A Blueprint for Managing Complex Therapies
Cedars-Sinai’s New Process Outlining Safe, Effective Management of New Alzheimer’s Drug to Serve as a Guide for Administering Complicated Therapies
A new report recently published by a multidisciplinary team of investigators from Cedars-Sinai outlines a coordinated care process to safely and effectively manage the administration of a new medication for early-stage Alzheimer’s disease patients.
The plan, published in the peer-reviewed journal Neurology® Clinical Practice, covers all aspects of the complicated medication regimen, from guidelines for emergency management of patients on lecanemab, and biweekly patient assessments, to a comprehensive informed consent process, including a provision for an authorized surrogate for adult patients who may lack the cognitive ability to manage their own care.
Lecanemab, recently approved by the Food and Drug Administration (FDA), is a complex therapy requiring biweekly infusions, periodic imaging and laboratory tests, clinical patient assessment, and drug interaction screening. Rita Shane, PharmD, vice president and chief pharmacy officer at Cedars-Sinai, said the guidelines will help guide the management of future complex therapies.
“With an increasing number of FDA approvals of these types of high-cost, innovative therapies, a comprehensive, multidisciplinary planning process not only supports access, but also safety for patients,” Shane said. “The process design we implemented for lecanemab can serve as a blueprint to support safe and effective management of these new, complex neurologic therapies at institutions across the country.”
Additional authors: Sarah Kremen, MD; Zaldy S. Tan, MD, MPH; Hai Tran, PharmD; Thanh G. Tu, PharmD; Nancy L. Sicotte, MD.
Funding: The authors report no targeted funding.
Conflict of interest: S. Kremen was a consultant for Eli Lilly and Company relating to donanemab.
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