FDA Approves First Alzheimer Drug to Slow Disease Progression

FDA Approves First Alzheimer: Drug to Slow Disease Progression

First Alzheimer Drug : The US Food and Drug Administration (FDA) has granted traditional full approval to Leqembi, an Alzheimer’s drug that has been proven to slow the progression of the disease. This marks a significant milestone in the fight against Alzheimer’s, as Leqembi is the first medication to demonstrate clinical benefit in slowing the devastating effects of the disease.

Broader Medicare coverage for Leqembi to benefit millions with early forms of Alzheimer’s

The Centers for Medicare and Medicaid Services (CMS) announced that they will expand coverage of Leqembi, making the drug more accessible to an estimated one million people suffering from early forms of Alzheimer’s. This decision will provide greater support to individuals in need of treatment and alleviate the financial burden associated with the cost of the drug.

A breakthrough in Alzheimer’s treatment

Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, expressed her excitement regarding this groundbreaking development. She stated, “Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease. This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”

Leqembi: Accelerated approval and limited usage

Leqembi, developed by Eisai and Biogen, initially received accelerated approval in January based on its ability to clear amyloid plaque buildups in the brain, which are associated with Alzheimer’s disease. However, due to a prior coverage decision by CMS, the drug has not been widely utilized. The cost of Leqembi stands at $26,500 annually before insurance coverage, making it inaccessible for many patients.

Limited eligibility and potential risks

Leqembi is approved only for individuals with early forms of Alzheimer’s, specifically those with mild cognitive impairment or mild dementia who have confirmed amyloid plaques in their brains. Dr. Lawrence Honig, a neurology professor at Columbia University Irving Medical Center, estimates that this group constitutes about one-sixth of the over 6 million Americans currently diagnosed with Alzheimer’s.

However, the drug may not provide significant benefits to individuals in the advanced stages of the disease and may pose increased safety risks for this population. Dr. Honig emphasized that while Leqembi represents an important advancement, it is not a cure. In an 18-month clinical trial, the drug demonstrated a 27% slowdown in cognitive decline and functional deterioration.

Support and hope for the future

Dr. Joanne Pike, president and CEO of the Alzheimer’s Association, welcomed the FDA’s full approval of Leqembi. She emphasized that while the drug is not a cure, it provides individuals in the early stages of Alzheimer’s with more time to maintain their independence and engage in activities they love. The approval of Leqembi offers hope for patients and their families, allowing them to cherish moments with their loved ones for an extended period.

Side effects and monitoring requirements For First Alzheimer Drug 

While Leqembi offers promising benefits, it is not without risks. The drug comes with side effects and requires regular brain imaging for monitoring. Approximately 13% of participants in the clinical trial experienced brain swelling or bleeding. Certain groups, such as individuals with specific genetics or those taking blood-thinning medications, may face higher risks. The FDA has included a boxed warning in the prescribing information to ensure patients and caregivers are fully informed about these potential side effects.

Preparing for broader use Of First Alzheimer Drug

Healthcare systems have been makingpreparations to accommodate the wider use of Leqembi. Infusion centers, such as Vivo Infusion, which serves approximately 50,000 patients in the US, are anticipating an increase in patient referrals for the drug. Sue Rottura, the chief operating officer of Vivo Infusion, mentioned the need to expand capacity and adjust schedules to meet the expected demand.

The road ahead For First Alzheimer Drug

While Eisai anticipates a gradual uptake of Leqembi, they do not expect the immediate use of the drug by all individuals estimated to have early Alzheimer’s disease. The company’s US CEO, Ivan Cheung, explained that the number of users may increase in the future as therapeutic options become more accessible and testing is reimbursed. However, reaching a million patients within the next few years is unlikely.

FDA Approves First Alzheimer: Drug to Slow Disease Progression

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Expanded Medicare coverage for Leqembi

CMS, in alignment with its commitment to improving care for individuals with Alzheimer’s, has confirmed that it will provide broader coverage for Leqembi following the FDA’s approval. Administrator Chiquita Brooks-LaSure emphasized the significance of this decision, stating, “CMS today affirms our commitment to help people with Alzheimer’s disease have timely access to innovative treatments that may lead to improved care and better outcomes.”

Out-of-pocket costs and coverage qualifications

Medicare recipients can expect out-of-pocket costs for Leqembi. Traditional Medicare beneficiaries will be responsible for a 20% coinsurance of the Medicare-approved amount after meeting their Part B deductible. The costs for individuals enrolled in Medicare Advantage or supplemental plans will vary based on their specific policy.

Additionally, Medicare’s coverage of the approved drugs is contingent upon physician and clinical team participation in a registry. This registry will collect data on the real-world effectiveness of these medications for individuals with Medicare, providing valuable insights into their impact and benefits.


FDA Approves First Alzheimer: Drug to Slow Disease Progression

Concerns and potential impact on spending

While the broader coverage of Leqembi is expected to benefit millions, there have been concerns raised about the use of a registry as a requirement for coverage. Critics argue that it may create barriers to treatment. However, CMS believes that the registry will provide essential data to answer key questions regarding the drug’s efficacy and potential risks in real-world settings.

The expanded Medicare coverage of Leqembi and similar medications to slow Alzheimer’s disease progression is projected to have a significant impact on program spending. According to an analysis by KFF, if 10% of the estimated 6.7 million older adults affected by the disease were to utilize Leqembi, it would increase spending by $17.8 billion, surpassing the total spending on the top 10 Part B drugs administered in doctors’ offices in 2021.

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