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Step therapy for OAB imposes burdens for patients, expert says

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"The evidence is starting to show us that although efficacy in terms of managing OAB symptoms may be equal or similar across studies for these 2 classes of medications, safety and tolerability are very different," says A. Lenore Ackerman, MD, PhD.

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.

"You get to the point where now they're paying $200 a month to get this medication, and it's just not sustainable for most people. And it probably shouldn't have to be, is the point," says A. Lenore Ackerman, MD, PhD.

"You get to the point where now they're paying $200 a month to get this medication, and it's just not sustainable for most people. And it probably shouldn't have to be, is the point," says A. Lenore Ackerman, MD, PhD.

Could you describe the background for this paper?

It's probably well known to many urologists that we are subject to a lot of restrictions on what we can provide for patients in terms of therapies based on their insurance coverage. Having a practice that focuses a lot on OAB, particularly in older patients, I find that I spend a lot of time trying to manage the approach to therapy in a way that conforms with whatever the individual insurance plan is. One of those things that comes up quite frequently is that a lot of insurance plans will have what is called a step therapy requirement, which basically means that you have to try typically a less expensive generic medication for the treatment of a condition before you can be given a more expensive, branded therapy that might be more appropriate for the patient.

We encounter these kinds of restrictions across medicine, so OAB is not really a unique feature of that, OAB therapies, there are some significant differences between some of the more recent classes of medications and some of the older generic medications. Those includes some big differences in safety, efficacy, and adverse events. So, when you're dealing with this on a day-to-day basis with patients, you find that their therapy is really inhibited by some of these restrictions and their ability to get to a point where you're actually managing the condition effectively. Given all that pressure on the day-to-day of my clinical practice, I really wanted to look into what is the justification, what is the rationale behind these restrictions, just generally, and specifically within the world of OAB that keep us from sometimes prescribing the medication that we think is the most appropriate for the patient. That's the background on how I got started on trying to explore this topic a little bit further.

Could you discuss the use of step therapy in OAB specifically?

In general, the OAB guidelines from the American Urological Association go through a stepwise approach. 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 show 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 aren't really 100% in on this, but there's this decent concern, particularly with the oldest [and] 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 OAB 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 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 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, [and] their continuation of 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.

As you highlighted in your paper, what “hidden long-term costs” are associated with step therapy?

There are 2 ways to go. One is if you're able to get the patient the right medication, and by right medication, I mean for that patient. Let's say that they're really not appropriate for an anticholinergic; you're trying to get them a β3 agonist. Even just the process of getting that β3 agonist is going to cost them time and energy and effort that can be quite frustrating and take a lot out of you. On top of that, there are typically delays in getting patients that care, because you have to wait for the appeal or the prior authorization or the insurance approval. And very frequently, even when you can get those medications covered under a prior authorization, the out-of-pocket costs to patients can be substantially higher. We actually did another study, recently, where we looked at what formularies say that patients would pay for some of these more recent β3 agonists. What we found is that almost none of the insurance plans that we had surveyed offered it for a co-pay of less than $50 a month. When you consider that in comparison with oxybutynin, which often you can get for $5 a month—on GoodRX, you can get it for a couple dollars a month—there is a substantial cost to patients, even when you can get them the right therapy. That's sort of the best-case scenario, when you're getting a medication that's actually covered, you're getting it at this specific pharmacy that that insurance company contracts with.

Let’s say you don't know about all of these little things that can happen, and you go to get it at your neighborhood CVS, and they charge you $200. You pay it anyway because you don't know that there's another option, and you don't know that sometimes the pharmacy you get it at makes a difference or that you got a 90-day supply instead of a 30-day supply. So, all those little things can really add up as costs for patients. They want to be better, and they'll often do some pretty extreme things to get better. It's just really unfortunate that all of these things add up even when we can get them the medicines that we want.

Now, let's say we don't get them the medicines that they want. Well, there are 2 options there. One, they end up on a suboptimal therapy that I wasn't super happy about, something like one of these early, nonspecific anticholinergics, and now they've got all these [adverse events]. So now they're buying Metamucil and MiraLAX to try to manage their constipation, and eye drops, and they're having to drink water late into the night because their mouth is so dry, so their OAB is not really getting that much better. They're still in diapers, and they're still needing all of these other things to help manage all the [adverse events] of the medication, and that's if they stay on it. Because the odds are, at least from all of our studies, 80% to 90% of them are just going to stop taking it.

So, then they're just going to be in that second boat, which is not getting therapy at all. Then they're spending all this money on diapers and on underwear. They're starting to do all these other things that I think are much more concerning and it's the hidden costs of all of this, which is now they're limiting their life. They're not going out, they're not being social, they're not interacting with people, [and] they're afraid to be intimate. All of those social connections, which we know are hugely important to both just quality of life, but also longevity. I mean, these things directly influence how long you live and how happy you are while you're doing it. So, all of that is a very hidden cost of not being able to provide patients with medications that are sustainable for them.

