Challenges of connecting to care for neurodegenerative conditions
With innovative memory disorder drugs on the horizon, Penn Medicine is working to address the challenges patients and families still face, from diagnosis, to treatment, to supportive care.
There is no cure for any neurodegenerative disease—not Alzheimer's disease, or Parkinson’s, or Huntington’s, or amyotrophic lateral sclerosis (ALS), or any of the numerous other diseases that, slowly or quickly, erode away at a person’s ability to think, remember, or control their body movements. People who live with these conditions are forced to navigate a bewildering journey through the labyrinth of cognitive decline. As their condition progresses, memories fade, words slip away, and daily tasks become elusive puzzles, casting a shadow over both their personal lives and cherished relationships. Caregivers—family and close friends who support those living with cognitive impairment—grapple with significant losses, both financial and emotional, as they navigate the journey alongside their loved ones.
So it’s an especially hopeful time for families when new treatments for neurodegenerative diseases arrive. While it may not cure a loved one’s condition, a new treatment can help manage symptoms or slow the progression of the disease, potentially giving families more time to enjoy life as they’ve always known it.
The Food and Drug Administration’s (FDA’s) recent approval of Leqembi is one of those hopeful moments. The anti-amyloid treatment promises to slow decline in patients with early-stage Alzheimer’s disease. It’s the first in a new class of medicines that target amyloid plaque in the brain, a suspected culprit of several cognitive conditions. But the time and distance between a new treatment being approved by the FDA and being delivered to the patients who need it, are often fraught with challenges.
And now growing numbers of patients with Alzheimer’s disease and their families, while energized with new hope, are navigating these challenges as an added uphill climb. At Penn Medicine, a determined coalition of interdisciplinary clinicians, physicians, and researchers is working to dismantle the barriers hindering patients’ access to vital care.
Ready or not?
New treatments for neurodegenerative diseases don’t come along often. The FDA approved Radicava in 2017, making this drug, which reduces oxidative stress in cells, the first new treatment designed specifically for ALS in 22 years. Leqembi is the first new Alzheimer’s disease therapy to receive full FDA approval in over 20 years. Leqembi is also generating a lot of excitement in the industry because it represents a new class of drugs, monoclonal antibodies that attack plaques in the brain to slow cognitive decline by directly acting on molecules associated with the disease. There are others like it in the making, including Aduhelm and donanemab, both of which are in various stages of the journey toward proving efficacy and gaining full FDA approval. But as a first, Leqembi is both an exciting and challenging new offering for patients and health care centers.
While Medicare has agreed to cover the cost of Leqembi (an estimated $26,500 per year), the tests and scans required to qualify for the drug are not covered by many insurance plans. Felicia Greenfield, MSW, LCSW, a longtime executive director of the Penn Memory Center (PMC) who started a private practice in 2024, estimates the positron emission tomography (PET) scan required to confirm the presence of amyloid in the brain costs around $9,000. Medicare only recently announced that it will cover these scans. In the meantime, patients who can’t afford a PET scan will have to undergo a spinal tap instead. The procedure, which requires local anesthesia and uses a needle to collect cerebrospinal fluid from the space surrounding the spinal cord in the lower back, is more likely to be covered by private insurance plans but is also mildly uncomfortable relative to a PET scan.
Before even reaching this point in an evaluation, patients and their families must go through a gamut of systemic challenges. It begins with a race against time. Neurons, the brain cells responsible for memory, cognition, and information processing, are the linchpin of our mental faculties. Cognitive decline is irreversible. Once neurons are damaged or lost, they typically cannot be replaced or repaired.
But the reality is that most people grappling with the initial signs of cognitive decline fail to seek professional help until symptoms worsen, often explaining away symptoms as normal signs of aging. Those who voice concerns about their cognition to their primary care physician (PCP) often find themselves at a crossroads.
“PCPs are not necessarily trained or equipped to diagnose specific diseases that cause dementia, and that can be a barrier for enrolling in research, receiving appropriate care, or medication,” Greenfield said.
Many PCPs, constrained by time and training, may refer patients to geriatricians, neurologists, geriatric psychiatrists, and neuropsychologists instead, but, Greenfield explains, these specialists are in woefully short supply, especially in rural areas.
Patients who specifically hope to receive Leqembi first must consider the drug’s risks, which include the potential for brain bleeds, hypersensitivity reactions, headaches, and more. Patients and their families also have to consider the logistical challenges of frequent hospital visits for a lengthy qualification process. It begins with a clinician assessment to determine if the person experiencing symptoms of cognitive decline has mild cognitive impairment (MCI) or mild-stage dementia. MCI affected 13 million Americans last year alone. It’s predicted that number will reach 21 million by the year 2060, representing a vast number of people who might be eligible to receive the drug. However, if a patient transitions to moderate dementia, as all patients eventually will with the progression of the disease, the journey ends there. They no longer qualify for Leqembi.
If the patient does have MCI or mild-stage dementia, they move on through a series of additional evaluations including magnetic resonance imaging (MRI) scan, blood tests, and genetic testing to rule out the potential for brain bleeds and other adverse effects; followed by either the PET scan or a lumbar puncture to confirm the presence of beta-amyloid in the brain. The journey requires time, patience, and—depending on a patient’s insurance coverage—a lot of out-of-pocket fees. It also requires access to an expert who can provide careful interpretation of this complex set of evaluations and test results—a level of expertise that most clinicians do not currently have.
