Benjamin H. Lowentritt, MD, FACS

Expert Perspectives on Advanced/Metastatic Prostate Cancer

,” key experts in managing hormone-sensitive or castration-resistant prostate cancer share insights into advancements in the field, including considerations on using various leuprolide formulations for advanced or metastatic prostate cancer. In this interview, Benjamin H. Lowentritt, MD, FACS, from Chesapeake Urology Associates in Baltimore, Maryland, discusses different leuprolide formulations and the financial and operational challenges associated with their use in a medical practice.

Does your institution have more than 1 type of leuprolide formulation on formulary? Do you typically specify a particular regimen when writing prescriptions?

Currently, we offer both types of leuprolide acetate in our practice for all the different intervals that they're provided. We certainly want to allow for our physicians to have [a] choice across the platform to cater care toward any patient’s needs. That's always been our approach to it, both in duration of the depot preparations as well as the particular agent that's being used.

Do you think that cost is a barrier for providing leuprolide to patients? How does the cost compare across the individual formulations?

When you're talking about cost, there are 2 [issues]. The cost to the patient should be the same, because [use of all formulations is] essentially billed the same. To the payer, [it all looks] the same. The cost to the practice can be different. On a certain level, yes, that is important, because, as a practice, we don't want to be underwater on a treatment or have any risk of losing money on a therapy that we're trying to offer. In many cases, we're doing these as a buy-and-bill, so they're provided in our practices. We're on the hook for the cost side, as well, so that does have an impact in certain cases. Our goal is always to offer everything to our patients and to our doctors to use, but it is important to be aware of the cost to the practice.

Which team members at your practice address challenges specific to leuprolide prescriptions, such as those related to coding, prior authorization, and billing and reimbursement?

We have a number of teammates [who] are involved throughout the whole process [of providing] leuprolide. Certainly, our operations team is involved in scheduling and ordering, since we provide these [agents] in our office settings; [this team] is involved from the get-go. Our procurement team is involved in making sure [that] we have the correct supply in the correct place. We have a prior authorization team that authorizes every injection given [so] that we have a fresh authorization, even if a patient's been on longstanding therapy or maybe getting it multiple times a year. We always want to make sure [that] those are updated. And then, of course, our billing and reimbursement team follows through on any of that aspect [throughout] the course of treatment. It is a multidisciplinary team in that respect.

What are some of the strategies that you use in your practice to address these challenges?

To make the injection process flow as [smoothly] as possible, it takes effort across the whole practice. As I mentioned earlier, it's important to actually have the right product in the right office for the right patient. We're a practice [with] a number of locations, so [it] is essential [to] make sure that the initial communication is done correctly so that the right medication is available when the patient's actually coming in. [It is also important to] make sure that the prior authorizations happen so that the patient isn't coming in too early for their therapy, where there might be a question of whether it would be reimbursed. That's a component, as well. Of course, [we also] make sure that we follow through on the clinical aspect to make sure that the therapy [is] appropriate for the patient. That's always [a] critical first step.

We have our teams looking forward several weeks to make sure that we're ordering the correct preparations at the right time. We certainly don't want to have a very large inventory. Some [formulations] require refrigeration, [and] some require mixing. There's an expense to just holding onto the medication, so we want to make sure that we're keeping up with and staying slightly ahead of our demand while not becoming overloaded with a certain amount of a particular formulation. It takes a fairly well-oiled group mentality to pull this off in the most effective way.

Videos

EP. 3B: Economic and Reimbursement Perspectives on Leuprolide for Prostate Cancer

In the third interview of the series, Benjamin H. Lowentritt, MD, FACS, reflects on financial and operational considerations in the use of leuprolide with emphasis on managing the cost burden, coding and reimbursement, and product inventory.

EP. 3A: Financial Perspectives on the Use of Leuprolide Formulations in Prostate Cancer

 You mentioned some of this before, but the other trial that was a interesting was the ODENZA trial, which is the beginning of a comparison between darolutamide and enzalutamide. Is there anything that you found interesting in what we know, or anything you can share?

 The one we have at OHSU [Oregon Health & Science University] is called DaroACT. We need to wait for the data. I wouldn’t be surprised if we see that darolutamide is better tolerated, but sometimes we get surprised.

