Evaluating Medicare Coverage and Costs of Overactive Bladder Medications - Katherine Shapiro
January 5, 2024
Katherine Shapiro discusses her research on the cost and access to overactive bladder medications. She highlights the prevalence of overactive bladder and its significant cost to the healthcare system. Dr. Shapiro focuses on second-line pharmacologic therapies, comparing anticholinergics and beta-3 agonists, noting the side effects and emerging concerns about cognitive decline with long-term use of anticholinergics. Her study, primarily targeting Medicare beneficiaries and the uninsured, reveals the high costs and coverage challenges associated with these medications. Dr. Shapiro emphasizes the importance of including coverage phase in patient-physician discussions and advocates for more affordable medication access. She suggests that the complexity of medication costs might prompt quicker progression to third-line therapies for some patients.
Biographies:
Katherine Shapiro, MD, Urology, RWJBarnabas Health Medical Group, NJ
Ruchika Talwar, MD, Urologic Oncology Fellow, Department of Urology, Vanderbilt University Medical Center, Nashville, TN
Biographies:
Katherine Shapiro, MD, Urology, RWJBarnabas Health Medical Group, NJ
Ruchika Talwar, MD, Urologic Oncology Fellow, Department of Urology, Vanderbilt University Medical Center, Nashville, TN
Read the Full Video Transcript
Ruchika Talwar: Hi everyone, and welcome back to UroToday's Health Policy Center of Excellence. My name is Ruchika Talwar, and today I'm joined by Dr. Kate Shapiro, who is a urologist at Robert Wood Johnson Barnabas Health. She's here today, and we'll be discussing some recent work she's done exploring cost and access to overactive bladder medications. Dr. Shapiro, thanks for being with us today.
Katherine Shapiro: Thank you so much for this opportunity to share a little bit more, and to dive into the research that I did. During my fellowship at NYU, this was a passion project of mine, because so often in the world of overactive bladder, we want to prescribe medications, and often can't, because costs are too high, and patients can't afford these medications, even though they work very well. So, just as an overall view here, these are the AUA/SUFU guidelines for overactive bladder.
They're broken down into first, second, and third-line therapies. The reason why there's been so much research into overactive bladder is because it's so prevalent; so many women are dealing with this. It's a $8 billion yearly cost to the healthcare system for individuals with overactive bladder. And what I'm going to focus on primarily is the pharmacologic second-line therapy.
So, how do we choose which medication to give? There are two classes out there. There are the anticholinergics and the beta-3 agonists. The anticholinergics have been around for many, many decades. They work very well, but tend to have a lot of side effects; dry mouth, dry eyes, constipation, and there's even emerging research saying that with long-term use, there can be cognitive decline or cognitive impairment with the use of these medications.
And so, the newer medications out there are the beta-3 agonists. Mirabegron and Vibegron are the newer ones, which have lower rates of dry mouth, dry eyes, and constipation. It's not zero, but much lower than the anticholinergics. But the side effect we tend to counsel patients on is new onset or worsening hypertension in these patients. So, oftentimes we'll say, "Hey, which one has a better side effect profile? Let's just go with that one."
However, there's a lot more that goes into prescribing these medications. We have to think about what plan the patient's on. Are they uninsured? Are they on Medicare? Do they have private insurance, government insurance? What phase of coverage are they in? And about utilization management strategies. And what I mean by that is prior authorizations and step therapy requirements.
My study specifically looked at Medicare beneficiaries and also the uninsured. And the Medicare population makes up about 18% of the population in the US, and about 8% of people are uninsured. So, it's a hefty amount of people that fall into those categories. And within Medicare, I want to just spend a second talking about phases of coverage, because this determines the ultimate cost that the patient is going to see when they go to a pharmacy to fill a prescription.
Phase one, two, three, and four are the four total phases. And this is how I kind of like to think about it. And what's interesting is that in 2025 with the Inflation Reduction Act, this is all going to be wiped away, and it's going to be one large phase that the patient sees. So, hopefully, it will change for the better. But when the patient is in phase one, this is before they've reached their deductible. And the deductible is usually around four to five hundred dollars within the Medicare Part D plans.
