Response to Comments: Transurethral Waterjet Ablation of the Prostate (L38682)

Dear Dr. Noel,

I am writing this letter in support of coverage of Aquablation® for the surgical treatment of benign prostate hyperplasia (BPH). I have been in practice for 15 years, the last 10 years as part of Comprehensive Urology and William Beaumont Hospital. Currently, the primary surgical option is transurethral resection of the prostate (TURP) which is still considered the gold standard in BPH surgery. In addition, our practice offers Urolift and Rezum for men who have a strong desire for preservation of ejaculation but are willing to sacrifice the clinical improvement seen with TURP. For very large prostates, greater than 100 mL, we will offer an open or robotic assisted laparoscopic simple prostatectomy which is more invasive with a higher rate of bleeding complications and longer hospital stay. Laser enucleation is also an effective treatment for very large prostates but carries a steep learning curve, unlike Aquablation, which is an approach that many community urologists can master in a lower number of cases.

Aquablation is the first new technology to be randomized in comparison to TURP as part of an FDA study. I believe it meets an unmet clinical need as it provides consistent and reproducible outcomes regardless of prostate size which is detailed in the WATER and WATER II studies. I also believe that it is cost-effective when compared to a laparoscopic or open surgery or a staged TURP. In addition, it provides a significantly lower rate of retrograde ejaculation compared to other resective techniques. With Aquablation, I am able to offer patients a significant reduction in symptoms while minimizing their risk of sexual dysfunction. In addition, it has been studied on very large prostates (up to 200 mL in volume) and demonstrated similar outcomes.

I have had the opportunity to review WPS pending coverage policy issued May 28, 2020. I support coverage of Aquablation® for my Medicare patients and commend WPS for the favorable policy. However, I noted in the policy a limitation on prostate volume of 30-80cc by TRUS. I strongly encourage coverage of Aquablation with no limitation of prostate volume based on recently published 2-year data of WATER II when viewed in combination with the full body of existing clinical data on Aquablation. My recommendation is aligned with FDA label and the two private payer policies (Anthem and Humana) where no prostate size limitation is imposed. The retreatment rate at 2-years in the WATER II (prostates 80ml to 150ml) is low and is comparable to the retreatment rates reported at 2-years and 3-years in WATER (prostates 30ml to 80ml), and I can now reliably predict that these trends will continue in WATER II out to 3-years. I fully expect the durability with Aquablation to be similar to those rates reported using other tissue resective techniques.

I would welcome an opportunity to discuss my observations as well as the clinical utility of the technology. Medicare makes up a significant percentage of my practice and I believe it is important to provide patients access to new technologies. I can be reached at my office (248) 336-0123 to discuss this matter any further. Thank you in advance for your consideration.

Jason Gilleran, MD

Associate Professor, Dept of Urology
Oakland University William Beaumont School of Medicine
Comprehensive Urology
Royal Oak, MI

WPS agrees to amend prostate volume to 30-150 cc after careful review of very recently published literature.

Dear WPS:

This communication is regarding WPS’s proposed LCD (DL38682) Fluid Jet System Treatment for LTS/BPH. I support WPS’s proposed coverage of the Aquablation procedure used in the treatment of benign prostatic hyperplasia (BPH). As a practicing Urologist at PPG Urology in Fort Wayne, IN., I have extensive experience with a multitude of surgical approaches to address LUTS from BPH, and can personally attest to the efficacy and response to this new novel technique, particularly patients with very large prostates that have limited treatment options. The alternative treatments for severe BPH frequently necessitate travel well outside of our demographic area, or forces to undergo much more invasive procedures that carry increased risks and morbidities, and ultimately may be less effective. I am pleased that my Medicare BPH patients will have access to Aquablation therapy and hope to see CMMS remove any and all restrictions to the procedure.

Of note, recently published WATER II study 2-year clinical data addresses the efficacy of Aquablation in large prostates up to 150 mL. Desai M, et al. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80 – 150 cc): 2-Year Results. Canadian Journal of Urology, April 2020. As treatment options are limited for patients with large prostates, Aquablation is a safe and efficacious alternative to open prostatectomy with minimal side effects. Highlights from the study include:

Large Prostates - Water II 2-yr Highlights

Safety and efficacy
The 2-year results of the WATER II study demonstrate comparable outcomes in safety and efficacy to those reported in the WATER study despite twice the size in prostate volumes (107 v 54 mL).
Post procedure bleeding
In large prostates there have been no procedure-related hemorrhagic events 28 days post-Aquablation
Retreatment rate
The very low 2-year WATER II retreatment rate is comparable to that reported in the WATER 2-year and 3-year data
FDA labelling
The recently published 2-year data aligns with the Aquablation FDA labelling - no prostate size limitation is imposed

Given the new published data, it is my sincere hope that WPS’s final coverage LCD will not restrict prostate size to 80ml, but rather include prostates up to 150 ml. Doing so will allow Aquablation treatment for my Medicare patients, including those with large prostates, access to this new and effective BPH therapy which provides minimal side effects compared to other BPH treatments including open prostatectomy.

