Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia Open Public Meeting - July 15, 2020 - JF Part A
Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia Open Public Meeting - July 15, 2020
Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia Open Public Meeting Transcript - July 15, 2020
Good afternoon, and welcome members of the public to the Open Meeting for the proposed LCD Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia. LCD number, DL 38705 for Jurisdiction E, and DL 38707 for Jurisdiction F. The meeting will be recorded.
The audio recording and written transcript will be posted on our website following today's meeting.
All lines are currently being muted by our system and will remain muted throughout the meeting. Only registered comments, commenters will be allowed to comment during today's meeting. For the commenters, each of you are being allotted 10 minutes to make comments. Your line will be opened when it is your turn to speak. Make sure you are not on mute within your system or we will not be able to hear your comments.
You should be prepared to begin presenting immediately when called upon and will hear the moderator's voice when one minute remains.
By signing in today, you are giving consent to the use of your recorded voice and your comments. Please be mindful of sharing any personal health information in your verbal comments. We ask that any comments made today also be submitted in writing.
While only registered speakers will be commenting today, anyone in attendance may submit written comments. I will now turn the meeting over to Dr. Larry Clark.
Dr. Larry Clark:
Thanks, Jocelyn Can you hear me with no reverb?
Yes, you’re loud and clear.
Dr. Larry Clark:
Thank you, everybody that's joined us this afternoon.
We're going to talk about a new treatment and development in the treatment of a very old and omnipresent disease that being benign prostatic hyperplasia, and we'll be talking about Fluid Jet System in the Treatment thereof. I’m gonna, at the request of a lot of people, I think I'll take two minutes to open this, just talking about the 21st Century Policy Development process.
And, the fact that this is one of the first, really collaborative policies that has been brought forward by the AB MACs. And, per our mandate, to make sure that there is transparency and adequate comment from all of the Jurisdictions, other Contractors may have had or will be having Open Meetings. It is not necessary for everybody to present at every meeting, particularly the stakeholders, we will be sharing and discussing the policy. This policy has been reviewed by multiple Contractors, and our input has been gathered. And, in fact, you know, it's been a little bit of a while since we had a CAC, we had Dr. Lurvey, Dr. Funk, Dr. Chi from UCSF. We had a group of individuals who were kind enough to review the data and the literature, and that was a number of months ago, but we, we took our time so that everybody could get together and we also waited. There has been release of three year data on the safety and efficacy of this technology, which was really great in terms of timing.
So, after a round of Open Meetings, we, our comment period, will go on until August 7th, and we invite anybody who is not here talking today to please submit your comments in writing. And also, I'll repeat, if our commenters today could give us a written synopsis of their, their key points, what they want us to take away, we would appreciate having that in writing as well and then we will progress with finalization of the policy as a collaborative policy. So, with that, Jocelyn and I will turn it back to you for our first introduction. Thank you.
Sure. Thank you, Dr. Clark. Our first commenter is Mr. Matthew Salkeld.
Mr. Salkeld, your line is open.
Great. Thanks, Jocelyn, and thank you, Dr. Clark, for the the opportunity here. I'd like to thank Noridian for the opportunity to speak as part of the Open meeting process, and what I'll do in the next 10 minutes is review some of the evidence that was highlighted in the proposed LCD as well as review some recently published data that's new and relevant to the LCD. Slide two includes the, next slide, includes my conflict of interest, which I am an employee of PROCEPT BioRobotics.
Next slide, please.
We'd like to support the LCD for the coverage of the Fluid Jet System as medically reasonable and necessary. First, based on the body of clinical evidence. Some of it included in the LCD and some new published evidence that I'll touch on, as I said during this 10 minutes.
