Medical Policy

Policy Num:      07.001.065
Policy Name:    Artificial Intervertebral Disc: Lumbar Spine
Policy ID:          [07.001.065]  [Ac / B / M- / P-]  [7.01.87]

Last Review:      May 20, 2024
Next Review:      May 20, 2025
 

Related Policies:

07.001.058- Artificial Intervertebral Disc: Cervical Spine
07.001.102- Lumbar Spinal Fusion

Artificial Intervertebral Disc: Lumbar Spine

summary

Description

Total disc replacement, using an artificial intervertebral disc designed for the lumbar spine, is proposed as an alternative to spinal fusion in patients with degenerative disc disease leading to disabling symptoms.

Summary of Evidence

For individuals who have lumbar degenerative disc disease who receive a lumbar artificial intervertebral disc, the evidence includes randomized controlled trials (RCTs) of artificial discs versus fusion with 5-year outcomes and case series with longer term outcomes. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Five-year outcomes for the ProDisc-L RCT have provided evidence for the noninferiority of artificial disc replacement compared to spinal fusion. The superiority of ProDisc-L with circumferential fusion was achieved at 2 but not at 5 years in this unblinded trial. The potential benefits of the artificial disc (eg, faster recovery, reduced adjacent-level disc degeneration) have not been demonstrated. Also, considerable uncertainty remains whether response rates will continue to decline over longer time periods and long-term complications with these implants will emerge. Although some randomized trials have concluded that this technology is noninferior to spinal fusion, outcomes that would make noninferiority sufficient to demonstrate the clinical benefit of the artificial lumbar disc have not been established. No RCTs compared activL to spinal fusion or conservative care. In general, RCTs were limited by a lack of blinding, insufficient follow-up to evaluate potential harms, and lack of comparison to the criterion standard for treatment of degenerative disc disease. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information

Not applicable

OBJECTIVE

The objective of this evidence review is to determine whether implantation of a lumbar artificial intervertebral disc improves the net health outcome in patients with degenerative disc disease.

POLICY

Artificial intervertebral discs of the lumbar spine are considered investigational.

POLICY GUIDELINES

Coding

See the Codes table for details.

BENEFIT APPLICATION

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

BACKGROUND

Degenerative disc disease, the most frequent cause of back pain requiring surgery, is common with age or trauma. Spine imaging, such as magnetic resonance imaging (MRI), computed tomography, or plain radiography, shows that lumbar disc degeneration is widespread, but for most people it does not cause symptoms. Potential candidates for artificial disc replacement have chronic low back pain attributed to degenerative disc disease, lack of improvement with nonoperative treatment, and no contraindications for the procedure, which include multilevel disease, spinal stenosis, spondylolisthesis, scoliosis, previous major spine surgery, neurologic symptoms, and other minor contraindications. Patients who require procedures in addition to fusion (eg, laminectomy, decompression) are not candidates for the artificial disc.

When conservative treatment of degenerative disc disease fails, a common surgical approach is spinal fusion. More than 200,000 spinal fusions are performed each year. However, outcomes with spinal fusion have been controversial, in part due to the difficulty in determining if a patient's back pain is related to degenerative disc disease and in part due to the success of the procedure itself. Also, spinal fusion alters the spine biomechanics, potentially leading to premature disc degeneration at adjacent levels, a particular concern for younger patients. During the past 30 years, various artificial intervertebral discs have been investigated as an alternative approach to fusion. This approach, also referred to as total disc replacement or spinal arthroplasty, is intended to maintain normal biomechanics of the adjacent vertebrae and motion at the operative level once the damaged disc has been removed.

Use of a motion-preserving artificial disc increases the potential for various types of implant failure. They include device failure (eg, device fracture, dislocation, or wear), bone-implant interface failure (eg, subsidence, dislocation-migration, vertebral body fracture), and host response to the implant (eg, osteolysis, heterotopic ossification, pseudotumor formation).

