In recent months, Medicare officials have been inundated with impassioned pleas about how to handle coverage of the controversial new Alzheimer’s drug Aduhelm.
Patient advocacy groups have said the federal insurance program for people over 65 must pay for a drug approved by the Food and Drug Administration. Many Alzheimer’s doctors and experts warned against a treatment that scientific evidence shows has uncertain benefits and serious safety risks. Individual patients and families weighed in on both sides with emotional statements.
On Thursday, Medicare officials announced their final decision. The program only covers Aduhelm if people receive it as participants in a clinical trial, likely a small percentage of the estimated 1.5 million people in the United States with mild Alzheimer’s-related cognitive decline, the condition for which Aduhelm was approved.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare and Medicaid Services said the decision was designed to protect patients as they collected data to indicate whether Aduhelm, an expensive monoclonal antibody given as a monthly infusion, could actually help them by slowing the rate of their cognitive decline.
“It’s our duty at CMS to really make sure it’s reasonable and necessary,” Ms Brooks-LaSure said in an interview on Thursday. “The vast majority” of the roughly 10,000 comments the agency received on its website, she said, were in favor of “really limiting Aduhelm’s coverage to a really controlled space where we can continue to evaluate its Medicare suitability.” -population.”
A key issue for Medicare has been how to handle other similar Alzheimer’s drugs, some of which are likely to be considered for FDA approval soon. In a proposal in January, CMS had said it would cover them in the same way as Aduhelm, as it typically made coverage decisions for an entire class of drugs.
But after both experts and advocacy groups raised concerns, Medicare officials said Thursday they wouldn’t automatically apply the same restrictions to every new drug. Unlike Aduhelm, if the FDA finds that there is clear evidence that a drug can help patients, Medicare would cover this for all eligible patients and only require that the patient’s experience be followed.
dr. Lee Fleisher, the chief medical officer at CMS, said the two-pronged approach to dealing with the rapidly evolving field of Alzheimer’s therapies, a program called Coverage with Evidence Development, “is designed to be nimble and really respond to new drugs.” in this class that are in the pipeline and demonstrate clinical benefits.”
The decision is extremely unusual for Medicare, which almost always automatically pays for drugs approved by the FDA, at least for the medical conditions listed on its labels.
Understand the New Alzheimer’s Drug Aduhelm
But Aduhelm’s path was also very unusual. The FDA itself acknowledged that it was unclear whether the drug was beneficial when it approved Aduhelm last June. It gave the green light to the drug under a program called “accelerated approval,” which allows authorization of drugs whose benefit is uncertain if they are for serious diseases with few treatments and if the drug affects a biological mechanism in a way considered reasonably likely to help patients.
The FDA-reviewed clinical trial showed that patients in one study appeared to experience a slight delay in cognitive decline, while patients in a nearly identical study seemed to experience no benefit at all. About 40 percent of patients on the later approved dosage experienced brain swelling or hemorrhage, often mild, but sometimes severe. Both a board of senior FDA officials and the agency’s independent advisory committee had said there was not enough evidence for approval.
Questions about the approval and whether the FDA has worked too closely with Biogen, the manufacturer of Aduhelm, have led to investigations by congressional committees, the Inspector General of the Health and Human Services Department, the Federal Trade Commission and the Securities and Exchange Commission . Major medical centers, including the Cleveland Clinic, have refused to offer Aduhelm.
As a result of concerns from Alzheimer’s experts and some groups, Medicare officials announced several other changes to their earlier proposal. Rather than requiring randomized controlled trials approved by CMS, Medicare covers participants in any trial approved by the FDA or the National Institutes of Health. It will make it possible to conduct those trials in a wider range of locations, not just in hospital settings, and to include people with other neurological conditions such as Down syndrome, many of whom develop Alzheimer’s disease but were excluded from the previously proposed plan.
The trials will still have to meet a Medicare requirement to recruit a racially and ethnically diverse group of participants, unlike Aduhelm’s previous trials, in which most of the participants were white.
In the studies, “the manufacturers will have to come to us and ask how they are going to include all the patients representing the Medicare population, and how they are going to make sure all of these patients are getting the right medical treatment and overseeing their treatment while they are doing it.” are in each of these studies,” Tamara Syrek Jensen, the director of coverage and analysis for CMS’s Center for Clinical Standards and Quality, said in an interview.
The FDA has also asked Biogen to conduct another clinical trial to determine if the drug provided any evidence of benefit, but it said Aduhelm would be available to patients in the years it will take to complete that trial. Under Thursday’s decision, Medicare would cover costs for participants in Biogen’s trial.
Medicare’s evaluation team makes decisions without considering the cost of a drug, but the Aduhelm decision could allay some concerns about how hedging the drug could affect the wallets of the nation’s millions of Medicare beneficiaries.
Last year, the actuarial department of Medicare, acting unknowingly what the coverage decision would be, imposed one of the largest-ever increases in Medicare Part B premiums for 2022, driven in part by the possibility of coverage for Aduhelm, which at the time was priced by the manufacturer for $56,000 a year.
Since then, Biogen, faced with weak sales of the drug after many hospitals and doctors declined to prescribe it, has slashed its price to $28,800 a year, still much higher than many analysts believe is warranted.
Xavier Becerra, Minister of Health and Human Services, had said he would consider cutting premiums after the final decision on coverage for Aduhelm was made, adding: “We are going to make sure seniors don’t pay more than necessary. is. †
In Thursday’s interview, Ms. Brooks-LaSure, the CMS administrator, said, “The secretary said we should look into it, and we’re going to be in the business of reviewing the premium for Part B.”
Advocacy groups, several of which received some funding from Biogen and other drug companies, had campaigned vigorously for broad coverage of Medicare. These groups said patients should be able to decide with their doctors whether to try an FDA-approved drug, and claimed it was discriminatory to reimburse only participation in clinical trials that many patients may not be easily accessible.
“We just can’t leave it as it is,” Harry Johns, the director of the Alzheimer’s Association, told the organization’s staff, according to a recording of the meeting obtained by DailyExpertNews.
In an interview before the Medicare announcement, Mr. Johns indicated that the association would not be satisfied if the Medicare restrictions only applied to Aduhelm, saying, “We firmly believe that there is sufficient evidence to support coverage. offer for the first approved treatment.”