I appreciate the opportunity to comment on WPS’s Proposed LCD, DL38682: Fluid Jet System Treatment for LUTS/BPH.
Sincerely,

Scott Palmer, M.D. FACS
PPG Urology
Fort Wayne, Indiana

WPS agrees to amend prostate volume to 30-150 cc after careful review of very recently published literature

Dear WPS:

This communication is regarding WPS’s proposed LCD (DL38682) Fluid Jet System Treatment for LTS/BPH. I support WPS’s proposed coverage of the Aquablation procedure used in the treatment of benign prostatic hyperplasia (BPH). As a practicing Urologist at Van Wert, Ohio (and previously in Fort Wayne, Indiana with almost 10 years in practice and board certified by the American Board of Urology, I am pleased that my Medicare BPH patients will have access to Aquablation therapy.

My Aquablation patient outcomes are very positive and include quicker recoveries (less time off work and less time with significant discomfort and bother symptoms post-operatively), less ejaculatory dysfunction, no incidence of iatrogenic urinary incontinence, and overall better patient satisfaction. Most importantly in my opinion is the fact that I have been able to treat patients with larger prostates that previously I would have had to refer out to larger institutions offering HoLEP procedure. The nearest facilities to offer this are over 2 hours away for most of my patients. In addition to the major inconvenience, they are quite far if they experience any difficulties or complications and follow-up is also extremely inconvenient for them. I have had patients getting HoLEP who have developed permanent incontinence and other serious problems. For me, Aquablation has been an extremely reproducible, safe and clinically effective treatment for many of my BPH patients and has allowed me to help a much broader cohort of patients including patients with prostate size over 80 grams (in particular I have had success with prostates larger than 100 grams). I have also had success with catheter dependent patients in urinary retention and those with large residuals as well as the many, many patients wishing to have similar outcomes to TURP but preserve ejaculation and sexual function.

Of note, recently published WATER II study 2-year clinical data addresses the efficacy of Aquablation in large prostates up to 150 mL. Desai M, et al. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80 – 150 cc): 2-Year Results. Canadian Journal of Urology, April 2020. As treatment options are limited for patients with large prostates, Aquablation is a safe and efficacious alternative to open prostatectomy with minimal side effects.

Large Prostates - Water II 2-yr Highlights

Safety and efficacy

The 2-year results of the WATER II study demonstrate comparable outcomes in safety and efficacy to those reported in the WATER study despite twice the size in prostate volumes (107 v 54 mL).

Post procedure bleeding

In large prostates there have been no procedure-related hemorrhagic events 28 days post-Aquablation

Retreatment rate

The very low 2-year WATER II retreatment rate is comparable to that reported in the WATER 2-year and 3-year data

FDA labelling

The recently published 2-year data aligns with the Aquablation FDA labelling - no prostate size limitation is imposed

Given the new published data, it is my sincere hope that WPS’s final coverage LCD will not restrict prostate size to 80ml, but rather include prostates up to 150 ml. Doing so will allow Aquablation treatment for my Medicare patients, including those with large prostates, access to this new and effective BPH therapy which provides minimal side effects compared to other BPH treatments including open prostatectomy. I appreciate the opportunity to comment on WPS’s Proposed LCD, DL38682: Fluid Jet System Treatment for LUTS/BPH.

Sincerely,

Scott D. Shie, MD

WPS agrees to amend prostate volume to 30-150 cc after careful review of very recently published literature.

RE: Proposed Local Coverage Determination (LCD): Fluid Jet System Treatment for LUTS/BPH (DL38682); Related Draft Local Coverage Article: Billing and Coding: Fluid Jet System Treatment for LUTS/BPH (BPH) (DA58209)

Dear Dr. Noel,

On behalf of PROCEPT BioRobotics, I am submitting these comments to Wisconsin Physicians Service Insurance Corporation (WPS) regarding the proposed Local Coverage Decision (LCD) DL38682 and related proposed Article DA58209 for the Fluid Jet System Treatment for LUTS/BPH. Treatment delivered using the Fluid Jet System is also called “transurethral waterjet ablation of prostate” (see the code descriptor for CPT code 0421T) or “Aquablation® therapy.”

We would like to thank WPS for the opportunity to respond to the review of the literature and the proposed positive coverage determination. We support the determination within the draft LCD (DL 38682) that the Fluid Jet System is medically reasonable and necessary in the treatment of BPH. In these comments, we provide new, additional clinical evidence to support expanding the proposed coverage criteria beyond the inclusion and exclusion criteria of the original WATER Study. As discussed below in greater detail, we urge WPS to cover treatment with the Fluid Jet System for patients with prostate sizes up to 150 cc, and to cover patients without restrictions related to either catheter dependency or post void residuals (PVRs).

