Archived Policies - Surgery


Nerve Graft in Association With Radical Prostatectomy

Number:SUR710.019

Effective Date:05-15-2015

End Date:12-31-2016

Coverage:

Unilateral or bilateral nerve graft is considered experimental, investigational and/or unproven in patients who have undergone resection of one or both neurovascular bundles as part of a radical prostatectomy.

Description:

Nerve grafting to replace cavernous nerves resected at the time of radical prostatectomy is proposed to reduce the risk of erectile dysfunction after this surgery. The sural nerve is most commonly used in grafting.

Background

Erectile dysfunction is a common problem after radical prostatectomy. In particular, spontaneous erections are usually absent in patients whose extent of prostate cancer requires bilateral resection of the neurovascular bundles as part of the radical prostatectomy procedure. A variety of noninvasive treatments are available, including vacuum constriction devices and intracavernosal injection therapy. However, spontaneous erectile activity is preferred by patients. Studies have reported results from bilateral nerve grafts; there are also reports of unilateral grafts when only 1 neurovascular bundle has been resected.

There has been interest in sural nerve grafting to replace cavernous nerves resected at the time of prostatectomy. The sural nerve is considered expendable and has been extensively used in other nerve grafting procedures, such as brachial plexus and peripheral nerve injuries. As applied to prostatectomy, a portion of the sural nerve is harvested from 1 leg and then anastomosed to the divided ends of the cavernous nerve. Reports are also being published using other nerves, such as the genitofemoral nerve.

Rationale:

After an initial literature search was performed in 2003, the policy was updated regularly with a literature review using MEDLINE.

The first randomized controlled trial (RCT) that evaluated nerve grafting was published in 2009 by Davis et al. (1) Eligibility criteria included age 65 years or younger, normal self-report baseline erectile function, and scheduled for a unilateral nerve-sparing radical prostatectomy with preservation of 1 neurovascular bundle. All patients had the other neurovascular bundle removed, and patients were randomly assigned to receive or not receive sural nerve grafting after its removal. The primary outcome was potency 2 years post-surgery, defined as the ability to have intercourse with or without erectile dysfunction medication. The investigators estimated that the control group would have a 40% potency rate and powered the study to detect an absolute difference of 20% between groups. All patients received the same early erectile dysfunction therapy including medication and mechanical devices. A sample size of 200 was originally planned to provide 80% power. However, after 107 patients were randomly assigned, a preplanned interim analysis of evaluable patients found similar rates of potency in the 2 groups; the Data Monitoring Committee estimated that there was less than a 5% chance that there would be a significant difference between groups with additional recruitment and the trial was stopped early. When data collection ended, end point data were available for 66 patients who had either achieved potency or had been followed up for 2 years without potency. Potency was achieved in 32 of 45 (71%) sural nerve graft patients and 14 of 21 (67%) control patients (p=0.78). The authors concluded that unilateral sural nerve graft did not result in an absolute improvement of 20% in the rate of potency but that a smaller effect cannot be ruled out. A limitation of the study was that it was non-blinded, which could have impacted self-report of potency.

Other than the Davis et al. study, the published literature consists of case series. The largest published series and those with the longest follow-up are described below:

In 2007, Namiki et al. published a series in Japan with a 3-year follow-up.(2) A total of 113 patients were evaluated: 19 patients with unilateral nerve-sparing plus sural nerve graft, 60 patients with unilateral nerve-sparing but no grafting, and 34 patients with bilateral nerve-sparing surgery. Sexual function was assessed with validated questionnaires, and at 2 years, there was no difference between the nerve-grafted and the bilateral nerve-sparing patients with regard to sexual function scores. At 3 years, 25% and 28% of patients in the nerve-grafted and bilateral nerve-sparing groups, respectively, considered their sexual function as fair or good. Urinary function returned to baseline in the nerve-grafted and bilateral nerve-sparing groups at 6 months and in the unilateral nerve-sparing group at 12 months. Differences in sexual function were present at baseline with the nerve-grafted and bilateral nerve-sparing patients reporting higher baseline function than the unilateral nerve-sparing group.

