Cancer Drug Shortages Impact Clinical Trials
Most cancer centers reported a shortage of at least 1 systemic therapy in a survey published by the NCCN.
Cancer Drug Shortages Impact Clinical Trials
Eighty-nine percent of cancer centers reported shortages of at least 1 systemic therapy, according to updated survey results published by the NCCN, with polled data collected from May 28, 2024, to June 11, 2024, although shortages of carboplatin and cisplatin decreased from last year.1,2
In June 2023, 70% of NCCN member institutions surveyed (n = 27) from May 23, 2023, to May 31, 2023, noted a lack of an adequate supply for cisplatin, and the latest survey noted 7% of centers reported a shortage of cisplatin and 11% reported a shortage of carboplatin. Shortages of cancer agents impacted clinical trials at 43% of the 28 centers surveyed in 2024; among the 12 centers who reported this impact, trials were said to have been affected by greater administration burden (83%), reduction in enrollments (58%), reduction in open trials (17%), and other reasons (25%), such as budget changes. Further, 27% of cancer centers (n = 15) reported that treatment delays occurred due to shortage-related changes that required additional prior authorization.2
“Critical drug shortages were not a new problem last year and they continue to be a problem now,” Crystal S. Denlinger, MD, FACP, chief executive officer of the NCCN, stated in a press release.1 “The dual carboplatin and cisplatin shortage was particularly severe, and we were able to help sound the alarm during its peak. Despite a renewed attention to drug shortages over the past year, 89% of the responding centers in the latest survey are still reporting shortages of various important anti-cancer agents and supportive care medications. Most of them are still managing shortages for more than one type of medication right now. These shortages not only put a burden on patients, caregivers, and providers, but they could also delay vital clinical trials and slow the pace of progress for new cancer therapies.”
Responding cancer centers in the survey reported that they had 1 (14%), 2 (29%), 3 (18%), 4 (11%), 5 (11%), 7 (3%), or 9 (3%) drugs currently in short supply. These drugs included vinblastine (57%), other (46%), etoposide (46%), topotecan (43%) dacarbazine (18%), 5-Fluorouracil (14%), methotrexate (14%), carboplatin (11%), cisplatin (7%), leucovorin (7%), amifostine (4%), hydrocortisone (4%), and streptozocin (4%). Additionally, 11% of centers reported they were not experiencing a drug in short supply at their center. Drugs specified as in short supply in the “other” category included BCG Live (TICE BCG), dexrazoxane, docetaxel, doxorubicin HCI liposome, dronabinol, fludarabine, hydromorphone for injection, irinotecan, iron sucrose, liposomal doxorubicin, lorazepam in intravenous and injection formulations, mesna, mitomycin, mitoxantrone, octreotide, and vincristine.2
Further, 86% of 14 cancer centers reported that when treatment plans are modified or interrupted due to a drug shortage, re-prior authorization is needed prior to and during existing treatment; 7% of centers noted re-prior authorization is only needed during existing treatment and 7% noted it is not required. Most centers (60%) of the 15 responders said that re-obtaining prior authorizations because of modified treatment plans due to drug shortages has not resulted in treatment delays; 27% said that it did and 13% answered not applicable.
When all surveyed cancer centers were asked what policy solutions they would like enacted to address the shortages of oncologic agents, economic incentives to encourage high quality manufacturing of generics—tax incentives for manufacturers—(75%), a broad buffer stock payment like the one previously proposed by the Centers for Medicare and Medicaid Services (CMS; 64%), and better information systems to accredit/rate generics suppliers so hospitals can contract with those using high quality practice (64%), were the most frequently cited potential improvements.
Cancer centers also noted the following policy solutions to address the drug shortages: incentives for hospitals to use high quality suppliers (39%), restrictions on Group Purchasing Organizations from reducing generic pricing below a certain floor (39%), a narrow buffer stock payment impacting only certain small hospitals like the one currently proposed by CMS (4%), other (4%), and not sure (7%).
“The current situation [of drug shortages] underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, Senior Director of Policy & Advocacy at the NCCN, said in the press release.1 “The federal government has a key role to play in addressing this issue. Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain—ultimately safeguarding care for people with cancer across the country.”
References
- New survey from NCCN finds cancer drug shortage management remains a moving target, impacting clinical trials. News release. NCCN. June 26, 2024. Accessed June 26, 2024. https://www.nccn.org/home/news/newsdetails?NewsId=4620
- NCCN best practices committee new information and survey results from June 2024. NCCN. Published June 26, 2024. Accessed June 26, 2024. https://www.nccn.org/docs/default-source/oncology-policy-program/nccnbestpracticesdrugshortagesurvey.pdf?sfvrsn=b081351e_6
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