LCD Reference Article Response To Comments Article

Response to Comments: Water Vapor Thermal Therapy for LUTS/BPH

A56109

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
National Government Services, Inc.	MAC - Part A	06101 - MAC A	J - 06	Illinois
National Government Services, Inc.	MAC - Part B	06102 - MAC B	J - 06	Illinois
National Government Services, Inc.	MAC - Part A	06201 - MAC A	J - 06	Minnesota
National Government Services, Inc.	MAC - Part B	06202 - MAC B	J - 06	Minnesota
National Government Services, Inc.	MAC - Part A	06301 - MAC A	J - 06	Wisconsin
National Government Services, Inc.	MAC - Part B	06302 - MAC B	J - 06	Wisconsin
National Government Services, Inc.	A and B and HHH MAC	13101 - MAC A	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13102 - MAC B	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13201 - MAC A	J - K	New York - Entire State
National Government Services, Inc.	A and B and HHH MAC	13202 - MAC B	J - K	New York - Downstate
National Government Services, Inc.	A and B and HHH MAC	13282 - MAC B	J - K	New York - Upstate
National Government Services, Inc.	A and B and HHH MAC	13292 - MAC B	J - K	New York - Queens
National Government Services, Inc.	A and B and HHH MAC	14111 - MAC A	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14112 - MAC B	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14211 - MAC A	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14212 - MAC B	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14311 - MAC A	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14312 - MAC B	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14411 - MAC A	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14412 - MAC B	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14511 - MAC A	J - K	Vermont
National Government Services, Inc.	A and B and HHH MAC	14512 - MAC B	J - K	Vermont

Article Information

General Information

Article ID
A56109

Article Title
Response to Comments: Water Vapor Thermal Therapy for LUTS/BPH

Article Type
Response to Comments

Original Effective Date
12/01/2018

Retirement Date
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Article Guidance

Article Text

As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the Water Vapor Thermal Therapy for LUTS/BPH LCD. The official notice period for the final LCD begins on October 16, 2018, and the final determination will become effective on December 1, 2018.

NGS received comments from Boston Scientific, which recently acquired Rezum (and from ten clinicians with remarkably similar structure and content), requesting the elimination or modification of most of the draft LCD indications and contraindications, most of which were based on the inclusion/exclusion criteria in the Rezum pivotal trial. The comments will be responded to individually below.

NGS also received unique comments from several clinicians (17-20 below).