A 2010 case series reviewed the records of 131 men who had unilateral nerve grafts after radical prostatectomy with unilateral neurovascular bundle resection.(3) Men who had prior radiation or hormonal treatment were excluded. Another eligibility criterion was satisfactory erections presurgery as assessed by a 5-point scale (1=full erections; 2=diminished erections, but routinely sufficient for sexual intercourse; 3=partial erections occasionally satisfactory for intercourse; 4=partial erections unsatisfactory for intercourse; and 5=no erections). A total of 49 men received sural nerve grafts, 79 received genitofemoral nerve grafts, and 3 received ilioinguinal nerve grafts. Recovery of erections was evaluated at each follow-up visit according to the 5-point scale (also called 5 levels). The median patient age was 58.7 years, and the median follow-up was 37 months. According to actuarial analysis, the 5-year probability of recovering erections of level 3 or better was 46%. The probability of recovering erections of at least level 2 or level 1 was 34% and 12%, respectively.

A 2007 study by Secin et al. had 5-year follow-up. (4) The authors reported results on 44 consecutive patients who underwent bilateral nerve grafting from 1999 to 2004 at Memorial Sloan-Kettering Cancer Center. The overall 5-year recovery of erectile function was 34%, and the rate of consistent function was 11%. None of a number of variables (e.g., age, type of nerve [sural, genitofemoral, ilioinguinal], comorbidities) was significantly associated with recovery of postoperative erectile function.

2014 Update

Literature was searched through March 2014. A search of peer reviewed literature identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Ongoing Clinical Trials

Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial (NCT01770340) (5): This single-blind study includes 60 patients with prostate cancer. Patients have been randomized to receive radical prostatectomy with or without implantation of an allogenic nerve graft. The primary outcome is erectile function and follow-up is at least 24 months post-surgery. The expected date of final data collection is January 2014, although no outcome data has been published to date.

Summary

Nerve grafting, most commonly using the sural nerve, at the time of radical prostatectomy has been proposed to reduce the risk of postoperative erectile dysfunction. Only 1 randomized controlled trial (RCT) that evaluated sural nerve grafting with radical prostatectomy has been published, and this study did not find that unilateral nerve grafting was associated with a statistically significant improvement in potency rates 2 years post-surgery. An additional RCT is underway and results are expected in 2014

Practice Guidelines and Position Statements

The 2013 (V. 4) National Comprehensive Care Network (NCCN) prostate cancer guideline states that replacement of resected nerves has not been shown to be beneficial for recovery of erectile function after radical prostatectomy.(6)

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:

Disclaimer for coding information on Medical Policies

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

55840, 55842, 55845, 55899, 64999

HCPCS Codes

None.

ICD-9 Diagnosis Codes

Experimental, investigational and/or unproven for all diagnoses.

ICD-9 Procedure Codes

None

ICD-10 Diagnosis Codes

Experimental, investigational and/or unproven for all diagnoses.

ICD-10 Procedure Codes

0VT00ZZ


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. Davis JW, Chang DW, Chevray P et al. Randomized phase II trial evaluation of erectile function after attempted unilateral cavernous nerve-sparing retropubic radical prostatectomy with versus without unilateral sural nerve grafting for clinically localized prostate cancer. Eur Urol 2009; 55(5):1135-43.

2. Namiki S, Saito S, Nakagawa H et al. Impact of unilateral sural nerve graft on recovery of potency and continence following radical prostatectomy: 3-year longitudinal study. J Urol 2007; 178(1):212-6; discussion 16.

3. Rabbani F, Ramasamy R, Patel MI et al. Predictors of recovery of erectile function after unilateral cavernous nerve graft reconstruction at radical retropubic prostatectomy. J Sex Med 2010; 7(1 Pt 1):166-81.

4. Secin FP, Koppie TM, Scardino PT et al. Bilateral cavernous nerve interposition grafting during radical retropubic prostatectomy: Memorial Sloan-Kettering Cancer Center experience. J Urol 2007; 177(2):664-8.

5. Sponsored by Kantonsspital Winterthur KSW (Switzerland). Nerve Grafting With an Allograft during Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial (NCT01770340). Available online at: <www.clinicaltrials.gov>. Last accessed November, 2013.

6. National Comprehensive Cancer Network. Prostate Cancer. Clinical practice guidelines in oncology, V4.2013. Available online at <www.nccn.org.>Accessed April 29, 2014.

7. Nerve graft in association with radical prostatectomy. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2014 December) Surgery 7.01.81.

Policy History:

DateReason
5/15/2015 Reviewed. No changes.
7/1/2014 Document updated with literature review, coverage unchanged. CPT/HCPCS code(s) updated.
10/15/2013 Document updated with literature review, coverage unchanged and entire rationale section revised. Codes updated.
9/1/2009 Revised/ updated entire document. Coverage remains experimental, investigational and unproven.
9/1/2007 Revised/updated entire document.
8/15/2003 New Medical document.

Archived Document(s):

Back to Top