Understanding Reasons for Excluding Patients From Alzheimer’s Disease Anti-Amyloid Therapy in the United States Veterans Affairs Healthcare System

Author(s)

Cambi X1, Biskach M1, Mittler B2, Reisman J3, Berlowitz D4, Morin PJ1, Zhang R5, Tahami Monfared AA5, Zhang Q5, Xia W3
1Boston University, Boston, MA, USA, 2South Texas VA Healthcare System, San Antonio, TX, USA, 3Bedford VA Healthcare System, Bedford, MA, USA, 4University of Massachusetts Lowell, Lowell, MA, USA, 5Eisai, Inc, Nutley, NJ, USA

OBJECTIVES: In February 2023, the United States Veterans Affairs Healthcare System (VAHS) established criteria for use of newer anti-amyloid therapy (AAT) for Alzheimer’s disease. We described reasons patients were excluded from AAT after issuance of the VAHS criteria.

METHODS: Reasons for ineligibility for AAT were ascertained by manual review of computerized clinical notes in the VAHS nationwide databases (March 13, 2023–December 31, 2023). The most frequent treatment exclusions based on VAHS criteria were delineated.

RESULTS: There were 1668 Veterans with notes referencing AAT. Among them, 49.7% had documented mild cognitive impairment and 33.3% Alzheimer’s dementia (AD). Mean age was 76 years; 3.8% were Female, 9.2% Black vs 81.1% White, and 3.8% identified as Hispanic vs 90.6% non-Hispanic. Discussion with clinicians regarding AAT took place for 1139 patients; 629 patients (834 notes) were ineligible for AAT. Reasons for exclusion were: 142 had advanced AD stage, 14 carried 2 copies of ApoEe4 allele, 13 aged <65 years (VAHS-specific criteria), 12 PET amyloid-negativity, and 7 preclinical Alzheimer’s. Additionally, 47 patients were considered ineligible by clinician and 59 with undefined comorbidity. Among excluded patients, comorbidities/medications consistent with VA-specific AAT exclusionary criteria included comorbidities of psychiatric/behavioral disorders (n=94), intracerebral/subarachnoid hemorrhage/brain bleed (n=71), pacemaker (n=23), substance abuse (n=19), cerebral amyloid angiopathy (n=15), aneurysm (n=5), amyloid-related imaging abnormalities (ARIA) from prior AAT/clinical trials (n=5), and suicidal ideation (n=2). Potentially exclusionary medications included anti-coagulants (n=121), anti-platelet agents (n=19), and anti-psychotics (n=2). Additionally, 23% of excluded patients were on aspirin, relative to 32% of ATT-treated patients.

CONCLUSIONS: About 23% of patients were excluded from ATT due to advanced-stage AD. Homozygous ApoEe4 status and negative PET findings each excluded 2% of patients. A substantial number of patients may have been excluded due to VAHS-specific criteria (e.g., anti-coagulant/anti-platelet medications) that are not among contraindications in the FDA-approved prescribing information.

Conference/Value in Health Info

2024-11, ISPOR Europe 2024, Barcelona, Spain

Value in Health, Volume 27, Issue 12, S2 (December 2024)

Code

RWD36

Topic

Epidemiology & Public Health, Study Approaches

Topic Subcategory

Electronic Medical & Health Records, Public Health

Disease

Geriatrics, Neurological Disorders

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×