Medicare will require research registry for coverage new Alzheimer’s drugs

The Centers for Medicare and Medicaid Services says it will cover a new class of drugs meant to treat the early stages of Alzheimer’s disease in the brain. However, the payment coverage will require doctors and patients to take the extra step of enrolling in a research registry to track the effectiveness of the drugs.

In an announcement from CMS Administrator Chiquita Brooks-LaSure, the agency says it will grant coverage once the Food and Drug Administration grants full traditional approval of the drugs.

"If the FDA grants traditional approval CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered," said Brooks-LaSure in a statement.

But the Alzheimer’s Association, the world’s leading advocacy organization for research and patient support, is not yet ready to fully celebrate the CMS decision.

"Well, the headline sounds great, doesn’t it," said Susan Parriott, the CEO of the Minnesota and North Dakota chapter of the Alzheimer’s Association. "They’re going to cover this drug, but the devil is really in the details."

The details include coverage being contingent upon doctors and clinical teams participating in a research portal to understand how the drugs work in a real-world setting. That research-collecting process is what CMS calls a registry. The Alzheimer’s Association is concerned that it creates a barrier, especially for patients and physicians in rural areas who may not have the resources to participate in the registry.

"If you think about some of the rural communities in Minnesota, they really might not have the time to do all of these things and the financial burden that it would bring to the clinic or the physician that are administering the drugs," said Parriott. "While we think registries are really important, you can learn a lot from them. That is a huge burden on the physician and the patient. And so that just should not be allowed when we're talking about a disease like Alzheimer's."

The new Alzheimer’s drugs are part of an emerging class of therapies that are at various stages of research and the FDA approval process. None of these drugs are a cure, but in clinical trials, they have demonstrated a varying ability to slow the progression of the disease in the earliest stages in the brain. 

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"So there are now three drugs that have been demonstrated to remove some of this amyloid protein from the brain and slow the clinical progression of the disease," explained Dr. Ronald Petersen, the director of the Mayo Clinic Alzheimer’s Research Center in an earlier interview with FOX 9. "We haven’t had that prior to this. So this is very important for our patients."

The FDA has already granted accelerated approval to the drugs Aduhelm and Leqembi. The FDA is expected to grant full traditional approval to Leqembi next month. A third drug, Eli Lilly’s Lacanemab is expected to apply for FDA approval later this summer. It means the provider community and clinics need to quickly decide how they can provide these drugs to their patients.

"That next question is, okay, so what do hospitals, clinics, physicians need to do?" said Parriott about all the unanswered questions the CMS decision creates. "What does this registry mean? How can we get people access to this drug?"

She points out that for patients in the early stages of the disease including mild cognitive impairment and early onset dementia, their window may be rapidly closing to seek meaningful treatment from this new class of drugs.

"Two thousand people in the early stages of Alzheimer's disease progressed beyond being able to use these drugs each and every day," said Parriott. "So every day that goes by, more and more people are losing out on time."

The Alzheimer’s Association of Minnesota and North Dakota is holding a "rally for access" on the steps of the Minnesota State Capitol at noon on Friday, June 16.