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Barriers to and Budget Impact of Lumbar Total Disc Replacement Utilization

Sandhu, Faheem MD; Blumenthal, Scott MD; Grunch, Betsy MD, FAANS, FACS; Kimball, Bent MD§; Ferko, Nicole MSc; Hollmann, Sarah MBiotech

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doi: 10.1097/BRS.0000000000002455
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Abstract

This session of the First Annual Lumbar Total Disc Replacement Summit focused on discussions regarding barriers to total disc replacement (TDR) utilization, population size for lumbar TDR, and the associated budget impact of growing TDR use from a commercial US insurer perspective.

Consensus Statements:

  • 1. There is no indication that there would be a dramatic increase in the patients seeking lumbar TDR annually, based on the data available.
  • 2. On the basis of the current economic model, the panel agrees that increased coverage to lumbar TDR will remain cost neutral for the US commercial insurer relative to fusion.

Before session discussions, an economic model based on the existing evidence was presented to the panel by a health economics researcher. Two consensus statements were developed and several additional coverage-related topics were discussed.

This session was initiated with a discussion on barriers to lumbar TDR utilization in the US. Panel members acknowledged that sometimes they do not implant a lumbar TDR device because their patients do not have coverage. The panelists discussed how this has been a source of frustration in their practices, quoting that “an ideal candidate may not receive this technology due to a lack of coverage.” One panelist cited an example whereby certain patients could easily obtain coverage with international insurance. In review of the survey results, 100% of panelists reported that lack of coverage was a barrier to lumbar TDR use in patients less than 65 years of age. In contrast, 0% of panelists indicated that patient preference for an alternative (i.e., non-TDR) intervention was a barrier for lumbar TDR use. These findings demonstrate that limitations in TDR utilization are driven by coverage restrictions rather than patient preference and clinical need.

The panelists discussed interpretation of the terms “experimental and investigational,” which are commonly included in the rationale for non-coverage of TDR in US insurance policies. Policies as recent at the time of the Summit have cited that lumbar disc replacements are considered investigational.1 In general, surgeons were unclear why such terms were still being used to describe lumbar TDR technology, as several of these devices are Food and Drug Administration (FDA)-approved and supported by published randomized controlled trials with 5-year safety and efficacy follow-up periods. It was suggested that “experimental and investigational” may be confused with the perceived need for long-term data, of which “long-term” may be variably defined across policies. It is likely that there is variability across states and insurance policies regarding the definition, interpretation, and legalities associated with use of these terms. As such, the panel did not develop a consensus statement on this topic. However, panel members did acknowledge the data available to support coverage of lumbar TDR, with panelists quoting that “there is very good data that refute these outdated arguments” and that “the scientific data absolutely supports coverage.”

Budgetary considerations were suggested to be one possible factor in commercial insurer noncoverage decisions for lumbar TDR, given rising health care costs and concerns on affordability. To address this topic, a budget impact model of lumbar surgical interventions from the US commercial health insurer perspective was developed and presented to the panel (Figure 1).2 In brief, total annual costs without lumbar TDR coverage and with TDR coverage were compared for a plan with 1 million insured members. Utilization inputs for the model were primarily based on nationally reported rates of lumbar fusion, the proportion of patients with fusion reported to be eligible for lumbar TDR (i.e., 5%), and the commercially insured population size. These data and assumptions led to an estimate of approximately 14 lumbar TDR procedures being completed annually per 1 million insured members. Procedure costs were informed by Medicare 2016 DRG payment rates. The base-case (default) analysis assumed that patients who underwent TDR would have had a lumbar fusion if TDR had not been available. In other words, the actual surgical pool of patients was not assumed to increase with adoption of TDR. This analysis predicted that lumbar TDR would not have any budget impact, but rather an estimated cost savings of $169,144 per 1 million insured patients. In summary, the results of this economic model align with published findings that greater patient access to lumbar TDR would save costs relative to fusion from a payer perspective (see Table 1).

Figure 1
Figure 1:
Budget impact model schematic. CIRC indicates circumferential; SOB, source of business.
TABLE 1
TABLE 1:
Annual Budget Impact Results for Adoption of Lumbar TDR per 1 Million Insured Patients

The base-case results of the economic model were discussed with panel members and it was recognized that local payers will have different annual TDR utilization rates due to variance in local factors, such as the availability of specialized centers for TDR procedures. It was discussed that a key factor in the model was the assumption for the predicted annual number of TDR procedures, as well as what intervention these patients would have had if lumbar TDR was not covered. To more accurately inform this model assumption, a follow-up survey was conducted with the surgeons after the meeting. In review of these findings, surgeons predicted some growth in lumbar TDR compared with the original estimate of 14 TDR procedures per 1 million insured. One surgeon noted that there may be cases where patients would rather wait for lumbar TDR to be covered and thus forgo a surgical fusion, even though waiting could result in disease progression that would render them ineligible for TDR at a later stage. Utilizing feedback from the panelists, additional model scenarios were analyzed to control for the sensitivity that, in limited instances, the pool of surgical patients would expand with coverage of lumbar TDR. The alternative scenario analyses demonstrated either a slight cost savings or a small budget impact (−$4125 or $45,649 per 1 million insured, respectively) depending on the assumptions chosen. In summary, these results still show minimal, if any, budget impact with TDR coverage as per the base-case model findings.2 As such, the consensus statement derived at the meeting whereby the panel agreed that increased access to TDR will remain cost neutral for the insurer still reflects the updated model findings. The panel chose to use the term “cost neutral,” considering the slight chance of very small incremental costs, as well as the cost savings predicted with increased lumbar TDR uptake relative to the total cost of providing coverage for interventions to treat lumbar degenerative disc disease (DDD) patients, in some markets.

