How Alzheimer’s is diagnosed and treated is changing. Is the US healthcare system ready?

In 2022, approximately 4.2 million U.S. residents aged 65 and older suffered from Alzheimer’s disease. This number is projected to soar to 13.8 million by 2060, driven by an aging population. How will the U.S. healthcare system confront this challenge?

Despite massive financial and scientific investments, many attempts at an Alzheimer’s cure have failed. Hope has arrived, however, with Leqembi (lecanemab) and Kisunla (donanemab) both gaining full approval from the U.S. Food & Drug Administration. While there are scientific disputes about their clinical effectiveness, many experts agree these therapies will usher in a tide of new Alzheimer’s treatments.

As diagnoses increase and Alzheimer’s treatments expand, the U.S. healthcare system will need to navigate three complex challenges.

Put simply, the U.S. doesn’t have enough dementia specialists. With its relatively low physician density compared to other Group of Seven nations, there are legitimate concerns about the U.S. healthcare system’s ability to treat significantly more Alzheimer’s patients. According to a survey from the National Center for Health Workforce Analysis, 20 U.S. states are “dementia neurology deserts” because they have fewer than 10 neurologists for every 10,000 dementia patients. U.S. patients also must wait far too long to see a dementia specialist—the average wait time is currently about 20 months.

As more people are diagnosed with Alzheimer’s—many of whom will be eligible for and interested in anti-amyloid treatments—the strain on neurologists and dementia specialists will intensify. The average wait time to see a dementia specialist in the U.S. is predicted to increase to about 50 months within five years. In comparison, wait time increases will be negligible in countries like Germany and Sweden, where care models are equipped to handle the rise in Alzheimer’s patients.

It's no secret Alzheimer's progresses rapidly. Long wait times to see a specialist will lead to worsening disease progression for more patients.

Not all primary care providers (PCPs) are well equipped to identify early signs of dementia, which unnecessarily prolongs the period before they refer a patient to a dementia specialist. Many PCPs lack awareness and familiarity with the signs and symptoms of early Alzheimer’s, especially because many patients don’t proactively mention their concerns. Most PCPs also don’t have quick and easy tools to identify early Alzheimer’s patients—they instead rely on time-consuming cognitive tests to screen for impairment. The Alzheimer’s experts we spoke with said these factors lead to many patients arriving at a dementia specialist’s office far too late.

While most PCPs may not prescribe anti-amyloid therapies, they will still play a critical role. Their responsibility in screening and referral will become more pivotal as early intervention methods become increasingly prevalent.

Today’s diagnostic landscape poses another substantial roadblock. Dementia specialists still rely on burdensome biomarker tests like amyloid PET scans and CSF lumbar punctures, despite their limitations. Both tests require the patient to coordinate medical appointments, which may require lengthy wait times to schedule. It’s not uncommon for patients to wait several months to undergo diagnostic testing and then two to three more months to receive their results.

Blood-based biomarker tests have the potential to alleviate these challenges, but they have not yet achieved widespread adoption. While evidence shows that some are as accurate as a cerebrospinal fluid analysis, guidelines on utilization don’t exist, insurance coverage is inconsistent and awareness is limited. Blood-based biomarker tests should help address testing capacity concerns in the long term, but capacity constraints are likely to persist for the foreseeable future.

Meeting these challenges will require significant investments to expand healthcare infrastructure and foster collaboration between the public and private sectors. Collaboration between providers, payers, patient advocacy groups (PAGs) and professional associations is vital to ensure that patients receive the appropriate treatment in a timely matter. These four industry players will have key roles in the next era of Alzheimer’s diagnosis and treatment.

Provider networks: The most-used cognitive screening tests are far from ideal, given the time they take to conduct. Incorporating simple digital cognitive tests, such as BrainCheck or app-based paragraph recall tests, before PCP appointments can help streamline the path to a dementia specialist referral. Provider networks can support this acceleration by setting up cognitive screening tests on appointment portals and by including digital cognitive tests in existing appointment monitoring workflows and dashboards.

Conducting screening tests at annual Medicare appointments could help standardize the process and make it easier for PCPs to identify and prioritize patients. Providing PCPs with the digital tools that help them screen for the disease could transform diagnosis and treatment timelines.

We’ve seen how high blood sugar counts and long wait times for endocrinologist appointments have led PCPs to screen and diagnose patients with diabetes and osteoporosis. While Alzheimer’s patients face similar challenges, provider networks leveraging digital screening solutions can help speed up this process.

Payers: PCPs using blood-based biomarker tests to confirm Alzheimer’s diagnoses can potentially alleviate some of the diagnostic burden experienced by overwhelmed dementia specialists, but limited and inconsistent insurance coverage is currently preventing the widespread use of these tests.

Biogen, as part of its Amyloid Beta Confirmed Program, offered spinal fluid tests for free. As more evidence becomes available showing the accuracy of blood-based biomarker tests, manufacturers should continue to explore how they can accelerate diagnostic testing. Engaging with the scientific community will be critical to ensure guidelines are clear, which should help prevent confusion between providers, payers and patients.

Patient advocacy groups: PAGs, such as the Alzheimer’s Association, play a crucial role in supporting patients and caregivers in the early stages of Alzheimer’s. PAGs can bring attention and urgency to Alzheimer’s symptoms, while encouraging patients and their caregivers to mention symptoms to their physicians. They can also educate PCPs about the specific steps needed to identify symptoms early, share the importance of blood-based biomarker testing and discuss why forgetfulness is not always a part of the normal aging process. It’s vital to equip PCPs with the best tools and knowledge available.

Professional associations: Robust training programs tailored to PCPs and the broad neurologist community can help them manage and treat early Alzheimer’s patients. Collaboration between healthcare institutions, educational organizations and professional associations can facilitate the development and implementation of training initiatives. Professional associations could even develop Alzheimer’s certifications for community neurologists. Given that anti-amyloid treatments are still new, training modules should focus on amyloid-related imaging abnormalities (ARIA) management to increase neurologist comfort with these therapies’ safety profile. Some radiologists already participate in ARIA training, and similar programs for neurologists would be beneficial.

For pharma companies that want to succeed in this rapidly evolving environment, broad engagement with the entire healthcare ecosystem is essential. We are at the onset of a new treatment paradigm that will take time to fully develop. While the latest treatments offer potential, the path forward is complex. Pharma companies that embrace this complexity and develop creative, collaborative approaches will benefit. Those who resist change and pursue traditional strategies risk being left behind.