectiveness is insufficient to warrant coverage for all Medicare beneficiaries.
“This drug actually is showing some results because this is an area where most drugs have failed and failed pretty miserably in showing success at slowing or stopping this disease.”- John (CareTalk)
Future Implications and Challenges
Leqembi shows promise as a new treatment for Alzheimer's disease. However, there are several challenges that need to be addressed before its widespread use can be achieved.
The cost of Leqembi poses a significant barrier, as it is currently priced at a level that may be unaffordable for many individuals. This raises concerns about equitable access to the drug and the potential for limited availability.
Additionally, the potential for serious side effects, including ARIA, necessitates close monitoring and careful consideration of the risks and benefits of Leqembi. Further research is needed to better understand the long-term efficacy and safety profile of the drug, particularly in terms of its impact on cognitive function.
Furthermore, the acceptance and adoption of Leqembi by healthcare professionals and the public are essential for its successful integration into Alzheimer's treatment protocols. Addressing concerns and skepticism through ongoing research and transparent communication will be crucial in establishing confidence in the drug.
Moving forward, continued research and development, cost considerations, and efforts to ensure accessibility will be key in maximizing the potential benefits of Leqembi for individuals with Alzheimer's disease. By overcoming these challenges, Leqembi holds the potential to make a significant impact on the lives of those affected by this devastating condition.
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CareTalk is the only healthcare podcast that tells it like it is. Join hosts John Driscoll (President U.S. Healthcare and EVP, Walgreens Boots Alliance) and David Williams (President, Health Business Group) as they provide an incisive, no B.S. view of the US healthcare industry.
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