Regulatory Status

Three artificial lumbar disc devices (activL, Charité, ProDisc-L) have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process (Table 1). Production under the name Charité was stopped in 2010 and the device was withdrawn in 2012.

Because the long-term safety and effectiveness of these devices were not known when approved, approval was contingent on completion of postmarketing studies. The activL (Aesculap Implant Systems) and ProDisc-L (Synthes Spine) devices are indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographs. The activL device is approved for use at 1 level. Initial approval for ProDiscL was also limited to patients with disease at 1 level. In April 2020, the ProDiscL indication was expanded to include patients with disease at up to 2 consecutive levels.^1,

Table 1. U.S. Food and Drug Administration-Approved Lumbar Artificial Disc Devices

PMA: premarket approval

A number of other artificial lumbar discs are in development or available only outside of the United States:

• The INMOTIONlumbar artificial disc (DePuy Spine) is a modification of the Charité device with a change in name under the same premarket approval. The INMOTION® is not currently marketed in the United States.

• The Maverick artificial disc (Medtronic) is not marketed in the United States due to patent infringement litigation.

• The metal-on-metal FlexiCore artificial disc (Stryker Spine) has completed the investigational device exemption trial as part of the FDA approval process and is currently being used under continued access.

• Kineflex-L (Spinal Motion) is a 3-piece, modular, metal-on-metal implant. An FDA advisory committee meeting on the Kineflex-L, scheduled in 2013, but was canceled without explanation.

FDA product code: MJO.

RATIONALE

This evidence review was created in April 2003 with searches of the PubMed database. The most recent literature update was performed through March 28, 2024.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function, including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

This review focuses only on artificial discs currently available in the United States.

Population Reference No. 1 Policy Statement

Clinical Context and Therapy Purpose

The purpose of the lumbar artificial intervertebral disc in patients with degenerative disc disease is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with lumbar degenerative disc disease.

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographs.

Intervention

The therapy being considered is implantation of a lumbar artificial intervertebral disc.

Two artificial intervertebral discs are currently marketed in the U.S.: ProdiscL and activL.

Comparators

The following therapies are currently being used to make decisions about lumbar artificial intervertebral disc.

Relevant comparators are conservative therapy and lumbar spinal fusion.

Conservative treatment may include physical therapy, pharmacotherapy, epidural steroid injections, and many other modalities. The terms “nonsurgical” and “nonoperative” have also been used to describe conservative treatment. For example, professional societies recommend that surgery for lumbar spinal stenosis should be considered only after a patient fails to respond to conservative treatment, but there is no consensus about what constitutes an adequate treatment course or duration

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity.

Outcome measures for back surgery are relatively well-established (Table 2). These include back and leg visual analog scores to assess pain and the Oswestry Disability Index to assess functional limitations related to back pain. Broader functional status indices such as the 12-Item Short Form Health Survey or 36-Item Short Form Health Survey, particularly the physical function subscale of 36-Item Short Form Health Survey, are also used.

Table 2. Patient-reported Outcome Measures for Back Pain

MDD: minimal detectable difference; MCID: minimal clinically important difference.

Both short-term and long-term outcomes are important in evaluating back treatments. Net benefit should take into account immediate (perioperative) adverse events; improvements in pain, neurological status, and function at 12 to 24 months as measured by the Oswestry Disability Index, 36-Item Short Form Health Survey (SF-36), or visual analog scale measures; and 5-year secondary surgery rates, which reflect longer-term complications, recurrences, and treatment failures. Lumbar artificial disc devices are theorized to reduce the occurrence of adjacent-level degeneration, which has been observed after fusion more often than occurs naturally in nonfused segments; some RCTs have reported the occurrence of adjacent level degeneration at 5 years.

