Medicare chooses to limit coverage of controversial Alzheimer’s drug

The Center for Medicare and Medicaid Services (CMS) has chosen to limit coverage of Aduhelm, an Alzheimer’s drug that received controversial Food and Drug Administration (FDA) approval last year despite calls from experts that it was not working.

The drug, developed by Cambridge, Mass.-based Biogen, received the green light from regulators last summer, a move that kicked off a tumultuous time for the agency and the company.

Opponents of the drug include many doctors and scientists who criticize the failure of the clinical trial process and data collection practices performed by Biogen prior to approval.

Some key lobbyists, like the Alzheimer’s Association, have backed the drug, however, because there are no other drugs on the market that can slow the cognitive decline caused by the disease.

Aduhelm will not be covered by Medicare in situations that are not part of a clinical trial, the CMS announced Thursday, which means the drug will not be affordable for many patients and is unlikely to it be used (file photo)

Medicare officials announced the decision Thursday and will now limit coverage only to people who receive it as part of a clinical trial.

HOW TO DETECT ALZHEIMER’S DISEASE

Alzheimer’s disease is a progressive brain disorder that slowly destroys memory, thinking skills and the ability to perform simple tasks.

It is the cause of 60-70% of dementia cases.

The majority of people with Alzheimer’s disease are aged 65 and over

More than six million Americans have Alzheimer’s disease.

It is not known what causes Alzheimer’s disease. Those with the APOE gene are more likely to develop late-onset Alzheimer’s disease.

Signs and Symptoms:

  • Difficulty remembering newly learned information
  • disorientation
  • Changes in mood and behavior
  • Suspicion of family, friends and professional caregivers
  • More severe memory loss
  • Difficulty speaking, swallowing and walking

Stages of Alzheimer’s disease:

  • Mild Alzheimer’s (early stage) – A person may be able to function independently but has memory lapses
  • Moderate Alzheimer’s (middle stage) – Usually the longest stage, the person may confuse words, be frustrated or angry, or have sudden behavioral changes
  • Severe Alzheimer’s disease (advanced stage) – In the final stage, individuals lose the ability to react to their environment, hold a conversation, and eventually control their movements

Under the FDA approval received last year, Biogen would have to continue collecting data on the drug to prove its effectiveness, or have the green light revoked.

Aduhelm being removed from Medicare coverage is likely a death knell for his future, at least for now.

The drug is very expensive, with the current price of $20,500 for a year’s treatment being less than half of what Biogen initially wanted to charge.

The company chose to cut prices only after receiving widespread backlash from consumers, US senators like Vermont’s Bernie Sanders, advocacy groups and others over its astronomical costs.

Alzheimer’s disease is largely a disease of the elderly, and many will opt for other treatments covered by CMS instead of shelling out the bill out of pocket.

CMS administrator Chiquita Brooks-LaSure told The New York Times the decision was made to prevent patients from using a drug that may not work.

“It’s our obligation at CMS to really make sure it’s reasonable and necessary,” she said.

‘The large majority [of input the agency received]… [was in favor of] really limiting Aduhelm’s coverage to a really controlled space where we could continue to assess its relevance to the Medicare population.

Biogen launched two clinical trials for Aduhelm in 2016.

Both were stopped halfway because the researchers concluded that neither trial would achieve its goal.

Later, the company revealed updated data from the second study showing that patients had a 22% decrease in the rate of their cognitive decline.

It also showed that Aduhelm could remove beta-amyloid plaques from the brain.

Some believe that clearing these plaques can halt cognitive decline, making the drug the only treatment available for Alzheimer’s disease to do so.

Others criticize Biogen for extracting data from a failed trial and do not interpret the company’s data in the same way.

Dr. David Knopman, a neurologist at the Mayo Clinic, published an analysis of the Biogen data in November, in which he disagreed with the company’s conclusions about the drug’s effectiveness.

Knopman was part of an FDA advisory committee that voted 10 to 0 against approving the drug, and he later resigned in protest over the approval of the drug, with the agency disagreeing that its advisers to this point are unprecedented.

A survey of neurologists by Spherix Global Insights found that neurologists believe the drug is adequate for use in one in seven patients with Alzheimer’s disease.

Regardless of pent-up patient demand, expansion of Aduhelm’s prescriber base is likely to be slower than typically seen with other neurology market launches – as less than half of neurologists believe that they will become adopters within the first six months of availability,” Spherix wrote in a statement.

Biogen, which developed Aduhelm, has been criticized for its data collection practices on the drug after two failed clinical trials (file photo)

Biogen, which developed Aduhelm, has been criticized for its data collection practices on the drug after two failed clinical trials (file photo)

The FDA also began showing doubts in its own approval of the drug last year.

The agency revised its label for the drug, recommending it only for people in the early stages of the disease or with a mild case of Alzheimer’s, reversing the original recommendation to all Alzheimer’s patients.

Former FDA commissioner Dr. Janet Woodcock even asked the Office of Inspector General to investigate communications between her staff and Biogen employees before the drug was approved.

High-profile health networks like Mount Sinai in New York, New York, and the Cleveland Clinic in Ohio, have already opted out of offering the drug to Alzheimer’s patients.

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