First of all, with the Water study, which Dr. Clark referenced the 3 year data was recently published. A randomized study of Aquablation versus TURP Transurethral Resection of the Prostate, which is the gold standard where the Water Study demonstrated superiority and safety, comparability, in terms of efficacy and now durability out to three years. Second of all, societies support, with Aquablation included, in the American Neurologic Association guidelines, the European guidelines, as well as the Canadian guidelines. And then lastly, CMS's determination of Aquablation as a substantial clinical improvement through the Transitional Pass-Through, a new technology, add on payment. We recognize that and path and Transitional Pass-Through our payment methodologies do not coverage methodologies. However, the what I would consider rigorous review of the clinical literature by CMS at a national level based on the one-year clinical evidence, provided the determination of Aquablation of substantial clinical improvement. Next slide please. What we would ask as part of the LCD for consideration is expanding coverage criteria beyond the inclusion and exclusion criteria as noted in the LCD of the Water Study. Two areas, specifically, providing coverage, increasing the prostate size up to 150 grams by TRUS. First of all, this is consistent with the FDA labeling, which has no size limitation, but, also reflects some of the recent public, recent published evidence from the Water II study, where two year outcomes were just released evaluating Aquablation, enlarged prostate, as well as the Open Water, which was one-year outcomes of a real-world registry.
Second of all, is providing coverage for patients with no restrictions on catheter dependency or PVR. That was an exclusion in the Water Study, which was our first study. We took probably more conservative approaches, our first pivotal study. But there has been additional studies beyond that said it was not an exclusion criteria where nearly 400 patients were enrolled and demonstrated that those patients respond as well to the surgical approach for BPH.
What I'll start with on the next slide is looking at, really, the two landmark studies for Aquablation. The first one is the, the Water Study, and it's important to note that this is the only FDA pivotal study. Randomized, as I mentioned, again TURP, which is the gold standard. So, as you look at BPH surgery, less than 80 grams, TURP is still considered the gold standard, and what the outcome of the Water Study, what again demonstrated superior ... with superior safety, compared to TURP, similar efficacy and then three year durability now with a very low treatment rate.
The Water II study is the only FDA prospective study completed that assessed technology and enlarged prostate. In this group of patients with the larger prostate, open prostatectomy is the most common procedure performed which has higher rate of morbidity, longer lengths of stay, higher transfusion rates due to the bleeding complications. And what Aquablation demonstrated in this larger group was a safe and effective transurethral approach large prostate, reproducible outcomes as we will shows compared between the Water and Water II studies. So despite larger prostate size, similar sort of outcomes and now durability out to two years, which was just recently published.
I'll start with the review of the Water Study. The next slide shows the 3-year outcomes, which were published this year and what we're looking at here on the left-hand side is IPSS, which is improvement in symptoms scores. It's the international prostate symptom score validated questionnaire that's commonly used in Urology. And looking at the 3-year results on the right-hand side, the peak urinary flow rate, and a couple of things to take away, or statistically significant improvements from baseline, stable after three years, and consistent outcomes between TURP and Aquablation. And as Noridian noted in the LCD, the 3-year results were essentially unchanged from two years to three years.
The next slide shows what is a pre-specified subgroup analysis and as prostate get larger and larger, they become more complicated from a surgical approach. And in the Water Study, we looked at a subgroup analysis of 50 to 80 grand prostate. The average prostate treated in the study was about 54 grams. So, this was about half the patients in the study. And what was demonstrated here was Aquablation was superior to TURP both in safety and efficacy. And this speaks to the value of the robotic component in terms of the ability to have reproducible outcomes regardless of the size of the shape of the prostate.
On the next slide is just looking at the retreatment rates and this is a meta analysis of over 11,000 discharges, looking at TURP and laser and, and just comparing it. This is actually after five years. But looking at the results from the Water Study, both the TURP arm and Aquablation arm demonstrating that the retreatment rates. Again, kinda kinda well accepted or publish date out. There's about 2% retreatment rate per year and the results of the aqua, the Water Study are well within those, those published data.
On the next slide just a highlight of the Aquablation being added to the 2019 AUA BPH Surgical Guidelines and this was based on the one-year data that was published and available at that time. On slide 10, just highlighting the FDA labeling, where there's no restriction, in terms of size with the, with the FDA label. Which, next slide, please.
Thank you. And so, again, here's the FDA labeling. I'm going to jump in quickly to the next slide, which is the Water II study, and I'm just going to do an introduction. I am fortunate enough to have Dr. Mihir Desai from USC who is the PI for the Water II study. He'll go into it in more detail. But just to note here, this is the inclusion criteria. The patient demographics for the Water II study, compared to the Aquablation arm for the Water Study and very similar sort of inclusion criteria in terms of the patients with the exception of the prostate volume, where in the Water II, it was nearly two times greater prostate volume compared to the Water Study, and as I mentioned earlier, as prostate get larger and larger, get more complex from a surgical perspective and can influence the safety and efficacy outcomes.
