Abstract

Simple SummaryEnfortumab Vedotin (EV) is FDA-approved for advanced urothelial cancer in patients previously treated with chemotherapy and immunotherapy. In this report, we looked at the extent of EV wastage (i.e., discarding of leftover drug not administered to the patient) in a single institute and estimated the financial impact of EV wastage annually in the United States. We found that wastage occurred in 46% of administered doses, with an average waste per dose of 2.9% (range 0–18%). The average drug wastage cost per patient was $3127 ($252 per dose). The annual cost of EV wastage in the US is estimated to be $15 million.Enfortumab Vedotin (EV) is FDA-approved for advanced urothelial cancer in patients previously treated with platinum-based chemotherapy and a checkpoint inhibitor. We conducted a real-world study to determine the extent of EV wastage in a single institution and assessed the financial impact of EV wastage annually in the United States. Systematic examination of the usage and wastage of all standard-of-care EV treatments administered to urothelial cancer patients at Memorial Sloan Kettering Cancer Center (MSKCC) between 1 January 2020 and 31 December 2020 was performed. Drug wastage was calculated by subtracting the actual administered dose from the total dose in an optimal set of vials. We built a pharmacoeconomic model to assess the financial impact of EV wastage annually in the US using the January 2021 Average Sales Prices from the Centers for Medicare and Medicaid Services. Sixty-four patients were treated with standard-of-care EV, with a median of 11 doses per patient (range 1–28). Wastage occurred in 46% of administered doses (367/793), with a mean waste per dose of 2.9% (0–18%). The average drug wastage cost per patient was $3127 ($252/dose). The annual cost of EV wastage in the US is estimated to be $15 million based on wastage data from a single center in the US. In summary, EV wastage due to available vial sizes was 2.9%, which falls under acceptable thresholds. While the percentage of EV wastage is relatively low, waste-minimizing practices may reduce the financial toxicity for the individual patient and for society.

Highlights

  • The ongoing rise in cancer drug prices constitutes a financial burden for both patients and payers throughout the world

  • Drug wastage occurs when a parenteral drug is supplied in fixed-dose vials, and the dose required for an individual patient does not match an amount achievable through any combination of whole vials, resulting in one or more vials being opened but only partially used

  • We multiplied the number of Enfortumab Vedotin (EV)-treated patients by the average cost of wastage per dose and by the median number of doses per real-world Memorial Sloan Kettering Cancer Center (MSKCC) data

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Summary

Introduction

The ongoing rise in cancer drug prices constitutes a financial burden for both patients and payers throughout the world. Many strategies to lower drug costs have previously been described [1]. One approach to decrease drug-related costs without adversely affecting efficacy is minimizing drug wastage. Drug wastage occurs when a parenteral drug is supplied in fixed-dose vials, and the dose required for an individual patient does not match an amount achievable through any combination of whole vials, resulting in one or more vials being opened but only partially used. Prior studies have estimated wastage to be in the range of 1% to 33% for cancer drugs, with an annual total US revenue of $1.8 billion from discarded drugs [2,3]. Saltz, and colleagues recommend regulations requiring manufacturers to offer a reasonable selection of vial sizes with an acceptable threshold for vial waste of 3% [2]

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