Peter L. Salgo, MD: How expensive is this disease, and how expensive is a recurrence? How much money do you save? Because this drug is new, I’m sure, it’s not cheap. How much money do you save by using a drug which cuts your recurrence in about half, you said?
Yoav Golan, MD, MS: That’s a very good question, and the answer is, it depends on what you take into consideration when you talk about money. If you only take the cost of the drug into consideration, you don’t save any money.
Peter L. Salgo, MD: Yes, but I’m asking about the cost to society.
Yoav Golan, MD, MS: But, of course, if you take a societal perspective, that should be a perspective we should be taking into consideration here. First of all, you save half of the recurrences. So, then, the question is, how much is a recurrence?
We know some people get admitted and some people do not get admitted. We know that an average admission for a patient with Clostridium difficile may be up to $20,000 or $30,000; In some studies, up to $10,000, but we save all of that. One should also take into account the fact that when you prevent a person from becoming Clostridium difficile-positive, again, you also prevent secondary cases from this person. And this raises the question of how many secondary cases do you prevent?
Peter L. Salgo, MD: The so-called asymptomatic carriers, or spreaders.
Yoav Golan, MD, MS: This is the reservoir. Exactly. And you prevent that. You also have to take into account the fact that many people who get Clostridium difficile are actually productive people. They work, they lose work, they pay into quality of life as well. So, the cost of Clostridium difficile is enormous, and the cost of recurrence has been estimated to be enormous. And half of the recurrences number is a big savings.
Daniel E. Freedberg, MD, MS: I think Peter’s point is a good one. One reason why the drug probably hasn’t seen more widespread adoption is that it does carry a high-sticker price. And insurance companies balk at that high-sticker price.
Peter L. Salgo, MD: I’ve had this conversation with insurance companies—I bet we all have. But I get to do it on television over and over and over again. They’re on the hook for the global healthcare cost of America, not just the cost of Clostridium difficile. And shouldn’t they be aware of the dynamic here? Shouldn’t they be aware of the global cost of recurrence of Clostridium difficile? Shouldn’t that factor in to whether or not they’re going to approve this new drug?
Yoav Golan, MD, MS: I think, at least in the Northeast because I come from Boston, that payers take a reasonable approach. They may not approve fidaxomicin for everyone, but for patients who are at particularly high risk of recurrence or patients who were already started on fidaxomicin, they don’t really put obstacles because they see the value in that as well. The problem that we have is actually with hospitals that have a “silo” mentality and look at the cost of acquisition. But I think that payers are reasonable and they do understand.
I think that the obstacle is actually in the minds of many physicians who do not really consider fidaxomicin for many patients who would be very good candidates. Even in our hospital, where there is a very clear paradigm that identifies patients who will be at high benefit for fidaxomicin, we still see that we lose opportunities to benefit patients. I think that physicians should understand that this is one of the treatment possibilities.
Peter L. Salgo, MD: I saw this over and over and over again. What strikes me about this is it was the same kind of story in the early days of statins, which were quite expensive. We were saving ICU admissions, bypass surgeries, a lot of expensive medical care, and over time, it became an acceptable expense. Now, of course, it’s generic. But it does take time to penetrate the reimbursement community. Is that fair?
Yoav Golan, MD, MS: Yes. I think there is also an expectation that antibiotics will be cheap, as opposed to many other medications—so the cost-effectiveness is a bit skewed. But I think what’s important is that physicians understand that if they have a patient at a particularly high risk of recurrence, that patient will really benefit from a treatment—even if this treatment may be a little more costly.
Peter L. Salgo, MD: So, the appropriate patient for this right now would be somebody at high rate of recurrence? Or somebody that’s not responding? Or is it all-comers? Should everybody get this drug right now?
Erik Dubberke, MD: You probably can select out those people who are going to be at greater risk for recurrence. For people that are on antibiotics for other reasons that can’t be stopped, they’re going to be at higher risk for recurrence and that’s an easy-to-identify population. Age is also associated with the recurrence. You might be more inclined to give it to that 70-, 75- year-old. Maybe that 50-year-old will be at lower risk for recurrence. Immunocompromised patients are also at increased risk for recurrence.
There are subpopulations that you could selectively use fidaxomicin in to help balance that cost-benefit—for those that are going to be at more increased risk for recurrence or increased risk for complications if a recurrence occurs. So, fidaxomicin would be a good choice.
Yoav Golan, MD, MS: As well as people who already had an episode of Clostridium difficile—that’s important to remember. And when we studied fidaxomicin, we didn’t study it in patients who had multiple recurrences. We did study that in patients who had 1 recurrence. They were having their first recurrence, and it seemed to work just as well as it worked. So, this is a very high-risk population for additional recurrences.
Peter L. Salgo, MD: That’s nice. When you say there’s an expectation that antibiotics are going to be cheap, I’m still struck by the cost of vancomycin. I had no idea, out in the real world, it was expensive.
Dale N. Gerding, MD: Actually, getting approvals for vancomycin treatment can be just as difficult as fidaxomicin.
Peter L. Salgo, MD: Because they’re going all the way back to metronidazole?
Dale N. Gerding, MD: Well, many times they are looking to have a patient treated with metronidazole first, before approving vancomycin. So, it is difficult. And if you don’t have access to the intravenous formulation, which is very inexpensive, then you have to go to capsules.
Peter L. Salgo, MD: So, it’s, “Go ahead and get your irreversible neuropathy, and then we’ll consider the more effective drugs anyway.”
Dale N. Gerding, MD: I think we need to do away with this concept of prescribing an inferior drug first.