Cancer Drug Shortage: Causes, Trends, and Implications for Clinical Trials

Primary causes of the cancer drug shortage include manufacturing issues, supply chain disruptions, and regulatory delays, says Crystal S. Denlinger, MD, FACP, CEO of the National Comprehensive Cancer Network (NCCN).

Recently, the NCCN released a survey of best practices for drug shortage management.

Transcript

What are the primary causes of the current cancer drug shortage, and are there any specific trends or events that have exacerbated the situation?

This is a great question, and I think that the current cancer drug shortage is actually just an extension of a drug shortage that's been going on for a while across different generic medications. The causes are primarily related to supply chain issues, and a supply chain that has little redundancy or elastic capacity, with poor incentives in the market to make these drugs. So, we have few suppliers. When a supplier goes down, or when there's an issue with a particular supplier, there's not a lot of other opportunities for other suppliers to step in.

In addition, we have to acknowledge the fact that the markets for generic drugs and the markets for brand name drugs are completely different. In the brand name drug market, we normally have high list prices, and there is incentive to make those drugs. In the generic market, it's essentially a race to the bottom, which does ultimately potentially impact sustainability and quality. The incentives to produce generic drugs are really not as strong because there is market pressure for lower and lower cost. Ultimately, you hit a threshold below which you aren't going to be able to have a steady supply of these medications, and that's where some of these drug shortages come into play.

How are the current drug shortages impacting clinical trials, particularly in terms of enrollment, budgeting, and treatment protocols?

For most clinical trials, especially the larger randomized phase 3 trials, the trial will include some form of a current standard of care backbone plus a new drug. Many of the current standard of care backbone regimens involve these generic drugs like carboplatin or 5-fluorouracil. When these drugs are in shortage, that can affect clinical trials in a number of ways. In our survey of our member institutions, 43% of the responding institutions indicated that there was some impact on clinical trials because of drug shortages. One way that it was impacted was in the potential for reduction in enrollments to clinical trials that were already open and ongoing, to make sure that the patients who were going to enroll on the trial were able to get the therapy that was required by the protocol.

We've also seen reports that centers have reduced or delayed the opening of trials that they knew had a drug that was on shortage, so that they could ensure that there was in fact enough supply for the drug that was on the protocol.

Finally, we saw greater administrative burden in opening clinical trials because of the need for procurement challenges or ways to ensure that the drugs were available in order to proceed with protocol-directed therapy.