As part of the survey, panelists commented on the current volume of lumbar TDR procedures in their practice and predicted how this volume may increase if coverage was provided for patients who met eligibility criteria. In brief, the number of lumbar TDRs completed typically varied by surgeon practice between 1 and 10 TDR procedures per year. With coverage, panelists variably predicted that the number of TDR procedures would be expected to increase by 20% to 100%, with the use of fusion procedures decreasing by the same amounts. These predictions were discussed in context of the notion that payers may have concerns that lumbar TDR coverage could open the door to millions of patients with nonspecific back pain which led the panel to again reiterate the importance of diagnostic tools to rule out other pain sources. The panelists agreed that, given the small number of lumbar TDR procedures typically conducted annually, and the confines of the patient eligibility criteria, the increase in TDR procedures is not expected to be dramatic. These thoughts are aligned with the literature that has demonstrated that appropriate patient selection is arguably the most important factor in determining lumbar TDR treatment success, aside from implant characteristics.3 Essentially, coverage is not expected to change the number of candidates eligible for TDR but will instead shift the majority of patients from higher burden fusion procedures. As such, the panelists arrived at the consensus that on the basis of the available data, there is no indication that there would be a dramatic increase in the number of patients seeking lumbar TDR annually. Through deliberations, it was determined that the exact number of TDR procedures should not be included in this statement, given that this would be expected to vary by region and policy.

This session and the survey were both interspersed with topics pertaining to the general economic value of lumbar TDR technology and bundled payment initiatives. Several cost components that have been shown to be lessened with lumbar TDR can also be beneficial from a bundled payment model. Table 2 describes the cost components and results of three studies that compared lumbar TDR to fusion in treatment of DDD from the US hospital perspective.4–6 These studies demonstrated that health care resources such as operating time and length of hospital stay may be reduced with TDR, which can result in lower total costs than fusion. Less reoperation-related cost with lumbar TDR can also be an important economic value component, which was acknowledged by both the panel members and recent cost studies. In addition to these cost items, some panel survey responses noted that fusion is associated with more variability in upfront costs (e.g., number of screws, cages, need for osteobiologics), and this variability can have negative implications for bundled payments. In their overall comments, several panel members communicated that they predict, or have observed, that both long-term and short-term health care costs will be reduced in several ways if lumbar TDR is used in place of fusion in this patient population. In addition to savings in health care resource components, one panelist mentioned that improved patient satisfaction scores can also have a positive impact on hospital performance. In general, the feedback from the panel was that lumbar TDR can positively impact providers from the bundled care perspective.

TABLE 2
TABLE 2:
Published US Cost Analyses Comparing Lumbar TDR and Fusion for DDD from a Hospital Perspective

References

1. Excellus BlueCross BlueShield. (2016) Medical Policy: Artificial Lumbar Intervertebral Disc. Policy number: 7.01.63. Effective date: March 18, 2004. Revised: December 15, 2016. Accessed January 20, 2017. https://www.excellusbcbs.com/wps/wcm/connect/66be90cd-1eea-481c-b75c-9ad8fb9e0954/mp+art_+lumb_+disc+tac+16.pdf?MOD=AJPERES&CACHEID=66be90cd-1eea-481c-b75c-9ad8fb9e0954.
2. Ferko N, Sperber D, Banko D. A Budget Impact Analysis of Total Disc Replacement (TDR) for Single-Level Lumbar Degenerative Disc Disease (LDDD): A U.S. Private Health Insurer Perspective. Accepted abstract. AMCP Managed Care Specialty Pharmacy Annual Meeting 2017. March 27–30, 2017, Denver, CO.
3. Pettine K, Ryu R, Techy F. Why lumbar artificial disk replacements (LADRs) fail. Clin Spine Surg 2017; 30:E743–E747.
4. Kurtz SM, Lau E, Ianuzzi A, et al. National revision burden for lumbar total disc replacement in the United States: epidemiologic and economic perspectives. Spine (Phila Pa 1976) 2010; 35:690–696.
5. Patel VV, Estes S, Lindley EM, et al. Lumbar spinal fusion versus anterior lumbar disc replacement: the financial implications. J Spinal Disord Tech 2008; 21:473–476.
6. Guyer RD, Tromanhauser SG, Regan JJ. An economic model of one-level lumbar arthroplasty versus fusion. Spine J 2007; 7:558–562.
Keywords:

barriers; budget impact model; cost effectiveness; costs; economics; fusion; lumbar spine; total disc replacement

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