Westin Testifies to Senate Finance Committee on Cancer Drug Shortage

Shortages of several anticancer drugs continue to negatively impact clinicians’ ability to deliver the best possible care to patients, according to testimony before the Senate Finance Committee given by Jason Westin, MD, on behalf of ASCO on December 5, 2023.¹

There are over 15 anticancer agents that are currently listed on the FDA’s drug shortage list. The list includes multiple drugs that are necessary for the treatment of patients with leukemia and lymphoma.¹

“It's not a situation where we don’t know how to treat your cancer, it's that we can’t get the drug because it's not being made,” Westin, the director of the Lymphoma Clinical Research Program and the section chief of the Aggressive Lymphoma research team at The University of Texas MD Anderson Cancer Center in Houston, stated in a news release. “We have drugs that are lifesaving and shortages that are life threatening.”¹

Westin is also chair of the ASCO Government Relations Committee, treasurer of the ASCO Association Board of Directors, and chair of the ASCO Association Finance Committee.

In his testimony, Westin noted that providers are facing difficult decisions in terms of determining how to prioritize patients and deliver cancer drugs in a timely manner and in the optimal doses. In some cases, providers are forced to use alternative agents, delay care, or are unable to provide the necessary therapies at all.²

Westin highlighted the ongoing shortage of fludarabine, which he notes is essential in providing CAR T-cell therapy to patients with aggressive blood cancers. In his example, he noted that patients often only get 1 opportunity to receive treatment with a CAR T-cell agent due to its high cost and declining fitness for treatment, thus the absence of fludarabine could mean the difference between life and death for some patients.²

Westin went on to note that drug shortages are forcing clinicians to make impossible choices and work outside of recommended practice guidelines. When clinicians are forced to use treatment options that are not the standard of care, they are forced to get prior authorization, adding to the stress of patients and their families, he said.²

To address the shortage, Westin suggested that the United States needs a more reliable supply of generic agents. Additionally, he noted that current drug payment policies often compound quality issues by creating adverse market incentives for manufacturers to prioritize cost-cutting over quality improvements or investments of more capital. Westin argued that the Centers for Medicare & Medicaid Services could use its authority to investigate innovative reimbursement structures for sterile generic injectable drugs.²

“For example, CMMI could develop and test demonstration on projects that set a reimbursement floor on critical drugs that have been in and out of shortage; investigate novel methods of tying increased reimbursement to guaranteed supply by the manufacturer; or link increased reimbursement to the expansion of quality management maturity pilots already underway, such as the FDA’s Center for Drug Evaluation and Research pilot program to promote quality manufacturing and minimize risks to reliable drug supply,” Westin noted.

In response to the ongoing shortage, ASCO is asking policymakers on the Committee to incentivize changes to the drug supply chain, including:¹

• Consider alternative payment methodologies that would provide immediate relief from artificially low rates and encourage a more reliable supply of drugs;
• promote advanced manufacturing technology and development of continuous manufacturing for critical drugs and active pharmaceutical ingredients;
• consider coupling enforcement mechanisms to existing requirements for manufacturers’ risk management plans;
• and incentivize purchasers to favor manufacturers with reliable supply.

“The shortage of critical cancer drugs is an urgent crisis,” Westin said in the release. “My patients, and their families, deserve to know that they will get the care they need without delay. Providers shouldn’t have to make impossible choices about patient care.”¹

References

1. ASCO member testifies to Congress about the cancer drug shortage crisis. News release. ASCO. December 5, 2023. Accessed December 5, 2023.
2. Testimony of Jason R. Westin, MD, MS, FACP. December 5, 2023. Accessed December 5, 2023. https://old-prod.asco.org/sites/new-www.asco.org/files/JasonWestinMD-ASCO-WrittenStatement-12.05.2023-Hearing.pdf