Oral anticancer medicines are the fastest-growing type of cancer drugs, offering patients convenience and ease of administration. They are also among the most expensive outpatient prescription drugs, especially in the United States, with ever-rising costs. These drugs are often dispensed to patients as a 1-month supply of an established dose and package size determined by the drug manufacturer. If dose modifications or discontinuations are required to manage adverse events, the remaining initial drug supply may have to be discarded, leading to considerable costs for unused, wasted pills. Drugs may also be discarded in the event of disease progression or patient nonadherence, which may be driven by financial reasons. Dr Michael Lam and colleagues conducted a retrospective evaluation to estimate the wastage cost of 22 oral anticancer drugs in the US approved between January 2020 and August 2022 and of those on the top 50 best-selling pharmaceuticals list in 2021. Due to the high cost per pill and limited availability of multiple pill strengths, the cost of oral anticancer medicine wastage associated with dose reduction or discontinuation was median $1,750 (mean $4,290) per patient. Only 8 of the medications had available pill strengths that could be reused at each reduced-dose level, and subsequently had zero cost of dose reduction.
The high cost of wastage was attributed to a high percentage of patients requiring dose reductions, with 5 medicines whose dose-reduction levels necessitated new pill strengths, and only 36% of the drugs having pills that could be used for dose reduction. The authors stated that their calculations were conservative and that actual costs may be even higher. In a linked editorial, Dr Cathy Bradley and colleagues added to this by stating that controlled clinical trial data may not accurately reflect the true wastage, and suggested that additional studies be conducted using data from medical records or claims data to gather real-world results.
Dr Bradley also proposed some recommendations for reducing anticancer drug wastage. One is for regulatory bodies to require drug developers to study and manufacture oral agents in dose levels that can be safely adjusted without requiring new pill strengths. However, they caution that this could lead drug developers to further increase prices in response, potentially inflicting even greater financial burden on patients and the healthcare system and limiting financial savings benefits. Another suggestion is a step-up distribution model that starts the first prescription with fewer pills (eg, 7- or 14-day supply) to allow time for tolerability assessment, but this would also require cost-sharing for multiple prescriptions to be limited until the tolerated dose is reached. To develop an effective solution, drug developers, clinicians, insurers, and policy makers and regulators will need to collaborate and agree upon options that maximize patient well-being while minimizing waste and financial burden.
Dr Lam suggests that manufacturers can help reduce oral anticancer medicine wastage by developing dose strengths that can be reused at each dosing level or by creating packaging that allows for a different number of doses in case of discontinuation. Payors, such as pharmacy benefit managers, may consider plan designs that allow for a split-fill program that provides a 15-day supply with prorated copays for the first 3 months of treatment, when risk of drug wastage is highest. The authors of both articles concluded that to reduce the financial burden for patients with cancer, regulatory bodies will need to enforce availability of pill strengths that will limit wastage and/or recommend that drug manufacturers issue credit or rebates for unused pills. Future research should seek to determine the effect of pricing strategies and drug switching on wastage.
Clinicians can help mitigate the cost of oral anticancer medicine wastage by ensuring that adverse effects are optimally managed and by making necessary dose reductions prior to the dispensing of medication. For some medicines, clinicians may also consider recommending treatment holidays, if appropriate, rather than proceeding with a reduced dose. Integration of pharmacy dispensing within the clinic may also help, as it allows clinicians to dispense a shorter pill supply early in the patient’s treatment when they may already be monitored more closely and have more physician visits.
link to https://jamanetwork.com/journals/jamaoncology/article-abstract/2807473
link to https://jamanetwork.com/journals/jamaoncology/article-abstract/2807474