Lecanemab and Anticoagulants: Projected Effects on Health and Quality of Life

  1. Sachin J. Shah
  2. Tai Dinger
  3. Deborah Blacker
  4. Steven M. Greenberg
  5. John C. Giardina
  6. Jacquelyn M. Lykken
  7. Samhita Kalidindi
  8. Livia Qoshe
  9. Joseph P. Newhouse
  10. Ankur Pandya
  11. John Hsu
  12. Emily P. Hyle
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Abstract

Background

Lecanemab slows cognitive decline among people with early Alzheimer’s disease (early AD) but appears to increase the risk of intracranial hemorrhages (ICHs), including anticoagulant-related ICHs.

Objective

To examine the benefits and harms of co-prescribing lecanemab and anticoagulants in people with atrial fibrillation (AF) experiencing early AD.

Design

Microsimulation model to compare four treatment strategies. Using inputs from the literature, we modeled increased ICH risk with lecanemab (2.02-fold), apixaban (1.84-fold), and lecanemab/apixaban interaction (2.67-fold). We assigned quality-of-life estimates and increased mortality risk with cognitive decline, stroke, and ICH.

Data Sources

Clinical trials, observational cohorts

Target Population

People 65-90 years with AF and early AD

Time Horizon

18-month

Intervention

Apixaban (APIX), apixaban and lecanemab (APIX/LEC), lecanemab (LEC), neither

Outcome Measures

ICH, ischemic stroke, cognitive decline, quality-adjusted life months (QALMs), and survival, age-stratified.

Results of Base Case

For 100,000 simulated persons aged 65-74 years,APIX,APIX/LEC, andLECwould result in a similar clinical benefit (13.2 QALMs). Compared toAPIX,APIX/LECwould result in more ICH events (1,990 vs. 400), all-cause deaths (5,820 vs. 5,140), but slower cognitive decline (mean CDR-SB change, 1.11 vs. 1.53). For persons ≥75 years,APIXalone would always be preferred.

Results of Sensitivity Analysis

Results are sensitive to lecanemab-anticoagulant interaction on ICH, baseline ICH risk, and lecanemab’s effect on cognition.

Limitations

Significant parameter uncertainty; treatment burden and costs were not modeled.

Conclusions

Model-based results support anticoagulants alone as the preferred strategy for people ≥75 years with early AD and AF. There was greater equipoise across treatment strategies for persons 65-74 years, for whom improved estimates of the ICH risk and lecanemab-anticoagulant interaction are critical to identifying the preferred strategy.

Primary Funding Source

National Institute on Aging/National Institutes of Health (K76AG074919, P30AG062421, U01AG076478, and R01AG069575).

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