That's even on top of all the incontinence supplies that are much more tangible, and still very expensive. If you've ever had to purchase adult diapers, they're horrifically expensive. But let's imagine the patient who can't get the right treatment, so she stops, and she wants to go on a cruise with her husband to Canada. She wants to go see Alaska. Now you go from having to take that 1 carry-on piece of luggage for a 4-day cruise to having to bring the carry-on piece of luggage, as well as a giant piece of luggage just full of diapers. That may not be life-threatening, but every aspect of how you live ends up being affected. That reduces productivity. We can see that it also increases the number of visits to the doctor, for many reasons, for things like constipation, dry eyes. All of those things can lead to additional visits.

And all of the potential other health complications that are also in that realm of cognitive impairment or balance issues, falls, and those can be much more life-threatening or much scarier for patients. There are very high rates of mortality after something like a hip fracture. Well, if you're getting up in the middle of the night because your OAB is not treated, and you're running to the bathroom, because you don't want to be wet. It's all of these things have the trickle-down effects on all these other areas of general overall health. That's because we can't get people the medications that we need.

It's been interesting, because we have been able over the years to provide patients with samples so they can try things out. We find that a lot of patients who didn't respond well to anticholinergics, or who had [adverse events] with anticholinergics, will do quite well with some of the β3 agonists. Then they know what it's like, so they're actually willing to go through this whole process of paying for it and waiting for it and appealing things. But even then, you get to the point where now they're paying $200 a month to get this medication, and it's just not sustainable for most people. And it probably shouldn't have to be, is the point.

All of those things really accumulate, and we haven't even gotten to into what are the hidden costs of cognitive decline. That not only begins to impact the patient themselves, but their loved ones and their caregivers. When somebody goes from being able to live independently to being dependent on other people, the cost associated with that—even if you're in a situation where as a family member, you are able to take that loved one into your home and provide 24-hour care—the cost to a caregiver is sleep, productivity, and in your ability to function. Now, it's multiplied to all of the other people who are now responsible for this loved one who is more impaired, who is a fall risk, who is not safe to be left alone. It just makes you wonder, is it really financially better to be providing early generic medications to patients when there's potentially this. I think framing it in that way, maybe we need to reconsider this underlying assumption that a cheaper drug—if its efficacy is theoretically similar—should be offered first. When we start to think about what all those downstream consequences are, when we start to think about those hidden costs, and when we start to think about what patients' real experiences are in the course of trying to get care, is it really financially better to be doing it this way?

What are some of the other negative consequences of step therapy for patients?

I think the data are still really evolving on the question of the cognitive impacts of anticholinergic medications and what are the differences between the anticholinergic medications that we use for overactive bladder. The most highly studied is oxybutynin, which does tend to be the drug that is most often the first step in step therapy. That being said, we don't have good enough data to be able to say all anticholinergics are the same, and that some of the more selective ones are the ones that theoretically have reduced penetration into the central nervous system, whether those are really the same, or maybe they are better. I don't think we know yet. I think the jury's still a little bit out on this.

The thing that is concerning about some of these studies is this cumulative burden. OAB is a chronic disease, so if you're managing it with medication, you're not giving somebody a 90-day course of medicine and stopping it. What they've seen is that there are these impaired measures of cognitive activity that can occur within as little as a couple months of an anticholinergic. If you're a 65-year-old woman being diagnosed with OAB, and everyone in your family has lived to 97, that could be a 30-year cumulative impact of an anticholinergic medication. If it's reasonable to extrapolate from the shorter durations that we see to these longer durations, it could be a pretty concerning thing. The population-wide studies that have really looked at this have found that association. Those are not prospective studies, they're more observational. But when they've looked back and said, is cognitive impairment later in life associated with a prior history of anticholinergic medications, we do see that link.

All I can say is that if I tell that to a patient, they are very reticent, which I feel is my obligation. They're very reticent to take those. I have to say, if it was me, and I was sitting there as the patient, I wouldn't want them either. The fact that the only way to an alternative therapy is to do this thing that we have some concern about the risk, it seems like that undermines the concept of step therapy. It's supposed to be 2 drugs that are equivalent [and] there's not really strong evidence that one's better than the other, so it shouldn't be that big of a deal to take the one that's cheaper. I have no problem with that as an argument. The evidence is starting to show us that although efficacy in terms of managing OAB symptoms may be equal or similar across studies for these 2 classes of medications, safety and tolerability are very different. That needs to be included in the equation of how we cover these treatments for such a common condition.

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.

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