FDA Approves New Alzheimer’s Treatment
The U.S. Food and Drug Administration (FDA) recently approved Biogen and Eisai Co. Ltd.’s Alzheimer’s treatment, Leqembi, also known as lecanemab. This ground-breaking drug is designed to reduce the buildup of amyloid beta plaque in the brain – a hallmark of Alzheimer’s disease. This is a significant step forward, as Leqembi is the first drug shown to slow the disease’s progress rather than treat its symptoms. This FDA action has been hailed as the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has demonstrated clinical benefit.
Alzheimer’s disease is a widespread concern. About 6.7 million people in the U.S. aged 65 and older are living with Alzheimer’s, which could rise to 12.7 million by 2050 without medical breakthroughs to prevent or cure the disease. Leqembi could be a game-changer. Earlier this year, the FDA granted Leqembi accelerated approval, allowing for earlier approval of drugs that treat serious conditions with unmet medical needs. Clinical trials indicated that the treatment slowed declines in cognition and function by 27% compared with a placebo over 18 months.
Leqembi’s Clinical Trials and Approval
In early June, a panel of FDA advisers unanimously voted in favor of Leqembi, indicating that clinical studies had verified its benefit. However, safety issues identified during the clinical trials, including potential brain swelling or bleeding, raised concerns among several experts. Consequently, the drug’s label will carry a boxed warning about amyloid-related imaging abnormalities, which usually have no symptoms but can cause life-threatening brain swelling in rare cases.
The Role of Medicare in Alzheimer’s Treatment
With the FDA approval, the Centers for Medicare and Medicaid Services (CMS) confirmed that Medicare will cover new Alzheimer’s treatments such as Leqembi. This coverage hinges on the drug’s traditional FDA approval and the beneficiary’s doctor and clinical team participating in collecting real-world evidence about how the drugs are working. This announcement represents a significant win for Biogen and Eli Lilly, which is developing its treatment in the category of donanemab.
Despite Medicare coverage, Leqembi, with a list price of $26,500, may still be out of reach for many patients. Medicare patients taking the drug will have to pay more than $5,000 per year out of pocket, based on the 20% coinsurance required in traditional Medicare. This financial burden may be lessened for individuals with supplemental insurance, such as Medigap.
Impact on Medicare Part B and Patient Registry Concerns
Coverage of Leqembi could considerably boost total spending in Medicare Part B, which covers drugs that typically are not self-administered. Increased spending may lead to higher Part B premiums. Part B premiums jumped 15% for 2022, based on uncertainty about Medicare’s potential spending on new Alzheimer’s treatments.
Furthermore, the requirement of a patient registry as a condition for Medicare’s coverage of new Alzheimer’s treatments has been criticized by some patient advocates. While registries can gather valuable real-world evidence to improve patient care, some argue they should not be required to cover FDA-approved treatment.
FAQs about Leqembi and Medicare Coverage
What is Leqembi?
Leqembi, also known as lecanemab, is a drug approved by the FDA for treating Alzheimer’s. It is designed to reduce the buildup of amyloid beta plaque in the brain, a marker of Alzheimer’s disease.
How does Leqembi work?
Leqembi works by slowing the progression of Alzheimer’s disease rather than just treating its symptoms. It has been shown to slow declines in cognition and function by 27% compared with a placebo over 18 months.
Will Medicare cover the cost of Leqembi?
The Centers for Medicare and Medicaid Services have confirmed that Medicare will cover Alzheimer’s treatments such as Leqembi. However, patients may still have to pay more than $5,000 per year out of pocket, based on the 20% coinsurance required in traditional Medicare.
Are there any safety concerns related to Leqembi?
Clinical trials for Leqembi raised concerns about potential brain swelling or bleeding. Consequently, the drug’s label will carry a boxed warning about these potential risks.