Once they reach that deductible, they fall into phase two, which is the initial coverage phase. And so, that's either a co-payment or co-insurance that they need to pay. And that's set by the insurance company. That's set by each plan. So, it's different with each plan within Medicare Part D. And within Medicare Part D, just FYI, there are over 5,700 plans that patients can choose from.
So it's just such a variety that you see. Once patients get to about $4,000 worth of medication costs, they fall into the donut hole or the coverage gap, and that's where they have to start paying 25% of the average retail price. And the average retail price is really the uninsured cost of the medication. When they get to about $10,000 worth of medication costs, they then get into the catastrophic phase, and that's where they pay 5% of the average retail price.
And that's when drug prices really start to plummet, but they have to reach quite a high amount of costs before they can fall into that. So, our aim was to report the out-of-pocket costs associated with overactive bladder medications among Medicare beneficiaries and the uninsured. This was a cross-sectional analysis looking at one beta-three agonist, which was Mirabegron, because Vibegron was not on the Medicare formulary at that time.
And we looked at 17 anticholinergics, and it was a mix of both brand-name anticholinergics as well as generics. We used three different data sources. So, we looked at formulary data from quarter one in 2022 for the prescription drug plan for CMS. And then we looked at GoodRx and CostPlus prices. And CostPlus, if you're not familiar with it, is Mark Cuban's Discount Pharmacy, which has been around for a couple of years now.
And I'll kind of discuss the cost a little bit later on, but it's quite remarkable how low he can get these prices for some of these medications. It was really interesting to look at what medications he has available and what those prices are. So, when we looked at the overall coverage, so we looked at 5,700 plans, and we looked at what was the coverage of each of these medications.
We found that a hundred percent of plans offered coverage for Mirabegron, which was quite surprising, because when we prescribe Mirabegron or a beta-three agonist, it usually comes back as rejected, or there's some prior authorization you need to do, and it just seems like it's not a drug that gets good coverage, and it's so costly. So, this was surprising to us.
90.2% of plans offered coverage of Oxybutynin immediate release, and a hundred percent of plans offered coverage of extended-release Oxybutynin and Oxybutynin oral, or sorry, liquid suspension or syrup. And when we went over on the right side of the screen, these are the brand-name anticholinergics, and you can see that the coverage is actually pretty bad for these, except for Toviaz, and that's because there's no generic version of Toviaz.
So, Toviaz had the best coverage of the brand-name anticholinergics at 64%. And less than 10% coverage was available for all the other brand-names, whether that be Vesicare, Detrol, or Oxytrol, or Gelnique, those other forms of Oxybutynin or Ditropan. When we looked at prior authorization, again, it was quite surprising that Mirabegron, only 0.1% of plans required a prior authorization.
None of the other drugs required prior authorization except for Vesicare oral solution. And when looking at step therapy, once again with Mirabegron on the far left, 0.6% of plans required a step therapy. And when it came to the brand-name and generic anticholinergics, it was all over the place. But as you started to get more selective and into the brand-name, sorry, selective generics, and brand-name drugs, the step therapy requirements went up quite high, up to 43% or 48%.
When we broke down the actual cost to the patient, we looked at those phases like we had talked about before, phase one, two, three, and four. So, the phase one is the uninsured average retail price. Phase two was that cost in the initial coverage phase, and then we've got the coverage gap and catastrophic. And one of the interesting things we found was that Mirabegron, the initial cost, is over $500.
And so when the patient goes to do a first fill of Mirabegron, they oftentimes will just give up right there because the initial cost is so high. But when they get into that initial coverage phase, you see that it drops down quite a bit to $47, which is almost similar to the anticholinergics. When you get into the cost during the coverage gap, it does rise once again to over a hundred dollars for a Mirabegron prescription, but it does drop then to catastrophic.
So, it was really enlightening and exciting to see that the copayment could potentially be $47 for Mirabegron, if the patient maybe just has to get through that first fill that's so high with Mirabegron. When we looked at discount coupons, we found that, really, when it came to GoodRx, it offered the most benefit for the generic anticholinergics, but not so much for the brand-name anticholinergics.
