20 May New Alzheimer Drug Lecanemab and its Ancillary Services Could Cost Medicare up to 5 billion Annually
MedicalResearch.com Interview with:
Julia Cave Arbanas
Project Manager and
John N. Mafi, MD, MPH
Associate Professor of Medicine
General Internal Medicine & Health Services Research
David Geffen School of Medicine at UCLA
MedicalResearch.com: What is the background for this study? What is lecanemab used for and how well does it work?
Response: Lecanemab is a treatment for mild cognitive impairment and mild dementia that was approved in January 2023 as part of the Food and Drug Administration’s (FDA) accelerated approval program. The results from a recent phase 3 clinical trial show a modest clinical benefit: the rate of cognitive decline by 27% in an 18-month study involving participants experiencing the early stage of Alzheimer’s, with an 0.45-point absolute difference in cognitive testing scores. However, due to the risk of brain swelling and bleeding (also known as amyloid-related imaging abnormalities), treatment with lecanemab involves frequent MRIs and neurology or geriatrics appointments to monitor for these abnormalities, which can be life threatening. So far, three patient deaths have potentially been tied to lecanemab.
It is likely that the FDA will grant is lecanemab traditional approval later this year, prompting Medicare to reconsider its current coverage restrictions and potentially enabling widespread use.
MedicalResearch.com: What are the main findings?
Response: We found that if lecanemab was enabled for widespread use, it could cost Medicare between $2.0-5.1 billion annually. The addition of ancillary costs, such as infusion fees and MRIs and neurology or geriatrics visit to monitor for brain swelling and bleeding, increased total spending estimates by 28%. Out-of-pocket costs for patients could be as high as $6,600 for patients who have no supplemental insurance, which is approximately 20% of the median income of a U.S. Medicare beneficiary.
MedicalResearch.com: What should readers take away from your report?
Response: Lecanemab and its ancillary services could cost Medicare up to 5 billion annually, which could pose a significant cost burden to both patients and the Medicare program. For a medication with modest benefit and nontrivial patient risk, it is important for Medicare to comprehensively assess lecanemab’s value to patients with dementia as well as its risk of harm.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: This study was funded by the National Institute on Aging (NIA). Co-authors reported receiving funds from the National Institutes of Health (NIH), NIA, Arnold Ventures, the Commonwealth Fund, and the National Center for Advancing Translational Sciences (NCATS). Additionally, Dr. Mafi received nonfinancial support from Milliman MedInsight for studying low-value care in Medicare and has previously provided unpaid consulting to Milliman MedInsight. Dr Mafi also provided unpaid consulting to the Agency for Healthcare Research and Quality (AHRQ) outside the submitted work. No other disclosures were reported.
Arbanas JCDamberg CL Leng M, et al. Estimated Annual Spending on Lecanemab and Its Ancillary Costs in the US Medicare Program. JAMA Intern Med. Published online May 11, 2023. doi:10.1001/jamainternmed.2023.1749
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