Recent breakthroughs in therapies and diagnostics are creating real hope in Alzheimer's disease care — especially for treating early symptomatic stages of the disease. But despite this progress, major healthcare system and awareness gaps still risk leaving too many people behind.

We sat down with Laura Steele, Senior Vice President of U.S. Neuroscience at Lilly, to unpack how scientific progress has produced innovations that can improve detection and diagnosis for people with Alzheimer's disease. She also discussed what health care providers and policymakers must do to unlock the full value of these innovations.

1. First things first: What exactly is Alzheimer's disease, and how does it develop?

Steele: Amyloid is a naturally occurring protein that can begin to abnormally clump together in the brain. These clumps form amyloid plaques, which are associated with memory and thinking issues over time.

As these plaques accumulate, they may contribute to the progressive cognitive and functional decline seen in Alzheimer's disease. Importantly, this buildup can begin up to 20 years before any symptoms appear, meaning damage is happening long before it's detected.

That's why early symptomatic detection is so critical. By identifying and treating the disease earlier in the symptomatic stages, health care professionals can help slow the progression.

• More than 7 million Americans over 65 live with Alzheimer's disease, and that number is on track to nearly double by 2060.

2. The background: How would you describe the current moment in Alzheimer's disease care? What's changed, and what challenges remain?

Steele: We're at a historic inflection point. After decades of research, we have disease-modifying therapies and novel diagnostics that offer real promise for patients.

• These treatments are approved only for mild cognitive impairment or mild dementia, states of Alzheimer's disease where patients show symptoms but may maintain a degree of independence, making early and accurate diagnosis essential.

Uptake and adoption of amyloid-targeting therapies (ATTs) are promising: A number of healthcare systems and healthcare providers (HCPs) are already delivering care for appropriate patients, with more positioned to come online soon in diverse geographic areas.

But the healthcare system hasn't caught up with scientific innovation. Despite advances, many patients still face barriers at every step — from primary care detection to timely specialist referral, and cumbersome Medicare coverage restrictions.

3. The deets: How are new diagnostics — especially blood biomarkers — changing the landscape for Alzheimer's disease detection and care?

Steele: Blood biomarkers are a tool that can be used to confirm amyloid pathology and help aid in evaluation and diagnosis of symptomatic patients.

They could make detection more accessible across geographies and lower costs. While the science and administration of therapies and diagnostic tests in clinical settings continue to develop, the long game could change your annual check up.

These tests could be especially valuable in rural areas, where access to PET scans is sometimes limited.

Okay, but: Coverage must keep pace with innovation. As these tests reach the market, policymakers must continue to ensure providers are properly covered and reimbursed and out-of-pocket costs for patients don't skyrocket. And when coupled with appropriate insurance coverage for cognitive assessments for primary care providers, blood biomarker tests can help support earlier detection.

4. The goal: What are the top policy actions needed to close these gaps and deliver on the promise of innovation?

Steele: To reduce long-term healthcare costs of Alzheimer's disease and increase patient access to new treatments, the Centers for Medicare & Medicaid Services (CMS) and commercial insurance plans should provide coverage for FDA approved amyloid-targeting therapies (ATTs) and prepare to cover future approved innovations looking to treat the disease earlier in its progression, without hurdles like prior authorization.

• Learn from the past. For example, coverage for blood diagnostics must avoid the rollout delays seen with PET scans in earlier years.
• Expand system capacity. Telehealth, workforce investment and access to specialists — especially in underserved areas — are critical to timely care.
• Lead with urgency. Both public and private insurance should actively prepare to cover newly approved care at low out-of-pocket costs for patients.

The challenge: Despite new innovations in the Alzheimer's disease space, including the opportunity to speed up diagnosis with the help of blood biomarker tests, barriers to care and coverage can prevent patients from getting diagnosed and treated.

• We see major drop-offs at three critical points in the diagnosis journey: generalist evaluation, referral to a specialist and access to diagnostic testing.

Lilly is working to close these gaps by partnering across sectors to improve awareness, provider support and care delivery.

Learn what's needed to close the gap in Alzheimer's disease diagnosis and treatment.