Eisai, Biogen Alzheimer’s drug Leqembi would cost US Medicare up to $5 billion a year, study finds By Reuters

Written by Dina Beasley

(Reuters) – Broad coverage of the Alzheimer’s drug Leqembi, led by researchers at the University of California, Los Angeles (UCLA), will raise future costs to the U.S. health care plan by $2 billion to $5 billion a year, shows.

Leqembi, sold by partners Eisai Co (OTC:) Ltd and Biogen Inc (NASDAQ:) at an annualized price of $26,500, was approved this year under the US Food and Drug Administration fast-track. Trial results later showed that it slowed the rate of cognitive decline by 27% compared to placebo in patients with early disease.

The Centers for Medicare and Medicaid Services (CMS), the agency that administers the health plan for people 65 or older, currently only covers the drugs for patients enrolled in clinical trials.

The agency said it would expand coverage if Leqembi — and similar drugs that remove a toxic protein called amyloid from the brain — receive standard approval from the Food and Drug Administration. The FDA is due to decide by July 6 whether to grant standard approval based on evidence of Leqembi’s clinical efficacy.

Most of the 6 million Americans who suffer from Alzheimer’s disease receive their health coverage through Medicare.

UCLA researchers put annual spending at $2 billion for a low estimate of the 86,000 patients receiving Leqembi, and $5.1 billion if about 216,000 eligible patients were treated with the drug.

Eisai and Biogen have estimated that Leqembi will be used to treat about 100,000 American patients in the first three years of being on the market.

The cost of treating these patients “could strain Medicare and its beneficiaries, who may face increased premiums to help Medicare pay for the drug,” Julia Cave Arbanas, director of the research project and one of the paper’s lead authors, said in a statement.

Leqembi is approved for patients in the early stages of a brain wasting disease. The UCLA estimate assumes that only a limited number have access to the drug due to limitations in the health care system and other barriers.

Anti-amyloid drugs can cause serious swelling and bleeding in the brain, requiring close monitoring of patients with neurology visits and MRI scans, which contributes to the new cost estimates.

Medicare estimates, published in JAMA Internal Medicine, found that out-of-pocket costs for patients who lack supplemental health insurance can be as high as $6,600 a year — about a fifth of the median income of a Medicare beneficiary.

Last year, UCLA researchers published a similar analysis of Eisai and Biogen’s previous anti-amyloid drug Aduhelm, and estimated that if a quarter of eligible adults received the drug, the annual cost of Medicare would be between $7 billion and $37 billion.

In response to such expectations, Medicare said in 2021 it will raise premiums for its plan, which covers physician and outpatient services, by 15%. This increase was curtailed after Aduhelm’s price was cut and CMS placed strict limits on coverage.

Aduhlem’s spending projections at UCLA were based on estimates that 1.1 million to 5.7 million Medicare beneficiaries have mild cognitive impairment or mild dementia with amyloid plaques.

Study author Dr John Maffei said the latest study “takes our previous method a step further” by accounting for health system capacity limitations, realities and the difficulties in getting to a doctor, being screened for cognitive impairment, seeing a neurologist, and getting a PET scan to evaluate a plaque. amyloid.”

The researchers cautioned that the analysis was based on estimates of brain scan results and could not explain changes in health system capacity.