Leqembi, a pricey medication used to treat Alzheimer’s, has been completely approved by the Food and Drug Administration, a significant move that will increase elderly Americans’ access to it.

The antibody treatment is currently being covered by Medicare for individuals registered in the insurance programme for seniors, albeit there are a few restrictions, it was disclosed immediately after the FDA clearance.

The first Alzheimer’s antibody therapy to get complete FDA clearance is Leqembi. It is also the first such medication to be given extensive reimbursement by Medicare.

There is no cure for leqembi. In the course of Eisai’s clinical trial, the medication reduced the rate of cognitive deterioration brought on by early-stage Alzheimer’s disease by 27%. The antibody, which is given intravenously every two months, targets a molecule called amyloid that is linked to Alzheimer’s disease.

In order to assist older Americans with early-stage Alzheimer’s disease with treatment costs, Medicare coverage is essential. Most Medicare recipients, who make around $30,000 on average, cannot afford the $26,500 annual cost of Leqembi, as established by Eisai, without insurance.

Prior to the treatment’s accelerated clearance in January, Medicare had only consented to pay for Leqembi for patients taking part in clinical studies. Access to the medicine was severely constrained by this policy.

Patients must be Medicare beneficiaries, have a diagnosis of moderate cognitive impairment or mild Alzheimer’s disease, and be treated by a physician who participates in a data-collection system the federal government has set up to track the benefits and hazards of the treatment.

Leqembi is not a cure, but it will aid patients in the early stages of the disease in maintaining their independence, going about their daily lives, and spending more time with their families, according to Joanna Pike, president of the Alzheimer’s Association, the lobbying organisation that represents those who are living with the disease.

Pike said in a statement on Thursday that “this gives people more months of remembering their spouse, children, and grandchildren.” Additionally, a person will have more time to drive safely, handle family money precisely and on time, and engage fully in their hobbies and interests.

However, there is a significant danger of bleeding and brain swelling with the medication. In Eisai’s study, three patients passed away. Leqembi may or may not have contributed to these fatalities, according to FDA investigators.

According to the FDA, Alzheimer’s disease is the sixth most prevalent cause of mortality in the United States and the primary cause of dementia in older persons.

Leqembi obviously showed a benefit to patients in Eisai’s trial, according to Dr. David Knopman, a neurologist at the Mayo Clinic in Minnesota who specialises in Alzheimer’s disease, though he cautioned that the treatment’s efficacy was limited.

After assessing the advantages and disadvantages of the medication, as well as the potential practical difficulties of locating a location to receive the twice-monthly infusions, Knopman stated that adequately diagnosed and informed patients should be able to decide for themselves whether they wish to take Leqembi.

Medicare Benefits

Medicare is asking patients to locate a healthcare facility that is a member of a registry system that gathers actual information about the advantages and disadvantages of the medication in order to be covered. The system is divisive. The Alzheimer’s Association and a few Congressmen are concerned that this rule may put obstacles in the way of treatment.

There are worries that there won’t be as many healthcare professionals participating in these registries and that people in rural areas and other underprivileged groups will have to travel far distances to find these professionals.

To make it simple for medical professionals to provide the necessary information on patients getting Leqembi, the Centres for Medicare and Medicaid Services have established a national portal.

The free portal went up on Thursday shortly after the FDA verdict.

In a letter to CMS last month, Reps. Anna Eshoo of California, the top Democrat on the House Subcommittee on Health, and Nanette Barragan of California expressed worry that consumers would find it difficult to find a doctor who participates in the programme.

The amyloid protein linked to the disease, which is normally detected by a PET scan, or, in some cases, a spinal tap, is used to diagnose Alzheimer’s disease. Currently, Medicare only pays for one PET scan per individual’s lifetime for dementia. It’s unclear whether the programme intends to modify this rule.

There is also fear that, if Leqembi is widely accepted as a treatment and patient demand for the antibody is great, there may not be enough specialised doctors and sites to provide the infusions.

According to some research, depending on demand, the wait times for antibody treatments like Leqembi over the next ten years might range from months to even years.

Tomas Philipson, who provided guidance to the FDA commissioner and CMS administrator during the second Bush administration, believes Medicare should abandon the registry but doesn’t think it would provide an impractical obstacle to patients’ access to Leqembi.

