FDA approves Alzheimer's drug Leqembi, paving way for broader Medicare coverage

The U.S. Food and Drug Administration on Thursday fully approved Alzheimer’s disease treatment Leqembi, a key decision that will expand access to the expensive drug for older Americans.

medical insurance Shortly after the FDA’s approval, it announced that it now offers the antibody treatment to patients enrolled in a senior citizen’s insurance plan, subject to certain conditions.

Leqembi is the first antibody treatment for Alzheimer’s disease to receive full FDA approval. It is also the first drug of its kind to receive broad coverage through Medicare.

There is no cure for Leqembi. In Eisai’s clinical trials, the therapy slowed the rate of cognitive decline caused by early Alzheimer’s disease by 27% over 18 months. The antibody, which is given intravenously twice a month, targets a type of amyloid protein associated with Alzheimer’s disease.

Medicare coverage is a key step toward helping older Americans with early-stage Alzheimer’s disease pay for treatment. With a median income of about $30,000, most people enrolled in Medicare cannot afford the $26,500 annual Leqembi price set by Eisai without insurance.

Medicare had previously agreed to cover Leqembi only for patients participating in a clinical trial, and the treatment received fast-track approval in January. This policy severely restricts access to the drug.

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 who participates in a data collection system established by the federal government to monitor the benefits and risks of the treatment.

Joanna Peck, president of the Alzheimer’s Association, a lobby group that represents the rights of Alzheimer’s patients, said that while Leqembi will not cure the disease, it will help patients in the early stages of the disease maintain independence and go about their daily lives. , and spend more time with family.

“It gives people more time to recognize their spouses, children and grandchildren,” Pike said in a statement Thursday. “It also means more time for a person to drive safely, accurately and in a timely manner, Take care of family finances and get fully involved in hobbies and interests.”

But this treatment carries a serious risk of brain swelling and bleeding. Three patients who participated in Eisai’s study died. FDA scientists said it was unclear whether Leqembi was linked to those deaths.

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

Dr. David Knopman, a neurologist specializing in Alzheimer’s disease at the Mayo Clinic in Minnesota, said Leqembi clearly demonstrated a benefit for patients in Eisai’s trial, although he cautioned that the treatment’s effectiveness is limited.

Properly diagnosed and informed patients should be able to decide for themselves whether to take Leqembi after weighing the benefits and risks of treatment and the potential logistical challenges of finding a twice-monthly infusion site, Knoppman said.

health insurance coverage

To gain coverage, Medicare requires patients to find a health care provider who participates in a registry system that collects factual data on the benefits and risks of drugs. The system is controversial. The Alzheimer’s Association and some members of Congress fear the requirement would create a barrier to treatment.

There are concerns that the number of health care providers participating in such registries will be limited, and that people in rural towns and other underserved communities will have to travel long distances to find such a provider.

The Centers for Medicare and Medicaid Services created a nationwide portal to make it easy for healthcare providers to submit the required data on patients receiving Leqembi. The free-to-use portal went live shortly after the FDA’s decision Thursday.

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Rep. Anna Eshoo, D-Calif., and Nanette Barragan, D.C., the ranking Democrats on the House Health Subcommittee, in a letter to CMS last month Concerns have been raised, saying patients may have difficulty finding doctors who participate in the system.

Alzheimer’s is usually diagnosed with a PET scan to detect the amyloid protein associated with the disease or, in some cases, a spinal tap. Currently, Medicare only covers once-in-a-lifetime PET scans for dementia. It’s unclear if the program plans to change that policy.

There are also concerns that if Leqembi is widely accepted as a treatment and patient demand for the antibody is high, there may be too few specialist doctors and locations to deliver the infusion.

some studies estimate The wait time for antibody treatments like Leqembi could range from months to years over the next decade, depending on demand.

Tomas Philipson, who advised FDA commissioners and CMS administrators during Bush’s second administration, said registration was an unnecessary hurdle and Medicare should drop it, but he didn’t think the requirement would give Patient use of Leqembi poses an insurmountable barrier.

If demand for Leqembi is high, doctors will have an incentive to sign up and drug companies will be willing to help, said Philipson, an expert in healthcare economics at the University of Chicago.

How high the demand for Leqembi will be is uncertain, he said. Families concerned about serious side effects may choose not to undergo treatment, while others believe the benefits outweigh the risks, he said.

high cost

Leqembi’s price tag and the benefit-risk profile of the treatment are controversial.

According to CMS, Medicare patients treated with Leqembi will pay 20 percent of their medical bills after meeting the Part B deductible. Costs may vary depending on whether patients have supplemental health insurance or other secondary coverage, the agency said.

Patients could face damages of up to $6,600 per year Out-of-pocket costs for Leqembi are high even when covered by health insurance, according to a study published in JAMA Internal Medicine. Depending on how many people receive the infusion, the treatment could cost Medicare as much as $5 billion a year, the study estimated.

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

Out-of-pocket costs for Leqembi patients will amount to as much as one-sixth of many seniors’ gross annual income, Saunders said, noting that the high cost of treatment could drive up premiums for everyone on Medicare.

Eisai said Leqembi’s annual list price of $26,500 is below the company’s estimate of a total value of $37,600 per patient treatment. The Institute for Clinical and Economic Review, a nonprofit that analyzes health care costs, estimated in April that it should range from $8,900 to $21,500 a year.

While Leqembi could be costly for Medicare, Philipson said deferring coverage for the treatment would lead to a significant increase in health care spending because people with mild Alzheimer’s disease can be treated at home, but Can progress to more severe disease requiring expensive nursing home care.

Philipson and his colleagues at the University of Chicago estimate that delaying Medicare coverage for Alzheimer’s disease antibody treatments by one year would result in $6.8 billion in increased spending. Healthcare spending will increase by $248 billion by 2040.

clinical benefit

The full FDA approval came Thursday after a panel of six outside advisers voted unanimously in June in favor of the drug’s clinical benefit to patients. The group was unusually small, as some members shunned due to conflicts of interest.

In a letter to CMS in February, the American Academy of Neurology said its experts agreed that Eisai’s Leqembi clinical trial was well designed and that the results were “clinically and statistically significant.”

Some non-profit organizations, such as public citizenConsumer advocacy groups strongly opposed the FDA’s approval of Leqembi. A representative of Public Citizen told the advisory group that the evidence of the drug’s benefits did not outweigh the significant risks of brain swelling and bleeding.

Representatives of the National Institutes of Health and the American Physician Center, also nonprofits, told the panel that Eisai’s clinical trials did not include enough black patients, who are at higher risk of developing Alzheimer’s disease.

Technically, Leqembi has been on the U.S. market since January, when the FDA approved the treatment under the accelerated pathway. The FDA uses expedited approval to save time and get medicines to patients with serious diseases more quickly.

But Medicare denied coverage for Leqembi at the time and demanded more evidence that the costly treatment’s true clinical benefits to patients outweighed the risks.

The plan’s cautious coverage policy stems from the FDA’s 2021 approval of another Alzheimer’s antibody treatment called Aduhelm, also made by Eisai and Biogen, which has been controversial.

The FDA’s advisory committee declined to endorse Aduhelm because data did not support clinical benefit to patients. Three consultants resigned after the agency decided to approve the treatment.

Knoppman was one of the advisers who resigned over the FDA’s decision on Aduhelm. He said Leqembi’s data was different. Eisai ran a clean trial that showed the antibody had some clinical benefit in patients, Knoppman said.

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

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

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