Integrating Oral Testosterone Replacement Therapy into Clinical Practice

[Dr. Andrew Sun]
The newest, and in many ways, most interesting testosterones are now the oral testosterone. In a lot of ways, you think about all the versions that I've mentioned, they all have some drawbacks, right? Whether it's a side effect drawback. We haven't discussed cost or access, which is a huge issue that every patient and every urologist has knocked their head into a wall over prior authorizations and whatnot.

What do we really want? We want something that the patients can take at home. That's easy. That's got a lot of side effects, and that gets good levels, and that is safe, right? I think oral testosterone has a long history. Originally, there was methyl testosterone, which was metabolized through the liver, and had a lot of liver issues. For a long time, we didn't have orals. That's when the gels proliferated, and injections.

Now, we actually have three different orals, Jatenzo, Tlando, and Kyzatrex. They're all the same drug, testosterone undecanoate. There's slight differences between them, which we'll talk about. The interesting thing about these new oral testosterones is that because of the undecanoate ester, they're not metabolized through the liver. They're actually absorbed via the lymphatic system. They don't pass through the liver, and therefore, don't have a lot of the liver toxicity that we used to see.

It's sort of directly absorbed, and the peak usually hits within about two to four hours or so, but it's still excreted faster than say a depo injection, and that's why it's a twice-a-day dose. Most of them are recommended to take in the morning and in the evening. Sometimes I will actually tell the patients to take it in the morning and in the early afternoon to get maximum testosterone levels during the daytime when they're most likely to require or want that energy, because maybe it's not as necessary in the evenings.

When Jatenzo first came out, that was the first one to market, the biggest issue was just access. The insurance companies placed this as a third-line thing, so you had to fail the gels, and fail the injections, and then maybe you could get Jatenzo. With every other medical problem in the world, first-line therapy is usually a pill, right? The second-line therapy is usually an injection, and then the third-line is some surgery. It didn't make a lot of real-world sense to place the pill as a third-line option. It was just very difficult to get. The data was good. There's interesting data as well on SHBG. Going to a little tangent here, so all of our guidelines and most of what we treat is based on total testosterone numbers, right? The guideline number says 300. Now, real-world, does a guy with a testosterone of 302 probably, could benefit from some treatment? Yes. 300, but that's a total testosterone, and that does not take into account the extreme variability in patients' SHBG, sex hormone-binding globulin levels, or their androgen receptors, which we don't really have an assay for.

The more bioavailable version of testosterone, the one that's more correlated with symptoms, even though it's not what our guidelines are written on, is the free testosterone. In general, the more SHBG you have, the more binding globulin binds to the testosterone. That testosterone is not available, and therefore, the free testosterone goes down. We don't really have a great way of necessarily reducing SHBG, so mostly we just say, "Okay, give him more testosterone, get that total number up, and therefore the free will also rise, and we'll hope to get the effect."

What was really interesting about some of the oral testosterone undecanoate data is that it seems to actually lower the SHBG levels, therefore, proportionally increasing the free testosterone levels more than injections, or gels and whatnot. Given that the actual symptomatic benefit of testosterone seems to be coming from the increase in free testosterone, that's actually really revolutionary and attractive, and you can actually lower their SHBG levels and increase their free testosterone.

[Dr. Jose Silva]
Excellent. I think we have covered a lot of stuff regarding testosterone. In terms of how can you make it profitable as a urologist? Because sometimes, I'm sure your partners were happy when they started sending the testosterone patient to you. Because sometimes those testosterone patients, it takes a while to talk to them, and we as surgeons, we're trying to get people in the OR. How does a urologist make money out of this?

[Dr. Andrew Sun]
There's definitely a lot of pieces to that, and I think having a sort of dedicated men's health center is definitely advantageous because we deal with it all the time so that our partners don't have to deal with it. Because we deal with it so much, our efficiency and our sort of talk track, most of what I'd I'd just explained about all the different testosterones, I basically have it written down.

When the patients are coming in, they just sort of get this primer. It's like, "Here are all the options. Here's the pluses and minuses." It's a much quicker conversation that way. A few things, right? The dedicated center is really nice to be able to centralize that. I cannot overstate enough the importance of having APPs in the men's health space in general, but especially testosterone.

Most of this long-term follow-up is a great thing to have APPs help out with. I have two. They don't really work for me. I work for them because I just talk to the patients and hopefully do surgery, right? They're really doing all that. In fact, my APPs do my duplex ultrasounds, my xiaflex, my trimix, my testosterone management. It really helps alleviate the burden so that I can concentrate on surgery. APPs are huge.

Then it's about, how do you actually make it a meaningful part of your practice from a financial standpoint? In that realm, we want, I think, to take a little bit of a lesson from the hormone clinics, right? A lot of these places have definitely figured out a business model. I'm not saying that it's necessarily the right business model, but many versions of testosterone can be utilized in that fashion.