Patient preferences are important in decision-making about elective back surgery. In particular, to avoid the morbidity and risk of complications of the surgery, some patients may choose to prolong conservative treatments even if it means they have additional pain and functional limitation. Conversely, some patients will accept long-term outcomes of surgery similar to those of conservative therapy to get faster relief of symptoms and improvement in function. Patient preferences have not been compared in a systematic fashion.

Group means are commonly designated as primary outcome measures in spine studies. Variation in the calculation and definition of minimal clinically important difference makes it difficult to compare response rates across studies. Nevertheless, clinical trials should prespecify a minimal clinically important difference for Oswestry Disability Index and other measures when used, and report response rates in addition to group means.

The primary outcome in FDA regulated trials was a composite measure of success, which incorporates symptom improvement and absence of complications.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Randomized Controlled Trials

Three RCTs have compared the treatment of degenerative disc disease using lumbar fusion with artificial lumbar intervertebral discs currently available in the United States. They include the pivotal trials for the ProDisc-L and activL discs, and a U.S. Food and Drug Administration (FDA) regulated trial of the ProDisc-L for 2-level degenerative disc disease. A fourth trial compared ProDisc-L with multidisciplinary rehabilitation. The composite success endpoint included improvements in Oswestry Disability Index scores (typically 15 points), improvement or maintenance in neurologic status, radiologic measures of range of motion, freedom from additional surgery, and freedom from serious device-related adverse events. Five-year outcomes have been reported from the pivotal trials for both ProDisc-L and activL. Eight-year data have been reported from a comparison of ProDisc II with multidisciplinary rehabilitation.

A key feature all of these trials is the recruitment of patients specifically with degenerative disease of the intervertebral disc. Degenerative disc disease is partly a diagnosis of exclusion where the degenerated disc is believed to be the pain generator. Radiographic evidence of degenerative disc disease may include a reduction of disc height and Modic changes, a posterior high-intensity zone, or a dark/black nucleus pulposus on T2-weighted images. Patients with common indications for spinal fusion such as scoliosis, spondylolisthesis, instability, or radiculopathy were excluded.

Characteristics of these trials are summarized in Table 3, results in Table 4, and study relevance, design, and conduct limitations are summarized in Tables 5 and 6.

ProDisc -L at a Single Level Compared to Fusion

The pivotal study for the ProDisc-L was an unblinded noninferiority trial that originally followed patients for 24 months.^2,3, In the per-protocol analysis reported to FDA, ProDisc-L had a success rate of 53.4% and fusion had a success rate of 40.8%, which achieved both non-inferiority and superiority. Two-year results from this trial were published in 2007, and 5-year follow-up was reported in 2012.^4,5,6, The definition of success was changed from the analysis requested by FDA and was reported to be higher at 63.5% at 2 years and 53.7% at 5 years. Noninferiority, but not superiority, of artificial disc replacement was achieved at 5 years. This change in overall success in ProDisc-L patients indicates a possible decrement in response over time with the artificial disc. This decline in response rate was not observed in the standard fusion group and resulted in a between-group convergence of the primary outcome measure over time. Several individual components of the primary outcome measure and secondary outcome measures (Oswestry Disability Index, 36-Item Short-Form Health Survey Physical Component Summary, neurologic success, device success) were also statistically better in the ProDisc-L group than in the fusion group at 2 years, but not at 5 years. Post hoc analysis of radiographs found fewer patients with adjacent-level degeneration in the ProDisc-L group than in the control group. However, the adjacent-level reoperations did not differ significantly between groups (1.9% ProDisc-L vs 4% controls).

An updated TEC Assessment (2013) evaluated 5-year follow-up from the ProDisc pivotal trial.^7, The Assessment concluded that:

• Additional study of ProDisc in an appropriately powered clinical trial with minimum 5-year follow-up is needed to confirm the results of the investigational device exemption trial in patients with single-level chronic symptomatic degenerative disc disease unresponsive to conservative management.

