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GnRH Agonist/Antagonist Formulations for Treatment of Advanced Prostate Cancer
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Switching their focus to the treatment armamentarium, expert panelists reflect on selection and sequencing of therapy for patients with advanced prostate cancer.
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Paul R. Sieber, MD: I’ll switch over to what’s available these days, and that’s a challenge. You look at the current ADT [androgen deprivation therapy] market and you go, wow. We’ve got 2 different leuprolide acetates, which have their own J code. We’ve got a leuprolide methylate, which comes with a different J code, which in [and] of itself is interesting. And administration is a little different because we’ve got IM [intramuscular] administration, we’ve got subQ [subcutaneous] administration, we’ve got mixing requirements that are different for all 3 of those. We’ve got triptorelin, which is something else different again, which goes back to an IM injection, different J code again. Then we’ve got goserelin, once again, probably another J code and another slightly different administrative technique. And then we switched from this super agonist to the antagonist.
We’ve got degarelix and we’ve got relugolix, so ... a host of different things, which can be challenging. My next question to you was having this entire vast marketplace of things out there—and I’ll go through you guys one by one—one of my topics I was chartered with was, how do you order this stuff and what do you guys do? I’ll pick myself. I’ve got the smallest group, so it’s easiest. We stock basically an agonist, we stock an antagonist, and we have an IOD [in-office dispensary] so we dispense orals. But we’ve ... limited what we have available and we make a groupwide decision about what we’re going to do. So ordering is relatively simple for us because we’ve made a groupwide decision to limit the market, the products we use. Chris, I’ll start with you first. You’ve got a relatively controlled situation. How do you look at the agents you pick at ordering them or is that a relatively simple thing for you guys?
Christopher M. Pieczonka, MD: It’s important to realize that it took a while for us to … become integrated. We acquired practices in the area. We came under 1 banner and we weren’t at all integrated for a long time and we were effectively a bunch of different franchises. And only in the last year or two did we really ... look at this in our local level and say, OK, that’s how we have ... the same pathway, same procedures, and then limit the number of ... drugs on formulary. I think a lot of that has come from a couple of things. One, certainly we have a dispensary like my colleagues, and from a business standpoint we have looked at that as a favorable thing, particularly on the relugolix front. But at the end of the day, it's hard to get that medicine approved, and often there’s a pretty significant out-of-pocket expense for the patients. Particularly, it goes through their part D of Medicare.
And more recently we have looked at leuprolide methylate because it really has helped us for our nursing shortage and nursing staffing problems. We are really struggling with nurses, and New York state is pretty peculiar because injection therapy needs to be done by an LPN [licensed practical nurse] or an RN [registered nurse] ... Believe it or not, you can get a COVID-19 vaccine from somebody who’s completely unlicensed and has no formal training, but you can’t have an MA [medical assistant] you’ve been working with for years giving injection medicine. As we’ve had a hard time struggling with the hospitals … peeling these nurses off for traveling jobs [with] higher pay, we found that anything that can be done to make us more efficient vis-à-vis making injection therapy quicker is something we’ve looked at. We’ve really evolved to trying to put our patients on leuprolide methylate mostly because it’s a lot less nursing time.
Paul R. Sieber, MD: It’s curious because that’s been the same feeling on my end. We’ve had a significant change in terms of staff and the idea of understanding how to mix it. And particularly as some of the agents are more complex in their mixing cycle, one of the things that my older nurses who had been around a while were attracted to with methylate was, it was just so much easier to administer and … the teaching to understand how to mix the stuff and get it ready was much simpler so that we ... gravitated to that idea. Again, it's efficiency. If you spend a minute or two mixing something, and we have ADT Tuesday in my practice—we’re seeing 25 people in a day and if everybody takes an extra 5 minutes, spend 5 times 25—you just put in a couple hours of overtime just to mix this stuff up. Aaron, you’ve ... got a semi-big practice, but predominantly more than a minimum number of locations. Is that correct? And has that affected how you dispense different drugs, or do you have a whole host of things you’re dispensing in terms of picking the agent you’re going to use and how you administer it?
Aaron Berger, MD: We have 6 different office locations so we are a little bit spread out geographically, but when relugolix came out and since that was a good product clinically and could be dispensed for the IOD, we had a big push to try to use that as much as we could. But as Chris mentioned, there is a significant hang-up sometimes with coverage and out-of-pocket copays. It’s always ‘covered’ but then they get their copay and it’s $800 or $900 a month, which, for the average Medicare beneficiary, that’s a little bit out of bounds. So we still use a lot of the injectables. We’ve ... used one of the leuprolide acetate subQ products, mostly exclusively along with the leuprolide methylate since that’s come out and 100% agree with both of you.
