Dr Jessica Allegretti Addresses Rebyota Utilization, Access Considerations for Recurrent CDI

Rebyota is currently approved for the prevention of recurrent Clostridioides difficile infection (CDI), with access and coverage likely to be regionally dependent, said Jessica Allegretti, MD, MPH, medical director of the Crohn's and Colitis Center, Brigham and Women's Hospital.

Transcript

As Rebyota is a newly approved drug, can you speak on considerations for its use among patients with CDI? Are there any coverage or access-related issues that should be top of mind for providers and payers?

This product is approved for the prevention of recurrent C diff. And so traditionally, if we're looking at the guidance, the guidance for this product would be similar to what the guidelines tell us about FMT [fecal microbiota transplantation], because they're meant to be utilized in the same way. And so as of right now, that means patients with recurrent C diff, traditionally defined as 3 or more episodes, this is not indicated for primary C diff as of yet and really shouldn't be used in that arena.

There is also potential use in patients with fulminant C diff—again, those patients in the ICU [intensive care unit]—as there has been guidance around use of FMT in that scenario, as well. And again, this is meant to be used in the office. So the patient should have completed a course of antibiotics for that current episode of C diff; there should be an appropriate washout period, because you don't want antibiotics on board when you instill a microbiome-based therapy; and then you would instill this product, again, in the office—it's a rectal administration—and then watch the patients closely. We know the window of recurrence is 8 weeks, so if the patient is well 8 weeks after administration, you essentially can deem them cured.

I don't really have a good sense yet of how coverage will go. I think it'll be regionally dependent. Presumably, this will be on many payers’ formularies. I think the question will be, because it's a new agent, what will be the direct cost to patient? What will copays look like? And what will access be?

Because it's really a first-in-class, hopefully, the access is broad. I think we're all certainly hoping for that. But I think as we learned with several new agents that have come out in recent past, sometimes new agents, even though they're guideline approved and we know work really well, are still extremely expensive, and patients have had a hard time getting them—fidaxomicin is a good example of this. So, I certainly hope that doesn't happen with this therapy, and I hope pricing is such that it really can be accessed by all.