Technology Overview

PROCEPT BioRobotics is a U.S.-based medical device company that has developed and manufactures the AQUABEAM® System, which delivers Aquablation therapy for the ablation and removal of obstructions in males suffering from lower urinary tract symptoms (LUTS) due to BPH. The AQUABEAM System represents a novel mechanism of action to treat symptoms of LUTS, combining three components that are individually unique to BPH surgery:

1) real-time, multi-dimensional imaging;
2) the accuracy of an autonomous robot, and
3) a heat-free, submerged waterjet that selectively resects tissue from the prostate and prostatic urethra to remove the obstruction that causes the symptoms of BPH.

Support Coverage of the Fluid Jet System

PROCEPT BioRobotics supports coverage of the Fluid Jet System in the treatment of BPH as medically reasonable and necessary, and we highlight the following clinical information:

1. Body of clinical evidence (WATER (FDA study), WATER II (FDA study), OPEN WATER (post-market study)
2. Professional society support (AUA, EAU, CUA)
3. CMS determination of Aquablation as a “substantial clinical improvement”

Summary of Clinical Evidence

Aquablation therapy has been well researched with two significant FDA studies, commonly referred to as “WATER” (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) and “WATER II,” which are published in peer-reviewed journals. The AQUABEAM System is the first BPH surgical technique to execute a direct comparison to the gold standard in treating BPH, transurethral resection of the prostate (TURP), as part of an FDA pivotal study (NCT0205919).¹ Similarly, the AQUABEAM System is the first BPH surgical technique to be studied in an FDA IDE clinical trial for large prostates (NCT03123250).² Large prostates (generally 80 mL and above) present the greatest challenges for surgeons, and as a result, the typical treatment for large prostates until the advent of Fluid Jet Therapy has been the more-invasive open simple prostatectomy. In addition, male patients were enrolled in a global post-market registry, OPEN WATER, to evaluate Aquablation in a “real world setting” (NCT02974751)³.

The WATER study ⁴ is a 181 male patient double-blind, randomized clinical trial with 17 sites comparing Aquablation therapy to TURP in prostate sizes ranging from 30 to 80 mL. It is important to emphasize that the WATER study was double-blind requiring an independent blinded follow-up team at each site to minimize any bias.

Three-year outcomes of the WATER study demonstrate that Aquablation, when randomized to TURP, is superior in safety outcomes and comparable in BPH symptom reduction, urinary flow rate improvement, quality of life, and retreatment:⁵

• The mean in the symptom scores (IPSS) reduction at 3 years was 14.4 and 13.9 for Aquablation and TURP, respectively
• Aquablation demonstrated statistically superior outcomes in safety and efficacy in subjects with larger prostates (50 – 80 mL) within the WATER study as validated by reductions in symptom scores
• In both groups, maximum urinary flow rates increased markedly within 1 month after surgery and were maintained at 3 years. Mean 3-year improvements in Qmax were 11.6 and 8.2 for Aquablation and TURP, respectively
• There were no procedure-related adverse events between year 1 and year 3 in either arm
• No subjects required retreatment beyond 20 months post-operatively in either arm with an overall 3-year retreatment occurrence of 4.3% and 1.5% for Aquablation therapy and TURP, respectively
• Aquablation therapy demonstrated a marked reduction in the risk of postoperative anejaculation

WATER study conclusions:
As WPS noted in DL38682 when commenting on the outcomes published in the three-year manuscript, the “Three-year results were essentially unchanged”. This statement is correct, and this supports the fact the changes in patient outcomes from year 2 to year 3 are minimal and consistent with other BPH surgical options.

Furthermore, when publishing their 3-year results, the authors of the WATER study stated:

• Combined with results of other prospective trials, 3-year results from the current study provide compelling long-term evidence for the safety and effectiveness of Aquablation therapy in men with LUTS due to BPH.
• The evidence base for Aquablation therapy for LUTS due to BPH is increasing. In summary, our study provides high-quality 3-year evidence of Aquablation for LUTS due to BPH in men with prostate sizes between 30 and 80 mL with clinical efficacy and durability similar to TURP.