For example, Kyzatrex, like we talked about, oral testosterone, since it's not available through CVS, you can get the product to a patient either through in-office dispensing, and UroGPO, Specialty Networks has contracts and agreements with some of these companies, and you can purchase the medication and do in-office dispensing, you can utilize a pharmacy if you have the many large group practices, like our practice, we have our own pharmacy that helps us work with these kinds of medications, oncolytics, a lot of things.

or you can use Specialty Pharmacy. In that sense, at least you are sort of unburdening yourself from a lot of the paperwork, which in and of itself is actually significant revenue-saving, right?

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You can also dispense testosterone yourself, if you have the means to do that. I think the other thing to make people aware of is that, yes, if you just take testosterone for what it is, it definitely, for many urologists, it seems like a burden, but if you can unburden yourself from many of those insurance hassles, that's 90% of it. The realization that the low T patient almost always has other relevant urologic diagnoses to treat, right?

ED, BPH, PSA issues, prostate cancer, you're screening all these guys for PSA, and, if you get them into your practice, simultaneously, you're helping these guys out a lot, you're giving them a much better quality of life, you're doing it in a safe and responsible way, checking the labs, and being on top of things medically, but they're also in your practice, and eventually, when you have other things that come up, that's what we as urologists are equipped to do. They may not be getting that from this sort of pure hormone clinic situation.

[Dr. Jose Silva]
Andrew, you mentioned a lot of things, how to be successful. If there's any specific thing that you want to add in terms of how to successfully execute the men's health program?

[Dr. Andrew Sun]
I think it definitely takes somebody with passion, and not every urologist has that passion, and that's okay, because a lot of us do, and if you have that person, and you give them the means to execute on that vision, it can be a huge boon for any urology practice. You're going to take care of more patients, you're going to improve patients' quality of life. We've spent most of our time talking about testosterone, but obviously, in the men's health clinic, we also do a lot of post-prostatectomy rehab, and quality of life, and erectile dysfunction, and sexual dysfunction, and these are issues that patients definitely have.

These are issues that young men care about, and are ways to engage them in healthcare to hopefully better their outcomes in the future. They can be good ancillary streams for any practice. If you develop a champion in that space, and I can't state it enough, APPs are a huge part of it, I think so.

[Dr. Jose Silva]
Andrew, you mentioned that, for example, Kyzatrex is not in CVS, and you cannot get it in a regular pharmacy. How do you get the access? How can you get it?

[Dr. Andrew Sun]
A lot of different ways. For our practice, we have a pharmacy, and so, I basically have it in my pharmacy. It's really convenient, because I can see a patient, I can talk to them, and say, "Okay, here are the options, what version of testosterone do you want to do? You want to start the pill? Great. Walk down the hall, pick it up, go home today, take the pill tomorrow morning." You can't do that with any version of testosterone. That makes our practice so much easier, my life so much easier.

One thing I want to mention for follow-up, I think telemedicine has been really crucial. The initial low-T consult to explain all these options to really do a good job, going through all that, it does take a while. Low-T follow-ups do not take that much time. My first half hour of my clinic is just stacked telemedicine consults, which are mostly the three-month or six-month follow-ups. Once I have them on a stable pathway, then, my PAs, we share that telemedicine group of patients, we're doing testosterone follow-ups, and, that you can do 6, 7, 8, 9, 10 patients when it's just a testosterone follow-up in a pretty quick amount of time.

That's been a huge thing. I definitely think telemedicine should be chunked into a block, right?

[Dr. Jose Silva]
I do it at the end of the day.

[Dr. Andrew Sun]
Yes, at the beginning of the day or at the end of the day, for sure. In terms of access, pharmacy is one option. In-office dispensing is another option. Some states don't allow it, but most states do. Many urology practices already do this with oncolytic drugs and whatnot, the prostate cancer medications. It's a relatively straightforward thing to set up for in-office dispensing.

Then the third option is that there are some specialty pharmacies that, Marius Pharmaceuticals, the company that makes Kyzatrex has partnered with, you can send the prescription to them, and they can basically send it to the patient. A variety of different options, all of which significantly increase the access to care for the patients and decrease my paperwork burden, which is great.

[Dr. Jose Silva]
Exactly. Andrew, anything else you want to add? I think we covered a lot. I think you were very on point, and you explained everything very well. Anything else?

[Dr. Andrew Sun]
No, I think, every urologist, I'm sure, has dealt with testosterone. My goal is to convince everybody out there that men's health stuff, whether it's testosterone, whether it's Peyronie's, it can be actually really rewarding patient-wise, cognitively, scientifically, and practice-wise. You don't really have to see it as a burden. If there's somebody that should be doing this, it should be us, right? Urologists, men's health, we should be the ones that help the patients out with these kinds of options.

There's a lot of options out there. You definitely want to be complete in sort of explaining all of the different ways that these things affect, because there's probably more misinformation about testosterone on the internet than almost anything else, right? A lot of great options. Yes, the world is your oyster when it comes to testosterone.