Michael L. Krychman, MD, and Jack D. Sobel, MD, discuss the practical challenges of access to newer, FDA-approved medications for RVVC and how the third-party reimbursement landscape may take shape in coming years.
Michael L. Krychman, MD: Are there certain pearls where you would use one over the other? Once ibrexafungerp came to fruition and was FDA [Food and Drug Administration] approved, I looked at the data, the 25-day efficacy. Oteseconazole wasn’t even on the horizon, and I said, “Well maybe this would be an opportunity for RVBC.” I started using it but then had challenges getting reimbursement and cost and what have you. So, there are a lot of factors that go into this. I know you had mentioned more than likely, most of us will stay with fluconazole. But, as these drugs become more known and we start answering some of these questions and they’re approved, I think it’s going to be hard-pressed. I can tell you, I’ve been there where I said, look I’ve had a medication that’s approved for a condition and the insurance company came back and said, “We don’t want to approve this drug because it’s more expensive; we want you to use something that’s not approved, off-label.” And I said, “So for clarification, you’re telling me to use a medication that is not FDA-approved for a condition when I have an FDA-approved product? And you don’t want to use it because it’s too expensive?” It was very interesting, about 10 minutes later, often the approval came for an FDA-approved drug. So, I hear what you’re saying. I think in all good intentions, once we have FDA-approved products that have done the vigorous studies with safety, efficacy, and patient reliability, I think that you’re going to see an up-ticking of these. I’m wondering what your thoughts are.
Jack D. Sobel, MD: I would just be repeating what you’ve now just said. It’s easy to consider using 2 new drugs and any additional drugs that come down and for the most part, the pipeline is pretty empty after these 2 new agents. But we don’t know the optimal dose of these drugs, the optimal duration of therapy, the optimal frequency. And unfortunately, we as practitioners are forced to make decisions where we don’t have the comparative data of either of these 2 new drugs compared to fluconazole. So, if you ask me whether ibrexafungerp, given once a month, is it better than placebo? Of course, statistically significant. It is better than weekly fluconazole? I don’t know.
Michael L. Krychman, MD: I think your point is well taken. I think we’re more likely to see ibrexafungerp versus fluconazole and oteseconazole versus fluconazole. I don’t think either company is going to want to do ibrexafungerp versus oteseconazole. But I think everyone will kind of try to getfluconazole. The landscape is certainly changing and it’s interesting.
Transcript Edited for Clarity