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The FDA has approved the Alzheimer’s drug Leqembi from Eisai, Biogen

The Food and Drug Administration on Thursday approved the Alzheimer’s treatment Leqembi, a pivotal decision that would expand access to the expensive drug for older Americans.

Medicare announced shortly after the US Food and Drug Administration (FDA) approval that it now covers antibody treatment for patients enrolled in the insurance program for seniors, though several conditions apply.

To be eligible for coverage, patients must be enrolled in Medicare, be diagnosed with mild cognitive impairment or mild Alzheimer’s disease, and have a physician participate in a data collection system set up by the federal government to monitor treatment benefits and risks.

Medicare coverage is a critical step in helping older Americans with early-onset Alzheimer’s disease pay for treatment. With a median income of about $30,000, most people on Medicare can’t afford Leqembi’s $26,500 annual rate set by Eisai without insurance coverage.

Leqembi is the first antibody treatment for Alzheimer’s disease to receive full approval from the Food and Drug Administration. It is also the first such drug to gain broad coverage through Medicare.

Leqembi is not a cure. The treatment slowed cognitive decline from early-onset Alzheimer’s disease by 27% over the course of 18 months during the Eisai clinical trial. The antibody, which is given twice a month by intravenous infusion, targets a protein called amyloid that is associated with Alzheimer’s disease.

Although Leqembi is not a cure, it will help patients in the early stages of the disease maintain their independence, manage their daily lives and spend more time with their families, said Joanna Pike, chair of the Alzheimer’s Association, a lobby group that advocates for people living with the disease. .

“This gives people months to get to know their spouses, children and grandchildren,” Paik said in a statement Thursday. “It also means more time for the person to drive safely, accurately, and quickly, to take care of family finances, and to participate fully in hobbies and interests.”

But the treatment carries serious risks of brain swelling and bleeding. Three patients who participated in the Esay study died. FDA scientists said it’s unclear if Leqembi played a role in these deaths.

Alzheimer’s disease is the most common cause of dementia among older adults and the sixth leading cause of death in the United States, according to the Food and Drug Administration.

Dr. David Knopman, a neurologist who specializes in Alzheimer’s disease at the Mayo Clinic in Minnesota, said Leqembi clearly showed a benefit for patients in the Eisai trial, though he cautioned that the treatment’s efficacy was modest.

Adequately diagnosed and informed patients should be able to decide for themselves whether they want to take Leqembi after weighing the benefits and risks of treatment as well as the potential logistical challenges of finding a place to receive the twice-monthly injections, Knopman said.

Medicare coverage

Medicare has placed conditions on how Leqembi is covered. Patients enrolled in the insurance program who have been diagnosed with mild cognitive impairment or mild Alzheimer’s disease will need to find a healthcare provider who participates in an enrollment system that collects factual data on the drug’s benefits and risks.

The system is controversial. The Alzheimer’s Association and some members of Congress worry that this requirement will create barriers to treatment.

There are concerns that the number of healthcare providers participating in such registries will be limited, and that people in rural towns and other disadvantaged communities will have to travel many hours to find such a provider.

The Centers for Medicare and Medicaid Services has created a nationwide portal to make it easier for healthcare providers to provide required data on patients receiving Leqembi. The free-to-use portal went into effect moments after the FDA’s decision on Thursday.

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Rep. Anna Esho D-Calif., the ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Barragan D-Calif. raised concerns in a letter to CMS last month that patients might struggle to find a physician involved in the system.

Alzheimer’s disease is usually diagnosed with the help of a positron emission tomography (PET) scan to detect the amyloid protein associated with the disease or in some cases with a spinal tap. Medicare currently covers one PET scan per age for dementia. It is not clear if the program plans to change that policy.

There is also concern that there may be too few specialist doctors and sites to administer the injection if Leqembi is widely adopted as a treatment and patient demand for the antibody is high.

Some studies have estimated that wait times for antibody treatments like Leqembi could range from months to years over the next decade depending on demand.

Thomas Phillipson, who advised the FDA commissioner and CMS official during the second Bush administration, said registration is an unnecessary hurdle and Medicare should drop it, but he doesn’t think the requirement will create an insurmountable barrier for patients arriving in Leqembi.