According to Philipson, a health-care economics expert at the University of Chicago, if there is a large demand for Leqembi, doctors will be motivated to sign up for the registry and the pharmaceutical corporations will want to assist.

Leqembi’s level of demand is not yet known, he added. Families who are concerned about the treatment’s serious adverse effects may decide against it, while others may conclude the advantages outweigh the risks, the doctor said.

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High Price

The cost of Leqembi and the benefit-risk ratio of the medication are debatable.

After meeting their Part B deductible, Medicare individuals who receive Leqembi will pay 20% of the medical bill, according to CMS. Depending on whether the patient has additional Medicare coverage or any secondary insurance, costs may change, the government warns.

Even with Medicare coverage, patients may incur annual out-of-pocket expenses for Leqembi of up to $6,600, according to a research printed in the journal JAMA Internal Medicine. Depending on how many patients need the infusions, the treatment might cost Medicare up to $5 billion annually, according to the study’s estimates.

The price of Leqembi has been referred to as “unconscionable” by Sen. Bernie Sanders, I-Vt., chair of the Senate Health Committee. Last month, Sanders wrote to HHS Secretary Xavier Becerra requesting that he take steps to lower the price.

Sanders observed that the patient out-of-pocket expenses for Leqembi would represent a sixth of many seniors’ whole annual income and that the expensive nature of the medication could result in higher Medicare rates for all beneficiaries.

According to Eisai, the $37,600 estimate for the entire cost of each patient’s therapy is higher than the $26,500 yearly list price for Leqembi. A nonprofit organisation that studies health-care costs predicted in April that it should cost between $8,900 and $21,500 year.

Leqembi may be expensive for Medicare, but Philipson warned that delaying coverage of the medication would result in sharply higher health-care costs as people with mild Alzheimer’s disease, which can be managed at home, develop more severe forms of the condition that necessitate high-cost nursing home care.

According to Philipson and his colleagues at the University of Chicago, Medicare coverage of Alzheimer’s antibody therapies would increase by $6.8 billion if it were delayed by one year. Spending on healthcare would increase by $248 billion by 2040.

Clinical Advantage

A panel of six independent experts unanimously supported the drug’s clinical benefit to patients in June, which led to Thursday’s complete FDA clearance. Due to some members recusing themselves due to conflicts of interest, the panel was exceptionally tiny.

In a statement sent to CMS in February, the American Academy of Neurology noted that its experts generally agreed that Eisai’s clinical trial of Leqembi was well planned and that the outcomes were “clinically and statistically significant.”

Leqembi’s FDA clearance was vehemently contested by some non-profit organisations, including the consumer advocacy group Public Citizen.

The advisory group was informed by a Public Citizen representative that the data for the drug’s benefits does not outweigh the substantial risks of brain haemorrhage and edoema.

Additionally, representatives from the National Centre for Health Research and Doctors for America, two charity organisations, informed the panel that not enough Black patients, who have a higher risk of developing Alzheimer’s disease, were enrolled in Eisai’s clinical trial.

Since the FDA approved the medication under an accelerated pathway in January, Leqembi has theoretically been authorised for sale on the American market. The FDA employs accelerated approvals to save time and speed up the delivery of medications to patients with life-threatening illnesses.

Medicare, however, declined to pay for the Leqembi at the time, requesting additional proof that the pricey procedure actually provided patients with clinical benefits that exceeded the dangers.

The program’s circumspect coverage approach is a result of the FDA’s contentious 2021 approval of Aduhelm, another Alzheimer’s antibody medication produced by Eisai and Biogen.

The evidence did not show a clinical benefit to patients, hence the FDA advisory committee decided against endorsing Aduhelm. Following the agency’s decision to still authorise the treatment, three advisors quit.

One of the consultants who left in protest of the FDA’s Aduhelm decision was Knopman. The data for Leqembi, he claimed, is different. According to Knopman, Eisai carried out a clear trial that demonstrated the antibody provided patients with a negligible therapeutic advantage.

After conducting its own inquiry, Congress concluded that Aduhelm’s FDA approval was “rife with irregularities.”

In a letter to Becerra, Sanders stated that the FDA “has a special responsibility to restore the public trust after its inappropriate relationship with Biogen during the agency’s review of a prior Alzheimer’s drug, Aduhelm.”

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