Politics: An Alzheimer's drug appears promising, but Medicare should wait to cover it

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In the coming months, Medicare will deliberate whether to cover the cost of the recently Food and Drug Administration (FDA)-approved Alzheimer's treatment, aducanumab. It may seem like a miracle drug to those who are hopeful for treatment, but it's hardly magic. Aducanumab binds to amyloid protein, a waste product of normal brain metabolism, and helps to clear it. Researchers theorize that amyloid protein builds up in abnormal levels in Alzheimer's disease and interferes with communication between brain cells, ultimately contributing to cell death.

a close up of a hand: An Alzheimer's drug appears promising, but Medicare should wait to cover it © Getty Images An Alzheimer's drug appears promising, but Medicare should wait to cover it

While it stands to reason that clearing amyloid protein might benefit those with Alzheimer's, the drug is somewhat controversial because some clinical trials have inconclusively demonstrated benefit. That is, we aren't sure that the drug actually works.

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That uncertainty, combined with the realities of experiencing Alzheimer's disease, should give the Centers for Medicare Services pause when deciding to cover the drug's cost. Medicare needs to prioritize payment for evidence-based care coordination interventions that more immediately and tangibly aid dementia sufferers and their caregivers.

Medicare is the largest health care insurer of those over age 65. Currently, nearly one in five Medicare dollars is spent for patients with Alzheimer's and this is expected to increase to one in three dollars by 2050. These cost projections were made before aducanumab's approval; by itself, the drug could cost Medicare $29 billion in one year alone. The costs to Medicare for aducanumab would represent 78 percent of the total 2019 Part B drug spend and 20 percent of total Part D costs.

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Aducanumab is estimated to cost $56,000 a year - which does not include the cost of imaging to monitor for the potentially serious side effect of brain swelling - to those who can afford it. Its cost, pitted against its efficacy, has caused some health systems to state that they won't pay for it. Whether private insurers will pay for it remains unclear.

Even with the drug, the real challenge in helping Alzheimer's patients is arranging for their proper care. A majority of those with dementia live in the community, cared for by family members or paid informal caregivers. Caregivers must navigate a multitude of concurrent losses while managing physical needs, challenging behavioral symptoms, and financial uncertainty. Research shows that caregivers' health commonly declines under the strain of the care they provide, leaving them and the person for whom they are caring even more vulnerable to untoward outcomes, including possible hospitalization or institutionalization.

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According to the Alzheimer's Association, more than 11 million Americans provide unpaid care for persons living with dementia, and many of these caregivers receive little guidance and support. They live with uncertainty about the future, often with little knowledge of how or where to get help. Indeed, total unpaid caregiving time in the U.S. is worth $257 billion per year, not including the costs of formal caregiving or out-of-pocket care.

Family caregivers often can't do the job by themselves. For example, two recent patients in Massachusetts General Hospital teetered on requiring restraints or a one-to-one sitter because they kept setting off their bed alarms and worrying the staff that they might fall out of bed. One of them simply needed to use the restroom in the middle of the night, kept jolting out of bed, and was unsteady doing this. It took several professionals to guide him to the bathroom and back to bed. A family care provider doesn't have such resources.

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Caregiver fatigue and a lack of support can lead to a person with dementia encountering the in-patient setting, which is an expensive and scary time for the patient. Adverse events such as hospital-induced delirium, falls, and accelerated functional decline can occur.

The lack of proactive care takes a toll on the well-being of caregivers, their families, employers, and our society. When Alzheimer's patients are admitted, case managers and social workers connect them to as many resources as possible - but by then, it can be too late for worn out caregivers.

But there is help - and it can save money, rather than draining the Medicare budget. Randomized controlled trials (RCTs) of dementia care coordination programs have shown that they meet ongoing needs of both the person with dementia and their care partner. Several of these programs, including the Maximizing Independence (MIND) at Home and the Healthy Aging Brain Center, have shown not only benefits for the person living with dementia and their caregiver but actual cost savings.

The Maximizing Independence (MIND) at Home Intervention, which used trained community health workers in the home, partnered with a specialty dementia care team, demonstrated annual Medicaid cost savings of $1,320 per patient. The Healthy Aging Brain Center showed annual Medicare cost savings of $3,474 per patient. If one-half of those in the United States taking medications for dementia (2 million in 2017) were given the opportunity to receive an intervention such as the Healthy Aging Brain Center intervention, Medicare would have the opportunity to recoup close to $3.5 billion.

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No drug will be a magic bullet. Part of the problem is that half of those living with dementia have not been diagnosed or told that they have the condition. Dementia is a spectrum of disorders of various severity and etiology, which include Alzheimer's (the focus of aducanumab). Most other forms of dementia, such as Lewy body dementia and primary progressive aphasia, have limited therapeutics.

Nevertheless, because of the burgeoning number of persons developing Alzheimer's dementia and a 19-year interval between the last drug approved by the FDA for Alzheimer's disease, many, including the Alzheimer's Association, endorse aducanumab. And there are equity considerations; if Medicare chooses not to cover aducanumab, it could lead to further segmentation between those who can afford aducanumab and those who can't.

There is no easy fix for Alzheimer's dementia, even for those with the finances to pay for this drug out of pocket. The challenges of caregiving for a loved one with dementia are significant, even for people with resources.

But providing compassionate care and caregiving is a shared societal problem. Rather than focusing our efforts on a costly, questionably effective drug, let's invest in effective and cost effective dementia interventions in our health systems and communities that support patients and bolster the well-being of those caring for them. Medicare should allocate further resources to focused dementia care and care coordination, while awaiting more data on aducanumab.

Christine Ritchie, MD, MSPH, is the Kenneth L. Minaker Chair in Geriatrics and director of the Mongan Institute Center for Aging and Serious Illness at Massachusetts General Hospital.

Adith Sekaran, MD, is a hospitalist at Massachusetts General Hospital.

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