• Questions remain about the durability of the disc, in particular, the long-term effects on patient health of polyethylene wear debris. Surgical revision of a failed or dysfunctional disc may be complicated and dangerous to the patient, so the lifespan of a prosthetic device is a key issue.

• The main claim of the artificial disc-that it maintains range of motion and thereby reduces the risk of adjacent-level segment degeneration better than fusion-remains subject to debate.

ProDisc -L at 2 Levels Compared to Fusion

The ProDisc-L for 2-level lumbar degenerative disc disease was reported in 2011 from a multicenter, randomized, FDA regulated noninferiority trial.^8, All patients had degenerative disc disease at 2 contiguous vertebral levels from L3 to S1 with or without leg pain, a minimum of 6 months of conservative therapy, and a minimum Oswestry Disability Index score of 40. The ProDisc-L group had faster surgeries (160.2 minutes vs 272.8 minutes), less estimated blood loss (398.1 mL vs 569.3 mL), and shorter hospital lengths of stay (3.8 days vs 5.0 days) than the arthrodesis group. The composite measure of success demonstrated noninferiority but not superiority of ProDisc-L. The ProDisc-L group showed significant benefit in the percentages of patients who achieved at least a 15-point improvement in Oswestry Disability Index scores and greater improvements in the SF-36 scores. A greater percentage of patients in the arthrodesis group required secondary surgical procedures. As noted in an accompanying commentary, the study had a number of limitations.^9, Comparison with a procedure (open 360° fusion) that is not the criterion standard precludes decisions on the comparative efficacy of this procedure to the standard of care. Other limitations include the relatively short follow-up and lack of blinding of patients and providers.

ProDisc -LCompared to Conservative Treatment

Hellum et al (2011) reported an RCT that compared the use of the ProDisc-L with a multidisciplinary rehabilitation program.^10, Patients (N=173) were ages 25 to 55 years, had low back pain for a least a year, received physical therapy or chiropractic treatment for at least 6 months without sufficient effect, had an Oswestry Disability Index score of at least 30, and showed degenerative intervertebral changes that included at least 40% reduction of disc height, Modic changes, a high-intensity zone in the disc, and morphologic changes identified as changes in the signal intensity in the disc of grade 3 or 4. The multidisciplinary rehabilitation included a cognitive approach and supervised physical exercise. The primary outcome was Oswestry Disability Index score, and the trial was powered to detect a 10-point difference in Oswestry Disability Index score. The analysis was intention-to-treat with the last observation carried forward. There were 13 (15%) dropouts in the surgical arm and 21 (24%) in the rehabilitation arm. Also, 5 (6%) patients crossed over from rehabilitation to surgery. Of the 34 patients lost to follow-up, 26 answered a questionnaire between 2.5 and 5 years after treatment. In the intention-to-treat analysis, there was a statistically significant benefit of surgery, but the mean difference did not achieve the 10-point difference in Oswestry Disability Index score considered clinically significant. There were significantly more patients who achieved a 15-point improvement in Oswestry Disability Index score in the ProDisc group, with a number needed to treat of 4.4. The radiographic assessment identified a similar level of adjacent segment degeneration in both groups, but an increase in facet arthropathy in the ProDisc II group.^11,

Eight-year follow-up of this trial was reported by Furunes et al (2017).^12, In both the intention-to-treat and per-protocol analysis there was a statistically significant benefit of surgery as measured by the mean Oswestry Disability Index, but these differences did not reach the clinically significant threshold of 10 points (see Table 4). More patients in the surgery group (43/61 [70%]) reached a clinically important difference of 15 Oswestry Disability Index points than in the rehabilitation group (26/52 [50%]; p=0.03). Twenty-one (24%) patients randomized to rehabilitation crossed over to surgery while 12 (14%) patients randomized to surgery had undergone additional back surgery.

activL Artificial Disc

There are no RCTs of activL^® compared to fusion or conservative treatment.