It maybe would lower the cost about 20 to 25 percent for both Mirabegron and the brand-name anticholinergics. So, it is substantial, but really not... It still doesn't make it possible for a lot of patients to fill these medications. And when we looked at CostPlus, at the time of the study, we found that they had four medications for overactive bladder. These were all anticholinergics.
They offered Oxybutynin immediate release, not surprisingly, because that is the cheapest across the board and most commonly used. They had Solifenacin and Tolterodine immediate release and extended release. And these prices were anywhere from $5 to $30, which was like nothing we had seen on the GoodRx side. And even for some of the insured patients, you can't even get it this low. So, these prices were greater than 50% off of what you could see on GoodRx.
So, our takeaways from this were that most plans provide coverage for generic anticholinergics and Mirabegron, and the brand-name anticholinergics tend to have less coverage overall. But when looking at the details, while Mirabegron might be covered, as we may say, the cost is still pretty high and might be cost-prohibitive to patients. There's no prior authorization, there's barely any step therapy, and there's a hundred percent coverage, but it's still $500 for the first fill. The more selective generics required step therapy.
So, even at the surface, where it looked like maybe the preferred medications or the more selective medications were preferred, there were still a lot of loopholes that patients have to go through in order to get the medications that we as providers might want to prescribe. So, in conclusion, we highly, highly recommend that the coverage phase be included in the conversation between the physician and patient when prescribing these medications.
It's really our responsibility, and we should take it upon ourselves to familiarize ourselves with what insurance a patient has and what that might mean for when we give a prescription, and they go to the pharmacy and see that sticker or that price tag, and they might have some sticker shock with it.
And how we can better counsel patients, whether we should try a different medication, or if we need to really move them along onto third-line therapies faster, because the second-line therapies are just not going to be feasible for them. And also, this information should really be used, if possible, at a national level to really lobby for more affordable overactive bladder medications and access to these medications. Thank you.
Ruchika Talwar: Thank you, Dr. Shapiro. You covered a lot of ground there, and I think you really distilled a complex topic down into a couple of digestible bullet points. So, that was really great. And I think our audience will benefit from seeing how you broke down Part D coverage. Although a big caveat to note, as you mentioned, is in a few years, that model will become a bit obsolete. It'll be a good step in the right direction for patients, as they'll have out-of-pocket cost caps, and that'll really limit the financial toxicity for the patient.
But I want to just dig into a couple of your findings. First of all, I think it's important to note that despite the fact that patients have either Part D, if they're on Medicare, or traditional prescription drug coverage for those who might be obtaining insurance, either in a marketplace exchange or through their employer, prescription drugs can actually be found cheaper when not using insurance. And my group has done some research in this.
There have been more emerging studies showing that physicians really should consider the fact that patients need to be made aware of this. I think it's important to note that despite the fact that they pay into their plans, often there are workarounds that can get cheaper drugs, such as CostPlus and other online pharmacies like Amazon, et cetera.
But tell me, how has all of this changed your approach to counseling patients? Is it, in some ways, that patients who may be a candidate for things like anticholinergics outside of Mirabegron, do you recommend that they often go to things like CostPlus drugs to avoid that initial payment before they meet their deductible?
Katherine Shapiro: I was kind of sad after finding out all of this because it puts so much on the patient and on us, but a lot on the patient, to, but like you said, find these workarounds. It's pretty silly, to be honest, that we have to do that for patients. It's really changed my prescribing patterns. One, I very strongly believe in the side effect profile and do tend to favor certain drugs over the others. That being said, I now kind of more quickly will push a patient maybe through the medication phase and go on to third-line therapies and talk about it really early on.
When a patient comes to see me, the first thing I do is I tell them all three, first, second, and third-line options, and I say, "Hey, let's start here with first and second line, but you may have these problems, and I can try and walk you through how to get these medications if they work for you in the trials, and I'm going to give you samples, and if it works, that's great, let's stick with it. But if it doesn't, let's not belabor the point, and let's go on to PTNS, Botox, things that are covered, and things that work really well."
