CMS: Alzheimer’s patients must participate in clinical trials to take Aduhelm

key takeaways

  • The FDA approved Aduhelm in June 2021 for the treatment of Alzheimer’s disease.
  • In January 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposal, which could be finalized by April, that would limit the drug’s coverage to those enrolled in Aduhelm’s clinical trials.

In January 2022, the Centers for Medicare and Medicaid Services (CMS) released a preliminary proposal that would limit Medicaid coverage for Aduhelm, a recently approved drug for Alzheimer’s disease, if Patients are participating in clinical trials of the drug.

Aduhelm, made by Biogen, was approved for Alzheimer’s patients in June 2021. At the time of approval, the drug’s out-of-pocket cost was $56,000 per year. Biogen has since cut that cost to $28,200.

So far, few doctors have prescribed the drug and few insurance companies have covered it. Medicare coverage decisions have been long awaited. Insurance companies generally follow coverage decisions made by CMS.

CMS expects to issue a final underwriting decision on Aduhelm in April and is currently accepting public comment on its proposal until mid-February.

Why is FDA approval of a new Alzheimer’s drug so controversial?

How does Aduhelm work?

Aduhelm is a monoclonal antibody that is infused once a month. In clinical trials, the drug reduced amyloid plaques, which can be seen by imaging in the brains of Alzheimer’s patients. However, there was no indication in trials that reducing plaque improved memory in patients with the disease.

The U.S. Food and Drug Administration (FDA) asked Biogen to continue clinical trials of the drug even after it was approved. The agency said it may withdraw approval if it cannot show a benefit from taking the drug.

Even with the FDA withdrawing its approval, experts see the introduction of Aduhelm as an important advance in Alzheimer’s treatment.

“What may be needed to treat Alzheimer’s disease is a mixture of several drugs with different mechanisms of action,” Ronald Petersen, MD, director of the Mayo Clinic Alzheimer’s Disease Research Center, told VigorTip.

Why is clinical trial participation a requirement for treatment?

The clinical trial requirement that CMS can allow for reimbursement, called coverage of evidence development (CED), is a very unusual process for a drug, said David Farber, a partner in the FDA and Life Sciences Division of the Washington, D.C., legal office. Company King & Spalding.

The CMS proposal will also expand to other drugs in the same class as Aduhelm, Farber told VigorTip. At least two companies, including Eli Lilly, are developing similar drugs.

“Even if similar drugs show themselves to be more effective if required [than Aduhelm], patients may still need to enroll in clinical trials to get the drug,” Farber said. “It will be difficult for many people, especially minorities and people who don’t live in larger cities where clinical trials are more commonly conducted. ”

What is the purpose of a clinical trial?

exacerbating health disparities

Several advocacy groups representing Alzheimer’s patients and older adults expressed disappointment with the proposal.In a statement, Sue Peschin, president and CEO of the Alliance for Aging Research, called the requirement to participate in a clinical trial to take the drug “too strict and medically unethical. [and] Unlikely to achieve the agency’s goal of addressing health equity. ”

Alzheimer’s Association chief executive Harry Johns said the decision “shockingly discriminates against all people living with Alzheimer’s disease, especially those already disproportionately affected by this deadly disease,” Including women, blacks and Hispanics.” “Through this approach, treatment is now available to only a privileged minority, those who have access to research facilities, exacerbating and creating further health inequalities,” Johns said in the statement. .”

How Alzheimer’s affects the brain

Guaranteed advice?

Many doctors have been hesitant to prescribe Aduhelm, not only because of cost, but also because its effectiveness is unclear. The FDA approval points to potential side effects, including brain swelling, confusion, headache, dizziness and diarrhea.

Constantine George Lyketsos, director of the Center for Memory and Alzheimer’s Treatment at the Johns Hopkins School of Medicine, thinks the CMS proposal is a good decision.

It’s “preliminary, but likely to persist,” Lyketsos told VigorTip. “Aduhelm and similar drugs appear to reduce the accumulation of amyloid in the brain associated with Alzheimer’s, but have not been proven [to cause] Symptoms that people have, such as dementia. Many questions remain about long-term safety, so there must be evidence that these drugs help relieve symptoms before any widespread use. ”

More randomized controlled studies are needed, Lyketsos said.

While few Alzheimer’s patients have taken the drug so far, by 2022, Aduhelm will prove costly for all Medicare beneficiaries. In anticipation of the drug’s widespread availability, CMS raised the monthly Medicare premium rate by $21.60 for everyone in the insurance plan, although the decision is also under review.

what does this mean to you

If you or a loved one has been diagnosed with Alzheimer’s disease, talk with your healthcare provider about whether Aduhelm is a good fit. They may be aware of ongoing clinical trials of Aduhelm or other drugs being investigated for this condition. It is unlikely, but not impossible, that your insurance company will pay Aduhelm at this time.