Two-year outcomes from the multicenter investigational device exemption trial of the activL artificial intervertebral disc were reported by Garcia et al (2015).^13, In this patient-blinded noninferiority trial, patients with degenerative disc disease were randomized to treatment with activL or an FDA approved disc (ProDisc-L or Charité). At 2 years, activL was both noninferior and superior to the control group of patients treated with ProDisc-L or Charité. Intention-to-treat analysis of secondary outcome measures showed similar improvements between activL and controls. Range of motion at the index level, measured by an independent core radiographic laboratory, was higher in the activL group than in the controls.

Five-year results from this trial were reported in Yue et al (2019).^14, Of 341 patients enrolled, 261 contributed data at 5 years (76.5%). The primary composite endpoint results were reported graphically only, and demonstrated noninferiority at 5 years for activL versus control artificial discs. Sensitivity analyses using various imputation methods for missing data also showed noninferiority of activL, with the exception of the worst-case scenario (missing data counted as failure for activL and success for control). Freedom from serious adverse events through 5 years was 64% with activL and 47% with control artificial discs (P=0.0068). Seven-year results for 206 individuals who received activL or ProDisc-L were reported in Radcliff et al (2021) and showed no increase in serious adverse events between years 5 and 7.^15,

Because this study compared activL to other fusion devices, it provides only indirect evidence of effectiveness compared to fusion or conservative care. The study was not powered to detect differences by different control devices, and the control group included patients who received a device that is no longer available in the United States (Charite). Additional limitations were a high loss to follow-up at 5 and 7 years, unblinded outcome assessment, and no blinding of patients at the 5-year and 7-year assessments.

Table 3. Summary of Key RCT Characteristics for Lumbar Artificial Discs Available in the United States

IDE: Investigational Device Exemption; DDD: degenerative disc disease; ODI: Oswestry Disability Index; RCT: randomized controlled trial.

Table 4. Summary of Key RCT Outcomes for Artificial Intervertebral Discs Available in the United States

CI: confidence interval; MD: mean difference; NNT: number needed to treat; MD: mean difference; NR: not reported; ODI: Oswestry Disability Index; RCT: randomized controlled trial; Rehab: multidisciplinary rehabilitation; VAS: visual analog score.

Study Limitations

Tables 5 and 6 summarize the relevance, design, and conduct limitations of the RCTs of artificial discs available in the U.S. The most serious limitations included a lack of blinding, insufficient follow-up to evaluate potential harms, and comparators that are not relevant to current practice.

Table 5. Study Relevance Limitations for RCTs of Artificial Intervertebral Discs Available in the United States

DDD: degenerative disk disease.The evidence limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 6. Study Design and Conduct Limitations for RCTs of Artificial Intervertebral Discs Available in the United States

The evidence limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Observational Studies

While observational studies do not provide evidence of efficacy or comparative efficacy, they may provide information about the durability of any observed improvements and potential impacts of patient selection factors (see Tables 7 and 8).

Siepe et al (2014) reported on a minimum 5-year follow-up for 181 patients implanted with the ProDisc II at their institution.^16,This represented 90.0% of the initial cohort of 201 patients from this prospective clinic-funded quality review. Oswestry Disability Index and visual analog score pain scores were assessed by investigators not involved in pre- or postoperative decision making. At final follow-up, Oswestry Disability Index and visual analog score pain scores were significantly improved over baseline. Overall satisfaction rates were 89.1% for single-level and 69.0% for 2-level disc replacement.

Laugesen et al (2017) found significant improvements in pain and function with 1- or 2-level ProDisc II implantation at follow-up of 10.6 years, but pain remained moderate, and about one-third of patients required revision to fusion.^17, The authors noted the need for appropriate selection criteria.

Another case series, by Tropiano et al (2005), followed 55 patients for an average of 8.7 years after disc replacement with the ProDisc-L; 60% of patients reported excellent results.^18,

Table 7. Summary of Prospective Cohort Study Characteristics

DDD: degenerative disc disease.

