Study Limitations and Relevance

Opinion
Video

Overview of bias toward patients with C. Difficile, plus an overview of commercial insurances vs Medicare in treatment of C. Difficile.

Dr. Paul Feuerstadt: Within this study, there are a few limitations. One is that the antimicrobial courses were not defined. They weren’t defined in the clinical trials. It was up to the local investigator. I, as a clinician say, you know what, that means it’s mimicking the real world, the outcomes. The outcomes here were for 24 months. The outcomes within the actual study that we’re talking about was a lifetime. So do those 24-month outcomes actually apply over a lifetime. We don’t know, but we have to use the best available data. And I think that they did that here. Adverse events, this is a big thing. When we look at the entirety, we realize just how complicated it is. Michael, you did a really nice job before just hinting at some of the complexities of the cost of caring for these patients. And we haven’t included the adverse events that are associated with this. Now, adverse events are similar to placebo within the clinical trials, but they’re still patients calling, having to be seen in the office, potentially having to be seen in the emergency [department], etc. So this is another element here that unfortunately wasn’t accounted for within this, but certainly needs to be considered. And then finally, commercial plans versus Medicare. And I think that’s something you might be able to speak to a little bit with your experience.

Dr. Michael Kobernick: So this- so there’s a question that leads into that for you, which is the relation- the proportion of individuals that are, for instance, being treated for cancer that develop C. diff and recurrent C. difficile. And I know that’s a high proportion, and I bring it up because … in commercial, the trend driver really is oncology treatment. It’s the high-cost oncology medications and subsequent treatment. And so in commercial, you see this C. diff infection really occurs in those with comorbidities and those being treated for other conditions in large part. Because the older people, the average study [participant] was [age] 61, they’re on Medicare. And on …Medicare are all [ individuals with multiple comorbidities]. I think that the commercial [side], when I look at … how we approach it and employers approach it …, they only want the best for their members. And if … they spend a lot, they really want the highest quality care, the best outcomes for their employees. And they’re at the mercy of clinicians to help determine that. And they only expect us to validate the appropriateness of the treatment. And Medicare is similar, although a lot of our arrangements are more in the development of the Medicare Advantage space, where the providers, the physician organization, the hospital organizations are at risk for the whole payment. So it becomes their decision as clinicians and clinician-led organizations to give appropriate treatments. The argument … that we saw in the article and [about] the associated quality of life improvements is really an argument that none of us can argue with. We all agree with it. We all know the condition. And so I think that it’s just a matter of getting the word out there and getting more people to use this treatment appropriately.

Dr. Paul Feuerstadt: Now, I completely agree with you. This treatment is a game changer. It really opens the door for much wider network of providers to use this product and patients to receive this product. The previous bottlenecks that were experienced should largely be eradicated. And I think that this study provides further food for thought for providers to realize, you know what, this is a cost effective treatment in a big way. And for patients to realize also, even though there’s a price tag of $9,000 for the product, or at least that’s what was put in this model, this is a very cost-effective treatment to decrease the future sepsis, the future colectomy, the post-traumatic stress disorder. A lot of those things that we were talking about before. I think that what’s important here is to humanize the patients and realize that they’re not just lab tests, they’re not just treatments, but they’re individuals who also have a financial impact on their lives, their ability to go to work, their ability to earn a living, their ability to take care of their family, or do whatever they do in their personal time. I think all these things add together. And this study specifically really kind of is a snippet of, look, this is the finances associated with the management of C. diff with an antimicrobial as standard of care. This is the finances when you add RBL [live JSLM; Rebyota], and this is a very cost-effective treatment from the provider side, from the patient side, and I think also from the payer side.

Dr. Michael Kobernick: And so what occurs to me that one of my other areas of expertise and what I lead at our organization is our population health work. And I think … we’re alluding to the caregiver impact, the individual impact, and I think there’s a certain amount of historical bias that is attached to the condition. And it’s like all [older] people have diarrhea. … [It] sounds a little glib, but I think that there is a little bit of bias in this space and a lack of understanding in the general community that this is a serious condition. And the first episode is really our opportunity to impact these people. And I think that even getting the right first course of treatment … . And some physicians are … using older medications, and I’m sure you know way more about this than I do. And not using the newest medications for the first course, and not thinking about that the first course is really a predictor of future courses. And … getting upstream on disease is a big population health concept.

Dr. Paul Feuerstadt: [I agree] 100%. And … you’re right, there are a ton of providers [who] are … using metronidazole initially for treatment. And we know as far back as 15 plus years ago that it was inferior, inferior, to vancomycin. So now as the infection has evolved, we believe it has further become less effective. So using a treatment like that upfront causes more problems with the microbiota, more dysbiosis is the term that we use for it, or alteration of the microbiota. That first infection is our best opportunity to get rid of this. And being aggressive upfront has repeatedly been shown to shutting down the cycle of recurrence, having less of a burden on the patient, less a burden on the healthcare system, and of course, less burden financially. … This was an excellent dialogue. I really appreciate the back and forth and seeing kind of the payer side of things and the clinical side of things. And I think that this manuscript was very impactful for all of us to understand that this is a very cost-effective treatment in RBL. Hopefully, [it] will open doors for a lot of patients and providers to use it to shut down the cycle of recurrence of C. diff.

Dr. Michael Kobernick: And I agree with you. I was pleased when I went back and looked at our policy and everything that was reflected in the study was reflected in our policy. And it’s worth noting that it’s an open policy in the sense that anybody can prescribe it, not just a gastroenterologist. So I think all of the things that you were reflecting in the conversation today, I was pleased to note were in our policy.

Transcript is AI-generated and edited for clarity and readability.

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