The average cost of wastage associated with dose reductions or discontinuations of oral cancer drugs was found to be considerable, according to an economic evaluation of 22 medications.
Looking at the best-selling oral anticancer drugs in 2021 and FDA-approved oral anticancer drugs prescribed between January 2020 and August 2022, the median cost of wastage from dose reduction and discontinuation was $1,750 (range $43-$27,200), with a mean cost of $4,290 per patient, reported Vinay Prasad MD, MPH, of the University of California San Francisco, and colleagues.
Several factors accounted for the high cost of wastage, including high costs of the medications, limited options for the number of doses per package, and limited pill strength availability, they noted in JAMA Oncology.
“These results suggest that to reduce the financial burden for patients with cancer, regulatory bodies should enforce availability of pill strengths that will limit pill wastage during dose modification or recommend that drug manufacturers issue credit for unused pills,” Prasad and colleagues wrote.
The median percentage of wastage from the total cost of treatment was 1.04% (range 0.04%-10.80%), with a mean of 1.78%.
“Although 1.78% of wastage may seem low, the cost of wastage should not be ignored given the high cost of cancer treatment,” they pointed out.
The drug with the highest wastage cost per patient ($27,200) was avapritinib (Ayvakit) for the treatment of advanced systemic mastocytosis. The reason, according to the authors, was its combination of a high cost per bottle, multiple dose reduction levels at different pill strengths, and a high rate of dose reduction.
Other drugs with particularly high wastage costs per patient included infigratinib (Truseltiq), pemigatinib (Pemazyre), olaparib (Lynparza), and tivozanib (Fotivda).
Relugolix (Orgovyx) for advanced prostate cancer had the lowest cost of wastage at $43, due to the fact that dose reduction was not allowed for relugolix, and the cost of wastage came from the 3.5% of patients who received a dose discontinuation.
Asciminib (Scemblix) — used for the treatment of chronic myeloid leukemia — had the lowest percentage of wastage at 0.04%, while infigratinib, used for the treatment of cholangiocarcinoma, had the highest percentage of wastage at 10.08%.
In an editorial accompanying the study, Cathy J. Bradley, PhD, MPA, of the University of Colorado Comprehensive Cancer Center in Aurora, and colleagues wrote that addressing inefficiencies in drug development and distribution could help reduce the number of discarded drugs.
For example, they suggested that the FDA could require developers of oral agents to study and manufacture drugs in dose levels that could be safely adjusted without requiring new pill strengths, and that manufacturers could be incentivized to provide rebates or to reimburse for discarded drugs.
However, Bradley and colleagues acknowledged that implementing policies advocating for rebates or refunds could be challenging, since clinicians prescribe, but do not administer, the drugs. Thus, they would have to rely on patients to accurately self-report the number of discarded pills. Furthermore, they noted that drug manufacturers could simply further increase prices in response to requiring rebates or reimbursement for discarded drugs.
In the end, they said, the fundamental issue is the high cost of prescription drugs.
“High prices are especially problematic for oral anticancer medications because prices of these agents have grown at a faster pace than their infused counterparts,” they wrote. “Ideally, drug developers, clinicians, insurers, alongside policymakers and regulators would collaborate on the important problem of oncology drug pricing to develop agreed on solutions that maximize patient well-being and minimize waste and financial burden.”
For this study, Prasad and colleagues included 26 unique oral chemotherapy medications that were extracted from the 2020-2022 FDA Novel Drug Approvals and the 2021 top 50 best-selling pharmaceuticals lists. Four drugs were excluded because of variability of starting dose, market withdrawal, and an indication for pediatric use only, leaving 22 for the evaluation.
For each drug, the authors extracted data relating to price, strength availability, number of pills per bottle, indication, tumor type, and registration trial information.
Dose reduction levels and the percentage of patients with dose reductions and discontinuations were obtained from the latest version of the FDA package insert or from published clinical studies.
As for calculating the number of pills wasted, the authors made a number of assumptions “based on the most likely scenarios presented in the literature.”
For example, they assumed each patient who experienced adverse reactions leading to treatment discontinuation wasted half of the bottle prescribed. Thus, the cost of discontinuation was the number of patients with dose discontinuation multiplied by the cost of half a bottle.
“These assumptions may have resulted in estimates that were higher or lower than in reality,” they wrote. “[H]owever, we selected a midpoint estimate to account for this.” In fact, they suggested that their calculations were on the conservative side, and that it is likely wastage costs are even higher.
This project was funded by Arnold Ventures through a grant to Prasad paid to the University of California San Francisco.
Prasad reported receiving grants from Arnold Ventures during the conduct of the study and receiving personal fees from Johns Hopkins University Press, Medscape, MedPage Today, UnitedHealthcare, and Optum Rx and subscriber fees from YouTube, Substack, and Patreon. Co-authors reported no conflicts of interest.
Bradley reported no conflicts of interest. Co-authors reported serving on Flatiron Health Equity Advisory Board and receiving grants from the National Cancer Institute.
Source Reference: Lam M, et al “Cost of drug wastage from dose modification and discontinuation of oral anticancer drugs” JAMA Oncol 2023; DOI: 10.1001/jamaoncol.2023.2306.
Source Reference: Bradley CJ, et al “Discarded targeted oral anticancer medication — a hard pill to swallow?” JAMA Oncol 2023; DOI: 10.1001/jamaoncol.2023.2226.