Ruchika Talwar: Yeah. Great. Great. Well, thank you so much for being here with us today. Again, I think that your work is a tremendous addition to the literature because it helps raise awareness about these alternative sources, but also, it really does encourage physicians to become familiar with the resources that are out there.
And I couldn't agree more when you say that these discussions should be a part of treatment decisions. So, research like this really tries to get that point across and get the information that we need to have those discussions out into the literature. So, congratulations on this study, and thank you for being here with us today.
Katherine Shapiro: Thank you so much.
Ruchika Talwar: And to our UroToday audience, I really hope you found this discussion valuable. I hope that this is information that you can go back and reference as you have discussions with your patients. And of course, I hope that you'll join us again next time.
Ruchika Talwar: Hi everyone, and welcome back to UroToday's Health Policy Center of Excellence. My name is Ruchika Talwar, and today I'm joined by Dr. Kate Shapiro, who is a urologist at Robert Wood Johnson Barnabas Health. She's here today, and we'll be discussing some recent work she's done exploring cost and access to overactive bladder medications. Dr. Shapiro, thanks for being with us today.
Katherine Shapiro: Thank you so much for this opportunity to share a little bit more, and to dive into the research that I did. During my fellowship at NYU, this was a passion project of mine, because so often in the world of overactive bladder, we want to prescribe medications, and often can't, because costs are too high, and patients can't afford these medications, even though they work very well. So, just as an overall view here, these are the AUA/SUFU guidelines for overactive bladder.
They're broken down into first, second, and third-line therapies. The reason why there's been so much research into overactive bladder is because it's so prevalent; so many women are dealing with this. It's a $8 billion yearly cost to the healthcare system for individuals with overactive bladder. And what I'm going to focus on primarily is the pharmacologic second-line therapy.
So, how do we choose which medication to give? There are two classes out there. There are the anticholinergics and the beta-3 agonists. The anticholinergics have been around for many, many decades. They work very well, but tend to have a lot of side effects; dry mouth, dry eyes, constipation, and there's even emerging research saying that with long-term use, there can be cognitive decline or cognitive impairment with the use of these medications.
And so, the newer medications out there are the beta-3 agonists. Mirabegron and Vibegron are the newer ones, which have lower rates of dry mouth, dry eyes, and constipation. It's not zero, but much lower than the anticholinergics. But the side effect we tend to counsel patients on is new onset or worsening hypertension in these patients. So, oftentimes we'll say, "Hey, which one has a better side effect profile? Let's just go with that one."
However, there's a lot more that goes into prescribing these medications. We have to think about what plan the patient's on. Are they uninsured? Are they on Medicare? Do they have private insurance, government insurance? What phase of coverage are they in? And about utilization management strategies. And what I mean by that is prior authorizations and step therapy requirements.
My study specifically looked at Medicare beneficiaries and also the uninsured. And the Medicare population makes up about 18% of the population in the US, and about 8% of people are uninsured. So, it's a hefty amount of people that fall into those categories. And within Medicare, I want to just spend a second talking about phases of coverage, because this determines the ultimate cost that the patient is going to see when they go to a pharmacy to fill a prescription.
Phase one, two, three, and four are the four total phases. And this is how I kind of like to think about it. And what's interesting is that in 2025 with the Inflation Reduction Act, this is all going to be wiped away, and it's going to be one large phase that the patient sees. So, hopefully, it will change for the better. But when the patient is in phase one, this is before they've reached their deductible. And the deductible is usually around four to five hundred dollars within the Medicare Part D plans.
Once they reach that deductible, they fall into phase two, which is the initial coverage phase. And so, that's either a co-payment or co-insurance that they need to pay. And that's set by the insurance company. That's set by each plan. So, it's different with each plan within Medicare Part D. And within Medicare Part D, just FYI, there are over 5,700 plans that patients can choose from.
So it's just such a variety that you see. Once patients get to about $4,000 worth of medication costs, they fall into the donut hole or the coverage gap, and that's where they have to start paying 25% of the average retail price. And the average retail price is really the uninsured cost of the medication. When they get to about $10,000 worth of medication costs, they then get into the catastrophic phase, and that's where they pay 5% of the average retail price.
