Overcoming Barriers in Steroid-Refractory irAEs: A Pharmacist’s Guide

Secondary immunosuppressants are becoming increasingly important in the management of steroid-refractory immune-related adverse events, yet the logistical and clinical hurdles around these rare cases can leave even experienced oncology pharmacists on uncertain ground. In this interview, Emma Jones, PharmD, BCOP, shares real-world examples of access challenges, explains how pharmacists can anchor multidisciplinary care, and offers practical strategies for staying current as consensus guidelines and treatment approaches continue to evolve.

Q: Your session touches on logistical hurdles in initiating secondary immunosuppressants. Can you give a concrete example of a barrier that came up in a real clinical case and how your team navigated it?
Emma Jones, PharmD, BCOP: Unfortunately, because these cases are so rare, we don't have a great, streamlined process to operationalize this escalation of immunosuppression, so we oftentimes have logistical barriers that pharmacists are navigating, both inpatient and outpatient. I recently had a patient in clinic whose insurance denied vedolizumab (Entyvio; Takeda) for steroid-refractory colitis. You'll see this a lot because insurance companies prefer infliximab (Remicade; Janssen). It's much lower cost. They have biosimilars to use, so it makes sense. But in that case, I had to write a letter of medical necessity to get insurance to approve vedolizumab because my provider felt that it was the most appropriate option. That's just one example, but there are many.

Q: Coordinating subspecialty care is often cited as a challenge in managing complex irAEs. What does the pharmacist’s role look like in that coordination, and how do you make sure critical decisions don’t fall through the cracks between teams?
Jones: Something I have learned throughout my pharmacy career is we are often the liaison between many different services and parts of the process of patient care. I think that's the same in the management of steroid-refractory irAEs, where we are often the ones recognizing steroid refractoriness because of our attention to detail. We can assess the response to corticosteroids. We’re also the ones sifting through all of the evidence and educating our providers, recommending escalation of care with the appropriate immunosuppression. We often play a role in even creating monitoring plans for these additional agents, so we play a large role in this. We help with the logistics of medication access, and we’re well suited to recommend alternatives if our preferred agent is not appropriate. Overall, we take care of the entire process and hold the team together to take the best care of the patient.

Q: Are there irAEs outside the major four—the less common toxicities your session briefly addresses—that you think pharmacists are underprepared for when they present as steroid-refractory?
Jones: I think the reality of the situation is that these are extremely rare, and it is virtually impossible to be well versed in every single irAE, particularly the steroid-refractory cases, which are increasingly rare. So I think as long as pharmacists are aware of the general concepts of how we manage these patients, they can feel more prepared, but I think feeling a little bit comfortable in the unknown is okay in this space.

Q: With consensus guidelines continuing to evolve and clinical trials ongoing, how do you recommend pharmacists stay current in this space, and what’s the single most important practice change you’d want them to walk away with from this session?
Jones: First, of course, I have to put a plug in for our presentation at HOPA on Friday. But in all seriousness, I think CE programming is a great way to stay abreast of the data, like other strategies we use to keep up with all the ever-changing oncology data. That’s definitely a good way. Regular review of those consensus guidelines is important. They are changing. We’re hoping for ASCO to update their guidelines soon. It hasn’t been updated since 2021, but compare and contrast those and regularly look at them as they’re often updated. Subscribe to NCCN or SITC and subscribe to their emails or newsletters. Follow them on social media, and you can get those regular updates. If you’re really interested in irAEs, you could join consortium groups—ASPIRE is a good one—where you can lean into that expert community. There are a lot of ways to stay up to date and follow your normal practices of how you do so with other data.

My main takeaway for steroid-refractory cases of irAEs is that corticosteroids are a necessary evil at this time. They work well in the majority of cases, until they don’t. I think what we’ll see in the future of irAE management is using a lot of these selective immunosuppressive therapies earlier on in the course of irAEs, and maybe even preventing certain refractory cases going forward. I think that’s a general theme we’re trying to portray in our talk today.