Discarded Lecanemab Leads to Medicare Drug Waste of Up to $336 Million

That lecanemab (Leqembi; Eisai/Biogen) is administered solely through weight-based dosing (10 mg/kg) and only offered in single-use vials of 200 mg and 500 mg may be to blame for the predicted $133 million to $336 million in wasted, and wasteful, spending among adult patients with Medicare coverage who receive the drug through Medicare Part B, because of substantial unusable leftover drug.

An analysis published online today in JAMA Internal Medicine¹ estimated this economic in-the-red spend from biweekly dosing of the amyloid beta-directed antibody by using data on patients 65 years and older (N = 1490) who were participants in the 2020 Health and Retirement Study and potentially eligible for lecanemab through a diagnosis of mild cognitive impairment or mild dementia. All had Medicare Part B drug coverage, both fee-for-service and Medicare Advantage. The investigators determined 3 action items for each participant:

• Required dose
• Cost-efficient total vials to provide the required dose
• Wasted drug amount, which was determined by subtracting their required dose from the total dispensed

The FDA granted accelerated approval to lecanemab in January 2023,² which it converted to full traditional approval in July that same year, based on data from the phase 3 Clarity AD trial (NCT03887455).^3,4

From this analysis, the authors predicted Medicare to spend between $133 million and $336 million on lecanemab for Alzheimer disease that had to be discarded following administration of the medication from its single-use vials. | Image Credit: © stock.adobe.com

For this analysis, there were 13 categories of body weight ranges, from 40 kg or less to more than 150 kg to 160 kg or less. Most patients fell into the ranges of less than 60 kg to 70 kg or less (20.9%), less than 70 kg to 80 kg or less (20.4%), and less than 80 kg to 90 kg or less (18.2%).¹ Mean weight ranges for the entire study cohort ranged from 34.0 kg and 47.9 kg for the 2 lowest ranges (40 or less kg and less than 40 kg to 59 kg or less, respectively), to 94.7 kg and 104.7 kg at midrange (less than 90 kg to 100 kg or less and less than 100 kg to 110 kg or less, respectively), to 143.8 kg and 158.9 kg on the high end (less than 140 kg to 150 kg or less and less than 150 kg to 160 kg or less, respectively).

Looking at the mean required dose compared with the minimum dispensed dose, the least amount of lecanemab was wasted among the patients who fell into the highest weight range (11 mg wasted per dose), and the most amount of lecanemab was wasted among the patients in the next lowest range (62 mg per dose). These amounts correspond to 286 mg and 1557 mg wasted each year over 26 doses, or 0.7% and 15.0% that needed to be discarded because it was leftover, and $375 and $2044 in wasted expenditures per person per year.

Minimum dispensed does ranged from 400 mg to 100 mg to 1600 mg for the lowest to the highest weight ranges. The top amount of 500-mg vials was 3, while the most 200-mg vials used came in at 4.

To best estimate cost savings at different vial sizes, the authors performed 189 simulations of replacing the current vial sizes with 2 vials that ranged in dose from 25 mg up to 500 mg, at 25-mg increments, and then 7 additional simulations where a third vial of 25 mg to 75 mg was added; these simulations did not consider cases where 4 vials were needed per patient per dose. They found that using one 250-mg vial to replace one 500-mg vial had the potential to reduce lecanemab waste the most, at $61 million to $155 million, or 5.8% of total waste to 3.2%. Further, in cases where a third vial was required, using a 75-mg size could result in savings of $99 million to $251 million, or 5.8% of total waste to 1.5%.

To make some inroads, the authors of the present study say there is potential to reduce wasteful spending by up to 74% just by changing vial sizes, “with no impact on quality of care or risk of drug price increase exceeding inflation, given restrictions introduced by the Inflation Reduction Act.” The government could also institute a lower reimbursement threshold, with current legislation that only sees manufacturers having to reimburse Medicare for waste of more than 10% and develop protocols that allow vial sharing.

An editorial in response to the present research noted that while this analysis is useful, reducing lecanemab waste will only save little when considering the up to $5 billion Medicare is predicted to spend each year for these patients, which encompass direct drug reimbursements, specialist-follow-up visits, and apolipoprotein E serum testing.⁵

There is also the ongoing debate on lecanemab’s adoption, “especially when weighed against the drug’s very modest clinical efficacy and substantial risk of harmful side effects,” they wrote.^5-7 For example, although lecanemab was approved by the FDA, it was rejected by the European Medicines Agency in July.⁸ The money currently being spent on lecanemab could be put to better use elsewhere, the editorial authors noted, such as for prevention efforts, including those that target hearing aids, with hearing loss a primary modifiable risk factor for dementia; delirium; and promoting a healthy lifestyle, which helps to both decrease the risk of dementia and other geriatric syndromes.

References

1. Zhou FF, Tseng CH, Leng M, et al. Reducing wasteful spending on discarded lecanemab in the US Medicare program. JAMA Intern Med. Published online October 14, 2024. doi:10.1001/jamainternmed.2024.5292

2. Joszt L. FDA approves lecanemab to treat early Alzheimer disease. AJMC^®. January 6, 2023. Accessed October 14, 2024. https://www.ajmc.com/view/fda-approves-lecanemab-to-treat-early-alzheimer-disease

3. Joszt L. FDA grants full approval for Alzheimer drug lecanemab. AJMC. July 6, 2023. Accessed October 14, 2024. https://www.ajmc.com/view/fda-grants-full-approval-for-alzheimer-drug-lecanemab

4. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer’s disease. N Engl J Med. 2023;388(1):9-21. doi:10.1056/NEJMoa2212948

5. Stall NM, Covinsky KE. Reducing lecanemab waste is penny wise, but Medicare coverage may be pound foolish. JAMA Intern Med. Published online October 14, 2024. doi:10.1001/jamainternmed.2024.5299

6. Widera EW, Brangman SA, Chin NA. Ushering in a new era of Alzheimer disease therapy. JAMA. 2023; 330(6):503-504. doi:10.1001/jama.2023.11701

7. Molchan S, Fugh-Berman A. Are new Alzheimer drugs better than older drugs? JAMA Intern Med. 2023;183(9):902-903. doi:10.1001/jamainternmed. 2023.3061

8. Mahase E. Lecanemab: European Drug Agency rejects Alzheimer’s drug amid debate over efficacy and safety. BMJ. 2024;386:q1692. doi:10/1136/bmj.q1692