The anti-amyloid agent lecanemab (Leqembi, Eisai) and associated ancillary services could add an estimated $2 to $5 billion annually to Medicare spending, with substantial out-of-pocket costs for Medicare beneficiaries who don't have supplemental coverage, a new cost analysis suggests.
"These additional costs could strain the Medicare program and its beneficiaries, who may face rising premiums to help Medicare pay for the drug," study investigator Julia Cave Arbanas, with the David Geffen School of Medicine at the University of California, Los Angeles, notes in a news release.
"Additional premium increases are especially concerning because many older Americans rely on a fixed income," Arbanas adds.
The study was published online May 11 in JAMA Internal Medicine.
Earlier this year, the US Food and Drug Administration granted accelerated approval to lecanemab for the treatment of early Alzheimer's disease (AD).
As reported by Medscape Medical News, the approval was based on findings from the CLARITY AD trial, which showed modest cognitive benefit but at a cost of increased risk for amyloid-related edema and effusions.
The investigators note that lecanemab's $26,500 proposed annual acquisition cost and ancillary spending could increase Medicare spending, possibly leading to increases in beneficiary premiums.
To estimate annual Medicare spending on lecanemab, the investigators conducted a cost analysis using nationally representative survey data from the 2018 Health and Retirement Study (HRS).
They incorporated direct drug costs as well as indirect costs for associated healthcare services, such as imaging, neurology visits, and other related care.
Among 7588 HRS participants, who represented 44 million Medicare beneficiaries, 16.2% had mild cognitive impairment (MCI) or mild dementia and would be eligible to receive lecanemab.
The researchers estimate that the total annualized medication costs would be $25,850 and that ancillary costs would be $7330 per beneficiary.
According to these estimates, if 85,687 eligible patients (lower-bound estimate) received lecanemab, Medicare would spend $2.0 billion annually (95% CI, $1.8 billion to $2.2 billion).
If 216,536 eligible patients (upper-bound estimate) received lecanemab, Medicare would shell out $5.1 billion annually (95% CI, $4.6 billion to $5.7 billion), the study team calculates.
Without supplemental insurance, Medicare beneficiaries would be responsible for $6636 out-of-pocket for the drug, the researchers note.
They caution that the analysis did not account for rebates, price changes, or societal costs, such as caregiver burden, "which may shift due to transportation to infusions and appointments or changes in patients' cognitive function."
"Despite incorporating increases in cognitive screening and case positivity rates, these estimates are conservative; changes in physician behavior, cognitive screening capacity and demand, new diagnoses of MCI or mild dementia, and associated spending may increase more than anticipated," they write.
The study was funded by the National Institute on Aging. The authors have disclosed no relevant financial relationships.
JAMA Intern Med. Published online May 11, 2023. Abstract
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Cite this: Annual Costs of Lecanemab Estimated to Be Upwards of $2 Billion - Medscape - May 12, 2023.