And that's when drug prices really start to plummet, but they have to reach quite a high amount of costs before they can fall into that. So, our aim was to report the out-of-pocket costs associated with overactive bladder medications among Medicare beneficiaries and the uninsured. This was a cross-sectional analysis looking at one beta-three agonist, which was Mirabegron, because Vibegron was not on the Medicare formulary at that time.
And we looked at 17 anticholinergics, and it was a mix of both brand-name anticholinergics as well as generics. We used three different data sources. So, we looked at formulary data from quarter one in 2022 for the prescription drug plan for CMS. And then we looked at GoodRx and CostPlus prices. And CostPlus, if you're not familiar with it, is Mark Cuban's Discount Pharmacy, which has been around for a couple of years now.
And I'll kind of discuss the cost a little bit later on, but it's quite remarkable how low he can get these prices for some of these medications. It was really interesting to look at what medications he has available and what those prices are. So, when we looked at the overall coverage, so we looked at 5,700 plans, and we looked at what was the coverage of each of these medications.
We found that a hundred percent of plans offered coverage for Mirabegron, which was quite surprising, because when we prescribe Mirabegron or a beta-three agonist, it usually comes back as rejected, or there's some prior authorization you need to do, and it just seems like it's not a drug that gets good coverage, and it's so costly. So, this was surprising to us.
90.2% of plans offered coverage of Oxybutynin immediate release, and a hundred percent of plans offered coverage of extended-release Oxybutynin and Oxybutynin oral, or sorry, liquid suspension or syrup. And when we went over on the right side of the screen, these are the brand-name anticholinergics, and you can see that the coverage is actually pretty bad for these, except for Toviaz, and that's because there's no generic version of Toviaz.
So, Toviaz had the best coverage of the brand-name anticholinergics at 64%. And less than 10% coverage was available for all the other brand-names, whether that be Vesicare, Detrol, or Oxytrol, or Gelnique, those other forms of Oxybutynin or Ditropan. When we looked at prior authorization, again, it was quite surprising that Mirabegron, only 0.1% of plans required a prior authorization.
None of the other drugs required prior authorization except for Vesicare oral solution. And when looking at step therapy, once again with Mirabegron on the far left, 0.6% of plans required a step therapy. And when it came to the brand-name and generic anticholinergics, it was all over the place. But as you started to get more selective and into the brand-name, sorry, selective generics, and brand-name drugs, the step therapy requirements went up quite high, up to 43% or 48%.
When we broke down the actual cost to the patient, we looked at those phases like we had talked about before, phase one, two, three, and four. So, the phase one is the uninsured average retail price. Phase two was that cost in the initial coverage phase, and then we've got the coverage gap and catastrophic. And one of the interesting things we found was that Mirabegron, the initial cost, is over $500.
And so when the patient goes to do a first fill of Mirabegron, they oftentimes will just give up right there because the initial cost is so high. But when they get into that initial coverage phase, you see that it drops down quite a bit to $47, which is almost similar to the anticholinergics. When you get into the cost during the coverage gap, it does rise once again to over a hundred dollars for a Mirabegron prescription, but it does drop then to catastrophic.
So, it was really enlightening and exciting to see that the copayment could potentially be $47 for Mirabegron, if the patient maybe just has to get through that first fill that's so high with Mirabegron. When we looked at discount coupons, we found that, really, when it came to GoodRx, it offered the most benefit for the generic anticholinergics, but not so much for the brand-name anticholinergics.
It maybe would lower the cost about 20 to 25 percent for both Mirabegron and the brand-name anticholinergics. So, it is substantial, but really not... It still doesn't make it possible for a lot of patients to fill these medications. And when we looked at CostPlus, at the time of the study, we found that they had four medications for overactive bladder. These were all anticholinergics.
They offered Oxybutynin immediate release, not surprisingly, because that is the cheapest across the board and most commonly used. They had Solifenacin and Tolterodine immediate release and extended release. And these prices were anywhere from $5 to $30, which was like nothing we had seen on the GoodRx side. And even for some of the insured patients, you can't even get it this low. So, these prices were greater than 50% off of what you could see on GoodRx.
