National Cancer Drug Shortages: History and Current Status

Over the past decade, the United States has been facing ongoing issues regarding the supply and demand of generic prescription drugs. In general, generic drugs make up approximately 90% of prescriptions filled by American consumers. Given that these drugs are non-branded and have expired patients, they are manufactured at a lower cost.

Moreover, it is difficult for drugmakers to generate a profit, especially with consumers, payers, prescriber and pharmacies all encouraging manufacturers to produce these drugs with low profit margins to allow for affordability.

The pandemic brought many supply-chain related difficulties, including many factories being shut down. The current issues surrounding high inflation rates have also brought about unique challenges. Given the low ability of generics to generate significant revenue, they are often the first to be scaled back during resource strains. Additionally, manufacturers are less likely to invest in producing low-cost generics, which makes them particularly vulnerable to shortages when a plant is shut down. Experts have also raised concerns that the drug negotiation provisions set to take effect in several years after passage of the Inflation Reduction Act, as well as the power of pharmacy benefit managers, both already have and will further exacerbate this ongoing issue.

Currently, there is a severe shortage of two essential chemotherapy drugs: carboplatin and cisplatin. These medications are used for a variety of cancers but are heavily utilized within urologic oncology in the metastatic, adjuvant, and neoadjuvant settings for urothelial carcinoma and testicular malignancies. The etiology of the current platinum chemotherapy shortage is due to a “cascade” effect – carboplatin, manufactured in India at a plant owned by Intas, was the initial agent to be affected. A Food and Drug Administration (FDA) inspection found major quality control issues that forced Intas to cease all carboplatin production. In response to this shortage, patients who were originally on carboplatin regimens were switched to cisplatin. This outstripped demand depleted cisplatin supplies nationally. It is important to note that, despite four additional companies also producing both of these chemotherapy agents, all have been unable to keep up with national demand.

A recent reported published in early June by the NCCN demonstrated that 93% of cancer centers surveyed (n=27) reported a shortage of carboplatin and cisplatin. Furthermore, 67% of centers reported a strained supply of methotrexate, with 5-fluorouracil (26%), fludarabine (11%), paclitaxel (4%) and hydrocortisone (4%) also being in short supply.

The American Society of Clinical Oncology (ASCO) has published clinical guidance for clinicians who prescribe chemotherapy for breast cancer, bladder cancer, gastrointestinal cancer, gynecologic cancer, and small cell lung cancer as they navigate these drug shortages. Within the bladder cancer guidance they provide several recommendations. For patients who meet criteria for neoadjuvant chemotherapy (NAC), they note that despite a lack of evidence suggesting equal efficacy, radical cystectomy alone or definitive radiation with concurrent chemotherapy (as an alternative to NAC + radical cystectomy) are both options. For adjuvant treatment, nivolumab alone is recommended in both the lower and upper urinary tract guidance.

Written by: Ruchika Talwar, MD, Urologic Oncology Fellow, Department of Urology, Vanderbilt University Medical Center, Nashville, TN

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  4. “Urothelial Cancer Guidance.” ASCO. June 2023.