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Alicia Morgans: Hi, my name is Alicia Morgans, and I'm a GU Medical Oncologist and Associate Professor of Medicine at Northwestern University. I'm so excited to have here with me today, a friend, colleague, and my right-hand lady, NP, Brenda Martone, who is the nurse practitioner who really keeps my clinic on track and is here to talk with us today about how we think about operationalizing the use of relugolix, which is an oral GnRH antagonist in our clinical practice. Thank you so much for being here with me today, Ms. Martone.

Brenda Martone: Thank you. It's a pleasure to be here and we are all part of the team. That's what makes us successful.

Alicia Morgans: Thank you. So I just wanted to talk with you a little bit about this oral agent, because whenever a new drug is approved, particularly an oral agent, there are unique challenges sometimes to getting that treatment into the patient hands. And obviously, it doesn't work when it's not with the patient because they do need to have that bottle at home.

So I'd like to start by first talking about new patients, new starts on androgen deprivation therapy or ADT, and the use of relugolix and then we can talk a little bit about whether we can think about transitioning patients who have been on long-term injectable, GnRH agonists, onto an oral agent, but really just to pick your brain and learn what are some best practices or ways that you think about making that a successful process. So to start with new starts, have you started any patients who are newly starting androgen deprivation therapy on relugolix, and what are your thoughts or advice for best practices and making that a successful process?

Brenda Martone: I have started new patients on relugolix. I think to make it successful, patients need to understand that the dosing, so three tablets, the first day is the loading dose, and then one tablet daily, can be taken with or without food. Also to get the medication to the patients, that can be somewhat challenging being a new medication. So sometimes there are delays in getting this started. And so we have to look at that and the patient and how quickly we need to suppress the testosterone and then just utilizing our resources if we do see barriers to obtaining this medication for patients and basically utilize those resources to get that medication successfully to the patient as soon as possible.

Alicia Morgans: Yeah. So let's start with the first comment that you made, which is that there are three tablets on the first day, then daily after that. I know, we actually had some hiccups when we first started using this where our pharmacy asked us to write two separate prescriptions. And I don't know if this will be the case for every pharmacy, but just to put out there that there may be an option for clinical practices to have what our pharmacy is calling a starter pack, which is a little text in the text that the pharmacy would write out that says, "Take three pills on day one, then take one pill daily," and they wanted that as a separate prescription.

And then they wanted another prescription that they called the maintenance packs, that we could put on refill, and that one just took one tablet daily. So, that was one thing I learned actually very early on in this process, that using the two prescription approach is what was most preferred by our pharmacy and seems to work in terms of communicating clearly with the patients-

Brenda Martone: I actually have an answer for you, why that is.

Alicia Morgans: Oh wonderful.

Brenda Martone: Yes. So the starter pack and the maintenance pack prescription need to be written that way because there are only 30 tablets in each bottle and they are not able to break into a bottle, so they have to dispense the 30 tablets in their entirety, so that is why we have to order it that way.

Alicia Morgans: Thank you, Brenda, because she is certainly responding to what I just said now, but also to my many complaints, why do I have to write two prescriptions. Thank you, and that makes a lot of sense. And also we wouldn't want to be unclear and have a prescription that said, "Take three tablets on day one," repeating over and over, that's not good communication to patients. So thank you for clarifying that and asking I'm sure after I complained, not that I do that often, but once in a while. So thank you for clarifying that.

I think the other thing is that we certainly send this prescription to a specialty pharmacy and sometimes I have accidentally clicked and sent it off to Walgreens and that does not work, so obviously we have to send it to a specialty pharmacy. And once it gets there, Brenda, can you talk a little bit about the process and how the pharmacy engages, not the details of how that happens, but the pharmacy does engage, I think with the patient's insurance and tries to come up with what's going to happen in terms of patient copay. What happens then?

Brenda Martone: So once the pharmacist does the prior authorization and confirms with the patient that it's approved, getting approved isn't necessarily the hardest part, so the copay can vary. And so the pharmacist will communicate with the patient that the medicine has been approved, but this is the copay. If the copay is higher than the patient can afford obviously, they do reach out and start with some assistance programs to try to get that co-pay as minimal, if not to zero, as possible. Then the pharmacy staff also sends messages to the care provider team to let us know what's going on and they always keep us in the loop.

