Archived Policies - Surgery


Aquablation of the Prostate

Number:SUR710.024

Effective Date:01-01-2016

End Date:06-30-2016

Coverage:

Aquablation of the prostate for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is considered experimental, investigational and/or unproven.

Description:

Aquablation of the prostate is a novel minimally invasive water ablation therapy combining image guidance and robotics (AquaBeam®) for the targeted and heat-free removal of prostatic tissue in men suffering from lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The AquaBeam is a personalized image-guided tissue removal system, which utilizes proprietary heat-free high-velocity waterjet technology to resect and remove a predetermined volume of tissue with precise and automated incisions conforming to the shape of the prostate.

BPH is a non-cancerous enlargement of the prostate gland which can result in irritation or blockage of the urethra, the tube that carries urine out of the body from the bladder. BPH may lead to difficulty urinating, incontinence, bladder infections and the formation of stones or kidney damage. One out of every two men over the age of 50 develops symptoms of BPH, and one out of ten will need surgical intervention to remove part of the prostate. (1) Standard surgical procedures for BPH utilize heat (high thermal energy technologies) to remove or reduce the size of the prostate to improve symptoms and urine flow.

The Procept AquaBeam® aquablation system is not available for sale in the U.S.

Rationale:

Desai et al. reported on clinical experience in patients with symptomatic benign prostatic hypertrophy (BPH) undergoing image-guided waterjet ablation of the prostatic adenoma using a novel technology called aquablation. In this study aquablation was performed in 9 patients with symptomatic BPH (Mean age 68 years, prostate volume 37 cubic centimeter (cc) and median lobe present in 56%). All patients had urodynamic confirmation of bladder outlet obstruction. All procedures were technically successful with a mean operative time of 49 minutes and aquablation time of 12.2 minutes. Waterjet-guided laser fulguration was required in 3 cases. There were no peri-operative complications and no patients had dysuria 24 hours after catheter removal. The authors reported a novel robotic image guided technology that provides rapid ablation of prostate tissue in patients with symptomatic BPH. Use of waterjet-guided blue laser technology was determined to be of limited value as this initial clinical experience suggests that aquablation alone requires minimum hemostasis resulting in no postoperative dysuria. 1, 3, 6 and 12 month follow-up confirm significant improvement in IPSS, QoL and peak flow rates. Clinical trials with larger number of patients are currently ongoing.

Early clinical experience of aquablation was reported in Melbourne with 9 males suffering from lower urinary tract symptoms (LUTS) due to BPH (2). The 9 males with symptomatic BPH were enrolled and treated with aquablation under general anesthesia. Mean age was 66.7 years (SD=4.4, 62-75) and baseline prostate size was 61g (SD=26.4, 30-102). Median lobe was present in 7 of the 9 subjects treated. All procedures were technically successful with a mean total operative time of 32 minutes (SD=6.3, 23-43) and mean anesthesia time of 54 minutes (SD=7.6, 43-65). Mean aquablation treatment time was 5.0 minutes (SD=2.9, 2-7) and mean time for focal cautery instrumentation was 4.6 minutes (SD=1.1, 3-7). All 9 subjects were catheterized post-procedure and discharged from the hospital next day. Median catheterization time was 1 day. There were no bleeding complications, no clot retention nor blood transfusions. Post-operative dysuria was minimal and there were no cases of retrograde ejaculation, urinary incontinence or erectile dysfunction related to the procedure. At 3 month review mean International Prostate Symptom Score (IPSS) scores decreased from 23.1 to 5.0 and mean peak urinary flow rate (Qmax) increased from 8.3ml/s to 17.9ml/s. Preliminary results from this early clinical experience show promise for this treatment as a potential ablative treatment option for BPH. Further patient data will be required to validate this clinical experience.

Gilling et al. conducted a prospective, non-randomized, single-center trial in men between the ages of 50 - 80 years of age with moderate-to-severe LUTS. Under real-time image-based ultrasonic guidance, AquaBeam technology enabled surgical planning and mapping, and lead to a controlled heat-free resection of the prostate using a high-velocity saline stream. Patients were evaluated at one, three, and six months. Fifteen patients were treated (range of 59 to 86 years), and a mean prostate size of 54 ml (range of 27 to 85 ml). A significant median lobe was present in 6 of the 15 subjects. The mean IPSS was 23 and Qmax was 8.4 ml/s at baseline. The mean procedural time was 48 minutes with a mean aquablation treatment time of 8 minutes. All procedures were technically successful with no serious or unexpected adverse events. All but one patient had removal of catheter on day one, and the majority of patients were discharged on the first postoperative day. No patient required a blood transfusion, and post-operative sodium changes were negligible. No serious 30 day adverse events occurred. One patient underwent a second aquablation treatment within ninety days of the first procedure. The mean IPSS score statistically improved from 23.1 at baseline to 8.6 at 6 months (P<<0.0001) and the Qmax increased from 8.6 ml/sec at baseline to 18.6 ml/sec at the six month follow up (P<0.001). At 6 months, mean detrusor pressure @ Qmax decreased to 45 cmH20 from 66 cmH20 at baseline (P<0.05), and mean prostate size was reduced to 36 ml, a 31% reduction in size when compared to baseline (P<0.001). There were no cases of urinary incontinence or erectile dysfunction reported. The authors of this study note that these preliminary results from this initial study demonstrate that aquablation of the prostate is technically feasible with a safety profile comparable to other BPH technologies. The combination of surgical mapping by the operating surgeon and the high-velocity saline provides a promising technique delivering a conformal, quantifiable, and standardized heat-free ablation of the prostate. Advantages of this technique include reduction in resection time compared to other endoscopic modalities as well as the potential to preserve sexual function.

ClinicalTrials.gov identified an ongoing phase III study: “Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)”. A prospective multicenter randomized blinded study comparing aquablation of the prostate with the Aquabeam System and transurethral resection of the prostate (TURP) for the treatment of LUTS. The primary endpoints for safety and effectiveness will be measured at 3 and 6 months, respectively, and subjects will be followed out to 3 years to collect long-term clinical data. The estimated primary completion date is March 2017.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

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Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0421T

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Desai, Mihir et al. Image Guided Robotic Waterjet Ablation (Aquablation) of the Prostate: Clinical Experience of a Novel Technology for BPH. American Urological Association. Accessed Nov 20, 2015.

2. Gilling P., Reuther R., et al. - Aquablation - Image Guided Robotically-Assisted Waterjet Ablation of the Prostate: Initial Clinical Experience. BJU Int. 2015 Oct 19.

3. Early Clinical Experience in Melbourne of a Novel Treatment for BPH: Aquablation - Image Guided Robotic Waterjet Ablation of the Prostate BAUS 2015 ePoster online library. Anderson P. Jun 18, 2015.

Policy History:

DateReason
1/1/2016 New medical document. Aquablation of the prostate for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is considered experimental, investigational and/or unproven.

Archived Document(s):

Title:Effective Date:End Date:
Aquablation of the Prostate12-01-201711-14-2018
Aquablation of the Prostate07-01-201611-30-2017
Aquablation of the Prostate01-01-201606-30-2016
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