The WATER II study⁶ is a 101 male patient single-arm clinical trial with 16 sites assessing the safety and effectiveness of Aquablation in large prostates between 80 and 150 mL in volume, where open prostatectomy is still considered the gold standard. New evidence that became available recently (published in April 2020) with two-year outcomes revealed the following⁷:

• Statistically significant increase in symptom improvement and flow rates at two-years
• Safe and effective transurethral surgical alternative for large prostates between 80 and 150 mL
• Clinically normalizes outcomes among patients regardless of prostate size and shape
• The ability to move patients who would likely otherwise receive inpatient procedures to the outpatient setting (LOS = 1.6 days)
• Two patients (2%) required retreatment through two-years

WATER II study conclusions:
The authors of the WATER II Study noted:

• Our study provides strong evidence that the Aquablation procedure provides excellent mid-term (2-year) long-term relief of LUTS related to BPH. Our study is especially notable in that we enrolled men with a large prostate size (target range 80 – 150 cc, mean 107 cc, 83% with a large median lobe), a group that typically cannot undergo TURP.
• More important, it is feasible and effective for the subgroup of large prostates, for which treatment options are limited.
• The Aquablation procedure is a safe and effective, robotically executed and globally reproducible surgical option for the treatment of BPH-related LUTS in men with large prostate glands with durable outcomes at 2 years coupled with short operative times, limited hospitalization and low retreatment rates.

The recently published (February 2020) OPEN WATER Study⁸ is a multi-center, prospective, all-comers study of Aquablation therapy in a commercial real-world setting enrolling 178 patients in five commercial sites:

• This is the first multi-center publication of outcomes of the Aquablation procedure performed in a commercial setting with prostates ranging from 20 to 150 mL in volume
• At one-year follow-up, the Aquablation procedure was found to be safe and effective for men with LUTS due to BPH, and the results obtained in the commercial setting replicate those observed in previously reported trials of this procedure
• The mean IPSS reduction at one year was 15.3 which is comparable to the reductions of 15.1 and 17.0 reported at one year in the WATER and WATER II studies, respectively
• Maximum urinary flow rates increased to 11.8 mL/s at one year in this study compared to 10.4 mL/s and 12.4 mL/s in the WATER and WATER II studies, respectively
• The overall safety results were comparable to the WATER and WATER II studies with an extremely low rate of anejaculation (approximately 8%)
• There were no retreatments reported at one year

In addition, the OPEN WATER study further highlights that the learning curve for Aquablation therapy for practicing urologists is short and the positive results achieved in the WATER and WATER II studies are readily reproducible by urologists practicing in community-based hospitals who treat patients with prostate volumes ranging in size from 20 to 150 mL.

OPEN WATER study conclusions:
The authors of the OPEN WATER study noted:

• Our results indicate that the Aquablation procedure is safe and effective for men with LUTS due to BPH, and that the results obtained in the commercial setting replicate those observed in previously reported trials of this procedure.
• Real-world evidence shows that the Aquablation procedure is safe and effective for the treatment of symptomatic benign prostatic hyperplasia.

Society Support
Aquablation has been added to the BPH Surgical Guidelines by the American Urological Association (AUA), European Association of Urology (EAU), and the Canadian Urological Association (CUA) over the past few years based on the clinical evidence available and prior to the publication of the current evidence base.

American Urologic Association (AUA)

• As a result of the WATER study and the published outcomes at one year, the AUA included Aquablation therapy in its 2019 Practice Guidelines for the “Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia,” May 2019 ⁹
• Aquablation was the only surgical technique added in the amendment
• In addition, in October 2019 the AUA issued a letter to all MACs supporting coverage of Aquablation

European Association of Urology (EAU)
As a result of the WATER study and the published outcomes at two years, the EAU recognized Aquablation therapy in its 2020 “Management of Non-neurogenic Male LUTS”, March 2020.¹⁰ Aquablation therapy has been included in “Techniques Under Investigation” with a recommendation to offer Aquablation to patients with moderate-to-severe LUTS and prostates between 30 – 80 mL as an alternative to TURP. The EAU states that recommendations on new interventions will only be included in the guidelines once supported by RCTs looking at both efficacy and safety, with three-year follow-up.
The WATER study three-year outcomes were not available at the time of the clinical search for the preparation of the guidelines.

Centers for Medicare and Medicaid Services (CMS)
We acknowledge that the new technology add-on payment (NTAP) and the transitional pass-through (TPT) are elements of the payment process for CMS and are separate from the coverage process. In order to receive NTAP and TPT, the designation of a “substantial clinical improvement” is required including a rigorous review and assessment of the clinical literature. Based on both the WATER and WATER II studies, CMS found Aquablation therapy to represent a “substantial clinical improvement” to both TURP and simple prostatectomy in the FY 2019 inpatient rulemaking process (CMS-1694-F) granting Aquablation NTAP status:

• Results of the WATER study are statistically significant and superior to TURP in safety as evidenced by a lower proportion of persistent CD Grade 1 adverse events.
• Patients enrolled in the WATER study with prostate sizes > 50 mL and treated with Aquablation therapy had superior IPSS improvement [compared to] TURP.
• Results from the WATER II study for patients with large prostate volumes demonstrate better outcomes of the AquaBeam System over the standard-of-care, the open prostatectomy.