And as you look at the next slide, which is just a quick summary of the Water II compared to Water Study at 2-year outcomes, again, recently published 2-year outcomes. And we're looking at the International prostate symptom score. Two things to note here is sustained improvement and symptom scores after two years for the large prostate. And what's interesting here is, as you look at each time point, consistency in terms of the outcomes at each time point that out to 2-years between Water and Water II. So, despite the fact that the prostate volume was greater two times in the prostate sizes greater than two times. Similar sort of outcomes of up to two years.
Next slide shows looking at the Open Water, which is the first really post market registry and this was All-Comers. This was 178 patients in five centers with prostates ranging from 20 to 148 grams in size with an average prostate of 59 milliliters, similar sort of safety profile and what you're seeing on this chart here on the left-hand side, symptom improvements at one year on the right Qmax. And we've got the Open Water plotted results plotted compared to Water and Water II, again, demonstrating consistency outcomes, So even in a commercial setting, where you're outside of the FDA controlled clinical environment, similar sort of outcomes between the two, between the three studies, really. Again, so reproducible outcomes.
The next slide. Just speaking to the contraindications that are included in the LCD. As we mentioned, excluding the catheter dependent patients from the from this, from the exclusion criteria. Again, this catheter dependency wasn’t on the exclusion criteria for the Water study, that was our first pivotal study. Subsequent to that, there's been the Water II, Open Water, as well as a Single Center Study out of Germany, where, again, nearly 400 patients were enrolled, and many of them with catheter dependency, and, and, or a higher rate of PBR. And, as a result, we demonstrated comparable outcomes, patients did well, and these are the type of patients who would benefit from a BPH surgery. So we'd recommend excluding that from the exclusion criteria as well.
So, in conclusion, we definitely support the LCD that considers Aquablation to be medically reasonable and necessary. Again, request modifying the inclusion criteria beyond just the Water Study. Increasing the prostate volume up to 150 ml, as well as including coverage for patients regardless of catheter dependency. And this is based, again, on the Water Study with the 3-year data recently published as well as society guidelines designation from CMS nationally. A substantial clinical improvement, which a lot of that was based on some of the outcomes from the Water II Study. And then, as I mentioned, the recently published 2-year data from the Water II Study demonstrating Aquablation with reproducible and predictable results regardless of the prostate size or shape. And I'll conclude there, and I've also asked Dr. Desai to speak on. As Dr. Clark, as you mentioned, this is a collaborative working group amongst the MACs. And I know a question came up on the last Open Meeting with Novitas about concern about potential cancer and Aquablation in terms of possible disruption there, so I've asked Dr. Desai to comment on that as well, based on his experience. So, I'll conclude there if there's any questions, thank you for the time.
Dr. Larry Clark:
Thank you. That was, I'm glad you're including that question. So that’s great. Jocelyn, do we have Dr. Mehan next or are we moving directly to Dr. Desai?
He has signed in.
Dr. Larry Clark:
OK, so our, our order is going to be then Dr. Mehan from East Valley Urology in Arizona and then the follow-up discussion with Dr. Desai, correct?
Dr. Larry Clark:
All right. If you would proceed, and thank you very much.
Thank you Mr. Salkeld. Our second commenter is Dr. Rahul Mehan.
Dr. Mehan, your line is open.
Dr. Rahul Mehan:
Hey, thank you so much.
It's an honor to be here and a pleasure to to address all of you. I'm a urologist in sunny Arizona. I'm in private practice. I've been out for over a decade and mainly focus on BPH enlarged prostates in my practice.
We were early to adopt Aquablation. We started in January and I've done a number of cases since then and it just just absolutely loved it. Our patients have been thrilled to have that here in Arizona, and the results that have really just conform to the enlarged study that we, that we looked at.
And I'm here just to, kind of, share my experience as a single center, and, like you guys know that, that, you know, we really value technology and seen it firsthand. It's awesome. Cool.
Can I ask you a question, this Dr. Clark.
You know, I noted that you had no conflicts of interest, so you actually, your practice went out to invest in this technology out of a potential other options or whatever you invested in this technology for your practice or are you using it at a local facility.
