Medicare to Cover Alzheimer's Medicine With Full FDA Approval

The Centers for Medicare & Medicaid Services (CMS) announced on June 1 that it would pay for new Alzheimer's medications that received full FDA approval, albeit it would necessitate data collection from doctors regarding the effectiveness of the medicines in actual use.

In a statement, CMS Administrator Chiquita Brooks-LaSure announced the change which would make new medications affordable for more Alzheimer's patients.

The Alzheimer's Association and other advocacy groups have been fighting for greater access to a newer class of drugs shown in clinical trials to slow the progression of the disease.

In the United States, 6.7 million people over 65 have Alzheimer's disease and may be eligible for Medicare coverage.

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These drugs, which have received accelerated approval, a fast-tracked version of support, were previously only covered by Medicare if a patient participated in a clinical study. Aduhelm by Biogen and Leqembi by Eisai received fast approval for their respective medications.

According to the FDA, drugs that "fill an unmet medical need" are eligible for accelerated approval. The manufacturers of the medicines must carry out additional clinical trials to receive complete support. To monitor how well patients are doing, doctors who prescribe the medications must use a national register.

The Alzheimer's Association called it an "unnecessary barrier" to ask doctors to submit patient information to a registry in a statement released on June 1.

"We look forward to learning more details from CMS and we are hopeful for the future of health care access for our constituents," states the group.

The action on June 1 was taken before a June 9 FDA advisory committee meeting when a group of specialists would decide whether to recommend that the FDA fully approve Leqembi. Clinical trials revealed that the medication decreases the disease's progression in those with early-stage or mild cognitive impairment.

Brooks-LaSure says Alzheimer's disease impacts those who have it, as well as their loved ones and carers, in a way that nearly no other illness does and that CMS has always been dedicated to assisting individuals in gaining timely access to cutting-edge therapies that significantly enhance care.

Most people cannot afford the $26,500 yearly cost of the drug. However, under the new Medicare regulations, anyone on Medicare who needs the medication should be able to acquire it if the advisory committee meeting goes well and the FDA gets formal approval.

Brooks-LaSure concludes: "If the FDA grants traditional approval, CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered. I'm pleased to make this announcement today as part of CMS' mission to help improve the lives of Americans we serve. I hope we see more private sector partners in this work making their own announcements soon."

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