On November 1, 2019, CMS granted approval for a transitional pass-through (TPT) payment for Aquablation Therapy as part of the 2020 Outpatient Prospective Payment System (OPPS) ruling (CMS-1717-FC). Like the NTAP designation, CMS determined that Aquablation represents a “substantial clinical improvement” to current surgical techniques for BPH, stating “In conclusion, after review of the additional data and literature, we agree that the AquaBeam® System provides a substantial clinical improvement.” Specifically, CMS noted the following in the final rule:

• CMS concluded that the WATER study findings were statistically significant and showed Aquablation superior to TURP in safety, as well as that patients in the WATER study with prostates larger than 50 mL in volume treated with Aquablation had superior improvement in quantifiable symptom outcomes.
• The additional scientific data provided demonstrated Aquablation therapy’s superiority to other techniques, specifically reducing operative time and complications in general, especially for larger prostates. The results of the WATER clinical study were statistically significant and show Aquablation therapy was superior to TURP in safety as evidenced by a lower proportion of persistent adverse events (incontinence, ejaculatory dysfunction and erectile dysfunction) at three months.
• Additionally, results from the WATER II clinical study for patients with large prostates demonstrated better outcomes from Aquablation therapy over open prostatectomy, regarding shorter operative time, shorter length of stay, and decreased rates of severe hemorrhage and transfusions. The minimally invasive nature of Aquablation therapy offers men with large prostates (>80mL) an outpatient option.

We support the draft LCD determining the Fluid Jet System in the treatment of BPH as medically reasonable and necessary based on the literature referenced above and corroborated by the global urological societies as well as the CMS designation of Aquablation as a “substantial clinical improvement.”

Expand Coverage Criteria Beyond the Inclusion/Exclusion Criteria of WATER Study

Below we provide additional clinical literature and information to support expanding the coverage criteria beyond the inclusion and exclusion criteria of the WATER study, specifically requesting consideration for the following:

• Provide coverage for prostate sizes at least up to 150 cc by TRUS
• Provide coverage for patients with no restrictions on catheter dependency or PVR
  WATER and WATER II Comparison of Outcomes

Surgical options, especially with short learning curves, are limited when treating large prostates with LUTS due to BPH. Figure 1 compares the symptom improvement outcomes of Aquablation in 30–80 mL prostates with those in 80–150 mL prostates.

Figure 1 – WATER v WATER II 2-year Outcomes (IPPS) (See PDF Transurethral Waterjet Ablation of the Prostate (L38682) Attachment A attached to LCD L38682.)

As demonstrated in the graphs above, the symptom improvement in the larger prostates (80 to 150 mL) of the WATER II study as reported by the change in IPSS at 2 years is nearly identical at each time period despite the prostate volume nearly double in size compared to the WATER study. Based on the close alignment in the 2-year outcomes in WATER (30 to 80 mL sized prostates) and WATER II (80 to 150 mL sized prostates), one may conclude that for a resective technique like Aquablation, the outcomes of WATER and WATER II beyond two years of follow up will continue to mirror one another.

The results of WATER II demonstrate that Aquablation therapy clinically normalizes outcomes among patients regardless of prostate size or shape. Furthermore, the benefits of Aquablation therapy observed in the WATER study, including short OR time, short length of stay, and maintenance of antegrade ejaculation are comparable in both small-to-moderate and large-to-very-large volume prostates.

Aquablation Therapy Outcomes in Large Prostates (typically larger than 80mL in volume)

As noted in the proposed LCD, complication rates for standard of care (SOC) therapy are higher for larger prostates because they are typically more vascular and difficult to treat, and because the presence of a middle lobe also makes procedures technically more difficult. Clearly, larger prostates pose a clinical challenge for all other transurethral surgical approaches to BPH, and historically, this has limited hospital outpatient treatment options for men with larger prostates.

In fact, the FDA indications for use for many of the BPH treatment modalities are limited to prostates less than 80 mL in volume.^11,12 We provide additional new clinical studies and address additional aspects of Aquablation therapy in comparison to other treatment modalities for larger prostates ( 80 mL in prostatic volume and beyond) in the subsection below.

Table 1 summarizes the full scope of surgical approaches for LUTS due to BPH, including the primary list of those that would be considered for the treatment of large prostates. We have highlighted published data on the outcomes and how this influences the surgeon’s ability to treat these large prostates in the outpatient setting.

Table 1: Outcomes in Larger Prostates (Generally 80 mL in Volume and Larger) (See PDF Transurethral Waterjet Ablation of the Prostate (L38682) Attachment A below.)

