Dataset Information

Cost-utility Analysis of Evoke Closed-loop Spinal Cord Stimulation for Chronic Back and Leg Pain.

ABSTRACT:

Objectives

The effectiveness of Evoke closed-loop spinal cord stimulation (CL-SCS), a novel modality of neurostimulation, has been demonstrated in a randomized controlled trial (RCT). The objective of this cost-utility analysis was to develop a de novo economic model to estimate the cost-effectiveness of Evoke CL-SCS when compared with open-loop SCS (OL-SCS) for the management of chronic back and leg pain.

Methods

A decision tree followed by a Markov model was used to estimate the costs and outcomes of Evoke CL-SCS versus OL-SCS over a 15-year time horizon from the UK National Health Service perspective. A "high-responder" health state was included to reflect improved levels of SCS pain reduction recently reported. Results are expressed as incremental cost per quality-adjusted life year (QALY). Deterministic and probabilistic sensitivity analysis (PSA) was conducted to assess uncertainty in the model inputs.

Results

Evoke CL-SCS was estimated to be the dominant treatment strategy at ~5 years postimplant (ie, it generates more QALYs while cost saving compared with OL-SCS). Probabilistic sensitivity analysis showed that Evoke CL-SCS has a 92% likelihood of being cost-effective at a willingness to pay threshold of £20,000/QALY. Results were robust across a wide range of scenario and sensitivity analyses.

Discussion

The results indicate a strong economic case for the use of Evoke CL-SCS in the management of chronic back and leg pain with or without prior spinal surgery with dominance observed at ~5 years.

SUBMITTER: Duarte RV

PROVIDER: S-EPMC10498882 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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Publications

Cost-utility Analysis of Evoke Closed-loop Spinal Cord Stimulation for Chronic Back and Leg Pain.

Duarte Rui V RV Bentley Anthony A Soliday Nicole N Leitner Angela A Gulve Ashish A Staats Peter S PS Sayed Dawood D Falowski Steven M SM Hunter Corey W CW Taylor Rod S RS

The Clinical journal of pain 20231001 10

<h4>Objectives</h4>The effectiveness of Evoke closed-loop spinal cord stimulation (CL-SCS), a novel modality of neurostimulation, has been demonstrated in a randomized controlled trial (RCT). The objective of this cost-utility analysis was to develop a de novo economic model to estimate the cost-effectiveness of Evoke CL-SCS when compared with open-loop SCS (OL-SCS) for the management of chronic back and leg pain.<h4>Methods</h4>A decision tree followed by a Markov model was used to estimate the ...[more]

PMID: 37440335

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Project description:ImportanceChronic pain is debilitating and profoundly affects health-related quality of life. Spinal cord stimulation (SCS) is a well-established therapy for chronic pain; however, SCS has been limited by the inability to directly measure the elicited neural response, precluding confirmation of neural activation and continuous therapy. A novel SCS system measures the evoked compound action potentials (ECAPs) to produce a real-time physiological closed-loop control system.ObjectiveTo determine whether ECAP-controlled, closed-loop SCS is associated with better outcomes compared with fixed-output, open-loop SCS at 24 months following implant.Design, setting, and participantsThe Evoke study was a double-blind, randomized, controlled, parallel arm clinical trial with 36 months of follow-up. Participants were enrolled from February 2017 to 2018, and the study was conducted at 13 US investigation sites. SCS candidates with chronic, intractable back and leg pain refractory to conservative therapy, who consented, were screened. Key eligibility criteria included overall, back, and leg pain visual analog scale score of 60 mm or more; Oswestry Disability Index score of 41 to 80; stable pain medications; and no previous SCS. Analysis took place from October 2020 to April 2021.InterventionsECAP-controlled, closed-loop SCS was compared with fixed-output, open-loop SCS.Main outcomes and measuresReported here are the 24-month outcomes of the trial, which include all randomized patients in the primary and safety analyses. The primary outcome was a reduction of 50% or more in overall back and leg pain assessed at 3 and 12 months (previously published).ResultsOf 134 randomized patients, 65 (48.5%) were female and the mean (SD) age was 55.2 (10.6) years. At 24 months, significantly more closed-loop than open-loop patients were responders (≥50% reduction) in overall pain (53 of 67 [79.1%] in the closed-loop group; 36 of 67 [53.7%] in the open-loop group; difference, 25.4% [95% CI, 10.0%-40.8%]; P = .001). There was no difference in safety profiles between groups (difference in rate of study-related adverse events: 6.0 [95% CI, -7.8 to 19.7]). Improvements were also observed in health-related quality of life, physical and emotional functioning, and sleep, in parallel with opioid reduction or elimination. Objective neurophysiological measurements substantiated the clinical outcomes and provided evidence of activation of inhibitory pain mechanisms.Conclusions and relevanceECAP-controlled, closed-loop SCS, which elicited a more consistent neural response, was associated with sustained superior pain relief at 24 months, consistent with the 3- and 12-month outcomes.