I'm using a local facility. I'm not. I have no financial interest in Aquablation. Other than bringing it out to my patients and I'm a kind of innovator in my field. [Inaudible] I worked for a number, there are other companies, for Green Light, for [inaudible]. And I always wanted to be on the cutting edge and this came out, it's just, so exciting and what it does, my God. I spent hours in the operating room doing large prostates, doing laser surgeries on, and we're doing TURPs on them. It takes hours and hours, and they have permanent retrograde ejaculation afterwards, permanent sexual side effects. And when this came out, you can do large prostates. And if you look at my series, I'm doing them in minutes and they have no sexual side effects, no retrograde ejaculations, it is an utter game changer for men and it is the future. It's what it is and I realized that. I have no interest financially. With Aquablation, you know, we use them at a hospital, and, there's, no, it's, we used, I go to Banner Health, and I've actually operating right now, and at Banner Health, and, and, you know, they're fortunate to get that, gives us a demo machine that we've been using it.
Thank you. Let me ask you another question. A couple of the people on the CAC mentioned comparing this to a Holmium laser, how does it match up? Do you use any of those other Blue light? You think this is better?
100%, so I trained with James Lingeman at Indiana University, where Holmium first came to the United States. That is my best friend, my mentor, my, my grandpa I call him. And I love that guy to no end. And we did so many, Holmium. So they came out and did Holmium in private practice for large prostate. You don't have to do an Open Prostatectomy or a Robotic Prostatectomy, which is barbaric to make an abdominal incision to treat a prostate. So I love Holmium, it came out and ran with it, but the problem with Holmium this you have retrograde ejaculation in all patients and for men with large prostates or even normal size prostates, you want to have a procedure. That is not an option. That is something that we overlooked when you talk to the older guys, in Urology. They downplay retrograde ejaculation to no end. They're like, “Oh, it's no big deal, it's less messy, nobody cares.” I have so many of these guys that I did Holmiums on when I first came out that have come back to me and are like I know this has just changed how I have sex, you know. My wife, for myself, it's not the same experience. And it is a permanent change when you have a Holmium laser procedure compared to this.
Dr. Larry Clark:
Thank you very interesting and if you allow me one more question since it sounds like, you're, you're basically talking about your your Center's experience, I notice on the slide is that one patient or several? You have somebody with a 140 gram prostate and your procedure time was 30 minutes. Is that correct?
Yes, it blew my mind, Absolutely blew my mind, and that, actually, that case was earlier on in my series. I'm quicker now, we've been doing them in, you know, in the 20 minute range, all sizes. And this is the future. The future is now. But this is what, how we're going to treat all prostates once Urologists adapt this and run with it. And once we get approved for Medicare, I mean, this is the future. A 140 gram prostate would take me 2 to 3 hours on Holmium. And I'm a fast surgeon for a robotic prostatectomy that took me 2 to 3 hours 3 out. You know, 1 or 2 days in the hospital, abdominal incisions, a lot of complications. You know this there's no comparison.
Dr. Larry Clark:
Do you have anything else to add from your [inaudible]? And thank you. We appreciate it when you know financially uninvolved clinicians come forward like this. So, thank you very much. Any other comments?
No. I'm excited to see what you do. I’m on a role with this. So many patients that are interested.
Dr. Larry Clark:
OK. Jocelyn, let us then, I guess, proceed and introduce Dr. Desai.
Okay, our third commenter is Dr. Mihir Desai. Dr. Desai, your line is open.
Dr. Mihir Desai:
Yes. Yeah, perfect. Again, thank you for the opportunity to share my thoughts about this technology. This is my background. I'm a Professor of Neurology at the University of Southern California.
Next slide, please.
I do have a conflict of interest. I've been a consultant with PROCEPT since the past six years, and I have also been I'm also the Co-PI of the Water II Study, which I'll be mainly talking about today.
Next slide, please.
So I've been involved with the Aquablation since it’s initial concept. The the pre commercial design devices, and international trials, and so my overall experience from 2013 with this technology is approximately 70 to 75 clinical procedures.