And then once we do have a final answer, they reach out to the patient, set up the delivery, and review instructions for taking the medication, as well as potential side effects. Another big piece of this puzzle is they also do all the drug, drug interactions. So it's important when a patient is being prescribed relugolix, that all of their prescription medicines are recorded in the chart. So we can potentially identify any sort of issues upfront that may require either a medication substitution or a dosing change.

Alicia Morgans: Yeah. Thank you for mentioning that because with oral medications, I think it's even more important for us to try to check those drug, drug interactions. They can be so critical and we have not come across many, but I do think it's important for us to have, as you said, every medication, including sometimes people are on herbals and different supplements, so as much information as we have about those things as well, can be really important for the process. And then once you've got somebody on the treatment, how often do you have them come back? Do you have them come back within a relatively short period of time, to check lab work and talk about tolerance, or is that different than when you use an injection? What are your thoughts on follow-up?

Brenda Martone: So if it's the injection only, I think four weeks as a return visit and to check labs is a good kind of point of contact or a good timeframe. With the relugolix, I like labs in about two weeks because we do know there can be some liver function abnormalities, and then seeing them back in about four weeks to assess again labs and toxicity. It's just important to kind of let the patient know that at the beginning, there is going to be a little bit increased frequency with visits and labs, and it's important for us to monitor for these things, and then if a side effect is developing or becomes problematic, we can actually address it before it becomes catastrophic, not catastrophic, but before it becomes so intense that it's intolerable.

Alicia Morgans: Okay, great. So let's talk a little bit just for a minute on patients who are on GnRH agonist, sort of a stable injection. Are there patients that you would consider talking about a switch to this relugolix agent?

Brenda Martone: Especially, yes. That answer is yes, and especially in patients with a significant cardiovascular history or comorbidities with diabetes, or just anything that puts them at an increased risk, discussion of switching to relugolix is important because of the decreased risk of cardiovascular events.

Alicia Morgans: Yeah. I would agree, and one of the tricks that I tried and I talked to Ashley Ross about this, I think a couple of weeks ago, is that when we know patients are coming in for their next shot, maybe about a month in advance, we do try to start the pharmacy process, to try to work out the prior authorization, understand the copay, apply for assistance if necessary, reach out to the company for further assistance, which is also a program that can be found, I'm sure on the company's website and do whatever we can to have the bottle in hand for the patient by the time he comes back or needs that next appointment. And then we can talk at that appointment about remembering to take three tablets on day one and those kinds of things.

So having a little bit of lead time before the next injection is due, has been really helpful for our clinic, and I'm actually asking because I can never rely on my own memory. I hate to rely on the memory of my team, I'm actually asking the patients to give us a little note in the chart a month in advance, so that if they are interested in the relugolix so that we can start that process, that lets me know one, that they are interested and responsible and hopefully can take that daily pill. And two, that we can rely on them to do the follow-up as appropriate to make sure that everything is safe, so, that's been one of our little tricks. So any final thoughts on relugolix in practice, any other tidbits of advice you have for practitioners?

Brenda Martone: Just to ensure that patients are taking their medication, the importance of it, and then monitoring closely for certain side effects and then intervening early before the side effect becomes problematic and then the patient does not want to take the medication. So I think being an oral med, I think it's important that we are following these patients, touching base, checking in, and making sure they are taking it. If patients have side effects that they don't really appreciate, they may choose to stop the medication and not inform us or tell us at their next visit.

Alicia Morgans: So great point, as we are checking labs, we are actually for all patients on relugolix, and actually many of our patients on GnRH agonists as well now.  This is sort of a difference in our practice over the last year, we are checking testosterone and that is particularly important when we are worried about, or even just to monitor the adherence to an oral agent.

If patients aren't taking the medication, their testosterone will go up probably relatively quickly, and we can then have a conversation about why. Are these the side effects that we need to deal with? Is it that they don't like a pill? Is it that they can't remember a pill? And getting to the bottom of that will really help us understand how to best take the next steps to keep our patients safe and do all that we can to optimize their outcomes. So thank you so much for your time, your expertise, and your continued help in the clinic. I really appreciated talking with you.

Brenda Martone: I appreciate it too. Thank you for having me.