Medicare will only cover new Alzheimer’s medications in trials

April 8, 2022 – Federal officials make their final decision: Medicare will only pay patients to take the new Alzheimer’s drug aducanumab (Aduhelm) if patients undergo medical trials.

On Friday, the Centers for Medicare & Medicaid Services (CMS) released its state ban for aducanumab and other similar drugs that target beta-amyloid in the brain, which is thought to be a sign of cancer. Alzheimer’s disease.

In a press release, CMS said its decision was a two-part policy based on currently available evidence for anti-amyloid substances.

Last year, the FDA approved aducanumab for Alzheimer’s disease using the fast-acting pathway, because tests have shown that the drug removes beta-amyloid from the brain, but it’s not clear how medication improves the symptoms of people with Alzheimer’s.

The decision sparked controversy and led to the withdrawal of three members of the FDA’s advisory board who voted against the drug’s approval.

CMS has set minimum standards for covering anti-amyloid drugs that could receive full FDA approval in the future. In such cases, coverage will include participation in CMS -approved studies, such as data collection through standard practice or enrollment, not just clinical trials. .

Howard Fillit, MD, founder and Chief Scientific Officer of the Alzheimer’s Drug Discovery Foundation, supported the decision.

“Medicare will now provide coverage for patients who are enrolled in an FDA- or NIH-approved trial,” Fillit said.

“While this is an improvement, the CMS is more efficient to include patient registrations, which collect real -world data that accurately reflects the actual population living with Alzheimer’s, compared. in small numbers to enroll in medical trials, ”he said. “This approach will increase Aduhelm’s coverage to other patients living with Alzheimer’s disease.”

He also hosted the CMS facility which was designed to cover medications with critical data.

“Medications are not all in the same class and each needs to be evaluated and provided to patients on its own,” Fillit said.

In a statement, aducanumab manufacturer Biogen does not accept the limitation of CMS in coverage for the drug and opposes the two-tier approach developed for amyloid-targeting antibody drugs.

“These coverage limits, as well as the difference between fast approval and traditional approval, do not apply to FDA medications for other medical conditions,” Biogen said.

Biogen and others of the CMS decision to deny patients access to a drug can prolong the decline in Alzheimer’s -related thinking, even as people question support if the drug shows that beta-amyloid is removed from the brain to help with the symptoms of the disease.

CMS officials said the company has tried to create a process that will guide the decision and make it clear and relevant to the evidence. It is estimated that more than 10,000 opinions were collected about his decision and considered more than 250 papers reviewed by peers.

“This final decision of the National Coverage Determination demonstrates the CMS’ to provide the American public with a clear, reliable, decision based on the reports – regardless of cost – that are made. after carefully considering the public comments, ”CMS Administrator Chiquita Brooks-LaSure said in a statement.

“Through this decision, we are creating a way for people with Medicare to immediately access medications that the FDA has decided have demonstrated a medical benefit and encourage manufacturers and administrators to ensure that testing medical tests on different people, ”he said.

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