But what I'd like to talk today about is the use in the larger prostates, and this was the Water II study, and just as a way of background the pivotal randomized trial comparing it to TURP restricted the volume at 80cc, primarily because prostates beyond 80cc are not considered standard of care for TURP. And so, the control arm kind of dictated what size of prostates we received. But, as, as Mr. Salkeld presented in the Water data, that, it was very clear that this procedure was not volume dependent. In other words, operating time complications and outcomes did not change compared to the prostate volumes.
Number two, in the subset analysis of the larger prostates, there was superiority. And so as an extension of the initial North American trial, we did a PS II study which included prostates up to 150cc. And I truly feel having done Aquablation for the entire spectrum of prostate volume and sizes. It is these large prostates where the clinical benefit is even amplified further, because as we heard that the treatment outcomes are not volume dependent, as times do not go up, complications do not go up, and the options for treatment, alternative options for treatment for these large prostates are somewhat limited. Next slide.
So, just focusing on the data, just comparing the two groups. The Water II study obviously had larger prostate so that the average prostate volume was 107cc and the vast majority of these large prostates do have an intravesical medium low.
Next slide please.
Overall, these procedures were fairly quick. The total procedure time was 55 minutes that included doing the ultrasound and all aspects of the procedure and the resection time was only about eight minutes. The primary safety endpoint was met with the OPC being 65%, which is upper confidence limit level. But this was a 45% for all the Clavien 1 and persistent complications plus Clavien II or higher, which was below the OPC set for the safety endpoint. Next slide.
And also from a functional improvement, the symptom score reduced, and there was durable up to 24 months, and so also the improvement in the flow rates, as well as erection in the post-void residual.
Next slide, please.
So our conclusion was that, like, our experience with the initial Water randomized trial, Aquablation therapy was actually fairly good for patients with these larger prostates, with improvement with improved functional outcomes, low complication rates, and the reduced stay of hospitalization. It met both the primary safety and efficacy endpoints. And what are the other benefits? And there was a comment made about HoLEP and similar robotic procedures. The biggest, other benefit of Aquablation is that the learning curve is very short. In fact, the average number of cases done, or so they did in this trial, was only 0.5. And many sites did not have prior experience with Aquablation. And yet, the outcomes are consistent across the various treatment sites. And also, it is not restricted by the gland anatomy. In other words, intravesical lobes, median lobes, etc, can also be treated with Aquablation. Next slide.
The other important issue is that we found when we plotted the outcome data at various time points between the original Water study and Water II. The Water II outcomes essentially mirrored the outcomes of water in both the storage Fees Questionnaire, Voiding questionnaire, as well as the overall IP as a score. And so with this, we truly believe that the three are outcomes from Water II, are likely to also mirror the Water Study. Next slide.
Another aspect is comparing it what are the options for larger prostates and so Open Robotic Simple Prostatectomy is the one option for complication rates hospital Stay with these procedures are much higher. And while HoLEP or Enucleated procedures can be done with areas of centers of experience, even after 20 years of its being in practice or being introduced. Only a handful of centers in North America today offer HoLEP. So, it is very steep in its learning curve, and that was, that is one of the bigger benefits of Aquablation, where it can really be applied to centers doing fewer prostates in the community where BPH is primarily being treated. And so, that is a significant benefit.
And so, essentially, what we'd like to share is that the Water II outcomes are mirroring the Water Study outcomes that in terms of durability, the retreatment rate of of Water II with this study at two years was about 2%, which again is low and comparable to two more standard therapies for large prostates. And so one can reasonably state that the three year outcomes are very likely to be similar to what we saw at two years and has been recently published. Additionally, we did not see any more bleeding, complication rates, delayed bidding, complication rates in that second year after Aquablation.
And again, this again brings out the view of options for the large prostate.
And so, Aquablation truly, at this 80 grams plus volume will become a very applicable widely performable procedure in the hands of a Community and Academic Urologists, because of its low learning curve. And with a much lower morbidity, compared to Open or Robotics Simple Prostatectomy. And again, many of the Transurethral procedures, like TURPs etc., are not really applicable or that efficacious or safe in very large prostate. So this does bring about a an important treatment option for the large volume prostate.
