The new drug, developed by Japanese drugmaker Eisai and U.S-based drugmaker Biogen, is a monoclonal antibody treatment targeting beta-amyloid. Whilst Eisai began the trials in September 2021, it was not until earlier this January that the FDA approved the drug using the accelerated approval pathway.
Researchers conducted clinical trials for the drug in a multicentre, randomised, double-blind group study, enrolling 1,795 patients with Alzheimer's. The result of the phase three clinical trial requested by the FDA showed that the drug effectively slowed down cognitive decline in early-stage Alzheimer’s' patients. The antibody reduced brain amyloid build-up by 27% in the 18th-month study, significantly improving previous Alzheimer's drug trials.
The drug has received approval for intravenous injection and is recommended only for patients with mild cognitive impairment. Despite the advancement, the drug has serious side effects such as temporary swelling in brain areas- although the FDA has claimed this usually resolves itself over time. Infusion-related reactions, including breathing difficulties, flu-like symptoms, and heart rate changes, are also noted on the Leqembi website.
It is common for drugs to lead to side effects due to the complexity of the human body. However, the most pressing concern is that individuals aged 65 and above, already at a heightened risk, will primarily consume the drug.
The Controversy surrounding the drug’s price tag
Leqembi may be impressive, but its price tag is undoubtedly eye-watering.
In addition to the company's $26,500 annual price tag for the drug, treatment could cost U.S. taxpayers $82,500 per patient per year, on average, for genetic tests and frequent brain scans, safety monitoring, and other care, according to estimates from the Institute for Clinical and Economic Review. This presents a challenge for the average patient and healthcare systems looking to roll it out to patients.
Given stagnant wage growth and rising essential service costs, many Americans will struggle to afford treatments, perpetuating disparities. Additionally, geographic health disparities in the U.S. and the uncertainty surrounding Alzheimer's risk will limit drug access for many.
Medicare's coverage of the drug also contributes to cost concerns.
Medicare will cover the drug for all indicated populations (those with mild cognitive impairment). While well-intended, it will raise Medicare spending. Estimates suggest that approximately 100,000 people may take up Leqembi within three years. All in all, this will increase Medicare spending from $2.7 billion to $17.8 billion annually.
Racial disparities
Amid the hopeful thinking towards the new treatment is the unfortunate stark reality of racial disparities in the rollout of the drug and Alzheimer's care in general.
Studies show varied outcomes and effectiveness among diverse racial and ethnic populations. Black Americans and Hispanics, at higher risk of Alzheimer's, were underrepresented in all drug clinical trials due to lower brain amyloid levels, adding to disparities in access to potential therapies.
The healthcare disconnect with black patients has a resounding impact on Alzheimer’s disease and related dementias (ADRD) care, as data indicates that black patients are 35% less likely to be diagnosed with Alzheimer's and related dementia. Moreover, according to an Alzheimer's Association study, black patients are twice as likely to avoid healthcare for cognitive issues than white patients.
The FDA has attempted to quell such concerns. Last year, the FDA recommended guidelines to reflect the diversity of drug users in trials.
Promising approaches to Alzheimer's care
Beyond drug-based treatments, researchers have studied non-pharmacological interventions to address Alzheimer's. Transcutaneous electrical nerve stimulation (TENS) has been explored as an alternative treatment for dementia, showing short-lived improvements in certain cognitive aspects. However, the quality of evidence from these studies is considered poor, and more research is still needed to understand the effectiveness of TENS in treating dementia.
Researchers have also explored cannabis and cbd oil as options for managing behavioural symptoms like agitation and anxiety in Alzheimer's patients. Studies conducted in labs and on mice have shown promising results regarding their effects on amyloid protein build-up in the brain. However, clinical trials on the effects of cannabis and CBD oil in people with dementia remain lacking.
Whilst both TENS and Cannabis and CBD oil have shown some promise, the use of both treatments remains shaky. This is due to a lack of strong research studies and anecdotal reports that fail to replace concrete evidence.
These approaches cannot halt, reverse, or prevent dementia. However, they offer patient-centred care for late-stage patients, relieving and managing behavioural symptoms like agitation and aggression.
We must also remember that Leqembi is not a cure for Alzheimer's, but a treatment that addresses the disease's underlying biology of the disease.
Hope or no hope?
As the landscape of Alzheimer's treatment evolves with the introduction of new drugs like Leqembi, it is essential to confront the challenges such drugs may present.
Policymakers, healthcare providers, and the pharmaceutical industry must work together to ensure affordable and accessible treatments for all. Addressing racial disparities and conducting inclusive clinical trials will also enhance our understanding of how these drugs work in diverse populations, ensuring no one is left behind in the fight against Alzheimer's.