Table 8. Summary of Key Cohort Study Results

FU: follow-up; ODI: Oswestry Disability Index; PDQ: Dallas Pain Questionnaire; VAS: visual analog scale.

Summary of Evidence

For individuals who have lumbar degenerative disc disease who receive a lumbar artificial intervertebral disc, the evidence includes RCTs of artificial discs versus fusion with 5-year outcomes and case series with longer term outcomes. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Five-year outcomes for the ProDisc -L RCT have provided evidence for the noninferiority of artificial disc replacement compared to spinal fusion. The superiority of ProDisc -L with circumferential fusion was achieved at 2 but not at 5 years in this unblinded trial. The potential benefits of the artificial disc (eg, faster recovery, reduced adjacent-level disc degeneration) have not been demonstrated. Also, considerable uncertainty remains whether response rates will continue to decline over longer time periods and long-term complications with these implants will emerge. Although some randomized trials have concluded that this technology is noninferior to spinal fusion, outcomes that would make noninferiority sufficient to demonstrate the clinical benefit of the artificial lumbar disc have not been established. No RCTs compared activL to spinal fusion or conservative care. In general, RCTs were limited by a lack of blinding, insufficient follow-up to evaluate potential harms, and lack of comparison to the criterion standard for treatment of degenerative disc disease. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

SUPPLEMENTAL INFORMATION

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Clinical Input From Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2008 Input

In response to requests, input was received from 1 physician specialty society and 3 academic medical centers while this policy was under review in 2008. The 4 reviewers disagreed with the policy statement that artificial intervertebral discs for the lumbar spine are investigational.

After considering the clinical input in 2008, it was concluded that, due to limitations of the available randomized controlled trials (described herein), combined with the marginal benefit compared with fusion, evidence was insufficient to determine whether artificial lumbar discs are beneficial in the short term. Also, serious questions remained about potential long-term complications with these implants.

PRACTICE GUIDELINES AND POSITION STATEMENTS

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Pain Society

In 2009, the American Pain Society’s practice guidelines concluded there was “insufficient evidence” to adequately evaluate the long-term benefits and harms of vertebral disc replacement.^19, The guidelines were based on a systematic review commissioned by the Society and conducted by the Oregon Evidence-Based Practice Center.^20, The rationale for the recommendation was that, although artificial disc replacement has been associated with outcomes similar to fusion, the trial results were only applicable to a narrowly defined subset of patients with single-level degenerative disease, and the type of fusion surgery in the trials is no longer widely used due to frequent poor outcomes. Also, all trials had been industry-funded, and data on long-term (>2 years) benefits and harms following artificial disc replacement were limited.

National Institute for Health and Care Excellence

In 2009, the National Institute for Health and Care Excellence updated its guidance on the safety and efficacy of prosthetic intervertebral disc replacement in the lumbar spine with studies reporting 13-year follow-up but with most of the “evidence from studies with shorter durations of follow-up.”^21,The Institute concluded that evidence was “adequate to support the use of this procedure.”

North American Spine Society

In 2019, the North American Spine Society issued coverage recommendations for lumbar artificial disc replacement.^22, The following recommendation was made:

Lumbar Artificial Disc Replacement is indicated for patients with discogenic low back pain who meet ALL of the following criteria:

1. Symptomatic single level lumbar disc disease at L3-L4, L4-L5 or L5-S1 level

2. Presence of symptoms for at least 6 months or greater and that are not responsive to multi-modal nonoperative treatment over that period that should include a physical therapy/rehabilitation program but may also include (but not limited to) pain management, injections, cognitive behavior therapy, and active exercise programs

3. Any underlying psychiatric disorder, such as depression, should be diagnosed and the management optimized prior to surgical intervention

4. Primary complaint of axial pain, with a possible secondary complaint of lower extremity pain

Lumbar Disc Arthroplasty is NOT indicated in ANY of the following scenarios:

