Challenges and Opportunities Bringing Lecanemab to Neurology Community Clinics

Jose Soria, MD;Olena Bueno, RN;Uriel Romero, MD;Claudia Asencio, MA;Kevin McGehrin, MD;Branko Huisa, MD;

Publication

Article

October 8, 2024

NeurologyLive

Fall 2024

Volume

Challenges and Opportunities Bringing Lecanemab to Neurology Community Clinics 

Author(s):

Jose Soria, MD,Olena Bueno, RN

Key Takeaways

Lecanemab is FDA-approved for early Alzheimer's, but equitable access remains a challenge, especially in underserved communities.
The Neuron Clinic's program for Latino populations emphasizes comprehensive screening and treatment coordination.
Operational challenges include high labor costs and insurance barriers, highlighting the need for specialized expertise.
Understanding local healthcare ecosystems is crucial for improving access and outcomes for Alzheimer's treatments.

A group of experts from The Neuron Clinic shared their experience developing a novel inclusive clinical program to treat patients with early Alzheimer disease using lecanemab.

Jose Soria, MD

(Credit: The Neuron Clinic)

Olena Bueno, RN

(Credit: LinkedIn)

Lecanemab Approval

Lecanemab is an FDA-approved antiamyloid Alzheimer disease (AD) treatment shown to reduce cognitive and functional decline in the early stages of the disease.¹ The medication became available under accelerated approval in January 2023 and later received full traditional approval in July 2023. There are well-known disparities in the use of newly approved medications (such as lecanemab) in historically underserved communities.² Bringing this and other antiamyloid therapies to the public will be challenging and require several operational and regulatory questions to be considered:

Where will the treatment centers be located to ensure equitable patient access to therapy and avoid widening health disparities in the future?

How can we leverage treatment registries to include more historically underrepresented patients in AD clinical research in the community?

What funding mechanisms will be available to support neurology community clinics?

What regulatory incentives are needed to achieve patient outcomes and maintain quality standards in community clinics?

What happens if we are not able to treat patients with AD in the communities where they live?

The Neuron Clinic Experience

Here, we share our experience developing a novel inclusive clinical program to treat patients with early AD using lecanemab. We discuss our early experience treating Latino populations at our Southern California neurology community clinics.

Our community clinics see many seniors, over 50% of whom are of Latino origin. Patients with cognitive decline concerns undergo a rigorous, comprehensive screening process, including neurocognitive assessments and physical examinations by bilingual and bicultural behavioral neurologists. Selected patients undergo blood tests for reversible causes of dementia and a test for the apolipoprotein E (APOE) gene, a well-known genetic factor for sporadic AD.^3,4Once a clinical diagnosis of AD is made, patients are offered subsequent biomarker confirmation of disease with amyloid PET brain imaging and/or lumbar puncture (LP) with cerebrospinal fluid (CSF) evaluation. Patients are subsequently offered treatment with lecanemab and opportunities to participate in clinical trials depending on their clinical profile and biomarker test results.^5-8

Diagnostic LP procedures, infusion treatments, and clinical visits are all conducted within The Neuron Clinic facilities in Southern California. Our in-house operations allow us to simplify care coordination while maintaining quality control and safety monitoring. Care coordination includes scheduling multiple infusion visits, imaging studies, and follow-up visits, as well as maintaining vigilance about adverse effects associated with treatment.

Bicultural and bilingual staff perform clinical and neurocognitive evaluations for Spanish-speaking patients who self-identify as Latinos. All patients are included in the Centers for Medicare & Medicaid Services (CMS) database and the newly available Alzheimer’s Network for Treatment and Diagnostics database. The breadth of operations requires the collaboration of talented clinicians with unique clinical and operational skills.

In the last 14 months, we have treated more than 50 patients with lecanemab. Over 50% of the patients treated are female, and over 40% self-identified as being of Latino origin. We have also identified more than 200 additional patients eligible for lecanemab who are undergoing diagnosis/confirmation pathways and are pending treatment. Over 30% of the patients pending treatment self-identify as Latino, over 60% are pending confirmation of AD-specific biomarkers (amyloid PET imaging or CSF analysis), over 40% are pending APOE testing, and over 30% are pending MRI completion. Once the required diagnostic tests are completed, patients will be offered treatment with lecanemab depending on their preferences and clinical profile. In our experience, about 50% of the patients who enter our diagnosis/confirmation pathway end up receiving treatment with lecanemab.

We have observed 3 asymptomatic cases of amyloid-related imaging abnormalities (ARIA) among the patients receiving treatment.⁹ In 2 cases, we decided to continue treatment uninterrupted. However, in the remaining case, we have temporarily paused treatment. All 3 cases of asymptomatic ARIA were detected early in the treatment course, before the seventh infusion, within 3 months of starting therapy. There have been no cases of symptomatic ARIA so far. Additionally, 20% of patients receiving treatment experienced infusion-related reactions.

Challenges and Opportunities

Kevin McGehrin, MD

(Credit: The Neuron Clinic)

Branko Huisa, MD

(Credit: The Neuron Clinic)

There are operational challenges and opportunities to consider. We have seen significant labor costs associated with scheduling, billing, and coordinating care that are not directly covered by the existing billing codes. Additionally, there are other activities, including cognitive testing, for which the existing billing codes are insufficient to cover the cost. CMS has recently released a voluntary Guiding an Improved Dementia Experience (GUIDE) model to support patients and caregivers.¹⁰ GUIDE is a step in the right direction, and we hope to see it flourish. Lastly, we have had some difficulty securing treatment for patients with Medicare Advantage programs despite our best efforts following treatment recommendations and phase III clinical trial inclusion criteria in our selection of patients.^1,11

In our Latino-predominant patient cohort, early diagnosis and confirmation of AD continue to be an important barrier to address with treatment with lecanemab. Our unique location in the community allows us to reach patients who would not otherwise have access to treatment. However, barriers to treatment implementation in this community setting remain, such as medical insurance coverage, financial concerns by patients and families, and caregiver availability.

We appreciate this opportunity to bring new AD therapies to our patients and the long-term relationships we form. However, no specific solution will work in every community nationwide. In the future, we need to better understand local patient preferences, regional health care ecosystems, and available resources to bring this kind of therapy across diverse regions of the country. Additionally, longitudinal collaboration with academic centers and other large regional health care institutions will be needed to sustain local community clinic operations.

The use of antiamyloid disease-modifying agents should remain in the hands of neurologists, geriatricians, and other dementia specialists. It requires unique expertise for patient selection, treatment, and care coordination that cannot be replicated safely by other specialists or treatment centers. We cannot outsource these responsibilities without direct supervision from experienced specialists. Dementia specialists should collaborate directly with large teams of general practitioners and advanced health providers, leverage digital technologies to maintain oversight of such treatments, and continue to move the field forward.