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Medicare coverage debates amplify as FDA approves Rexulti for Alzheimer's agitation

Stock image of FDA approved concept. Rubber stamp with FDA and medicine illustration.
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Stock image of FDA approved concept. Rubber stamp with FDA and medicine illustration.

The Food and Drug Administration (FDA) approved the first treatment for agitation as a result of dementia in Alzheimer’s disease. Brexpiprazole, sold under the brand name Rexulti, is not a new drug. Doctors have been prescribing it for major depressive disorder and schizophrenia.

“Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease,” Dr. Tiffany Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a statement.

Agitation can include symptoms ranging from pacing or restlessness to verbal and physical aggression. “These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression,” Farchione said.

But antipsychotic drugs, like brexpiprazole, come with what’s called a Boxed warning. In some older Alzheimer’s patients, the medication can increase the risk of death.

“Most physicians and other clinicians prescribing for treatment of agitation are going to look for medications first that likely have less serious side effects,” said Dr. Kristina Zdanys, chief of geriatric psychiatry and behavioral health at UConn Health.

None of those other drugs are FDA-approved to treat agitation in Alzheimer’s patients. Weighing the known risks against the potential benefits is part of the FDA drug approval process. And doctors may suggest off-label drugs — approved for depression and anxiety.

Both Zdanys and Christy Kovel, director of public policy at the Connecticut chapter of the Alzheimer’s Association, advocate for the use of non-pharmacological treatment options to manage behavioral symptoms in Alzheimer’s.

“If symptoms don't respond to non-drug approaches, particularly those who have potential to harm themselves or others, medications may be considered,” Kovel said.

According to the Alzheimer’s Association, an estimated 45% of people living with Alzheimer’s have symptoms of agitation.

Families should talk to their doctor about lifestyle changes before considering medication, Zdanys said.

“There's lots of different things that can trigger behavioral changes and mood changes and agitation,” she said. “Something as simple as somebody's sleep schedule being improved, or maintaining a routine, or addressing triggers in the environment that might be making the patient uncomfortable, even something like the temperature in the room or the lighting in the room can make a big difference.”

The Alzheimer's Association offers guidelines on how to recognize and respond to agitation.

A fight for Medicare coverage 

Rexulti is covered by Medicare. But Medicare does not cover two other FDA-approved monoclonal antibody drugs shown to reduce cognitive decline in Alzheimer’s patients.

“Leqembi, Aduhelm, they currently do not have access,” Kovel said. “You are only able to get these drugs right now if you are in a clinical trial, or if you're able to pay privately. We believe that's wrong.”

Kovel said the lack of Medicare coverage is preventing people from accessing beneficial medication, even if their doctor prescribes it to them.

On Dec. 19, 2022, the Alzheimer’s Association filed a formal request asking Centers for Medicare & Medicaid Services (CMS) to provide full and unrestricted coverage for FDA-approved Alzheimer’s treatments.

The association has an ongoing campaign urging lawmakers and President Biden to reverse the CMS decision.

Sujata Srinivasan is Connecticut Public Radio’s senior health reporter. Prior to that, she was a senior producer for Where We Live, a newsroom editor, and from 2010-2014, a business reporter for the station.

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