A summary of Table 1 data notes that the complications can include, but are not limited to, the following:

• High rates of sexual dysfunction in TURP, SP, PVP, HoLEP and ThuLEP
• High rates of blood transfusions in TURP and SP
• Longer operative time due to the size of prostate in PVP, HoLEP and ThuLEP
• Transurethral resection (TUR) syndrome due to length of procedure
• High rates of re-intervention or secondary procedures in PVP
• Transient incontinence in HoLEP and ThuLEP

The gold standard intervention for large prostates 80 mL and above is to perform an open simple prostatectomy, a form of abdominal surgery that requires an inpatient hospitalization. The WATER II results for Aquablation therapy compare favorably to simple prostatectomy because the severe hemorrhage rate (defined as patients with a diagnosis related to hemorrhage and those who underwent transfusion) has been reported as high as 29% (range 12-29%) based on a claims analysis of 35,171 patients who underwent simple prostatectomy.¹⁸ Additionally, patients treated with Aquablation have an average length of stay of 1.6 days,⁶ with approximately half the patients being discharged in one day (outpatient) and the remaining patients typically being discharged the next day.

In summary, the WATER II results when compared to published literature of other BPH surgical approaches in large prostates demonstrate:

• Aquablation therapy is an outpatient, transurethral surgical alternative for patients with prostates larger than 80 mL;
• Aquablation provides reduced risk of complications and transfusions rates compared to open prostatectomy; and
• Aquablation has an average length of stay of 1.6 days, which is significantly shorter compared to simple open prostatectomy, which typically requires a 5-day inpatient hospitalization.^18,24

These results demonstrate a substantial clinical improvement for large prostates compared to the gold standard and most common procedure for large prostates in excess of 80 mL in size, as well as other BPH surgical approaches. In summary and as noted in Table 1, most of the transurethral surgical techniques are not recommended for large prostates, and therefore, options to surgically treat larger prostate glands are limited per guidelines to transurethral enucleation using either HoLEP or ThuLEP or open simple prostatectomy, which are discussed above.

FDA Labeling

The FDA labeling has no restrictions or limitation on prostate size. The indication for the AquaBeam System is: “The AquaBeam System is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.”²⁵

Therefore, a removal of prostate size limitation from the LCD is consistent with FDA labeling where no limitation is stated.

Outcomes of Aquablation In Patients With High Post-void Residual (PVR) Or Catheter Dependent

Proposed LCD DL38682 includes in its contraindications “other pivotal study exclusion criteria” and references the WATER study. Specifically, the WATER study excluded patients with PVRs > 300 mL, urinary retention at time of enrollment, or intermittent self-catheterization. Given the WATER study was the first pivotal trial of Aquablation, investigators recommended excluding these patients as these comorbidities can complicate the interpretation of outcomes assessment of a new surgical procedure.
Subsequent to the WATER study, there have been three prospective studies enrolling approximately 400 patients where PVR and catheter dependency were not an exclusion criterion for enrollment. The studies were WATER II, OPEN WATER, and a single-center experience from Germany (Bach et. al.).
The published results of these studies were aligned with the published outcomes in the WATER study. Specifically, the published literature highlights the following outcomes in those patients identified as catheter dependent:

• WATER II – at 3-month follow up, no subject was using a catheter routinely (n=16)
• OPEN WATER – at 12-month follow up, mean IPSS was ¹⁰ (n=36)
• Bach et al – at 3-month follow up, all patients successfully had catheter removed (n=29)

Bach et. al. goes on to conclude, “The wide range of prostate volumes, ….and avoiding strict exclusion criteria, like chronic urinary retention allows the conclusion that it is safe and efficient to include Aquablation treatment into clinical routine, without compromising the functional outcomes as reported in RCTs.”²⁶

Based on these results, Aquablation is a surgical alternative for treatment of catheter-dependent urinary retention in patients who also meet the other requirements for BPH surgery.

Conclusion

We support WPS’ proposed LCD (DL38682) concluding that the Fluid Jet System is medically reasonable and necessary in the treatment of BPH. We urge WPS to modify the proposed LCD to expand the coverage beyond the inclusion/exclusion criteria of the WATER Study, specifically:

• Increase coverage under the LCD to include prostates up to at least 150 mL in prostate volume or completely remove the size restriction, which more closely aligns with FDA labeling where no size restriction is identified
• Include coverage for patients regardless of catheter dependency or PVR

These recommendations are based on the following:

• The strength of clinical research, including recently published three-year follow up in the WATER RCT (published in February 2020), demonstrating safety, efficacy and durability comparable to other currently available surgical treatment options for BPH
• Society guidelines recommendation despite not inclusive of recently published clinical data
• Medicare’s TPT/NTAP determination that Aquablation represents a substantial clinical improvement over the existing standard of care treatment, that is, Aquablation is better than the standard of care (Oct 2018, Nov 2019)
• The recently published two-year outcomes from WATER II (published in April, 2020) demonstrating the application of Aquablation therapy for treatment of LUTS is prostate size independent and is a less invasive option for patients with very large prostates not generally eligible for TURP
• The recently published OPEN WATER study (published in February, 2020) further highlights that the learning curve for Aquablation therapy for practicing urologists is short and the positive results achieved in the WATER and WATER II studies are readily reproducible by urologists practicing in community-based hospitals located throughout the United States for prostates ranging in size from 20 to 150 mL in volume.
• The results from the WATER II, OPEN WATER, and Bach et al. studies indicating that clinical outcomes from Aquablation are unrelated to the degree of PVRs or the presence of catheter dependency.