Response To Comments

Number	Comment	Response
1	Change the title to “Water Vapor Thermal Therapy for LUTS/BPH as “WAVE” is no longer utilized by the manufacturer.	As stated by one commenter, “the various names for the Rezum procedure is something of a Tower of Babel.” There does now seem to be consensus, however, on the name Water Vapor Thermal Therapy, so we agree to this change.
2	Change the age indication from “> 50” to “> 45” based on 2018 AUA BPH Guidelines.	While NGS agrees that the lower age limit for prostate detection has moved from 50 to 45 between the 2010 and 2018 AUA guideline, the pivotal RCT only studied patients “at least 50.” Our indications were meant to match so will be modified to ≥50.
3	Remove the prostate volume of 30-80 cc restriction, citing two retrospective reviews of treated patients with larger prostates.	NGS disagrees. The 30-80 cc restriction matches the FDA clearance, the indication used in the pivotal trial, and the 2018 AUA Guideline (“water vapor thermal therapy may be offered to patients with LUTS attributed to BPH provided prostate volume <80g”). This is a curious example where, since the commenters don’t agree with the new AUA guideline, they uncharacteristically don’t consider it dispositive.
4	Add “if present” to the obstructing median lobe requirement, since “some patients present with only lateral lobe obstruction and benefit from the Rezum procedure.” It is noted that the FDA indication didn’t restrict to the median lobe only and that the pivotal trial showed similar benefit in patients with lateral and median lobe hyperplasia.	NGS disagrees. We had significant concerns with the existing Rezum data, as outlined in the draft Analysis of Evidence, such that we inclined toward non-coverage pending long-term data. We ultimately decided on coverage in cases of an obstructing median lobe as a compromise given Rezum’s apparent advantage over other minimally invasive therapies in this regard.
5	Remove the restriction to “poor candidate for other surgical interventions for BPH due to underlying disease.” They cite as a rationale that many men do not want to undergo surgical interventions such as TURP.	NGS disagrees. Other minimally invasive surgical interventions with long-term data, and endorsed by AUA, exist. The choice is not limited to TURP or Rezum. Also, most guidelines cite “poor surgical candidate” as at least a relative indication for the choice of minimally-invasive ablative treatments, given their poor durability vis-à-vis resection approaches such as TURP, as noted in the draft LCD. For example, EAU guidelines note that “TUMT is a true outpatient procedure and an alternative for older patients with comorbidities and those at risk for anaesthesia or otherwise unsuitable for invasive treatment” (1), and UpToDate recommends TURP “for men who require an invasive procedure and are in good health” (2). As with the median lobe limitation, NGS decided coverage of this group represented a reasonable balance considering the cited data limitations. European Association of Urology. Guidelines on the management of non-neurogenic LUTS-BPH. 2014; https://uroweb.org/wp-content/uploads/Non-Neurogenic-Male-LUTS_2705.pdf. Cunningham GR, Kadmon D. Transurethral procedures for treating benign prostatic hyperplasia. Uptodate 2018; https://www.uptodate.com/contents/transurethral-procedures-for-treating-benign-prostatic-hyperplasia?topicRef=6891&source=see_link
6	Change the > 2.5 ng/mL PSA contraindication to > 10 ng/mL, saying “the restriction concerning the RCT was to avoid enrolling men into the trial at risk for an unexplored risk for prostate cancer. A more clinically relevant criterion is that the patient not be known or suspected to have prostate malignancy and/or PSA > 10 ng/mL.”	We agree the goal is to exclude patients known or suspected to have prostate cancer. We, therefore, agree with changing the upper PSA limit to 10 ng/mL, assuming NCCN Prostate Cancer Early Detection guidelines to rule out prostate cancer are satisfied.
7	Change the “active urinary tract infection” contraindication to “Patients with a UTI will be appropriately treated and have a negative urine culture before initiating treatment with water vapor thermal therapy procedure.”	NGS believes the goals here are the same but declines to define for clinicians what would constitute an adequately treated infection in every situation.
8	Remove PVR reference in the urinary retention contraindication, noting that “this limitation relates to the absence of published data for BPH medical therapies in those men…rather than clinical evidence that this level of PVR volume is in some way harmful.” They also cite the Darson Rezum community study (and a 2017 presented abstract) of treated men with higher PVRs.	NGS disagrees. These were the patients studied in both the pilot study and pivotal RCT. Although the Darson study (described in the draft) included 30 patients with a PVR > 250 mL (including three in retention), the results of this subgroup were not specified. Regarding the abstract, NGS only considers peer reviewed studies cited in PubMed.
9	Delete the “urethral stricture” contraindication, noting that “the limitation on urethral stricture is relevant only to men with active stricture conditions rather than the entire cohort of men with strictures. This revision is to ensure that the stricture is not the source of the current LUTS complaint.”	NGS agrees with better defining the contraindication to include patients with an “active urethral stricture (i.e., the source of the current LUTS).”
10	Delete the sentence: “The most apt comparators to WAVE include transurethral needle ablation (TUNA), and transurethral microwave thermotherapy (TUMT), both minimally invasive thermal ablative techniques,” citing 2018 AUA BPH Guidelines.	NGS disagrees. NGS outlined in the draft LCD Analysis of Evidence, and stands by, how the combination of various guideline recommendations (including the just issued 2018 AUA BPH Guideline), and our review of the published data, informed the final coverage position.
