For the past few months, Medicare officials have been bombarded with pleas about how to handle coverage of the controversial new Alzheimer's drug Aduhelm.
Advocacy groups for patients say the federal insurance program for people over the age of 65 must pay for a drug approved by the FDA. Many Alzheimer's doctors and experts cautioned against covering a treatment that has uncertain benefit and serious safety risks. Individual patients and families made emotional statements.
Medicare officials made their final decision on Thursday. The program will only cover Aduhelm if it is used in a clinical trial for people with mild Alzheimer's related cognitive decline.
The administrator of the Centers for Medicare and Medicaid Services said the decision was made to protect patients while gathering data to see if Aduhelm could help them by slowing their cognitive decline.
It is our obligation at C.M.S. to make sure it is reasonable and necessary.
Several of the similar drugs for Alzheimer's are likely to be considered for F.D.A. approval soon, which is a major issue for Medicare. C.M.S. said it would cover them in the same way as Aduhelm because it typically made coverage decisions for an entire class of drugs.
After experts and advocacy groups raised concerns, Medicare officials said they would not apply the same restrictions to each new drug. If the F.D.A. finds that there is evidence that a drug can help patients, Medicare would cover it for all eligible patients and only impose a requirement that the patients experience be tracked.
The two-track way of dealing with Alzheimer's therapies is meant by Dr. Lee Fleisher, the chief medical officer at C.M.S.
Normally, Medicare pays for drugs that the F.D.A. has approved, at least for the medical conditions designated on labels.
Aduhelm's path has been very unusual. The F.D.A. acknowledged that it was unclear if Aduhelm was beneficial when it was approved. It greenlighted the drug under a program that allows authorization of drugs that have uncertain benefit if they are for serious diseases with few treatments and if the drug affects a biological mechanism in a way that is likely to help.
The F.D.A. reviewed the clinical trial evidence and found that patients in one trial appeared to have a slight slowing of cognitive decline, while patients in a nearly identical trial didn't appear to benefit at all. About 40 percent of patients on the dosage later approved experienced brain swelling or brain bleeding. The council of senior F.D.A. officials and the independent advisory committee said there wasn't enough evidence for approval.
Questions about the approval and whether the F.D.A. worked too closely with the manufacturer have prompted investigations. The Cleveland Clinic is one of the major medical centers that has declined to offer Aduhelm.
Several other changes to their earlier proposal were announced after concerns were raised by Alzheimer's experts and some groups. Medicare will cover participants in any trial approved by the F.D.A. or the National Institutes of Health. It will allow those trials to be conducted in a broader array of locations, not just hospital settings, and to include people with other neurological conditions like Down syndrome, who were excluded from the earlier plan.
The previous trials of Aduhelm, in which most participants were white, did not comply with a Medicare requirement to recruit a racially and ethnically diverse group of participants.
In the trials, the manufacturers will have to come to us with how are they going to include all patients that represent the Medicare population, and how are they going to ensure that all of these patients are getting appropriate medical treatment and monitoring of their treatment.
The F.D.A. requires Biogen to conduct another clinical trial to determine if the drug provided any evidence of benefit, but it says that Aduhelm will be available to patients in the years to come. Medicare would cover the costs of participants in the trial.
The Aduhelm decision could ease some concerns about how the drug might affect the pocketbooks of millions of Medicare beneficiaries.
One of the biggest-ever increases in Medicare Part B premiums was imposed last year, partly due to the possibility of coverage for Aduhelm, which was priced by its manufacturer at the time.
The price of the drug has been lowered by Biogen, despite the fact that many hospitals and doctors wouldn't prescribe it.
After the final coverage decision for Aduhelm was made, the secretary of health and human services said he would consider lowering premiums.
The C.M.S. administrator said in the interview Thursday that they would review the Part B premium.
Several advocacy groups that receive funding from pharmaceutical companies have fought for broad Medicare coverage. Patients should be able to decide if they want to try an F.D.A.-approved drug, and only reimburse participation in clinical trials that may not be easily accessible to many patients, according to these groups.
According to a recording of the meeting, the Alzheimer's Association's chief executive told the organization's staff that they can't let it stand as it is.
In an interview before the Medicare announcement, Mr. Johns indicated that the association wouldn't be satisfied if Medicare restricted coverage only to Aduhelm.
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