Medicare chooses to limit coverage of controversial Alzheimer’s drug

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

The drug, developed by Cambridge, Massachusetts-based Biogen, received the green light from regulators last summer, a decision that started a turbulent time for both the agency and the company.

Among the drug’s opponents are many doctors and scientists who have criticized Biogen’s failed clinical trial and data collection practices prior to approval.

However, some leading lobbyists, such as the Alzheimer’s Association, supported the drug because there was no other drug on the market that could slow the cognitive decline caused by the disease.

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

As part of the FDA approval it received last year, Biogen is expected to continue collecting data on the drug to prove its effectiveness or have the green light revoked.

Aduhelm’s removal from Medicare risks being the death knell for her future, at least for now.

The drug is very expensive, with the current price of $20,500 for a year of treatment less than half the price Biogen was willing to charge initially.

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

Alzheimer’s disease is largely a disease of the elderly, and many will opt for other treatments under CMS rather than paying the bill.

CMS director Chiquita Brooks-LaSure told the New York Times that the decision was made to protect patients from taking a drug that might not work.

“It’s our job at CMS to make sure it’s reasonable and necessary,” he said.

‘the vast majority’ [of input the agency received]† [was in favor of] Really limiting Aduhelm’s coverage to a truly controlled area where we can continue to evaluate whether it’s appropriate for the Medicare population.

Biogen launched two clinical trials for Aduhelm in 2016.

Both were stopped in the middle because the researchers concluded that neither study could achieve its goal.

The company then released updated data from the second study, which showed a 22% reduction in patients’ rate of cognitive decline.

It also showed that Aduhelm was able to remove beta amyloid plaques in the brain.

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

Others criticize Biogen for extracting data from a failed process by not interpreting the company’s data in the same way.

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

Knopman served on an FDA advisory committee that voted 10-0 against the drug’s approval, and later resigned to protest the drug’s approval because the agency disagreed and its advisors were unprecedented to this extent.

A study by neurologists led by Spherix Global Insights found that neurologists believe the drug is suitable for use in one in seven Alzheimer’s patients.

Regardless of the suppressed patient demand, the expansion of Aduhelm’s prescriber base will likely be slower than would normally be seen with other neurology market launch, as less than half of neurologists believe they will adopt it within the first six months of release. being,” Spherix wrote in a post †

Biogen, which developed Aduhelm, was criticized for its practice of collecting data for the drug after two failed clinical trials (archive photo)

The FDA has also begun to have doubts about its approval of the drug last year.

The agency has revised the drug’s labeling and now only recommends it to people with early stages of the condition or mild Alzheimer’s and is reverting to the original advice for all Alzheimer’s patients.

Dr. Janet Woodcock, a former FDA commissioner, even asked the Office of the Inspector General to investigate the communication between her staff and Biogen employees that led to the drug’s approval.

Well-known health networks such as New York City, Mount Sinai in New York, and the Cleveland Clinic in Ohio have already chosen not to offer the drug to Alzheimer’s patients.