Puneeth Indurlal, MD, MS, MBBS
The alternative use of the monoclonal antibody cetuximab during the shortage of cisplatin in the treatment of head and neck cancer resulted in a 16% total cost increase, leading to a 144-fold increase in costs at the administrative level, impacting payer costs and patient cost-sharing amounts. These results, which were presented at the 2024 ASCO Quality Care Symposium,1 come from a study conducted by Puneeth Indurlal, MD, MS, MBBS, Vice President, Practice Operations at the American Oncology Network, and colleagues.
According to the U.S. Food and Drug Administration (FDA), in 2023, 138 drugs were in short supply, including 14 oncology drugs.2 The ongoing oncology drug shortage is increasingly affecting clinical decision-making, patient outcomes and their quality of life, as well as clinical trial enrollment and costs to both payers and patients, as detailed in this study.
(Editor’s Note: On June 28, 2024, the FDA announced that the supply of cisplatin now exceeds demand, bringing an end to a national shortage that has hindered cancer treatment since the drug was declared in short supply on February 10, 2023.3)
Study Methodology
The researchers focused on drug administration data from medical records and claims for 26 practices in the US Oncology Network prior to the shortage (July 2022 to January 2023), during the shortage (February 2023 to August 2023), and after the shortage (September 2023 to March 2024). They then assessed the effects of the cisplatin shortage on the treatment of head and neck cancer at those practices.
Key Results
The researchers found that during the shortage period, the use of cisplatin for head and neck cancer decreased by 15% compared with levels before the shortage. The lowest use occurred in June and July 2023, with a 60% decrease. The 26 practices initially obtained supplies through an allocation model and fair-share utilization guidance from the US Oncology Network’s Pharmacy & Therapeutics Committee. During the shortage period, alternative chemotherapy drugs for head and neck cancer saw increased use: carboplatin by 40%, paclitaxel by 24%, cetuximab by 15%, and fluorouracil by 5.3%.
The increased use of alternative drugs corresponded to the decrease in cisplatin use, with new starts shifting to carboplatin (with or without paclitaxel), cetuximab and fluorouracil. Ten percent of existing cisplatin recipients were shifted to an alternative drug during the shortage period. At this time, fluorouracil was also in short supply, although less acutely than cisplatin. After the drug shortage, cisplatin volumes rebounded by 8% of use before the shortage, whereas carboplatin use dropped below levels before the shortage. Cetuximab use remained consistently 12% higher.
In addition, when the researchers compared drug costs, they found that the average cost per administration was $2,607 for cetuximab, $22 for fluorouracil, $18 for cisplatin, $16 for paclitaxel, and $14 for carboplatin, based on the average sales price. The increased use of cetuximab instead of cisplatin resulted in a 16% total cost increase, leading to a 144-fold increase in costs at the administration level, which impacted payer costs and patient cost-sharing amounts.
Clinical Significance
Julie R. Gralow, MD, FACP, FASCO
“Cancer drug shortages in the United States most commonly occur with chemotherapy agents that are generic and inexpensive,” said Julie R. Gralow, MD, FACP, FASCO, ASCO’s Chief Medical Officer and Executive Vice President, in a statement. “This study shows that switches to alternative regimens in patients with head and neck cancer during the 2023 cisplatin/carboplatin drug shortage crisis involved the use of more expensive substitutes (specifically the monoclonal antibody cetuximab), resulting in significant increases in cost of care for payers and patients. Whether switches made during the recent drug shortages will ultimately be shown to result in equivalent or possibly poorer outcomes remains to be seen.”
A Call to Action
In a statement commenting on the study’s results, Dr. Indurlal, lead author of the study, said: “Drug shortages have become an all-too-common occurrence in oncology care, disrupting patient treatment, impacting where and how health-care providers spend their time, and causing broad-ranging effects on the health-care system. These results show the multifaceted consequences of drug shortages and serve to provide evidence in the call to action for all health-care and participating supply chain stakeholders to resolve the problem of drug shortages.”
DISCLOSURE: For full disclosures of the study authors, visit coi.asco.org.
REFERENCES
1. Indurlal P, Garey JS, Albaugh J, et al: Prescription predicament: Unveiling the financial fallout of drug shortages. 2024 ASCO Quality Care Symposium. Abstract 1. Presented September 27, 2024.
2. U.S. Food & Drug Administration: FDA Drug Shortages: Current and Resolved Drug Shortages and Discontinuations Reported to FDA. Available at https://dps.fda.gov/drugshortages. Accessed October 21, 2024.
3. U.S. Food & Drug Administration: FDA Roundup: June 28, 2024. Available at www.fda.gov/news-events/press-announcements/fda-roundup-june-28-2024. Accessed October 21, 2024.
