The Food and Drug Administration (FDA) granted full approval to Leqembi, an Alzheimer’s treatment, on Thursday. This milestone decision will increase accessibility to the costly drug for older Americans. Shortly after the FDA’s approval, Medicare announced that it will now provide coverage for the antibody treatment to patients enrolled in the senior insurance program, with certain conditions. Leqembi is the first Alzheimer’s antibody treatment to receive full approval from the FDA and is also the first drug of its kind to receive broad coverage through Medicare.
It is important to note that Leqembi is not a cure for Alzheimer’s. However, during Eisai’s clinical trial, the treatment demonstrated a 27% reduction in cognitive decline in individuals with early Alzheimer’s disease over a span of 18 months. The antibody is administered through intravenous infusion twice a month and targets a protein called amyloid that is associated with Alzheimer’s disease.
The coverage provided by Medicare is a significant step in assisting older Americans with early-stage Alzheimer’s disease in affording the treatment. With a median income of approximately $30,000, most Medicare beneficiaries cannot bear the cost of Leqembi, which is priced at $26,500 per year by Eisai, without insurance coverage. Previously, Medicare only covered Leqembi for patients participating in clinical trials after its expedited approval in January. This policy severely limited access to the drug. To be eligible for coverage, patients must be enrolled in Medicare, diagnosed with mild cognitive impairment or mild Alzheimer’s disease, and have a doctor who is part of a data-collection system established by the federal government to monitor the treatment’s benefits and risks.
Joanna Pike, president of the Alzheimer’s Association, expressed that while Leqembi does not cure Alzheimer’s, it helps patients in the early stages of the disease maintain their independence, carry out daily activities, and spend more time with their loved ones. Pike emphasized that the treatment grants individuals more time to recognize their family members, drive safely, handle financial matters accurately, and engage fully in hobbies and interests.
Despite its benefits, the treatment does pose serious risks of brain swelling and bleeding. Three patients participating in Eisai’s study died, but it remains uncertain if Leqembi played a role in their deaths, according to FDA scientists.
Alzheimer’s disease is the most prevalent cause of dementia among older adults and ranks as the sixth leading cause of death in the United States, according to the FDA. Dr. David Knopman, an Alzheimer’s disease specialist at the Mayo Clinic, acknowledged that Leqembi demonstrated a clear benefit to patients in Eisai’s trial. However, he cautioned that the treatment’s effectiveness was modest. Knopman further stated that patients appropriately diagnosed and informed should have the ability to decide whether to pursue Leqembi after weighing its benefits, risks, and the logistical challenges of receiving bi-monthly infusions.
To receive coverage from Medicare, patients are required to find a healthcare provider participating in a registry system that collects real-world data on the benefits and risks of Leqembi. This system has sparked controversy, with concerns raised by the Alzheimer’s Association and some members of Congress that it could create barriers to treatment. It is feared that only a limited number of healthcare providers will participate in such registries, resulting in individuals from rural communities having to travel long distances to access the treatment.
In response, the Centers for Medicare and Medicaid Services (CMS) has established a nationwide portal to facilitate the submission of required data on Leqembi patients by healthcare providers. This portal became operational immediately after the FDA’s decision.
Representatives Anna Eshoo and Nanette Barragan, who raised concerns in a letter to CMS last month, expressed worry that patients may struggle to find a participating doctor. Currently, Medicare covers only one PET scan per lifetime for dementia diagnosis. Whether or not the program plans to modify this policy remains unclear.
Another concern is the potential shortage of specialist physicians and facilities capable of administering the infusions if Leqembi becomes widely embraced as a treatment and the demand for the antibody rises. Studies indicate that wait times for antibody treatments like Leqembi could range from months to years over the next decade, depending on demand.
Tomas Philipson, an expert on healthcare economics at the University of Chicago, believes that the registry requirement is unnecessary and should be eliminated. However, he does not believe it will impede access to Leqembi. Philipson argues that if demand for the treatment is high, doctors will be incentivized to participate in the registry, and drug companies will assist in this process.
The high cost of Leqembi is another point of contention. Medicare patients receiving the treatment will be responsible for 20% of the medical bill after meeting their Part B deductible. The actual costs may vary based on whether the patient has supplemental Medicare coverage or other secondary insurance. According to a study published in JAMA Internal Medicine, patients could face annual out-of-pocket costs of up to $6,600, even with Medicare coverage. The study also estimated that Medicare’s expenses for the treatment could reach up to $5 billion annually, depending on the number of individuals receiving the infusions.
Senator Bernie Sanders has criticized Leqembi’s price as “unconscionable” and called for action to reduce its cost. Sanders highlighted that the out-of-pocket costs for the treatment would account for a significant proportion of many seniors’ annual income and that the high cost could result in increased premiums for all Medicare beneficiaries.
Eisai defends its annual list price of $26,500 for Leqembi, stating that it is lower than the company’s estimated total value of the treatment per patient, which is $37,600. The Institute for Clinical and Economic Review, a nonprofit organization that analyzes healthcare costs, suggested a price range of $8,900 to $21,500 per year in April.
Delaying Medicare coverage for Alzheimer’s antibody treatments like Leqembi would lead to significant increases in healthcare spending, as individuals with mild Alzheimer’s disease progress to more severe stages requiring expensive nursing home care. Estimates from Philipson’s team at the University of Chicago suggest that a one-year delay in coverage would result in $6.8 billion in additional spending. By 2040, healthcare spending would increase by $248 billion.
The FDA’s full approval of Leqembi follows a unanimous vote by a panel of six external advisors in June, supporting the drug’s clinical benefit to patients. The panel was smaller than usual due to some members recusing themselves due to conflicts of interest. The American Academy of Neurology stated in a letter to CMS that there is a consensus among its experts that Eisai’s clinical trial of Leqembi was well-designed and produced “clinically and statistically significant” results.
However, some nonprofit groups, such as Public Citizen, have strongly opposed FDA approval of Leqembi. A representative from Public Citizen argued before the advisory panel that the evidence supporting the drug’s benefits does not outweigh the significant risks of brain swelling and bleeding. The National Center for Health Research and Doctors for America, representing other nonprofit organizations, also noted that Eisai’s clinical trial lacked sufficient representation of Black patients, who face a higher risk of Alzheimer’s disease.
Technically, Leqembi received approval for the U.S. market in January under an accelerated pathway. The FDA uses expedited approvals to expedite the availability of drugs to patients suffering from serious illnesses. However, at that time, Medicare declined to cover Leqembi, requesting additional evidence of the treatment’s clinical benefits outweighing the risks.
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