1. Any case that does not fulfill ALL of the above criteria

2. Presence of symptomatic degenerative disk disease at more than 1 level

3. Presence of spinal instability with spondylolisthesis greater than Grade I

4. Chronic radiculopathy (unremitting pain with predominance of leg pain symptoms greater than back pain symptoms extending over a period of at least 1 year)

5. Osteopenia as evidenced by a DEXA bone mineral density T-score less than or equal to -1.0

6. Poorly managed psychiatric disorder

7. Significant facet arthropathy at the index level

8. Age greater than 60 years or less than 18 years

9. Presence of infection or tumor

10. Age greater than 60 years or less than 18 years

11. Presence of infection or tumor

U.S. Preventive Services Task Force Recommendations

Not applicable.

MEDICARE NATIONAL COVERAGE

Effective for services performed on or after August 14, 2007, Centers for Medicare & Medicaid Services (CMS) found “that lumbar artificial disc replacement is not reasonable and necessary for the Medicare population older than 60 years of age; therefore, lumbar artificial disc replacement is non-covered for Medicare beneficiaries older than 60 years of age.” “For Medicare beneficiaries 60 years of age and younger, there is no national coverage determination for lumbar artificial disc replacement, leaving such determinations to be made by the local contractors.”^23,

The national coverage determination was revised in September 2007 to reflect a change from noncoverage for a specific implant (the Charité), to noncoverage for the lumbar artificial disc replacement procedure for the Medicare population older than 60 years of age. CMS provided this explanation,

"The original NCD [national coverage determination] for LADR [lumbar artificial disc replacement] was focused on a specific lumbar artificial disc implant (Charite ) because it was the only one with FDA [Food and Drug Administration] approval at that time. In the original decision memorandum for LADR CMS stated that when another lumbar artificial disc received FDA approval [CMS] would reconsider the policy. Subsequently, another lumbar artificial disc, ProDisc -L, received FDA approval, which initiated the reconsideration of [the] NCD [national coverage determination] on LADR. After reviewing the evidence, CMS is convinced that indications for the procedure of LADR exclude the populations older than age 60; therefore, the revised NCD addresses the procedure of lumbar artificial disc replacement rather than lumbar artificial disc replacement with a specific manufacture’s implant."^24,

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in March 2024 did not identify any ongoing or unpublished trials that would likely influence this review

