How step therapy for overactive bladder affects care quality

In this interview, A. Lenore Ackerman, MD, PhD, discusses the use of step therapy in overactive bladder (OAB), which she highlights in her paper, “Penny-wise but Pound-foolish: The hidden costs of step therapy for overactive bladder.”¹ Ackerman is a urologist at the University of California, Los Angeles Medical Center.

A. Lenore Ackerman, MD, PhD

How does step therapy for OAB impact urologists?

One of the ways it [affects] us is that there is a need for an allocation of additional staff to just manage these medication requests, to follow up with patients to make sure that they were able to get the medication, and if they weren't, to initiate the prior authorizations or appeal decisions. That can be quite a substantial amount of effort or staff time to just doing that, which, of course, for a lot of practitioners, is completely uncompensated labor. As much as we'd love to be able to donate our time, we have to keep our offices running. If you have to spend every month devoting nearly a full-time person's week to doing these medication requests, you're probably going to be motivated to not do it, just in reality. So, you're going to give people those anticholinergics.

The sad thing is that with something like OAB, we already have so many barriers to getting patients in to initiate care in the first place. They perceive that this is a normal part of aging, that there's nothing that they can do They're embarrassed to talk about it. They're embarrassed to tell you what's happened, or what's going on with their symptoms. They're embarrassed to tell you their constipation is terrible. There are all these preconceived ideas about OAB that keep patients from coming in and being honest with us and really telling us the whole story. So, now, we send them home with something that maybe made their incontinence a little bit better, but now they can't poop at all, and so they just don't come back. There are plenty of data to show that your best time to catch somebody is that first visit. If you do something to them that makes them worse and makes them miserable, most of them will just stop the medicine and never come back.

Even if you couldn't get them the next medication down the line, we have other therapies. But what ends up happening is that we underutilize those higher level or those third-line therapies, things like sacral neuromodulation and Botox injections. We end up underutilizing those because we never see them back. We never follow up with those patients, and they're just lost to us. Which again, if they don't get any treatment, then they're still spending money on their diapers, and they're not going out with their friends, and they're afraid to go on vacation with their husband and all these things that we talked about.

I think for us as urologists, we're missing out on an opportunity to actually do the things we can do. We're not treating them with all those tools that we have. We're wasting money in our practices fighting with insurance companies, rather than just being like, "let's do some Botox and get you better.” And then, on top of all of that, as a clinician, there's this frustration [of] there are so many insurance plans, and even just within the Medicare system. The drug plans are so different from state to state, from person to person. There are so many variations that it's really hard for us to know what is and what isn't covered.

There's 2 aspects of that. One is you kind of give up. I think there's some group of us that may just look at a patient and be like, "Well, I'm going to have to do oxybutynin anyway, so just do it," and you end up prescribing more than you would otherwise. And then there's also the aspect of it where as a provider, you are just demoralized by the whole process, because you can't know. And that undermines your relationship with the patient, because they don't really understand why we don't know what medicine should be covered. You walk in the office, and they're like, "Why don't you know what to give me?" And we have to say to them things—I mean, this adds like, 10 minutes on to my visit at the end—where I say, "Hey, I'm going to write you this prescription for this β₃ agonist. You're going to go to the pharmacy. If it costs more than this amount of money, you're going to call me back, and we're going to deal with it then." The feedback I often get from people is like, "Well, why don't you know how much it should cost?" And they're totally right. This is a crazy system where I can't tell you what's covered, and I can't tell you what it's costing, and the only way that I can really find that out is to either do a bunch of digging with your insurance formulary, or to just send in a prescription and see what happens. That's a crazy concept that my way of providing you with care is to just try something and see what happens. As a patient, you can understand that you would be demoralized by the idea that your practitioner was going to be [unsure]. So, I think there's that aspect to it, as well.

Not only do we lose patients and we lose this opportunity to actually take good care of them, but it actually undermines their trust in us as a profession when on the one, you could either give them an anticholinergic, they're going to have terrible [adverse events], and then they're going to not like you, or you try to go through this whole rigmarole of getting them the medication you'd prefer to get them, but then you have to give them this whole counseling about what's going to happen. Or you don't go through any of that, you try something, they go to the pharmacy, it's $200, and they just decide not to do it, but they don't want to come back because they don't want to disappoint you and say that they didn't take it. In all cases, everybody's losing.

What could be done in order to alleviate some of these burdens for patients and providers?

One of a couple of things needs to happen. There either needs to be accountability at the level of the insurance company as to if you're going to have a policy–and this goes for across the board, not just with urology or with OAB specifically–but there needs to be a policy of explaining why we're subject to these step requirements. If there's a good reason that somebody really can't take one of these preferred medications, there needs to be a streamlining of the process so we can actually get people the drugs that we need to get them. Either reform with better transparency at the level of insurance coverage, or a mechanism whereby if we can demonstrate the 2 medicines are not equivalent, there are regulations that say that an insurance company cannot force you to try a medicine that's associated with a risk that an equivalent medicine does not have.

That's the hard part is that there's a limited amount of what we as clinicians can do in the office-based setting to overcome these things. There has to either be reform about what kind of restrictions are reasonable at the federal level, or there needs to be greater transparency in the process so that we can have a clearer way of explaining to patients, "this is what your insurance company requires, and as long as we meet these criteria, we can get you on to the therapy that we think would be better for you." Maybe that isn't the case for everybody. Not everybody needs to necessarily be on a β₃ agonist. But in those cases where you've got an 80-year-old who's already got some cognitive decline, I should not have to make them try oxybutynin before I can get them something that's going to be a lot safer for them.

I think there just needs to be accountability at the insurance company level to say you need to have a reason why you're making me put this patient at risk. And if you're going to keep these restrictions in place, there needs to be a very transparent process as to what we need to do and what they expect to get and in a prompt way. It has to happen in a relatively prompt way, so we don't lose patients to care, so they don't incur all these [adverse events] and other risks that are just unnecessary.

Is there anything else that you’d like to add?

Just to finish up, I think that we already have so many obstacles to providing care that we need to be able to control the way we practice. I don't know how to say that in any better way. There's already so many things from the outside that are impinging on our ability to provide good care for patients with voiding dysfunction. Obviously, across the board, and all aspects of medicine, these things can rise up, but I think when you're talking about voiding dysfunction, it's a very sensitive issue for many people, and there's this huge bulk of data that shows that that's our chance. If they finally are willing to come into that office for the first time and talk to you about what to do, that's your best chance to make a big difference for them, and often we lose them. It just doesn't make a lot of sense to me to lose them over misunderstandings about insurance coverage issues. This shouldn't be the reason why people don't get treatment.

So, whatever we can do to make a difference is going to be great. A lot of that means that as physicians, we have to support things like legislation that challenge these step therapy requirements and come together to support reforms in the realm of formularies and insurance requirements to make sure we can do what we can for our patients to make them better.

Reference

1. Ackerman AL. Penny-wise but Pound-foolish: The hidden costs of step therapy for overactive bladder. J Urol. [published online ahead of print March 23, 2023.] Accessed April 13, 2023. doi:10.1097/JU.0000000000003430.