Change in Alzheimer's Drug Vial Size Could Be Big Money-Saver for Medicare
- A change in vial sizes for the Alzheimer's drug lecanemab could significantly reduce drug waste and save Medicare hundreds of millions of dollars annually, as the current vial sizes often lead to leftover medication due to weight-based dosing.
- The drug wastage is particularly concerning for Medicare, affecting its budget as some patients, especially those with lower body weights, end up discarding a larger percentage of their prescribed medication.
- Potential solutions to minimize wastage include standardized dosing, adjusting vial sizes, and improving distribution systems, targeting to lessen economic impacts while ensuring sufficient supply for patients needing the treatment.
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Introduction
A recent analysis published in JAMA Internal Medicine has highlighted a significant issue with the distribution of the Alzheimer's medication lecanemab (Leqembi), leading to substantial waste and potential cost savings for Medicare. The drug, which was granted traditional approval by the FDA in July 2023, is administered through intravenous infusions to patients with early Alzheimer's disease. However, a tweak in the vial sizes of this medication could save Medicare hundreds of millions annually by reducing the amount of discarded drug.
The Problem with Leqembi Vial Sizes
Lecanemab is administered using a weight-based dosing system, requiring 10 mg/kg for each infusion. The medication is available in two vial sizes: 200 mg and 500 mg. This dosing method often results in leftover medication, particularly for patients with lower body weights. An analysis found that about 6% of the medication is wasted due to the mismatch in vial sizes and patient weights.
The Impact on Medicare Spending
The issue of drug wastage is particularly concerning for Medicare, which covers a significant portion of the drug's cost. The Centers for Medicare & Medicaid Services (CMS) has been actively monitoring the situation. According to the analysis, patients with lower body weights are more likely to have large amounts of leftover medication, leading to substantial wastage. For example, patients in the lower weight range (less than 60 kg) have the most amount of lecanemab wasted, with approximately 15% needing to be discarded.
Economic Impact
The economic impact of this wastage is significant. The analysis estimates that the total wasted expenditure on lecanemab could range from $133 million to $336 million annually, affecting patients with Medicare coverage who receive the drug through Medicare Part B. This figure is substantial, considering the ongoing efforts to manage healthcare costs within the Medicare program.
The Need for a Solution
To mitigate this issue, manufacturers and healthcare providers must consider a more streamlined approach to drug distribution. Here are some potential solutions:
- Standardized Dosing: Implementing a more standardized dosing system could reduce the variability in medication usage, minimizing waste.
- Adjusting Vial Sizes: Using smaller vial sizes or more flexible dosing options could help reduce the amount of leftover medication.
- Improved Distribution Systems: Streamlining the distribution process to ensure that the correct amount of medication is dispensed for each patient could also help reduce waste.
Broader Coverage and Current Status
Despite the challenges associated with drug wastage, lecanemab has received significant attention and approval for its therapeutic benefits. The FDA granted traditional approval to lecanemab based on data from the phase 3 Clarity AD trial, and CMS has announced broader Medicare coverage for the drug. To receive Medicare coverage, individuals must be enrolled in Medicare and diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia with documented evidence of beta-amyloid plaque in the brain.
Patient Considerations
For patients considering lecanemab, it is crucial to understand the treatment plan and its potential side effects. The therapy is administered through IV infusions every two weeks, lasting about one hour each time. Some patients may have a genetic risk factor, such as the ApoE ε4 gene, which may increase their risk for side effects like amyloid-related imaging abnormalities (ARIA). Healthcare providers should discuss these risks and implications with patients before initiating treatment.
Financial Assistance and Copay Programs
To make lecanemab more accessible, financial assistance programs are available. The Leqembi Copay Assistance Program provides support to individuals seeking the medication, and CMS has announced that it will cover the drug as long as the patient’s physician enrolls them in a CMS-approved registry.
Conclusion
The issue of drug wastage associated with lecanemab highlights the complexities of pharmaceutical distribution and the need for efficient systems to minimize waste. By implementing standardized dosing, adjusting vial sizes, and improving distribution systems, healthcare providers and manufacturers can significantly reduce the economic burden on Medicare and ensure that more of the medication reaches patients who need it. As research and development in Alzheimer’s disease continue to progress, it is essential to address these logistical challenges to maximize the benefits of therapeutic advancements.
References
- Lecanemab Approved for Treatment of Early Alzheimer’s Disease. Alzheimer’s Association.
- Broader Medicare Coverage of Leqembi Available Following FDA Traditional Approval. Centers for Medicare & Medicaid Services.
- Discarded Lecanemab Leads to Medicare Drug Waste. American Journal of Managed Care.
