Senators call on Medicare to approve Alzheimer’s drug with questionable efficacy

U.S. senators called for Medicare to offer broad coverage of Alzheimer’s treatments approved by the Food and Drug Administration, warning that current restrictions cost patients precious time as their disease progresses. They are asking the FDA to approve a drug based on hope, not science.

“Given the progressive nature of this terminal disease, we encourage you to take steps now to ensure patients have immediate access to FDA-approved treatments if the patient and clinician decide it is right for the patient,” the senators told Health and Human Services Secretary Xavier Becerra and Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure in a letter.

Public pressure on Medicare has mounted since the FDA granted accelerated approval of Eisai and Biogen’s treatment Leqembi, an antibody that targets brain plaque associated with the disease. The product has shown promise in treating early Alzheimer’s, slowing cognitive decline by 27% in a late-stage clinical trial. It also carries risks of brain swelling and bleeding.

The Alzheimer’s Association wrote CMS in December, calling for the agency to provide unrestricted Medicare coverage for Leqembi. The association’s letter was signed by more than 200 Alzheimer’s researchers and experts.

Leqembi is designed to clear amyloid plaque from the brain — an approach the drugmakers believe can stop or prevent the cognitive decline caused by Alzheimer’s disease. Scientists still don’t know definitively whether this amyloid protein plaque is the cause of Alzheimer’s or just a symptom.

But, in trials, Leqembi’s (lecanemab)’s approach did appear to improve cognitive function in patients by just under half a point (0.45 points) on an 18-point scale. (Some clinician experts have said this may not be enough improvement for family members to notice a difference.)

At the annual Clinical Trials on Alzheimer’s Disease (CTAD) conference on Alzheimer’s research, Eisai and Biogen presented data about their monoclonal anti-amyloid drug lecanemab, concurrently publishing the results in the New England Journal of Medicine. The trial showed that lecanemab slowed the rate of cognitive decline in people with mild cognitive impairment or mild dementia.

The key finding of the trial, lecanemab slowed cognitive decline by 27 percent. This is repeated repeatedly across different media outlets after the presentation at CTAD. From the sounds of it, 27 percent seems like a lot. But what does “slowing cognitive decline by 27 percent” mean for an individual with Alzheimer’s?

“What is underreported in the press discussions is that both treatment and control groups declined, and it was just slower with the drug,” Karl Herrup, an Alzheimer’s researcher at the University of Pittsburgh, told Being Patient.

“It is difficult to know if this will be noticeable for patients and their families,” Donald Weaver, a clinician and senior scientist at the Krembil Research Institute, told Being Patient. He was uncertain whether the results would be clinically significant but added that “some families would argue that even a day or two would be progress.”

Tara Spires-Jones, a professor involved in the UK Dementia Research Institute at the University of Edinburgh, also provided a comment to the Science Media Center. “There is not an accepted definition of clinically meaningful effects in the cognitive test they used, and it is not clear yet whether the modest reduction in decline will make a big difference to people living with dementia.”

Similarly, Nick Fox, the director of University College London’s Dementia Research Center, wrote that he was unsure whether slowing the disease 27 percent was meaningful.

Drug companies who make the drugs will collect windfall profits along the way. Medicare beneficiaries and millions of other Americans will pay much more for their health insurance due to its approval.

It is well known among journalists, though not necessarily among the public, that groups like the Alzheimer’s Association, the American Diabetes Association, and the American Heart Association, despite their altruistic reputations and “good guy” images, actually receive gobs of money from pharmaceutical manufacturers.

The 2021 annual report of the Alzheimer’s Association reveals that Biogen gave between $250,000 and $499,999 to the group. So did Eisai, Biogen’s Japanese partner, and Eli Lilly, which also has an Alzheimer’s drug in the pipeline.

The 2020 report of the Alzheimer’s Foundation of America also notes significant contributions from Biogen ($100,000 to $999,999) and Eisai ($50,000 to $99,999). The 2020 annual report of UsAgainstAlzheimer’s indicates that Biogen, Eisai, and Eli Lilly each contributed more than $200,000. Biogen and Eisai are listed as “premier sponsors” of the group’s 2021 National Alzheimer’s Summit.

2020 drug company contributions to four of the 25 comment letters to CMS signers. According to the CMS open payments database, one doctor received $33,255 from Biogen in 2020; a second doctor got $24,945; a third $10,735, and a fourth got $4,275. The signers, physicians, or academics connected in some way with the disease “strongly” supported allowing these patients with early-stage disease and their clinicians to ” effectively treat the amyloid accumulation before irreversible neurodegeneration progresses.”

In his column, Ed Silverman of STAT News noted that the Adhulem episode confirms the worst suspicions about drug makers.

Do I trust these drug makers? Hell no. Make no mistake; this is about money, enormous sums of money. The drug industry is not only lobbying Congress but advocacy groups as well.

We will pay for these drugs that may or may not work. The FDA needs to do its job without political interference, and physicians need to push back if there are issues with the data.