 The outcome of that study was that it wasn’t a statistically significant difference in patient preference, with some slight signals one way. But the bottom line is that we have these great drugs. We have a lot of options. We’re at a great time where we need to be aware of all these things and offering them to the patient. You don’t need to just pick 1 and go with it. You have multiple options. The best experience after a time is your own and what you feel comfortable with. We didn’t get a chance to even talk about 1 of the big hurdles, which is financial toxicity and getting stuff approved, because that unfortunately sometimes drives a choice between them. But when we have multiple good options, at least you can feel confident about what you’re using.

 Is there anything else that came out of either the AUA [American Urological Association 2021 Annual Meeting] or 2021 ASCO [American Society of Clinical Oncology Annual Meeting] this summer that you want to talk about? You mentioned some exciting trials about some new agents. Is there anything else on the horizon that we should know about?

 You may not know that I got to do the study that showed that pembrolizumab, which is a checkpoint inhibitor, can lead to profound responses in mCRPC [metastatic castration-resistant prostate cancer] when given with enzalutamide. We’d be remiss not to mention all the immunotherapy studies going on, from primary disease—where people are injecting the tumor and prostate gland directly with immunotherapy—to down the road, where they’re adding a bunch of immunotherapy agents together. I’m interested to see how that pans out. I’m hopeful. For men whose prostate cancer expresses mismatch repair deficiency or is microsatellite instable, checkpoint inhibitors like pembrolizumab can be helpful. But we’re still learning about the other men who seem to respond to it without those features.

 That’s really interesting to have more angles to approach this from the get-go. Dr Graff, thank you for joining us today. And to our viewing audience, we hope you found this 

 video series discussion to be rich and informative. Thank you very much for joining us.

A recap of presentations from AUA 2021 highlighting next steps using novel therapies as combination approaches to treat advanced prostate cancer.

Novel dual agents for advanced prostate cancer

 Some of the other data that have recently been coming out include real-world evidence out of groups, including mine, on the use of some of the different agents and whether we’re seeing different adherence or persistence on drug. One study we did looked specifically at a large group of patients who were receiving apalutamide while it was approved only for the nmCRPC [nonmetastatic castration-resistant prostate cancer] space. It was looking at a specific population and pulling out the Black patients to see if the PSA response and adherence on drug were there.

Some small studies have suggested possibly even improved responses in population subgroups like this. It was interesting to be able to look at those groups and see that even in real-world evidence in community groups, much like my own, we’re seeing patients who are adhering to the drug at a very high rate and are able to hopefully get the responses that we expected from the trial. As you said, that’s often a slightly different patient population. It’s a little more idealized. Do you glean anything from this real-world evidence? What does it mean for the structure of any future trials or anything else that might come down the road?

 I’m really glad you brought that up, Ben, because 1 of the underlying themes here is that not everyone is represented in trials. One of the questions is, how do we make our trial population more diverse? There’s a lot of work underway to do that. Some of the work is being done at the VA [Department of Veterans Affairs], where we have a much higher population of African American men. We learned through the PROCEED database for sipuleucel-T that cancers in African American men respond better to sipuleucel-T, also known as Provenge, than in their Caucasian counterparts. We have to do much better in diversifying our clinical trial populations. There’s a lot of work underway.

If I may tiptoe onto my soapbox for a second, we also need to improve diversity in our researchers, because not having prominent Black leaders, at least in medical oncology doing prostate cancer, could be discouraging to patients, who maybe won’t join the trial. Real-world data are interesting but not everything. People tend to believe in these data. I just mentioned the PROCEED database. If you read some of the guidelines, they’ll say that if you see an African American man, you should really consider sipuleucel-T. But that evidence isn’t very strong. Based on that, you’d have to enroll in a prospective clinical trial. So interpret the real-world data with caution.

 I really appreciate that. The trials that incorporate more patients, not just from the academic setting but from the community, are often a little more diverse. You can find areas that are more diverse and try to recruit and get better evidence. The partnership there is the important part.

Current limitations of real-world data available that support the use of novel therapies, including androgen receptor inhibitors, as treatment for advanced prostate cancer.

Benjamin H. Lowentritt, MD, FACS

Articles

EP. 3B: Economic and Reimbursement Perspectives on Leuprolide for Prostate Cancer

EP. 3A: Financial Perspectives on the Use of Leuprolide Formulations in Prostate Cancer

Novel dual agents for advanced prostate cancer

Interpreting real-world data in advanced prostate cancer