Care systems rising to the challenge
To ensure a patient can even go through this process to qualify for Leqembi, a health care center must possess significant resources. In an optimal scenario, a cohesive network of clinicians, including primary care physicians, geriatrics specialists, Alzheimer's specialists, genetic counselors, radiologists, and infusion teams, would operate within the same network. This synergy would facilitate a more efficient process for scheduling procedures and seamless referrals between practitioners. And, of course, those specialists would have the capacity to accommodate new patients alongside their existing caseload.
Comprehensive centers that are designated as Alzheimer's Disease Research Centers by the National Institute on Aging, including the Penn Memory Center, play a pivotal role in providing reliable diagnoses, treatment options, and access to clinical trials for patients who live in proximity to academic institutions with such centers. However, the PMC too is grappling with the challenge of trying to serve an increasing number of patients seeking evaluations with a limited pool of available providers to meet this demand.
“With the majority of our providers dedicating their time to research, we have a limited capacity to accept new patients into our clinical practice,” said Greenfield, who added that the center has taken steps to increase its clinical capacity and reduce evaluation wait times.
“For years we have worked on development of the tools to detect and monitor patients with Alzheimer’s disease,” said David Wolk, MD, co-director of the PMC and a professor of Neurology in the Perelman School of Medicine, “and we are now faced with the exciting, but daunting, task of moving these tools into clinical practice.”
The arrival of new anti-amyloid treatments has driven a need for what Penn Medicine clinical leaders see as a convergence of resources for a clinical endeavor that are typically only devoted to research programs. This represents a commitment that few health care centers are currently willing or equipped to undertake. But Penn, somewhat uniquely, has a great deal of expertise in one place.
Penn Medicine also has a track record of adapting to entire novel categories of treatments. When targeted gene therapies were first introduced in 2017, cancer centers had to adapt by establishing new infrastructure to support personalized medicine. It required a similar process of shifting interdisciplinary teams and resources from a research to a clinical effort, and advocating for coverage of the many new treatments that entered the market. This was a massive undertaking; it’s the same kind of effort that will be needed to accommodate care for patients as more advanced therapies for neurodegenerative diseases move toward the clinic.
As these new treatments emerge, Penn Medicine clinical leaders are working to control the things they can: increasing clinical capacity, shortening evaluation waitlists, and streamlining the qualification process for anti-amyloid treatments like Leqembi.
For matters beyond Penn Medicine’s control, like determining which treatments are covered by various insurance companies or payers, they advocate. Penn Medicine is working with several insurance companies who have yet to support coverage of Leqembi. The goal is to assure payers that with proper administration, the drug will only be given to the patients who truly need it.
With its vast network of providers and clinical resources, Penn Medicine is uniquely positioned to serve as a model for health care centers nationwide on how to screen for and administer anti-amyloid treatments effectively and efficiently.
Supporting more than medical treatment
For families facing the difficulties of cognitive decline, access to medical treatment is just one piece of the puzzle. As Greenfield explains, many families also need help navigating resources in their communities, or social or emotional support, or help finding an alternative living arrangement for their loved one; or they may need to learn specific techniques for managing challenging behaviors that dementia and other neurodegenerative diseases may cause.
The PMC offers several of these supports, including caregiver education and coaching; short-term psychotherapy for caregivers of people in mild stages of dementia; support groups; and a variety of programs such as Cognitive Comedy, grief yoga, mindfulness meditation, and memory cafes. Many of these services, however, are funded solely through philanthropy and community-based grants.
“If the support goes away, we run the risk of not being able to offer this care to our families,” Greenfield said.
Medicare’s coverage limitations present another critical challenge. Currently, Medicare does not cover the cost of in-home respite care or expenses associated with assisted living or memory care facilities. According to Greenfield, the average cost for in-home respite care in Philadelphia is $25 per hour with a 3-hour minimum, and the cost of a memory care facility is on average $7,000 to $10,000 per month.
“This is out of reach of the majority of people who need care,” she said, adding she believes this Medicare policy should be changed to alleviate the financial burden on families struggling to afford necessary care.
One positive development that PMC Co-director Jason Karlawish, MD, believes will be critical to helping families is The Center for Medicare and Medicaid Services (CMS)’s introduction of the GUIDE model. The voluntary, nationwide model is designed to ensure standardized dementia care, including caregiver training, education, and support services. When implemented, GUIDE can help dementia patients stay in their homes longer, delaying nursing home placement and enhancing their quality of life. The model also offers reimbursement for caregiver support services and a $2,500 annual allowance for respite or long-term care.
It’s the first time Medicare has ever been positioned to support this kind of care.
“Medicare’s default has been that it doesn’t pay for long-term care services and supports because, as the statute was originally written, those things weren’t considered medical care,” explained Karlawish, a professor of Medicine, Neurology, and Medical Ethics and Health Policy in the Perelman School of Medicine. “GUIDE will allow a participating health care system to deliver caregiver services and supports to people with dementia. That’s huge.”
Greenfield anticipates Penn Medicine and other health care centers nationwide will soon adopt GUIDE to improve access to these services; and Karlawish is optimistic that GUIDE will also help promote health equity by ensuring underserved communities have equal access to its interventions.
While the hurdles ahead are many, Karlawish says he and his colleagues are looking optimistically at how far the field of neurodegenerative disease care has advanced and the impact the work they are doing now will have on families for years to come.
“It's a very exciting time to be in the field. We’re very optimistic and very hopeful,” he said. “We recognize there will be some bumps and challenges along the way but we’re living in a revolution that’s going to improve the quality of life for thousands of families. To that, I say, it’s about time.”
Editor’s note: This article was updated in 2024 to reflect changes in job roles for some staff members quoted.