If Leqembi is in high demand, said Phillipson, an expert in health care economics at the University of Chicago, doctors will have an incentive to participate in the enrollment and drug companies will want to help.

He said how high the demand for Leqembi would be was uncertain. He said families concerned about serious side effects may choose not to take the treatment, while others will decide the benefits outweigh those risks.

high cost

Leqembi’s price and benefit-risk profile for the treatment are also controversial.

Medicare patients treated with Leqembi will pay 20% of the medical bill after they meet the Part B deductible, according to CMS. Costs may vary depending on whether the patient has supplemental medical coverage or other secondary insurance, depending on the agency.

Patients can face up to $6,600 in annual costs for Leqembi even with Medicare coverage, according to a study published in JAMA Internal Medicine. The study estimated that the treatment could cost Medicare up to $5 billion a year depending on how many people get the injections.

Senator Bernie Sanders, chairman of the Senate Health Committee, called Leqembi’s price “unreasonable” and in a letter last month asked Health and Human Services Secretary Xavier Becerra to take action to reduce the cost.

Sanders said the patient’s out-of-pocket costs for Leqembi would amount to one-sixth of seniors’ total annual income, and he noted that the higher cost of treatment could increase premiums for everyone on Medicare.

Leqembi’s annual list price of $26,500 is lower than the company’s estimate of $37,600 for the total value of the treatment per patient, Eisai says. The Institute for Clinical and Economic Review, a nonprofit organization that analyzes healthcare costs, estimated in April that it should be between $8,900 and $21,500 a year.

Delaying Medicare coverage for Leqembi, Philipson said, will lead to higher health care spending as people with mild Alzheimer’s disease, which can be managed at home, progress to a more serious disease that requires expensive nursing home care.

Phillipson and his colleagues at the University of Chicago estimated that delaying Medicare coverage of antibody therapies for Alzheimer’s disease by a year would lead to $6.8 billion in spending increases. By 2040, healthcare spending will increase by $248 billion.

Clinical benefit

Thursday’s full FDA approval comes after a panel of six outside advisors voted unanimously in June to support the drug’s clinical benefit for patients. The committee was unusually small because some members had recused themselves due to conflicts of interest.

The American Academy of Neurology said in a February letter to CMS that there is a consensus among its experts that Eisai’s clinical trial for Leqembi was well designed and that the results were “clinically and statistically significant.”

Some nonprofit groups such as Public Citizen, a consumer advocacy organization, have strongly opposed FDA approval of Leqembi. A representative from Public Citizen told the advisory committee that the evidence of the drug’s benefit did not outweigh the significant risks of brain swelling and bleeding.

Representatives from the National Center for Health Research and Physicians of America, also nonprofits, told the panel that the Eisai clinical trial did not include enough black patients, who are at a higher risk of developing Alzheimer’s disease.

Leqembi has been technically approved for the US market since January, when the US Food and Drug Administration (FDA) cleared the treatment under an accelerated course. The US Food and Drug Administration (FDA) uses accelerated approvals to save time and get drugs to critically ill patients faster.

But Medicare refused to cover Leqembi at the time, asking for more evidence that the expensive treatment had real clinical benefit for patients who outweigh the risks.

The program’s cautious coverage policy stems from the controversial Food and Drug Administration (FDA) approval in 2021 of another antibody treatment for Alzheimer’s disease called Aduhelm, which was also introduced by Eisai and Biogen.

An advisory committee for the US Food and Drug Administration (FDA) declined to approve Aduhelm because the data did not support a clinical benefit for patients. Three counselors resigned after the agency decided to approve the treatment anyway.

Knopman is one of the advisors who resigned because of the FDA’s decision on Adholm. He said Leqembi’s data is different. Knopman said Esay ran a clean trial that showed the antibody had modest clinical benefit for patients.

A subsequent congressional investigation found that the FDA’s approval of Adholm was “riddled with irregularities.”

In his letter to Becerra, Sanders said the FDA “has a special responsibility to restore the public’s trust following its inappropriate relationship with Biogen during the agency’s review of a previous Alzheimer’s disease drug, Aduhelm.”

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