Written by Ernie Mondel and Dennis Thompson, HealthDay Reporters>
TUESDAY, Jan 11, 2022 — It’s a move that could severely limit the number of people taking controversial new Alzheimer’s drug Aduhelm: Medicare proposed Tuesday to cover the cost of the expensive drug only for people enrolled in approved clinical trials.
A final decision on coverage is expected later this year.
The drug costs $28,200 annually, but that cost will only be covered for participants in randomized controlled trials approved by the Centers for Medicare and Medicaid Services (CMS), or “in trials supported by the National Institutes of Health,” the agency said in a statement. [NIH]. All trials should be performed on an outpatient basis in a hospital.”
This announcement comes after an unprecedented review that lasted months. The benefits of Aduhelm (aducanumab) have been in question since the U.S. Food and Drug Administration approved it in June, when its manufacturer, Biogen, set the price of the drug at $56,000 a year.
CMS tends to cover most drugs approved by its sister agency, the Food and Drug Administration, with little fanfare.
However, the Food and Drug Administration’s approval of Aduhelm sparked a storm of criticism because clinical trials did not show a clear improvement in patients’ 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 in 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 counter that CMS has been placed in the awkward position of correcting a serious mistake the Food and Drug Administration made when it approved Aduhelm on the basis of 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.”
Cost and Equity Issues
Medicare coverage would have delivered a lifeline to Aduhelm, which was 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, Biogen halved the annual cost of the drug last month.
Critics remained concerned that Aduhelm, even at $28,000 a year, could still bankrupt Medicare and put a huge financial burden on desperate families of anything to help elderly relatives with Alzheimer’s.
Karum noted that Medicare patients are already feeling the financial pressure from Aduhelm.
Health insurance premiums for 2022 are up about 15%, and CMS cited its potential coverage for Aduhelm as one of the reasons for the rise. However, these expectations may become outdated if Medicare limits coverage of Aduhelm.
Carrum added that the cost of Aduhelm is not limited to the sticker price.
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 will go beyond the drug itself,” Karume said.
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.
Soon after its approval was issued, the U.S. Food and Drug Administration narrowed the label for Aduhelm so that this drug could only be treated in patients with early and mild Alzheimer’s disease. Egg argued that, on top of lowering Biogen’s prices, would have an impact on the cost of Medicare.
Moreover, he believes 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 Medicare bankruptcy does exist, Ige said, and the only way to change that is through treatments.
More access, more risk?
Opponents countered, however, that Medicare coverage for Medicare may also expose more patients to health risks.
The biggest concern is that there will be more health problems and deaths “if aducanumab is released into the wilderness of normal clinical practice,” said Dr. Michael Gresius, MD, medical director of the Stanford Center for Memory Disorders.
He noted the risk of fatal cerebral hemorrhage and swelling 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.
adolhelm Do Clearing of beta-amyloid proteins that clog the brain from patients’ blood. Amyloid is a protein that clumps together in the brain, and amyloid plaques are a hallmark of Alzheimer’s disease.
However, the two trials are separated when it comes to any benefit to patients in terms of reducing symptoms. Removing amyloid from the bloodstream did not appear to make any difference to patients’ brain function in one trial, but in 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 agreed that by offering limited approval — one that would cover only Alzheimer’s patients who enroll in the drug’s clinical trials — CMS might help resolve the controversy surrounding 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. He believes that using Medicare coverage to spur a third clinical trial could 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.”
But Egg said the Alzheimer’s Association would not support such a move, as it would severely limit access to Aduhelm.
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.
For its part, Biogen released a statement Tuesday saying that the new proposal from CMS “negates the daily burden for people with Alzheimer’s disease,” adding that clinical trial requirements “would exclude nearly all patients who might benefit.” the The New York Times mentioned.
CMS’s proposal for coverage now enters a 30-day period for public comment. A final decision is expected sometime in April.
- 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.
- New York times
© 2022 HealthDay. All rights reserved.
Posted Jan 2022