At a time when there is increasing emphasis on treating elderly patients in ways that minimize their exposure to the health care system and promoting ability to return home to shelter in place, we urge you to give physicians and Medicare beneficiaries to opt for the use of Aquablation therapy for the treatment of LUTS due to BPH, especially for patients with limited clinical options such as individuals with prostates that are 80 mL in volume and above.

We appreciate the opportunity to provide comments regarding the AQUABEAM System and the proposed LCD.

Sincerely,
Matt Salkeld
Vice President, Healthcare Economics & Reimbursement
PROCEPT BioRobotics

1. https://clinicaltrials.gov/ct2/show/NCT02505919
2. https://clinicaltrials.gov/ct2/show/NCT03123250
3. https://clinicaltrials.gov/ct2/show/NCT02974751?cond=aquablation&draw=2&rank=5
4. Gilling, P. et al. WATER – A Double-Blind Randomized Controlled Trial of Aquablation vs. Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia, The Journal of Urology 2018
5. Gilling P, Barber N, Bidair M, et al. Three-Year Outcomes After Aquablation Compared to TURP: results from a blinded randomized trial. Canadian Journal of Urology February 2020.
6. Desai, M. et al. Aquablation for benign prostatic hyperplasia in large prostates (80–150 mL): 6-month results from the WATER II trial. BJUI 2019
7. Desai, M. et al. Aquablation for benign prostatic hyperplasia in large prostates (80-150 ml): 2-year results from the WATER II trial. Canadian Journal of Urology April 2020
8. Bach, et al. First Multi-Center All-Comers Study for the Aquablation Procedure. Journal Clinical Medicine. Feb 2020.
9. https://www.auanet.org/guidelines/benign-prostatic-hyperplasia-(bph)-guideline
10. https://uroweb.org/guideline/treatment-of-non-neurogenic-male-luts/
11. https://cdn2.hubspot.net/hubfs/2618738/L00136-01_RevA%20UroLift%20System%20UL400%20IFU.pdf
12. http://www.nxthera.com/pdf/3032-001-Rev-H_Rezum_IFU.pdf
13. Bachmann A, Tubaro A, Barber N et al: 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European multicenter randomised trial - the GOLIATH study. Eur Urol 2014; 65: 931
14. Kwon JS, Lee JW, Lee SW, et al. Comparison of effectiveness of monopolar and bipolar transurethral resection of the prostate and open prostatectomy in large benign prostatic hyperplasia. Korean Journal of Urology 2011; 52 (4) 2369-273
15. Mebust, W. et al. Transurethral Prostatectomy: Immediate and Postoperative Complications. A Cooperative Study of 13 Participating Institutions Evaluating 3,885 Patients. The Journal of Urology. 141, 243–247 (1989)
16. Data on file at PROCEPT BioRobotics
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20. Hueber P, et al. Mid-term outcomes of initial 250 case experience with GreenLight 120W-HPS photoselective varporization prostatectomy for benign prostatic hyperplasia: comparison of prostate volumes <60cc, 60 – 100cc, and > 100cc. The Canadian Journal of Urology October 2012
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WPS agrees to amend prostate volume to 30-150 cc after careful review of very recently published literature and to remove limitation #8 post void residual urine volume > 300 ml.

Dear Dr. Noel,

I submitted a letter in April 2020 addressed to Dr. Kettler supporting coverage of Aquablation for my Medicare patients prior to the recent policy being issued. I am pleased WPS has issued a positive coverage policy for Aquablation in the treatment of benign prostatic hyperplasia (BPH) due to lower urinary tract symptoms (LUTS). I am writing this letter to reiterate my support for coverage and the proposed coverage policy, and also request some modifications to the policy and its inclusions/exclusion criteria. Some of this information may be repetitive but relevant to the discussions of coverage.

I am a Urologist at the Michigan Institute of Urology, Associate Professor of Urology at the William Beaumont School of Medicine, Oakland University and the Director of Robotic Surgery at Beaumont Hospital Royal Oak. For my BPH patients, I offer a breadth of surgical options including Urolift, Rezum, Greenlight and finally, robotic simple prostatectomy for larger prostates.
Aquablation has been studied thoroughly including an RCT comparing Aquablation to transurethral resection of the prostate (TURP) as well as a study evaluating the technology in large prostates where these patients would most likely be treated using a more invasive procedure, open/robotic simple prostatectomy. In addition, my specialty society, the American Urological Association (AUA), added Aquablation to the BPH surgical guidelines in 2019.

