LAUSR

In this issue of Cancer, Truong et al highlight the potentially significant contribution of cancer drug wastage to the overall cost of cancer care delivery. This can be considered a hidden cost because most oncology practitioners are likely not aware of the amount of drug that may be unused when they are selecting a specific drug and dose for a given patient. With the current move toward value-based payment models in oncology and the rapidly growing contribution of cancer drugs to the overall expense of cancer care delivery, this is a problem that can no longer be ignored. The factors that lead to cancer drug wastage are multifactorial and well documented. The vial size availability, determined by pharmaceutical manufacturers, has been called into question. Many existing cancer drugs are available only in a single vial size, which often exceeds the dose of the average patient. If the drug remaining in the vial cannot be reused for another patient, then this can lead to significant waste. The major factor determining whether a practice will be able to reuse the remaining drug is the likelihood that another patient will need the same drug before the drug’s beyond-use date. The major factor that determines the beyond-use date is the ability to maintain sterility within the vial, which is an issue tightly regulated according to standards set forth by the US Pharmacopeial Convention. The US Pharmacopeia 797 standard limits the reuse of drugs remaining in single-dose vials to 6 hours only if the pharmacy preparing the cancer drug meets rigorous standards that promote extended sterility. Some manufacturers will make their products available in multidose vials that include a preservative and extend the beyond-use date up to 28 days. How significant is this problem of wasted cancer drugs? Truong et al compared cost-effective analyses and budget impact analyses provided by manufacturers and the economic guidance panel of the pan-Canadian Oncology Drug Review with an independent analysis incorporating wastage modeling. In their maximum-wastage scenario, there was a mean increase in the incremental cost-effectiveness ratio of 24%, there was a mean increase in the 3-year total incremental budget costs of 26%, and there was an increase in the 3-year total incremental budget cost of approximately CaD $102 million nationally across the 17 drug indications evaluated. These percentages varied considerably from one drug to another according to the likelihood of waste, which was determined by the drug vial size availability, average body surface area or weight, and indicated dose. Other groups have also evaluated the impact of drug waste on overall expenditures. In a United States–based model, Bach et al estimated that the proportion of leftover drug ranged from 1% to 33% for the top 20 drugs (based on 2016 projected sales), which were dosed by body size and were packaged in single-dose vials. This evaluation estimated the total US drug manufacturer revenue from these drugs to be US $18 billion, with 10% or US $1.8 billion from potentially discarded drugs. When formalized evaluations looking at the impact of cancer drug wastage are completed, the results are unanimous: the impact is significant. Knowing the significant impact that cancer drug wastage can have on health care spending, where do we go from here? One area of active interest related to this issue is the determination of who is absorbing these costs. If practices are able to bill for cancer drug waste, then it is likely that payers and patients are taking responsibility for these excess costs. If practices are not billing for waste, then health care providers are absorbing these excess costs. As of January 2017, providers billing for drug waste for Medicare beneficiaries are required to comply with specific documentation and billing requirements. This includes not only using specific billing codes but also documenting in the patient medical record the amount of the drug to be wasted. Because of the complexity of implementing this strategy, the potential exists for practices to implement an all-or-nothing strategy when they are deciding whether to bill for waste or not, and this could push practices