Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Total Facet Arthroplasty

Description:

Facet arthroplasty refers to the implantation of a spinal prosthesis to restore posterior element structure and function as an adjunct to neural decompression. This procedure is proposed as an alternative to posterior spinal fusion for patients with facet arthrosis, spinal stenosis, and spondylolisthesis.

Spinal fusion is a common surgical treatment following surgical decompression when conservative treatment fails (Lurie, 2016). However, spinal fusion alters the normal biomechanics of the back, which may potentially lead to premature disc degeneration at adjacent levels. A variety of implants have been investigated as alternatives to rigid interbody or posterolateral intertransverse spinal fusion. This policy addresses the implantation of prostheses intended to replace the facet joints and excised posterior elements, termed facet arthroplasty.

The objective of facet arthroplasty is to stabilize the spine while retaining normal intervertebral motion of the surgically removed segment following neural decompression (Gu, 2021). It is proposed that facet arthroplasty should also maintain the normal biomechanics of the adjacent vertebrae. If normal motion patterns are achieved by artificial joints in the spine, the risk of adjacent-level degeneration thought to be associated with fusion may be mitigated.

Regulatory Status

No facet arthroplasty devices have been approved by the U.S. Food and Drug Administration (FDA). The ACADIA™ Facet Replacement System (Facet Solutions, acquired by Globus Medical in 2011 was being evaluated in a FDA-regulated investigational device exemption (IDE) Phase III trial, which was completed in October 2017; results without statistical analysis were posted on ClinicaltTrials.gov but have not been published in peer-reviewed literature (ClincalTrials.gov, 2020). A Phase III trial of the Total Facet Arthroplasty System® (TFAS®, Archus Orthopedics) has been discontinued.

Another implant design, the Total Posterior-element System (TOPS™, Premia Spine), is currently available in Europe.

Policy/
Coverage:

Effective August 2021

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Total facet arthroplasty does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, total facet arthroplasty is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective Prior to August 2021

Total facet arthroplasty does not meet member certificate of benefit primary coverage criteria because the procedure is being studied in clinical trials to determine safety and effectiveness. (NCT00401518 This study is ongoing, but not recruiting participants; NCT00405691 This study has been completed, results not posted)

For contracts without primary coverage criteria, total facet arthroplasty is considered investigational. Investigational services are an exclusion in the member benefit certificate.

Rationale:

A search of the MEDLINE database in June 2009 identified several ex vivo biomechanical assessments in cadaver spine. For example, Phillips and colleagues reported a manufacturer-sponsored study that assessed the kinematics of implanted and adjacent lumbar segments in 9 human lumbar spines (L1 to sacrum) (Phillips et al, 2009). No clinical trial results were found.

A clinical trial sponsored by the device developer is publicly listed (on clinicaltrials.gov) as active, but not currently recruiting. The study is designed for patients with moderate to severe lumbar spinal stenosis requiring neural decompression with facetectomy at L3-L4 or L4-L5 at a single level to treat central or lateral stenosis, Grade I degenerative spondylolisthesis with objective evidence of neurologic impairment, and degenerative disease of the facets, with or without instability. Specific inclusion criteria are patients between 50 and 85 years of age with degenerative spinal stenosis, central or lateral, at spinal levels L3-L4 or L4-L5, with persistent leg symptoms, including pain, numbness, burning or tingling that are refractory to at least 6 months of conservative treatment, no greater than Grade I degenerative spondylolisthesis at the index level, and no more than three levels of degenerative lumbar spinal stenosis requiring decompression. Study participants will be randomized in a 2:1 ratio into treatment with the investigational artificial facet replacement device (TFAS™) or with standard posterior instrumented fusion. No device has received FDA approval; therefore, there is a lack of scientific evidence that Total Facet Arthroplasty is safe or improves health outcomes.

2010 Update

A search of ClinicalTrials.gov in June 2010 showed 2 active phase III clinical trials, both sponsored by the device developers. NCT00401518 is an actively recruiting U.S. multi-center randomized trial of the ACADIA™ Facet Replacement System (Facet Solutions, Inc) compared with posterior spinal fusion. The study began in 2006, is expected to enroll around 300 subjects, and has an estimated completion of 24-month primary outcome data in 2013.