REFERENCES

1. U.S. Food & Drug Administration. The prodisc L Total Disc Replacement P050010/S020. April 10, 2020. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050010S020 Accessed March 27, 2024.
2. U.S. Food and Drug Administration. Draft: PRODISC-L Total Disc Replacement package insert. 2005; https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050010c.pdf. Accessed March 26, 2024.
3. U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data: PRODISC-L Total Disc Replacement. 2006; https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050010b.pdf. Accessed March 28, 2024.
4. Zigler J, Delamarter R, Spivak JM, et al. Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease. Spine (Phila Pa 1976). May 15 2007; 32(11): 1155-62; discussion 1163. PMID 17495770
5. Zigler JE, Delamarter RB. Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc disease. J Neurosurg Spine. Dec 2012; 17(6): 493-501. PMID 23082846
6. Zigler JE, Glenn J, Delamarter RB. Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. J Neurosurg Spine. Dec 2012; 17(6): 504-11. PMID 23082849
7. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Artificial lumbar disc arthroplasty. TEC Assessments. 2013;Volume 28:Tab 7.
8. Delamarter R, Zigler JE, Balderston RA, et al. Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement compared with circumferential arthrodesis for the treatment of two-level lumbar degenerative disc disease: results at twenty-four months. J Bone Joint Surg Am. Apr 20 2011; 93(8): 705-15. PMID 21398574
9. Schoenfeld AJ. Commentary on an article by Rick Delamarter, MD, et al.: "Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement compared with circumferential arthrodesis for the treatment of two-level degenerative lumbar disc disease. Results at twenty-four months". J Bone Joint Surg Am. Apr 20 2011; 93(8): e41. PMID 21398573
10. Hellum C, Johnsen LG, Storheim K, et al. Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study. BMJ. May 19 2011; 342: d2786. PMID 21596740
11. Hellum C, Berg L, Gjertsen Ø, et al. Adjacent level degeneration and facet arthropathy after disc prosthesis surgery or rehabilitation in patients with chronic low back pain and degenerative disc: second report of a randomized study. Spine (Phila Pa 1976). Dec 01 2012; 37(25): 2063-73. PMID 22706091
12. Furunes H, Storheim K, Brox JI, et al. Total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain and degenerative discs: 8-year follow-up of a randomized controlled multicenter trial. Spine J. Oct 2017; 17(10): 1480-1488. PMID 28583869
13. Garcia R, Yue JJ, Blumenthal S, et al. Lumbar Total Disc Replacement for Discogenic Low Back Pain: Two-year Outcomes of the activL Multicenter Randomized Controlled IDE Clinical Trial. Spine (Phila Pa 1976). Dec 2015; 40(24): 1873-81. PMID 26630435
14. Yue JJ, Garcia R, Blumenthal S, et al. Five-year Results of a Randomized Controlled Trial for Lumbar Artificial Discs in Single-level Degenerative Disc Disease. Spine (Phila Pa 1976). Dec 15 2019; 44(24): 1685-1696. PMID 31404055
15. Radcliff K, Zigler J, Braxton E, et al. Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results. Int J Spine Surg. Aug 2021; 15(4): 612-632. PMID 34266934
16. Siepe CJ, Heider F, Wiechert K, et al. Mid- to long-term results of total lumbar disc replacement: a prospective analysis with 5- to 10-year follow-up. Spine J. Aug 01 2014; 14(8): 1417-31. PMID 24448028
17. Laugesen LA, Paulsen RT, Carreon L, et al. Patient-reported Outcomes and Revision Rates at a Mean Follow-up of 10 Years After Lumbar Total Disc Replacement. Spine (Phila Pa 1976). Nov 01 2017; 42(21): 1657-1663. PMID 28368983
18. Tropiano P, Huang RC, Girardi FP, et al. Lumbar total disc replacement. Seven to eleven-year follow-up. J Bone Joint Surg Am. Mar 2005; 87(3): 490-6. PMID 15741612
19. Chou R, Loeser JD, Owens DK, et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine (Phila Pa 1976). May 01 2009; 34(10): 1066-77. PMID 19363457
20. Chou R, Baisden J, Carragee EJ, et al. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine (Phila Pa 1976). May 01 2009; 34(10): 1094-109. PMID 19363455
21. National Institute for Health and Care Excellence (NICE). Prosthetic intervertebral disc replacement in the lumbar spine [IPG306]. 2009; https://www.nice.org.uk/guidance/IPG306. Accessed March 27, 2024.
22. North American Spine Society (NASS). NASS coverage policy recommendations: Lumbar Artificial Disc Replacement. 2019; https://www.spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations. Accessed March 27, 2024.
23. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Lumbar Artificial Disk Replacement (LADR) (150.10). 2007; https://www.cms.gov/medicare-coverage- database/details/ncd- details.aspx?NCDId=313&ncdver=2&CoverageSelection=National&KeyWord=lumbar+artificial+disc&KeyWordLo okUp=Title&KeyWordSearchType=And&id=170&bc=gAAAABAAAAAA&. Accessed March 27, 2024.
24. Centers for Medicare & Medicaid Services (CMS). Medicare Learning Network Matters: Lumbar Artificial Disc Replacement (LADR). Change request 5727. 2007; https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R1340CP.pdf. Accessed March 27, 2024.

Codes

APplicable Modifiers

N/A

Policy History