The three-year outcomes of the RCT, WATER Study, were recently published in February 2020 confirming durable results and comparable outcomes to TURP. The results of this trial showed that Aquablation offered patients a superior safety profile compared to TURP, with a lower rate of sexual dysfunction and non-inferior efficacy outcomes in both symptom improvement and increase in urine flow rates. Furthermore, in a pre-specified subgroup analysis of larges prostates in the WATER study, Aquablation demonstrated superior outcomes at three-years in both safety and efficacy. The WATER II study, which assessed the technology in separate patient group with larger prostates (80 - 150 ml in volume) demonstrated a similar safety and efficacy profile as the RCT results confirming the reproducibility of the results in a complex patient set. The two-year outcomes from WATER II were published in April 2020 and confirmed the durability and reproducibility of outcomes in broad range of prostates.

I support the positive coverage policy and request WPS remove the limitations of prostate volume as part of the treatment criteria. As a I noted earlier, many patients with large prostates would be subject to a more invasive procedure like open/simple prostatectomy which has a higher risk of bleeding and multiple days in the hospital as part of the recovery. For these large prostates, the transurethral options are very limited. The WATER II outcomes demonstrated a lower risk of bleeding and most patients being discharged the day following the procedure as an outpatient procedure. In addition, the policy appears to state patients with a catheter dependency would not be eligible. I would also request that be excluded as those patients can benefit tremendously from such a procedure.

I appreciate the opportunity to comment on the policy. I am interested in offering this approach to my patients as it offers a safe, durable, and reproducible outcomes regardless of prostate size or shape. In addition, this is a good option for patients who want the improvement in symptoms and flow rates published in respective techniques like TURP and Greenlight, but with a low risk of sexual dysfunction. I would be more than willing to speak live if you would like additional insights.

Jason M. Hafron, M.D.
Associate Professor of Urology, William Beaumont School of Medicine, Oakland University
Director of Robotic Surgery, Beaumont Health, Royal Oak, Michigan
Michigan Institute of Urology

WPS agrees to amend prostate volume to 30-150 cc after careful review of very recently published literature

Dear Dr. Noel,

We are Urologists in Nebraska and part of one of the largest Urology practices in the state. Our practice has ten providers and the two of us work predominantly with patients suffering from BPH and bladder dysfunction. We perform a majority of the BPH surgeries for our group. We were clinical investigators in the WATER study and WATER II study and have performed 13 Aquablation procedures. As you know, the WATER study randomized Aquablation to transurethral resection of the prostate (TURP) which is still considered the gold standard for prostates less than 80 ml in volume. The WATER II study assessed Aquablation in larger prostates with a prostatic volume range of 80 -150 ml. These larger prostates are more complex and as a result the surgical options are limited.

We appreciate the opportunity to participate in the Open Meeting on June 17, 2020 and share our experience with Aquablation. As we noted in the meeting, the results of our 13 procedures were very good and consistent with the broader results of the two clinical studies. In the WATER study, we treated only one patient with Aquablation as the other patients we enrolled were randomized to TURP, and we enrolled 12 patients in WATER II. The one patient we treated in WATER had a prostate volume of 80 ml and the average prostate size of the patients we enrolled in WATER II was 105 ml with a range of 80 - 150 ml. Our patients have experienced significant and consistent improvement in symptom scores, maximum urinary flow rates, and low rate of retrograde ejaculation. Unlike"some of the other surgical approaches to BPH, we have seen similar results regardless of the prostate size or shape. We have been successful in treating large prostates where traditionally we might offer a more invasive approach like open or robotic prostatectomy. These traditional approaches add significant cost and longer hospital stays.

We support the current proposed positive coverage policy for Aquablation.. A majority of the patients We treated with Aquablation had prostates greater than 80 ml in volume. Obviously, the current proposed coverage policy would not allow us to treat those patients. Therefore, we request removing the upper limit of the restriction on prostate size. In addition to the data recently published for the WATER II, we have our own experience which corroborates those outcomes. Also, we would like to be able to treat patient suffering from retention or requiring catheterization. These patients represent the end stages of BPH and shouldn't be precluded from treatment option, available to everyone else. We have treated similar patients and Aquablation is a minimally invasive approath offering clinical improvements to these patients.

We appreciate the opportunity to participate in the Open Meeting. We warit to offer Aquablation to our Medicare patients and are pleased to see the proposed coverage policy. We recommend the two modification to the policy to allow the treatment of large prostates and patient suffering from catheter
dependency. Both of us would be happy to speak with you to discuss our experience. We can be reached at our office at 402-397-7989.

Best Regards,

AndrewTrainer,MD
Andrew Arther, MD
Adult Pediatric Urology and Urogynecology

WPS agrees to amend prostate volume to 30-150 cc after careful review of very recently published literature and to remove limitation #8 post void residual urine volume > 300 ml.