The posting indicates an estimated enrollment of 450 subjects beginning in 2005. The information on ClinicalTrials.gov was last updated in February 2009 (Facet Solutions acquired Archus Orthopedics and all of their assets in November 2009). A search of the FDA site shows one adverse event report in the MAUDE database for new back pain in a patient following implantation of the investigational device (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=889455).

2012 Update

Searches of the MEDLINE database, most recently performed through May 2012, identified a report indicating that the FDA-regulated multicenter investigational device exemption (IDE) trial (NCT00418197) of the Total Facet Arthroplasty System® (TFAS®) was discontinued due to financial reasons (Palmer, 2012). (Facet Solutions acquired Archus Orthopedics and all of their assets in November 2009). Two out of 10 TFAS procedures performed at the authors’ institution had stem fracture after total facet replacement.

Identified from the EMBASE database was a conference proceeding of interim results in 100 patients from the U.S. multicenter, randomized trial of the ACADIA™ Facet Replacement System (NCT00401518) (Dryer, 2010). The study began in 2006, is expected to enroll around 300 subjects with lumbar spinal stenosis, and compares facet arthroplasty with the ACADIA™ system to posterior spinal fusion. Information posted in October 2012 on the online site ClinicalTrials.gov indicates that recruitment is ongoing. Study completion is expected in 2013.

A search of ClinicalTrials.gov in October 2012 showed a prospective, multicenter clinical study to assess the Impliant TOPS™ system (NCT00405691), This study is listed as completed as of May 2011. The study began in 2006 with an estimated enrollment of 450 subjects with back and leg pain resulting from moderate/severe lumbar spinal stenosis at a single vertebral level between L3 to L5. The objective of the study is to compare the safety and effectiveness of the TOPS System to a control group of patients undergoing posterior spinal fusion with pedicle screws and local autograft bone.

At this time, no device has received FDA approval.

2013 Update

A search of the MEDLINE database through August 2013 did not reveal any new literature that would prompt a change in the coverage statement.

2014 Update

A literature search conducted through July 2014 did not reveal any new information that would prompt a change in the coverage statement.

2015 Update

A literature search conducted through July 2015 did not reveal any new information that would prompt a change in the coverage statement.

2017 Update

A literature search conducted through July 2017 did not reveal any new information that would prompt a change in the coverage statement.

2018 Update

A literature search was conducted through July 2018. There was no new information identified that would prompt a change in the coverage statement.

2019 Update

A literature search was conducted through July 2019. There was no new information identified that would prompt a change in the coverage statement.

2020 Update

Annual policy review completed with a literature search using the MEDLINE database through July 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

For the TOPS™ device, Smorgick et al reported 11-year outcomes of 10 individuals from a single center in Israel who received the TOPS™ device as an adjunct to decompression to treat neurogenic claudication of at least 12 weeks' duration due to spinal stenosis with single-level grade 1 L4-5 degenerative spondylolisthesis (Smorgick, 2019). In this study, 6-week improvements in leg pain, back pain, disability and quality of life were generally maintained at 11 years. In terms of adverse events, there was 1 case of implant failure at 12 weeks that involved damaged polycarbonate urethane component that led to internal locking of the device. But, no other instances of screw loosenings or breakages, spontaneous fusion, or progression of the spondylolisthesis were observed. Although these findings are encouraging, more rigorous evaluation of the TOPS™ device in large randomized controlled trials is still needed to determine its effects on health outcomes.

2021 Update

Annual policy review completed with a literature search using the MEDLINE database through July 2021. No new literature was identified that would prompt a change in the coverage statement.

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through July 2022. No new literature was identified that would prompt a change in the coverage statement.

2023 Update

Annual policy review completed with a literature search using the MEDLINE database through July 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

A phase 3 multicenter randomized trial of the ACADIA Facet Replacement System (NCT00401518) was completed in October 2017, but results have not yet been fully published; results without statistical analysis are posted on ClinicalTrials.gov (ClincalTrials.gov, 2020). The trial enrolled 390 subjects with lumbar spinal stenosis and compared facet arthroplasty with the ACADIA system to spinal fusion.

