Medicare officially limits adduhelm coverage for patients in clinical trials

Over the past few months, Medicare officials have been embroiled in an emotional plea over how to handle the coverage of the controversial new Alzheimer’s drug Aduhelum.

The Patients Advocacy Group says the federal insurance program for people 65 and older must pay for drugs approved by the Food and Drug Administration. Many Alzheimer’s doctors and experts have warned against covering a treatment that has scientific evidence showing uncertain benefits and serious safety risks. Weights with emotional statements from both the individual patient and the family.

Medicare officials announced their final decision on Thursday. The program will cover adhuhelm only if people accept it as a participant in clinical trials, probably a small percentage of the estimated 1.5 million people in the United States who have mild Alzheimer’s-related cognitive impairment, a condition approved for adhuhelm treatment.

Chikuita Brooks-Lasur, administrator of Medicare and Medicaid service centers Says that the decision was made while collecting data for the purpose of protecting patients whether Eduhelm, an expensive monoclonal antibody given as a monthly infusion, could actually help them slow down their cognitive decline.

“It is our obligation at CMS to ensure that this is reasonable and necessary,” Ms Brooks-Laser said in an interview on Thursday. The “huge majority” of the agency’s approximately 10,000 comments received on its website, he said, “is really in favor of limiting Aduhelm’s coverage to a controlled area where we can continue to assess its suitability for the Medicare population.”

A major issue for Medicare was how to deal with other similar drugs for Alzheimer’s, some of which may soon be considered for FDA approval. In a proposal in January, CMS said it would cover them in the same way as Aduhelm because it usually decides coverage for a whole class of drugs.

But after both experts and advocacy groups raised concerns, Medicare officials said Thursday that they would not automatically impose the same restrictions on each new drug. If, in contrast to Aduhelm, the FDA finds that there is clear evidence that any drug can help patients, Medicare will cover it for all eligible patients and only impose conditions to track patients’ experiences.

Dr. Lee Fleischer, CMS’s chief medical officer, said the two-track approach to coping with the rapidly evolving field of Alzheimer’s therapy is a program called Coverage with Evidence Development, which means “being flexible and really responding to any newcomers.” This type of medicine is in the pipeline and has clinical benefits. “

The decision is highly unusual for Medicare, which almost always pays for FDA-approved drugs, at least for the medical conditions designated on the label.

But Aduhelm’s path was also very unusual. The FDA itself acknowledged that it was unclear whether the drug was effective when it approved Eduhelm last June. It has given the green light to the drug under a program called “Accelerated Approval”, which allows the approval of drugs that are uncertainly beneficial if they are for serious illnesses if they are for short-term treatment and if the drug is reasonably considered to help patients affect a biological process.

Evidence from clinical trials reviewed by the FDA shows that patients in one trial experienced a slight slowdown in cognitive decline, while patients in almost identical trials did not appear to benefit at all. Experienced cerebral palsy or cerebral hemorrhage is allowed after about 40 percent of the patients in the dose, often mild, but sometimes severe. Both the FDA’s Council of Senior Officials and the agency’s independent advisory committee said there was not enough evidence for approval.

Questions about the approval, and whether the FDA has worked closely with Biogen, have called for an investigation by Aduhelm’s manufacturer, the congressional committee, the inspector general of the Department of Health and Human Services, 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 the concerns of Alzheimer’s experts and some groups, Medicare officials announced several more changes to their earlier proposals. Instead of requiring a randomized controlled trial approved by CMS, Medicare will cover participants in any trial approved by the FDA or the National Institutes of Health. This would allow those trials to be conducted not only in hospital settings, but also on a larger scale to include people with other neurological conditions, such as Down syndrome, many of whom had Alzheimer’s disease but were excluded from previously proposed plans.

Trials still have to comply with a Medicare requirement to recruit a racially and ethnically diverse group of participants, in contrast to previous trials in Aduhelm, where most participants were white.

In the trials, “producers need to come to us on how they will include all patients representing the Medicare population and how they will ensure that these patients are receiving appropriate treatment and monitoring their treatment while they are in each of these studies,” said Tamara Syrek Jensen, CMS. The director of coverage and analysis at the 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 has been shown to be beneficial, but has stated that the trial will take years to complete and will be available to Aduhelum patients. Under Thursday’s decision, Medicare will cover the costs of participants in the Biogen trial.

Medicare’s coverage assessment team decides without considering the price of a drug, but Aduhelm’s decision may alleviate some concerns about how the drug could affect the pocketbooks of millions of Medicare beneficiaries in the country covered.

Last year, Medicare’s actuarial division, acting without knowing what the coverage decision would be, imposed one of the biggest increases in Medicare Part B premiums for 2022, partly driven by the prospect of Aduhelm’s coverage, which cost the manufacturer $ 56,000 per year.

Since then, Biogen, with many hospitals and doctors facing weak drug sales after not prescribing it, has slashed prices to $ 28,800 a year, much higher than many analysts have said.

Health and Human Services Secretary Xavier Besser said he would consider reducing the premium once he decides on the final coverage for Aduhelm, adding that “we’re going to make sure seniors don’t pay more than they do.”

In an interview on Thursday, CMS Administrator Mrs. Brooks-Lasur said, “The Secretary has asked us to look into this, and we are going to be engaged in the Part B premium review process.”

The Advocacy Group, which received some funding from several Biogen and other pharmaceutical companies, campaigned vigorously for broader Medicare coverage. These groups say patients should be able to decide with their doctors whether to try an FDA-approved drug and claim that it only discriminates against participation in clinical trials that may not be easily accessible to many patients.

According to a recording of the meeting obtained by The New York Times, Harry Johns, chief executive of the Alzheimer’s Association, told the agency’s staff, “We cannot allow this to continue as it is.”

In an interview before the Medicare announcement, Mr. Johns indicated that the association would not be satisfied if Medicare’s restrictions only apply to Aduhelm, saying “we strongly believe there is sufficient evidence to provide coverage for the first approved treatment.”

Leave a Comment

Your email address will not be published.