So, our takeaways from this were that most plans provide coverage for generic anticholinergics and Mirabegron, and the brand-name anticholinergics tend to have less coverage overall. But when looking at the details, while Mirabegron might be covered, as we may say, the cost is still pretty high and might be cost-prohibitive to patients. There's no prior authorization, there's barely any step therapy, and there's a hundred percent coverage, but it's still $500 for the first fill. The more selective generics required step therapy.
So, even at the surface, where it looked like maybe the preferred medications or the more selective medications were preferred, there were still a lot of loopholes that patients have to go through in order to get the medications that we as providers might want to prescribe. So, in conclusion, we highly, highly recommend that the coverage phase be included in the conversation between the physician and patient when prescribing these medications.
It's really our responsibility, and we should take it upon ourselves to familiarize ourselves with what insurance a patient has and what that might mean for when we give a prescription, and they go to the pharmacy and see that sticker or that price tag, and they might have some sticker shock with it.
And how we can better counsel patients, whether we should try a different medication, or if we need to really move them along onto third-line therapies faster, because the second-line therapies are just not going to be feasible for them. And also, this information should really be used, if possible, at a national level to really lobby for more affordable overactive bladder medications and access to these medications. Thank you.
Ruchika Talwar: Thank you, Dr. Shapiro. You covered a lot of ground there, and I think you really distilled a complex topic down into a couple of digestible bullet points. So, that was really great. And I think our audience will benefit from seeing how you broke down Part D coverage. Although a big caveat to note, as you mentioned, is in a few years, that model will become a bit obsolete. It'll be a good step in the right direction for patients, as they'll have out-of-pocket cost caps, and that'll really limit the financial toxicity for the patient.
But I want to just dig into a couple of your findings. First of all, I think it's important to note that despite the fact that patients have either Part D, if they're on Medicare, or traditional prescription drug coverage for those who might be obtaining insurance, either in a marketplace exchange or through their employer, prescription drugs can actually be found cheaper when not using insurance. And my group has done some research in this.
There have been more emerging studies showing that physicians really should consider the fact that patients need to be made aware of this. I think it's important to note that despite the fact that they pay into their plans, often there are workarounds that can get cheaper drugs, such as CostPlus and other online pharmacies like Amazon, et cetera.
But tell me, how has all of this changed your approach to counseling patients? Is it, in some ways, that patients who may be a candidate for things like anticholinergics outside of Mirabegron, do you recommend that they often go to things like CostPlus drugs to avoid that initial payment before they meet their deductible?
Katherine Shapiro: I was kind of sad after finding out all of this because it puts so much on the patient and on us, but a lot on the patient, to, but like you said, find these workarounds. It's pretty silly, to be honest, that we have to do that for patients. It's really changed my prescribing patterns. One, I very strongly believe in the side effect profile and do tend to favor certain drugs over the others. That being said, I now kind of more quickly will push a patient maybe through the medication phase and go on to third-line therapies and talk about it really early on.
When a patient comes to see me, the first thing I do is I tell them all three, first, second, and third-line options, and I say, "Hey, let's start here with first and second line, but you may have these problems, and I can try and walk you through how to get these medications if they work for you in the trials, and I'm going to give you samples, and if it works, that's great, let's stick with it. But if it doesn't, let's not belabor the point, and let's go on to PTNS, Botox, things that are covered, and things that work really well."
Ruchika Talwar: Yeah. Great. Great. Well, thank you so much for being here with us today. Again, I think that your work is a tremendous addition to the literature because it helps raise awareness about these alternative sources, but also, it really does encourage physicians to become familiar with the resources that are out there.
And I couldn't agree more when you say that these discussions should be a part of treatment decisions. So, research like this really tries to get that point across and get the information that we need to have those discussions out into the literature. So, congratulations on this study, and thank you for being here with us today.
Katherine Shapiro: Thank you so much.
Ruchika Talwar: And to our UroToday audience, I really hope you found this discussion valuable. I hope that this is information that you can go back and reference as you have discussions with your patients. And of course, I hope that you'll join us again next time.