I think we’ve probably had 70% to 80% turnover in our medical assistants and nursing staff since COVID-19 started. We were seeing for a while, not a huge number, but any patients who you are following who all of a sudden start to have rising PSAs [prostate-specific antigens] and testosterones that are not castrated, you have to look at what the problem is. And I think a lot of that was just for staff turnover, lack of education or knowledge about how to mix the products correctly. And I think some patients were just potentially getting injections that weren’t 100% mixed all the way and were having some breakthroughs. So I think, 100% agree that methylate has alleviated that problem and we have used that in our practice now a fair amount. We’re pretty much the leuprolide methylate, the subQ acetate product, and relugolix for the vast majority of patients.
There are still a couple of providers who like to start new patients on degarelix. I think we’d all probably agree degarelix is a very good drug. It’s been a good drug for a long time but they never could figure out how to make it last any longer than a month. That’s always been the limiting factor. We don’t use nearly as much of that as we used to, especially when they could potentially get a sample or get started on relugolix for a month and ... accomplish the same thing without ordering an entirely different injectable product because obviously the more of these things you have on the shelf are sitting around, the higher the chance something’s going to get lost. We do have a pretty revamped supply chain system now … It’s almost like being at Home Depot. Every product coming in gets scanned with a barcode and goes in the system. So we have a pretty good idea of where things are, but even so things can get tossed accidentally or lost or going to satellite offices, things get misplaced. The fewer things you keep on the shelf the better. We try to keep it relatively simple at this point.
Paul R. Sieber, MD: Richard, I assume you probably have by far the most complex setup in terms of offices because you travel large distances to every office, whereas Chris has got people traveling large distances to see him. How do you manage multiple large offices or multiple distances between offices—I assume many, many offices—in terms of picking your formulary that you stock out there on the West Coast?
Richard David, MD, FACS: It’s ... like being a lion tamer. You’ve got to keep a whip and you’ve got to keep a chair to keep them at a distance. But I think part of the challenge … we have in Southern California is that so much of the care of the medications we give is dictated by the prior authorization schema. So we don’t have as much liberty to prescribe the medications that we would normally just prescribe if it was all equal. But that being said, I agree with what other guys have said and the leuprolide methylate has pretty much taken over about three-quarters of our business for injectable medications. I think just like they said, the ease of use, the lack of a need of training, I think all that makes it way easier. Part of the challenge also is a lot of patients now when we diagnose them with a rising PSA, a biochemical recurrence, they’re hardly getting just 1 drug. When you put them on multiple oral drugs, getting their copay to a manageable level is really challenging.
Paul R. Sieber, MD: I agree. I think that’s a problem we all face across the board, that when you go between Medicare part B and Medicare part D, D is a real problem and especially with foundation support this year. It opened up yesterday and I thought my [authorization] person was going to have a stroke. She was just sitting here banging through as many [authorizations] as she could get because it had been closed for so many days. It was a challenge yesterday to go … crazy there to get caught up. Chris, you want to make a comment?
Christopher M. Pieczonka, MD: I just want to ... piggyback on what he just said. I think that the era of ADT alone is dwindling down. And one of the things that is just factual is that the NCCN [National Comprehensive Cancer Network] says that you shouldn’t use relugolix in combination with the other ARIs [androgen receptor inhibitors] or CYP17 inhibitors. And even if we want to do that, at the end of the day, the insurance companies have wisened up about the potential financial toxicity. And I’ve found that that’s not even worth trying to do because it gets denied essentially 100% of the time. I think because the leuprolides of the world are still ... the original formulation, all of the studies were done with leuprolide for whatever it may be, the androgen receptor inhibitors, the CYP17 inhibitors. And that just makes it easier because none of us have time to adjudicate and appeal to our ‘peers.’ You end up getting a pediatrician on the phone and you have to explain this to them and it’s a hassle. I think … that’s something … for the audience that they should just realize that again, maybe in a different world, maybe down the road, things change. But for right now, using the leuprolide in combination with the other therapies is just a lot easier insurancewise.
Paul R. Sieber, MD: I must say, I’ve been somewhat spared Richard’s hassle with the insurance company dictate, and I haven’t yet seen some of the hassles with the relugolix being denied because they’re taking one of the ARIs. But I know that you 2 guys in particular have insurance markets that sometimes drive you crazy. I’ve been removed from that.
Transcript is AI-generated and edited for clarity and readability.