I think that's it. I'd be happy to take any, any questions. I would like to make a comment about the question raised about the cancer risk of spreading with high pressure water jets. As Matt mentioned, the thing is in most people, most patients who present with symptoms of BPH that are to undergo any surgical procedure. That is typically a thorough work up for screening for intermediate to high risk prostate cancer. So these patients get a PSA, if their PSA is high, they typically would get either an MRI or a biopsy. And if they do have intermediate or high risk cancer, then they're usually counsel about treatment options that can fix both. And so, it is very unlikely that we'll be doing our population in the setting of higher risk prostate cancer.
Small volume, low risk prostate cancer is extremely [inaudible]. We, we perform multiple transurethral procedures such as TURP, laser therapy, etc., in that setting, which uses irrigation fluid etc., but the risk of spread is extremely low. And so, even in the setting of Aquablation, that should hold true. And so, in our entire experience thus far, we haven't really sensed any such link, and even theoretically, should not be a major backing.
Again, I'd be happy to take any questions.
Dr. Larry Clark:
Well, I'd like to ask you, besides the fact that I love the name, Open Water, would you comment upon that? I noticed on one of the slides there's a quote, real, The Real Life Study, what is different about that population? And do you think that is a more effective study in reflecting, let's say, university clinic population? I mean, is that the ultimate study?
Dr. Mihir Desai:
Well, yes and no. Again, Matt, correct me if I'm wrong, but the Open Water study was actually a study of, basically, a registry out of Europe. It's not in North America. And one of the problems with real life registries is the completeness and accuracy of data collection as compared to a prospective study, or a, or a regulatory study, where, you know, create more detail, goes into you know source data collection, audits, etc. So, yes, the, the, the Open Water study will reflect what happens in practices overall. But even if you look at the Water II study, there were multiple sites included in that study. And not all were academic tertiary care sites, in fact, I would say a significant bulk of these procedures were done in the community settings. So, it does actually reflect within the US. And North America practice settings, if fairly wide range of mix of cases. And many of these centers had done very few or no procedures priorly. And the average number of cases per site was only about four. So I think from that standpoint, the the Water II study, for the larger prostates also significantly reflects, you know, a wide spectrum of practices. But with more precise, source collected data, given the nature of the trial.
Dr. Larry Clark:
And just one more, if you would, you, you only mention median lobes once, it sounds as though that anatomic presence does not alter your ability to do this as simply or effectively. Is that right?
Correct. And the median lobe, in fact, you know, just you know, from personal experience is actually an easier lobe to visualize by TRUS ultrasound and, and we've had some very large, medium lobes. And those have all been effectively treated with it. So there is not anatomical or for that matter, real size restriction in which prostate cannot be treated.
Dr. Larry Clark:
Well, thank you very much.
I found this to be a very interesting presentation and put together very well. So, thank you very much. I mean, I think this is the way these meetings are, are designed to work. I don't know, Jocelyn, do I have, I do believe we have some representatives from other contractors, and we have, like, five minutes. Do we have any way to open lines, to anybody else that has a question? Or is that not within our electronic limitations, or outside our electronic limitations?
If you would like to comment, you can raise your hand, I guess.
Dr. Larry Clark:
Let's just see if any of our colleagues from other contractors have any questions or things they'd like to resolve.
And if not, then why don't I turn it back to you, Jocelyn, and thank you everybody for being here today.
Thank you. This concludes the presentation for today's open meeting.
In closing, we would like to communicate the next steps in the policy development process.
The comment period for the proposed LCD will remain open until August 8th, 2020. As noted earlier, all comments to be considered by our Medical Directors for the proposed LCD must be submitted in writing. Written comments can be e-mailed to email@example.com, or mailed to the address on your screen. Comment information for our proposed LCDs are located on our website at noridianmedicare.com. Upon review of the comments, our Medical Directors will either finalize or retire the proposed LCD. Please monitor our website or register for listserv notifications to be informed of actions taken on our proposed LCD.
Dr. Clark, do you have any comments?
Dr. Larry Clark:
Saying, I just realized, I'd like to remind everybody that Noridian will be having an Open Meeting, I believe, will be moderated by Dr. Janet Lawrence tomorrow on the topic of CT Scan Cerebral Perfusion. Is that correct, Jocelyn, you have any information on that meeting?
That is correct, it is tomorrow, and it is from, I believe, 3 to five PM Central.
Dr. Larry Clark:
Please check our website, and thank you for being with us today. Everybody, have a good day. Thank you.