Experts explore the availability and cost as well as other unanswered questions regarding emerging agents for the treatment of RVVC.
Michael L. Krychman, MD: Fast forwarding a little bit, I can’t read the future but I am very optimistic that we’ll have 2 approved drugs for recurrent VVC [vulvovaginal candidiasis]. We’ll still have the old, tested, tried-and-true off-label fluconazole as well as what you’re saying: in some cases, we must go back to the old paradigm of treating each infection, especially as we have no alternatives in pregnancy. How do you see the emerging landscape in terms of the overall treatment paradigms? Do you think that clinicians will adapt these newer medications? I appreciate your medical economics and insurance background. We’ve all been there, holding those insurance handcuffs. We have all best intentions with prescribing and getting our patients the right drugs that are safe and effective. Cost and access certainly is an issue but let’s be in an imaginary fantasy world and say cost and access is not an issue and we can get the drugs at appropriate, affordable pricing for all of our patients. Do you feel like the guidelines are going to change? I know myself; there’s no ICD10 code for recurrent vulvovaginal candidiasis? We’re already having problems at the get-go. We have a drug approved for a non-condition.
Jack D. Sobel, MD: You’re asking the zillion dollar question today because it’s important to recognize that even though fluconazole is not approved by the FDA [Food and Drug Administration], it is the treatment of choice for recurrent VVC from ACOL, CDC [Centers for Disease Control], every professional society in the world recommends fluconazole given weekly. It’s most important to understand that when you want to prescribe fluconazole for 6 months once a week, you’re not curing recurrent candida vaginitis. They have a greater than 90%, which is a wonderful chance of remaining asymptomatic, having a normal life, a normal sex life, no symptoms, as long as they’re taking the medication. They stop the fluconazole the end of 6 months, you haven’t changed the genes, they still could become recolonized again, and they can still have the inflammatory response. Once you stop the fluconazole, an overwhelming majority of women will go back to the same. So it’s easy to say if I have recurrent candida vaginitis and the patient’s not responding to fluconazole, and they’re breaking through on fluconazole, or they can’t tolerate fluconazole, or are allergic to fluconazole, we clearly must think about these 2 new drugs, whether we will actually use them will depend on availability and cost. On the other hand, we don’t know what the comparative short- and long-term success rate is with ibrexafungerp versus fluconazole. They’ve never been compared in a long-term study for recurrent candida vaginitis. What’s most important is to see how well the patient does once you stop the medication. The advantage of oteseconazole in this context, given the limitation of the patients who can be given the oteseconazole is that, because the drug sits around for a long time, the freedom of recolonization extends for more than just 3 to 6 months. It may continue for up to 2 years after stopping the medication. It’s got to be a limited market availability. I still think that probably in your private practice or your clinical practice in the next 6 months to a year, as we learn about these 2 new drugs, you probably are still going to be predominantly using fluconazole.
Michael L. Krychman, MD: Right. Your point is very well taken, just because you have availability of medications doesn’t mean they’re going to be clinically implicated. Besides the fact of cost and access, I think one of the issues that has me thinking about medication choice is patient compliance and patient adherence. We both struggle with what is going to be best accepted. If all things are considered, the cost and the access, what is going to be best for the patient in the end of the day? There’s other considerations that go into making this hardcore decision: drug interactions. With every medication that you take, there are multiple drug interactions. There are some with ibrexafungerp, and there are some with oteseconazole and those may factor in. It’s also patient awareness and compliance. I would say the drug regimen is a little more intricate for oteseconazole versus ibrexafungerp. I think they went to monthly because that’s relatively simple and easy for women. There’s a lot of variables as you had mentioned, safety, efficacy, drug interactions, cost, and access, and compliance. These all factor into our clinical decision-making about prescribing drugs. I think very often we have our best intentions, but access may be a problem and cost may be a problem. But, if you take those out of the equation, remember that there’s a lot of other facets as well for doing that.
Transcript Edited for Clarity