Project description:BackgroundSpinal cord stimulation (SCS) is an established chronic pain treatment, but the effectiveness of traditional, open-loop paradigms has been plagued by variable sustainability in a real-world setting. A new approach, utilizing evoked compound action potential (ECAP) controlled closed-loop (CL) SCS, continuously monitors spinal cord activation and automatically adjusts the stimulation amplitude of every pulse, maintaining stimulation at the prescribed ECAP level through this continual feedback mechanism. Recent studies demonstrated the long-term safety and efficacy of ECAP-controlled CL-SCS. Here, we report the design of a prospective, multicenter, single-arm feasibility study to characterize clinical outcomes in a real-world chronic pain population utilizing ECAP-controlled CL-SCS. Objective neurophysiological measurements such as device performance and patient therapy compliance, will be analyzed against baseline biopsychosocial assessments, to explore the clinical utility of these objective physiologic biomarkers in patient phenotyping.MethodsThis study will enroll up to 300 subjects with chronic, intractable trunk and/or limb pain in up to 25 United States investigation sites. Subjects meeting eligibility criteria will undergo a trial procedure and a permanent implant following a successful trial. Neurophysiological measurements (measured in-clinic and continuously during home use) and clinical outcomes including pain, quality-of-life, psychological, emotional, and functional assessments will be collected at baseline, trial end, and up to 24-months post-implantation.DiscussionAssociations between objective neurophysiological data, clinical evaluation and patient-reported outcomes may have important clinical and scientific implications. They may provide novel insights about the chronic pain pathophysiology, its modulation during CL-SCS, and identification of pain phenotypes and/or mechanisms associated with treatment response during SCS trials and long-term therapy. Data from the ECAP study could lead to improvements in diagnosis, assessment, patient identification and management of chronic pain. It could also provide the foundation for development of a new SCS treatment approach customized by the patient's pain phenotype, unique neurophysiology, and disease severity.

Project description:ImportanceChronic back and lower extremity pain is one of the leading causes of disability worldwide. Spinal cord stimulation (SCS) aims to improve symptoms and quality of life.ObjectiveTo evaluate the efficacy of SCS therapies compared with conventional medical management (CMM).Data sourcesMEDLINE, Embase, and Cochrane Library were systematically searched from inception to September 2, 2022.Study selectionSelected studies were randomized clinical trials comparing SCS therapies with sham (placebo) and/or CMM or standard treatments for adults with chronic back or leg pain who had not previously used SCS.Data extraction and synthesisEvidence synthesis estimated odds ratios (ORs) and mean differences (MDs) and their associated credible intervals (CrI) through bayesian network meta-analysis. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline for network meta-analyses was followed.Main outcomes and measuresThe primary outcomes were pain-related end points, including pain intensity (measured by visual analog scale) and proportion of patients achieving at least 50% pain relief (responder rate) in the back or leg. Quality of life (measured by EQ-5D index score) and functional disability (measured by the Oswestry Disability Index score) were also considered.ResultsA total of 13 studies of 1561 patients were included in the network meta-analysis comparing conventional and novel SCS therapies with CMM across the 6 outcomes of interest at the 6-month follow-up. Both conventional and novel SCS therapies were associated with superior efficacy compared with CMM in responder rates in back (conventional SCS: OR, 3.00; 95% CrI, 1.49 to 6.72; novel SCS: OR, 8.76; 95% CrI, 3.84 to 22.31), pain intensity in back (conventional SCS: MD, -1.17; 95% CrI, -1.64 to -0.70; novel SCS: MD, -2.34; 95% CrI, -2.96 to -1.73), pain intensity in leg (conventional SCS: MD, -2.89; 95% CrI, -4.03 to -1.81; novel SCS: MD, -4.01; 95% CrI, -5.31 to -2.75), and EQ-5D index score (conventional SCS: MD, 0.15; 95% CrI, 0.09 to 0.21; novel SCS: MD, 0.17; 95% CrI, 0.13 to 0.21). For functional disability, conventional SCS was superior to CMM (MD, -7.10; 95% CrI, -10.91 to -3.36). No statistically significant differences were observed for other comparisons.Conclusions and relevanceThis systematic review and network meta-analysis found that SCS therapies for treatment of chronic pain in back and/or lower extremities were associated with greater improvements in pain compared with CMM. These findings highlight the potential of SCS therapies as an effective and valuable option in chronic pain management.

Dataset Information

Cost-utility Analysis of Evoke Closed-loop Spinal Cord Stimulation for Chronic Back and Leg Pain.

Objectives

Methods

Results

Discussion

Publications

Cost-utility Analysis of Evoke Closed-loop Spinal Cord Stimulation for Chronic Back and Leg Pain.

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