Results of a planned interim analysis of the randomized, single-blind, multicenter FDA investigational device exemption trial of the TOPS device were published by Coric et al (Coric, 2023). Adults age 35 to 80 years with grade I spondylolisthesis with symptomatic stenosis despite at least 6 months of conservative therapy (such as physical therapy, systemic pain management, or local injections or nerve block) were randomized 2:1 to undergo surgical decompression followed by either stabilization with TOPS or transforaminal lumbar interbody fusion (TLIF). The primary endpoint is a composite clinical success rate, defined as improvement of at least 15 points from baseline in the Oswestry Disability Index (ODI) without new or worsening neurological deficit or treatment failure (need for surgical reintervention or radiographic evidence of device breakage or disassembly), analyzed at 24-month post-operative follow-up. The interim analysis compared the primary endpoint in 170 patients randomized to TOPS and 79 patients randomized to control (total N=249; planned minimum sample size for final analysis is 300). While the authors stated the primary endpoint was not being tested for superiority or noninferiority in this interim analysis and the analysis was descriptive, statistical comparisons were reported; adjustment for increased risk of type I error was not reported. Composite clinical success at 24 months was reported in 85% of the TOPS arm and 64% of the TLIF arm (p=.0138). Proportions of patients in the TOPS and TLIF groups who reported a minimum 15-point improvement in ODI were 93.1% and 80.6%, respectively; new or worsening neurological deficit was reported in 3.4% and 12.1%, respectively. Device removal, revision, or supplementation was reported in 2.9% and 6.3% and surgical reintervention occurred in 5.8% and 8.8% of TOPS and TLIF patients, respectively. Improvements by at least 20 points from baseline in patient-reported visual analog scale (VAS) scores for back pain were reported in 83.5% of TOPS patients and 65.8% of TLIF patients at 6 weeks post-operatively (p=.004); at 24-month follow-up, 87% of the TOPS group and 64% of the TLIF group reported at least 20-point VAS improvement from baseline (p=.015). Improvements in VAS scores by at least 20 points from baseline for leg pain were similar between TOPS and TLIF patients at 6 weeks (92% and 93%, respectively) and 24 months (90% vs. 88%, respectively). Radiographically-assessed range of motion for flexion/extension of the treated vertebral level in the TOPS and TLIF groups at 24-month follow-up were 3.76 (vs. 3.75 at baseline) and 1.21 degrees (vs. 4.39 at baseline), respectively; range of motion for left/right lateral bending of the treated vertebral level at 24 months were 3.75 (vs. 3.25 at baseline) and 0.88 degrees (vs. 0.88 at baseline), respectively.

CPT/HCPCS:

References:

ClinicalTrials.gov.(2020) A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis (NCT00401518). Updated September 10, 2020. Accessed February 22, 2023.

Coric D, Nassr A, Kim PK, et al.(2023) Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis. J Neurosurg Spine. Jan 01 2023; 38(1): 115-125. PMID 36152329

Gu BJ, Blue R, Yoon J, et al.(2021) Posterior Lumbar Facet Replacement and Arthroplasty. Neurosurg Clin N Am. Oct 2021; 32(4): 521-526. PMID 34538478

Lurie J, Tomkins-Lane C.(2016) Management of lumbar spinal stenosis. BMJ. Jan 04 2016; 352: h6234. PMID 26727925

Myer J, Youssef JA, Rahn KA, et al.(2014) ACADIA facet replacement system IDE clinical trial: Preliminary outcomes at two-and four-years postoperative [abstract]. Spine J. 2014;11(Suppl. 1):S160-161.

NCT00401518.(2012) The Investigational Plan for the Evaluation of the ACADIA® Facet Replacement System. www.clinicaltrials.gov; last accessed 11/21/2012.

NCT00405691.(2012) A Prospective, Multi-Center Clinical Study to Assess the Saftey and Effectiveness of the Impliant TOPS System. www.clinicaltrials.gov; last accessed 11/21/2012.

Phillips FM, Tzermiadianos MN, Voronov LI, et al.(2009) Effect of the total facet arthroplasty system after complete laminectomy-facetectomy on the biomechanics of implanted and adjacent segments. Spine J 2009; 9(1):96-102.

Smorgick Y, Mirovsky Y, Floman Y et al.(2019) Long-term results for total lumbar facet joint replacement in the management of lumbar degenerative spondylolisthesis. J Neurosurg Spine. 2019 Oct;1-6:1-6. PMID 31585417

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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