Addressing Barriers in the Management of <i>C Difficile</i>

Peter Salgo, MD: I come back to the question that always astounds me. We have balkanized our medical reimbursement system to a point where we can’t talk to each other. We can’t say, “Look, across the board, globally, all of these new technologies, all of these new agents, are going to significantly reduce recurrences. They’re going to significantly reduce the need for readmission. In the long run, they seem to be cheaper than the older drugs, which looked to be cheaper per-dose.” Why can’t we all just get along? What’s going on here?

Darrell S. Pardi, MD: My experience is that medical directors of insurance companies are pretty reasonable. It takes an extra step to pick up the phone or write an appeal letter, but if you can make a medical rationale and include some financial information in there, I often am successful with an appeal.

Peter Salgo, MD: But why should you even have to do that? Why can’t somebody sit down at a large table? Why can’t all of the players say, “This looks like a good idea”?

Yoav Golan, MD: As an example, fidaxomicin [Dificid] is actually available to many more clinicians for many more situations than it is actually used for. I think it’s important to talk about this. Many payers do pay for fidaxomicin because they do understand that the economics work in their favor—not to mention the fact that it benefits patients. But maybe you have to do a prior authorization once or just know the criteria. Physicians know that it’s costly to acquire. And so, I think it all starts with physicians. It all starts with the physician’s obligation to the patient’s benefit. Physicians have to ask, “What’s the best strategy to benefit the patient?” And then, they need to ask, “Is it possible to do that?” They will discover that many of those strategies to prevent recurrence are actually possible and will benefit patients tremendously.

Peter Salgo, MD: Does that make sense? That’s nice, but it sounds like it’s putting the physician out there with armor, a helmet, a lance, and a steed. Why do doctors have to go through this? Why do you have to jump through all of these hoops?

Yoav Golan, MD: We used fidaxomicin in a cost-effective way. Our patients benefit a lot. Like everyone else, we are very vulnerable to economics, and we find that we can do that in a cost-effective way.

Peter Salgo, MD: But he’s out there writing letters. He’s out there sending in justifications to a third-tier bureaucrat, somewhere, to get what you say is the best treatment.

Yoav Golan, MD: But again, we don’t get a lot of pushback from payers. If you start someone on fidaxomicin and they do fine, they usually agree to continue that. If the physician doesn’t prescribe it, obviously the patient is not going to get it. And so, I think that’s the very important first step in doing that.

Peter Salgo, MD: Am I crazy to think that we could get all of the stakeholders here to agree on one thing, easily?

Dale N. Gerding, MD: I think you are. It’s statistics. It’s extremely difficult. You have various economic motivational factors to integrate. In some ways, that’s why the guideline is trying to move the process in the most favorable direction. But it takes time. It doesn’t just happen overnight. We’ve gone through 25 years of metronidazole use—thinking it was just as effective without really having the adequate kinds of data.

Darrell S. Pardi, MD: I think that’s critical. In my experience, more insurance companies are covering fidaxomicin without much pushback. So, the insurance companies are catching on to this new drug. But I also think we need to do a better job in educating the physician community. There are multiple studies, including one that we did, that show that physicians are using metronidazole for severe Clostridium difficile [C. diff], which is contrary to the guidelines. They brought up that metronidazole is the first drug to use for C. diff. Physicians have so much information to integrate. There is new information all of the time. How can they possibly keep up? I bet that if you polled most primary care physicians or hospitalists, not many of them have heard of fidaxomicin.

Peter Salgo, MD: Well, we’re talking to you. We’re looking at you, out there. These folks have told you about fidaxomicin. They have told you that metronidazole isn’t where you want to be. This is one big step toward physician education. But we’ve got to educate third-party payers. We’ve got to educate the government. We’ve got to educate pharmacy people so that they realize that their budget is a small piece of the pie. I do have some sympathy for the pharmacy directors, because they’ve got to make a budget. The CEO of the hospital says, “You’re over budget. We’ll get a new pharmacy director.”

Dale N. Gerding, MD: We did our first study of metronidazole versus vancomycin. This was 3 years after the discovery of C. diff. Vancomycin was already being used heavily for therapies. It was the only identified treatment agent. Our pharmacy was complaining that the cost of vancomycin was breaking their pharmacy budget. We did a study of metronidazole for comparison. It was driven almost exclusively by economic factors. It was a small study. It was too small to really say that they were equivalent. But it showed that there was at least no difference. That brought metronidazole, together with vancomycin, into the forefront. And this happens repeatedly. It’s hard to believe that the argument was that vancomycin was too expensive as compared to metronidazole. Today, the argument is that fidaxomicin is too expensive. But cost acquisition—wise, even vancomycin is still high, even though it’s orally generic. The generics have priced it very close to the original drug.

Peter Salgo, MD: I recall a time when the statins were first introduced. There were folks taking statins off of the formulary because they were expensive. But folks were saying, “Look, 5, 10 years down the line, you’re going to be paying for these people’s bypasses, their CABGs [coronary artery bypass grafts], their MIs [myocardial infarctions], and their transplants.”

When I made that case, someone came back to me and said, “But I’ve not to make my next quarter. I’m a CFO [chief financial officer]. I’m responsible for the budget now.” There was a kind of unspoken addendum to that, which was, “By the time that causes hits, I’ll be gone.”

Darrell S. Pardi, MD: Or they’ll have another insurance company that will bear that cost.

Peter Salgo, MD: Right. Doesn’t it sound like we’re repeating our history, over and over? We’re not learning anything?

Dale N. Gerding, MD: We do it all the time.

Peter Salgo, MD: Well, that’s no excuse.

Yoav Golan, MD: In C. diff, the risk of recurrence is so high. What would you do if it was your mom or your spouse? What are you going to use to treat them? If you have an antibiotic in your right pocket that will give them a 25%, 30% recurrence, and one that will cut it by half in your left pocket, what are you going to use? In C. diff, there’s so much to gain by preventing recurrence if you choose the right patient. That’s really the important message. Once you do that, in the right patients, the population economics will follow. As you’ve heard, it’s highly cost-effective in this patient population. You should use it up front, because that’s the way it was studied. As Darrell said, some people use it without data; for example, in very severe C. diff. The new guidelines do not recommend it in very severe C. diff. But when we studied fidaxomicin, we found that it’s best use is when you use it initially in the first or second episode. If you allow patients to get into multiple recurrences, you don’t even know whether fidaxomicin is going to help.

Transcript edited for clarity.