Alzheimer’s Drug in Smaller Vial Sizes Could Save Medicare Hundreds of Millions

More than $100 million could be saved annually on discarded lecanemab (Leqembi), a simulation study suggested.

Current vial sizes may result in 5.8% of the Alzheimer’s disease drug being thrown away, representing $1,619 in wasted Medicare spending per patient per year, reported researchers led by John Mafi, MD, MPH, of the David Geffen School of Medicine at UCLA.

This translates to an estimated $133 million to $336 million worth of lecanemab discarded every year, assuming uptake rates of 1.1% to 2.9%, Mafi and co-authors said in a JAMA Internal Medicine research letter.

Lecanemab dosing is weight-based, and the drug currently is available only in single-use 500-mg and 200-mg vials.

Adding a 75-mg vial could achieve a waste reduction of 74% — from 5.8% to 1.5% — representing annual savings of $99 million to $251 million, the researchers reported. Alternatively, replacing 500-mg vials with 250-mg vials could drop waste from 5.8% to 3.2%, representing $61 million to $155 million in annual savings.

Policy approaches could produce these savings, Mafi and colleagues noted. “First, changing vial sizes could reduce wasteful spending by up to 74% with no impact on quality of care or risk of drug price increase exceeding inflation, given restrictions introduced by the Inflation Reduction Act,” they wrote.

“Second, the Infrastructure Investment and Jobs Act requires manufacturers to reimburse Medicare for waste exceeding 10%, but this penalty is ineffective if lecanemab waste is 5.8%, suggesting that Congress should enact a lower reimbursement threshold,” they added.

“Third, policymakers could develop protocols for sharing vials between multiple patients, similar to other countries.”

These savings are sensible but small compared with the up to $5 billion that Medicare is estimated to spend on lecanemab each year, observed Nathan Stall, MD, PhD, of the University of Toronto, and Kenneth Covinsky, MD, MPH, of the University of California San Francisco.

“These substantial costs have raised concerns about the widespread adoption of lecanemab, especially when weighed against the drug’s very modest clinical efficacy and substantial risk of harmful side effects,” Stall and Covinsky wrote in an accompanying editorial.

“These concerns have played out in mixed regulatory approval across countries,” they pointed out: while the FDA approved lecanemab in July 2023, the European Medicines Agency rejected it this year.

Money spent on anti-amyloid Alzheimer’s monoclonal antibodies might be better spent on support for people with dementia and their caregivers, or on targeting the 14 risk factors tied to dementia, the editorialists suggested.

“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,” they wrote.

Mafi and colleagues used data from 1,490 participants in the 2020 Health and Retirement Study who were 65 or older, had Medicare Part B coverage, and were potentially eligible for lecanemab (had Alzheimer’s disease with mild cognitive impairment or mild dementia).

The researchers determined each person’s weight-based dose, subtracted that amount from what would be dispensed to calculate how much would be discarded, and then multiplied that amount by the number of doses per year to estimate the annual wasted amount.

For example, a 65-kg patient would be prescribed a 650-mg dose — dispensed as one 500-mg vial and one 200-mg vial — meaning 50 mg per dose would be discarded.

To find alternatives with better cost savings, they performed 189 simulations replacing current vials with new sizes between 25 and 500 mg, and seven simulations adding a third vial between 25 and 175 mg.

The study sample may not have identical weights to actual lecanemab users, the researchers acknowledged. Expected uptake rates were not precise, and manufacturing and regulatory costs of changing vial sizes were not included in the analysis, they added.

In total, Medicare spent $33 billion on Part B infusion drugs in 2021, Mafi noted. “So, there is substantial opportunity for cost savings by reducing waste from all infusion drugs,” he said in a statement.