Dr. Ackerman on the use of step therapy for overactive bladder

In this video, 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.” Ackerman is a urologist at the University of California, Los Angeles Medical Center.

Video Transcript:

In general, the OAB guidelines from the American Urological Association go through a stepwise approach to the management of overactive bladder. Our first line tends to be things like behavioral management, fluid management, things like that. That can be done with or without a medication. Our second line is our medications. These often can be very effective for patients, but we find that they can be also extremely limited by adverse events that are associated with those medications.

In the class of potential medications, we've got 2 general classes. We have our anticholinergics, and we have our β₃-adrenergic agonists. As far as all the data shows in trials that have been done so far, they're relatively similar in terms of population-based efficacy. On an individual patient level, there may be some drugs that work better for some patients more so than others, and it's not consistent across the classes. But across the population, what you can also say is that those anticholinergic medications are associated with a lot more intolerable [adverse events] and interactions with other medications. We've known for decades about a lot of these [adverse events], particularly things like dry mouth, constipation, and dry eyes. But there's also some more concerning classes of adverse events that are only now becoming more clear, and the data isn't really 100% in on this, but there's this decent concern, particularly with the oldest, the least specific of the anticholinergics, like oxybutynin, that you may have some significant cognitive impairment with longer term use. It's unclear how much time or how much you'd have to take these to actually get that risk, but from what we can tell, there isn't really that much of a "it only happens in older people" or "it only happens in younger people"; it seems to just be a cumulative risk. The more you're taking it, the higher your risk of developing some of these [adverse events].

Given the overlap of overactive bladder in a population that tends to be people that are older and at higher risk for having cognitive impairment, the requirement on the part of insurance companies to administer one of these drugs that we are concerned has some potential cognitive [adverse events] is difficult to rectify as a clinician. I've got a drug, it works as well, it doesn't have the adverse events that are associated with it, but I can't give it. And, for me, and I think for many of us, obviously, that's a really frustrating situation to be in.

We can often overcome that. The insurance companies, they're not completely unwilling to go that direction if we make enough of an effort. But I think the other part of this is that the difficulty in overcoming these step therapy requirements requires a lot of burden on clinicians in their offices. To file a prior authorization, giving a justification as to why an anticholinergic isn't appropriate in a patient, why you need to use a β₃ agonist. All of this takes time, effort, and staff resources that you might not have. So, when you are in that situation, people end up doing 1 of 2 things, which is you end up hiring extra people and taking a financial hit in terms of how your practice runs and your staff is doing this, rather than actually taking care of patients, or you end up just not being able to do it at all, because it requires a staff burden that is just really not feasible. I think all of that really comes back to the superficial part is it frustrates me as a clinician that I can't do the right thing that I want to do for my patients. But when you look at the patient side, it actually has some real significant outcomes in terms of their ability to get care, the quality of their care, their satisfaction with care, their continuation in care. Overall, there are some potential ways in which all of those things impact their overall health and even longevity that I think were worth going through. So that's what we tried to do in this article is really explore some of those other [adverse events] that are the longer term consequences of not being able to get people the medications that may be the right choice for them.

This transcription has been edited for clarity.