Aduhelm: Will Medicare Cover the Controversial Alzheimer’s Drug?

By Dennis Thompson, HealthDay reporter>

FRIDAY, January 7, 2022 — After a months-long and unprecedented review, Medicare officials expect to announce within the next two weeks whether the program will cover the controversial Alzheimer’s drug Aduhelm. The benefits of the drug are in question and its annual price exceeds $28,000.

The US Centers for Medicinal and Medicaid Services (CMS) tends to cover most drugs approved by its sister agency, the US Food and Drug Administration, with little fanfare.

However, the Food and Drug Administration’s approval of Aduhelm (aducanumab) in June sparked a storm of criticism because clinical trials showed no apparent improvement in brain function, as well as a host of safety concerns.

Proponents such as the Alzheimer’s Association argue that Aduhelm’s success could pave the way for better treatments for degenerative brain disease. It is the first drug ever approved to treat Alzheimer’s disease.

“It was always an advance from the first treatments that was by no means all we had hoped for, but it was an important first step leading to incremental progression from treatment by treatment as we learned more and had more research and development,” Robert said. Egge, chief policy officer for the Alzheimer’s Association. “This is the path we see ahead for Alzheimer’s disease.”

Critics say the CMS was essentially put in the awkward position to correct a serious mistake the Food and Drug Administration made when it approved Aduhelm based on shaky evidence.

“The drug, in light of the available evidence, provides false hope for Alzheimer’s patients and their families,” said Dr. Michael Carrum, director of the Public Citizen Health Research Group. “The correct decision for CMS is not to cover the drug until there is sufficient evidence that the drug is working.”

In response to a request for comment, a CMS spokesperson said simply that the agency “expects to release more information regarding the National Coverage Determination (NCD) analysis of monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease by mid-January 2022.”

Cost and Equity Issues

Medicare coverage could deliver a lifeblood for Aduhelm, which has been struggling to find its place in the drug market.

A number of major health systems — the U.S. Department of Veterans Affairs, Cleveland Clinic, Mount Sinai and Mass General — said they would not offer Aduhelm to patients. After poor sales, the drug’s maker, Biogen, halved its annual cost — from $56,000 to $28,200 last month.

But critics worry that Aduhelm, even at its low price, could bankrupt Medicare and impose a huge financial burden on families desperate for anything to help elderly relatives with Alzheimer’s disease.

Karom said Medicare patients are already feeling the financial pressure from Aduhelm, although coverage for the drug is not certain.

Health insurance premiums rose about 15% in 2022, and CMS cited its potential coverage of Adhelm as one of the reasons for the rise.

“We are already seeing unacceptable financial implications for all Medicare recipients, even the majority who do not have Alzheimer’s,” Karume said. “If the agency chooses to cover the drug for a broad segment of Alzheimer’s patients among Medicare beneficiaries, it will place enormous financial pressure on the agency.”

In addition, Medicare patients who receive Aduhelm must pay up to 20% of the drug’s cost in co-payments, said Dr. Michael Graceius, MD, medical director of the Stanford Center for Memory Disorders.

“Outside of the cost of Medicare, there is still a huge amount of money for most recipients who decide they want treatment, amounting to several thousand dollars per patient in any given year,” Gresius said.

Karom added that the cost is not limited to the price of the drug only.

Patients receive Aduhelm through an intravenous infusion, which requires staff and space in a hospital or clinic. They also need regular MRI scans to make sure the medication has not caused any harmful side effects.

“The costs to Medicare and patients far exceed the drug itself,” Karume said.

narrow access

To such concerns, Egge of the Alzheimer’s Society responded that steps have already been taken to reduce Aduhelm’s financial impact on medical care and families.

Shortly after issuing its approval, the U.S. Food and Drug Administration narrowed the label for Aduhelm so that this drug should only be treated in patients with early and mild Alzheimer’s disease. Ige said that, in addition to lowering Biogen’s prices, should have an impact on the cost of Medicare.

Moreover, he argued that treatments like Aduhelm are necessary to avert the financial crisis Medicare is already facing in an elderly population falling prey to cognitive decline.

“Alzheimer’s and other types of dementia have really put a tremendous strain on the Medicare system, as well as Medicaid,” said Iggy. “This impact has been profound for years.” “If you look at it in terms of the financial impact, not just on household and household balance sheets but also on the federal government and state government and their balance sheets, there’s been tremendous pressure.”

The risk of bankruptcy already exists, Ige said, and the only way to change that is through remedies.

More access, more risk?

Opponents add that Medicare coverage for Aduhelm may expose more patients to health risks.

The biggest concern is that there would be more health issues and deaths “if aducanumab was released into the realm of regular clinical practice,” Griceus said, noting the risks of fatal cerebral hemorrhage and swelling found in clinical trials.

It’s possible that patients treated outside the rigors of clinical trials won’t receive the usual MRI needed to detect these dangerous side effects, Gresius said.

“A lot of these imaging complications that we saw in the trial such as brain swelling, I think in many cases it wouldn’t have been picked up beforehand by an MRI scan,” said Gresius. “They will be picked up late, when symptoms really appear.”

The FDA’s approval of Aduhelm was based on data from two nearly identical trials that were halted in early 2019 because independent monitors concluded that the drug was not helping patients.

Aduhelm removes beta-amyloid from patients’ blood. Amyloid is a protein that clumps together in the brain, and amyloid plaques are a hallmark of Alzheimer’s disease.

The two experiences are divided when it comes to any benefit to patients in terms of reducing symptoms. Removing amyloid from the bloodstream made no difference to patients’ brain function in one trial, but upon further analysis, the researchers found a slight slowing of mental decline in patients receiving the highest dose of Aduhelm.

More clinical trials

Carome and Greicius said CMS could help resolve the controversy by offering limited approval that would cover only Alzheimer’s patients who enroll in a third and final clinical trial of the drug.

Carrum said that as part of its approval, the Food and Drug Administration has asked Biogen to conduct a post-market clinical trial, but that the company has nine years to complete. Using Medicare coverage to incentivize a third trial can settle the matter more quickly.

“It would be great if they said we were going to cover it up for a randomized placebo-controlled trial,” Gresius said. “It will give everyone the information we need.”

Eig said the Alzheimer’s Association would not favor such a move, as it would severely limit access to Adelaide.

Only people who are wealthy or well-versed in the health system would be able to enter into a third trial, which would “increase health inequality,” he said.

“In general, the more we restrict access, the more those who have the financial resources are still able to find a way to get treatment,” Ige said.

Grasius said the fact that large health systems like the VA and Mount Sinai have already taken a strong stand against Aduhelm could enable CMS to limit coverage to clinical trials, or deny them entirely.

“The CMS would probably help to make a bolder negative decision on this matter, as there are already a lot of big bureaucratic decisions that have been made against aducanumab,” he said.

Resources

  • Robert Ige, Chief Policy Officer, Alzheimer’s Association, Chicago
  • Michael Carrum, MD, director, Health Research Group, Public Citizen, Washington, DC
  • Michael Grace, MD, MPH, medical director, Stanford Center for Memory Disorders, Palo Alto, Calif.

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