As payers tally up the potential costs of anti-amyloid antibodies for Alzheimer’s disease, a new study suggests that the vial design for Eisai and Biogen’s Leqembi could result in hundreds of millions of dollars in wasted spending each year for Medicare.
Since Leqembi is dosed based on a patient’s weight and offered in single-use vials, about 5.8% of the drug dispensed will be unused and discarded, according to a new study published in JAMA Internal Medicine. That could result in $133 million to $336 million in waste per year for Medicare, the study found.
“It is imperative to reduce spending on services that do not improve the health of patients, and this is a prime example of such, given that Medicare is paying for a drug only to literally throw part of it away,” the study’s first author, Frank Zhou, a medical student at the University of California, Los Angeles, said in a statement.
Despite Leqembi’s slow commercial uptake so far, the drug has prompted concerns about its potential impact on healthcare costs because of its price, required treatment frequency, the large Alzheimer’s patient base and other factors. Medicare has projected the drug will cost the U.S. program $3.5 billion in 2025.
Eisai and Biogen currently sell Leqembi in single-use 500 mg and 200 mg vials. To mitigate the potential waste, the UCLA team suggested that protocols could be developed for sharing vials between patients.
In addition, replacing the 500 mg vial with a 250 mg presentation could lower the overall drug waste from 5.8% to 3.2%, creating up to $155 million in annul savings, the team found.
Alternatively, adding a third 75 mg vial option could reduce waste by 74%, or generate up to $251 million in annual savings, the team proposed.
“There are significant opportunities for savings even with this single drug, implying that even greater savings could be achieved if our proposed solutions were applied to other infused therapies,” Zhou said.
In a statement to Fierce Pharma, Eisai said it agrees with the researchers’ goal of reducing healthcare costs and will further evaluate the team’s analysis. The company said it will continue to gather real-world data to “evaluate the factors that can help ensure maximum benefit to patients, care partners, the health system, and society.”
For their calculation, Zhou and collaborators analyzed Medicare insurees from the 2020 Health and Retirement Study (HRS) who were aged 65 years or older potentially eligible for Leqembi. HRS is a longitudinal survey of sample Americans conducted by the University of Michigan in Ann Arbor and supported by the National Institute on Aging. The findings were then generalized to the entire Medicare population under the assumption of 1.1% to 2.9% drug uptake, translating into an estimated 82,000 to 208,000 patients.
The cohort from HRS may not accurately match Leqembi users in terms of their weight and dosing required, the researchers noted as one limitation of their work.
Waste is not a Leqembi-specific problem, as it’s inevitable for single-dose, infused drugs that are dosed based on weight. Infusions are typically packaged as single-use vials for safety reasons.
On the flip side, uniform dosing can also generate waste because patients can receive additional unnecessary treatment under this approach. Drugmakers have been accused of both as potential tactics to bring in bigger revenues.
Medicare spent $33 billion on Part B infused drugs in 2021, UCLA’s John Mafi, M.D., senior author of the new Leqembi study, noted in a statement.
“So there is substantial opportunity for cost savings by reducing waste from all infusion drugs,” Mafi said.
As the UCLA researchers noted, U.S. law requires that drugmakers reimburse Medicare for drug waste exceeding 10%. Leqembi’s 5.8% falls below that bar, “suggesting that Congress should enact a lower reimbursement threshold,” the UCLA team wrote in the study.
Nevertheless, in an accompanying editorial, two researchers argued that while reducing discarded Leqembi is sensible, “the savings are small compared with the up to $5 billion that Medicare will be estimated to spend on the drug each year.” The estimate came from another UCLA study, published in JAMA Internal Medicine last year, by some of the same researchers, including Mafi. The figure covers the drug itself and other supporting services, including administration, brain imaging scans, biomarker testing, among others.
“Modifying vial sizes to reduce discarded doses is penny wise, but ultimately widespread coverage by Medicare may be pound foolish considering the limited potential for benefit, the substantial potential for harm, and better uses for those dollars to support proven preventive and supportive interventions for dementia,” Nathan Stall, M.D., Ph.D., from the University of Toronto and Kenneth Covinsky, M.D., from University of California, San Francisco, wrote in their editorial.