11	Add a paragraph with the FDA indications for Rezum.	NGS disagrees. A paragraph already includes most of the requested wording.
12	Delete the entire TUNA section, citing 2018 AUA BPH Guidelines.	NGS disagrees. See #10 response.
13	In the Analysis of Evidence sentence: “compared to TUNA and TUMT, water vapor thermal therapy data is limited in time (mid-term), scope (no studies comparing water vapor thermal therapy…,” remove scope and reference to no studies, citing a study comparing Rezum to medical therapy. Strangely, this followed an earlier comment stating: “the draft LCD is correct in stating that the “scope” of Water Vapor Thermal Therapy is an issue as there is no comparison with another technology (TURP or otherwise).”	NGS disagrees. The full sentence reads: “Compared to TUNA and TUMT, WAVE data is limited in time (mid-term), scope (no studies comparing WAVE to other surgical options), and independence (no studies independent of manufacturer funding, and at least some author conflict of interest (“financial interest and/or other relationship with NxThera”)).” The comment omitted the full quote which specified comparison “to other surgical options.” Of note, the commenter did not offer any rebuttal to the various Rezum data limitations as written (not just scope, but time and independence as well); these limitations were key in determining our commensurate limited coverage.
14	In the Analysis of Evidence section delete the sentence: “The lack of long-term results is particularly important in view of the relatively low IPSS and Qmax percent improvement after WAVE at 3 years (Table). Especially concerning is the sudden drop in Qmax improvement (53% to 39%) between years two and three, as this objective outcome metric is less subject to the placebo effect than IPSS. Although still significantly improved from baseline, the trajectory is troubling.”	NGS disagrees. The commenter cites the 3-year RCT data as a basis for this request (despite already detailed in the draft Summary of Evidence section), none of which either contradicts or specifically addresses the concerns outlined in the sentence requested for deletion. Curiously, the oft cited 2018 AUA recommendation did not review the concerning three-year data even though epublished six months prior. As noted in the draft Analysis of Evidence: "The new AUA WAVE recommendation based on one study’s two-year data seems premature, especially in light of the subsequent Qmax drop from year two to three."
15	Revise the sentence: “NGS, therefore, will tentatively cover WAVE treatment for LUTS/BPH (with an obstructing median lobe) in poor surgical candidates, under criteria otherwise largely based on the RCT, pending long-term data.” Change to” NGS will cover Water Vapor Thermal Therapy treatment for LUTS/BPH to include patients with an obstructive median lobe under criteria outlined in the “Coverage Indications, Limitations, and/or Medical Necessity” section of the LCD.”	NGS agrees with the name change only. The original wording reflects our considered, and hopefully reasonably balanced, coverage stance, given the (unrefuted) concerns with the data outlined in the draft LCD.
16	NGS received comments from the first author of the 3-year Rezum RCT study (who happens also to be the senior author of the recent 2018 BPH AUA update), which largely matched those of the Rezum manufacturer with a couple notable exceptions. First, this commenter simply stated that “the LCD document is correct in stating that the “scope” of Water Vapor Thermal Therapy is an issue as there is no comparison with another technology (TURP or otherwise),” but without going on to request deletion of the reference to scope and no studies. Second, the commenter did not request removal of the limitation to “poor candidate for other surgical interventions for BPH due to underlying disease.”	We appreciate acknowledging when there is agreement, not just when there is disagreement. Similar to the manufacturer, there seems to be also tacit agreement with the other two data limitations cited in the draft relative to time and independence.
17	Delete the prostatic length requirement of at least 25 mm.	NGS agrees. This wasn’t specified by the RCT so will be left to surgeon discretion.
18	Delete the indication: “Maximum urinary flow rate (Qmax) of ≤15 mL/s (voided volume greater than 125 cc),” as some patients have “retention or a very weak stream.”	NGS disagrees. Not only was this a primary inclusion criterion of the pivotal RCT, only two commenters objected to it.
19	Delete the contraindication of “prior prostate surgery” as the patient may have had tissue regrowth (e.g., after a TURP).	NGS disagrees. This was one area where about half of the clinicians, who otherwise echoed the manufacturer comments, differed. Since no prior prostate surgery was a requirement in the pivotal RCT, outcomes in a prostate with scarred and regrown tissue hasn’t been rigorously studied.
20	Delete the contraindication of “neurogenic bladder,” as “it is good for a study design to eliminate confounding factors but does not mean it is a contraindication.”	NGS disagrees. Not only was this an exclusion criterion of the pivotal RCT, only a single commenter objected to it. As to the broader point regarding “confounding factors,” it remains unknown how the introduction of “confounding factors” will confound clinical outcomes.

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Contents

Response to Comments: Water Vapor Thermal Therapy for LUTS/BPH

Document Note

Note History

Contractor Information

Article Information

General Information

CMS National Coverage Policy

Article Guidance

Response To Comments

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