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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. Kassem Faraj, who is a Urologic Oncology fellow at the University of Michigan. Dr. Faraj will chat with us today about his recent work, exploring the implications of the 340B program on advanced prostate cancer drugs. Thanks for being here with us today. We really appreciate it.

Kassem Faraj: Thank you. It's a pleasure to be able to present some of this work. Just wanted to share a few slides here on the study, just kind of the main overview, main points. Just as a brief background, advanced prostate cancer, there's been a paradigm shift in recent years as we know with decreased use of cytotoxic chemotherapy and increased use of oral-targeted therapies. And these oral-targeted therapies, things like the androgen receptor inhibitors and biosynthesis inhibitors are associated with increased out-of-pocket costs. And that's been demonstrated in prior work where this effect can potentially lead to reduced adherence, as well as disparities among patients who can't afford these medications. Socioeconomically disadvantaged patients, in particular, may be susceptible to these out-of-pocket costs.

And it's the financial and social barriers associated with the use of these drugs for advanced prostate cancer, may potentially be mitigated by existing healthcare policy. And so this is where the 340B program comes in. This is a program that requires pharmaceutical manufacturers to provide discounts on outpatient medications, that are purchased by participating hospitals that serve a disproportionate share of low-income patients. The program's goal is pretty vague in the original language where it states that it's to stretch scarce resources and provide more comprehensive care. Some have interpreted this to mean that it essentially provides hospitals with additional resources to improve healthcare for particularly vulnerable patients in their communities. There's been criticism of the program that's mainly due to studies demonstrating that hospitals who enter the program have not increased safety net engagement, which has essentially been a way that studies have interpreted the effectiveness or a measure of effectiveness, and has resulted in news articles like this from the Wall Street Journal criticizing the program.

In addition, the effects of the program on individual patient care and individual cancer patient care have not been assessed. So we sought to assess this in prostate cancer. Our question was how does the 340B program affect advanced prostate cancer care in socially vulnerable men? We looked at our primary outcome of the use of any targeted therapy agent and secondary outcomes of monthly out-of-pocket costs and adherence to treatment. And we have three exposures. The main exposure essentially was the interaction between 340B and social vulnerability, which was a regional measure of socioeconomic status. And the reason this was our main effect was that we hypothesized that outcomes would be worse in the most socially vulnerable patients. But that hospital 340B participation would narrow this gap in socially vulnerable patients. What we found was that with our primary outcome use of therapy, although the use of therapy decreased in socially vulnerable patients, 340B participation did not mitigate this effect. 340B also did not have any effect on out-of-pocket costs at any level.

However, with adherence, as social vulnerability increased, adherence to therapy significantly decreased in those managed at non-340B hospitals but remained stable in those managed at 340B hospitals. And so we concluded that although 340B was not associated with specialty drug use in patients with advanced prostate cancer, it was associated with better adherence in more socially vulnerable men. There are potential implications for policy reform that could potentially involve oversight committees partnering with hospitals to determine what type of safety net programs they could invest in to meet community needs. However, first and foremost, it would be important to implement screening programs to identify patients who may be at risk for financial hardships or poor outcomes at these hospitals.

Ruchika Talwar: Thank you. Really interesting stuff. I think exploring the prostate cancer implications of the 340B program is an important area. Particularly, as you mentioned, because so many men with advanced prostate cancer do get started on expensive therapies. And there are really a host of options out there, some oral specialty drugs, some generics, some IV, some continue to use cytotoxic chemotherapy. It's a complex space. But understanding who is getting what kind of therapy and perhaps what role a bit of bias plays or what we could do to better support the community as a whole, I think the 340B program in some ways seemed to be a bit of a letdown. But the reason I thought your study was really interesting was, although you didn't see increased specialty drug use, you did see improved adherence. So can you tell me a little bit about that? What do you think is driving that?

Kassem Faraj: Yeah, thank you. And you alluded to the program potentially being a letdown in regards to this study. We did hypothesize that use would be greater in 340B hospitals. And we did think that with prior work demonstrating these disparities, 340B would be able to kind of close that gap similar to how we saw with adherence. But we didn't see that with our primary outcome. However, with adherence, it's interesting; there could be several factors in play. Lack of adherence to therapy, as we know, could be multifactorial. It could be due to adverse events from the drugs, it could be due to the cost of the drugs, lack of education; there are just so many factors. In regards to 340B, there have been studies that have demonstrated that participating hospitals, in some measures and some reports, do increasingly offer discounts on medications at a higher rate than non-participating hospitals. However, they also seem to offer additional programs that could help improve quality like medication therapy management programs that can provide education and monitor patients better in regards to adverse events.

And just better keep an eye on things than what we may see in places where those resources may not be present. So it's likely a combination of several things. I think in regards to that outcome, it may be due to some of the additional support that may be invested in by some of these hospitals where patients are receiving care.

Ruchika Talwar: Yeah, I think that makes a lot of sense. I think the 340B program is just one avenue by which we can try to reduce financial toxicity in these really expensive drugs. But there are a host of other programs, potentially even coinciding with hospitals that do purchase drugs through the 340B program. For example, if you're at a high-volume academic center, a lot of times they have great relationships with pharmaceutical companies who have copay assistance programs and lots of patient-centered support there. So it'll be hard to know. And I'm curious, I know it'd be kind of difficult in this study to parse out whether or not those discounts through the 340B program were indeed being passed on to patients, but are you aware of any literature that's exploring if hospitals are indeed passing down some of those discounts?

Kassem Faraj: It's a great point that you mentioned, that the first part of that statement of hospitals having these resources to see if patients are candidates for medication discounts from manufacturers. And some hospitals claim that this is part of their 340B program. How they use some of their savings where they have this infrastructure, that nurse navigators meet with patients, and see if they're candidates are eligible for discounts from manufacturers to try to... Or various coupons, patient assistance programs, whatever it may be, to reduce that financial burden. To answer your question on whether there is evidence that hospitals are passing down discounts, in one of the more robust reports from a government agency oversight, they found that in a sample of 340B hospitals, half of the hospitals directly passed down discounts to patients. In terms of empirical work, looking at cohort studies, it is very difficult to be able to measure that. However, there is a qualitative study that looked at several measures and interviewed pharmacy managers at hundreds of 340B hospitals and non-340B hospitals.

And reported that there were some aspects of discounts that were being passed down to patients at the 340B hospitals at a higher rate compared to the non-participating hospitals. But empirically, it's very difficult to measure that, especially with claims data.

Ruchika Talwar: Yeah, no, and that's definitely a limitation, I think with claims data you just can't get that granular. But your point is definitely valid in that there's a lot of attention on this issue. So I think we'll be seeing more and more literature come out from government oversight agencies who look at how this program really can potentially reduce out-of-pocket cost savings for patients. So stay tuned. I'm sure we'll hear more about it in the news. But in the meantime, congratulations on this really important work. I think studies like this are really pivotal to ensure that in the field of urology, we're keeping up with all of these potential programs that have a benefit to patients, specifically in diseases like prostate cancer, where financial toxicity is such an issue. But more importantly, I think we really need to know how we can do better, what programs are available, how we can use those programs to pass along savings and improve care, but what's left in the work that we need to do. And your study certainly gives us some actionable targets here. So thank you for taking the time to chat with us today.

Kassem Faraj: Yeah, absolutely. It was a pleasure.

Ruchika Talwar: And to our audience, thank you so much for joining us. We'll see you next time.