. 2020 Mar 6;20(6):1–109.

Table 15:

Results of Economic Literature Review—Summary

Author, Year, Country of Publication	Analytic Technique, Study Design, Perspective, Time Horizon	Population	Intervention(s) and Comparator(s)	Results
Author, Year, Country of Publication	Analytic Technique, Study Design, Perspective, Time Horizon	Population	Intervention(s) and Comparator(s)	Health Outcomes	Costs	Cost-Effectiveness
NICE, 2019⁵⁸ United Kingdom (manufacturer's economic model submission)	Type of economic analysis: CCA Study design: model-based economic study Perspective: NHS and PSS Time horizon: 15 years	Adults with chronic pain^a Total: NA Mean age, y: NR Male, %: NR	Intervention Senza HF10 SCS + CMM as required Comparators CNR-SCS^b + CMM as required CR-SCS^b + CMM as required	Model outcomes based on utilities were not reported, to align with the NICE MTEP cost–consequence framework; reported outcomes of the model were costs only Clinical parameters^c were derived largely from the SENZA-RCT study^30,31 and informed transition probabilities^d in the decision tree and Markov model	Currency, cost year: £, 2016 Discount rate: 3.5% Total mean costs CNR-SCS^b + CMM: £95,156 CR-SCS^b + CMM: £92,192 Senza HF10 SCS + CMM: £87,400 Incremental costs Senza HF10 SCS vs. CR-SCS^b: −£320/y or −£4,795 over 15 y Senza HF10 SCS vs. CNR-SCS^b: −£500/y or −£7,755 over 15 y NICE determined that Senza HF10 SCS would accrue costs similar to low-frequency conventional SCS over 15 years, after taking into account an alternate estimate for the rate of unanticipated explantation⁶¹	Reference case Senza HF10 SCS vs. CR-SCS^b: dominant^e Senza HF10 SCS vs. CNR-SCS^b: dominant^e Sensitivity analyses PSA: Senza HF10 SCS vs. CR-SCS or CNR-SCS was cost-saving 73% or 74% of the time, respectively NICE determined that Senza HF10 SCS was approximately cost neutral compared with conventional SCS, when considering the new evidence for an alternate estimate of rate of unanticipated explantation⁶¹
Annemans, 2014⁵⁹ United Kingdom	Type of economic analysis: CUA Study design: model-based economic study Perspective: NHS Time horizon: 15 years	Patients with chronic pain Total: NA Mean age, y: 49.7 Male, %: 45	Intervention Senza HF10 SCS Comparators CMM only Reoperation CNR-SCS CR-SCS	Simulated cohort of 1,000 patients over 15 y Discount rate: 3.5% Intervention options vs. CNR-SCS^f Total QALYs: CNR-SCS 4,647; CR-SCS 4,648; Senza HF10 SCS 5,151 Mean difference: CR-SCS vs. CNR-SCS 1; Senza HF10 SCS vs. CNR-SCS 504 Intervention options vs. CNR-SCS^f Total QALYs: CR-SCS 4,439; CNR-SCS 4,648; Senza HF10 SCS 5,151 Mean difference: CNR-SCS vs. CR-SCS 209; Senza HF10 SCS vs. CR-SCS 712	Simulated cohort of 1,000 patients over 15 y Currency, cost year: £, NR Discount rate: 3.5% Intervention options vs. CNR-SCS^g,h Total mean cost: CNR-SCS £92,392,857; CR-SCS £87,440,887; Senza HF10 SCS £86,417,656 Mean difference: SCS vs. CNR-SCS −£4,951,970; Senza HF10 SCS vs. CNR-SCS −£5,975,201 Intervention options vs. CR-SCS^g,h Total mean cost: CR-SCS £92,561,091; CNR-SCS £87,440,887; Senza HF10 SCS £86,417,656 Mean difference: CNR-SCS vs. CR-SCS: −£5,120,204; Senza HF10 SCS vs. TR SCS: –£1,023,231	Intervention options vs. CNR-SCS^j CR-SCS vs. CNR-SCS: dominant^d Senza HF10 SCS vs. CNR-SCS: dominant^e Intervention options vs. CR-SCS^jCNR-SCS vs. CR-SCS: dominant Senza HF10 SCS vs. CR-SCS: dominant^e One-way deterministic sensitivity analyses (Senza HF10 SCS vs. CMM) Driving parameters were device longevity (ICERs £700 to £6,500/QALY) and device cost (ICERs £0 to £1,300/QALY) Threshold analyses Senza HF10 SCS must achieve ≥60% responder rate (≥50% pain relief) at 6 months to remain dominant^e

Abbreviations: CCA, cost–consequence analysis; CMM, conventional medical management; CNR-SCS; conventional nonrechargeable SCS; CRPS, complex regional pain syndrome; CR-SCS, conventional rechargeable SCS; CUA, cost–utility analysis; FBSS, failed back surgery syndrome; ICER, incremental cost-effectiveness ratio; MTEP, Medical Technologies Evaluation Programme; NA, not applicable; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; NR, not reported; PSA, probabilistic sensitivity analyses; PSS, Personal Social Service; QALY, quality-adjusted life-year; SCS, spinal cord stimulation; VAS, visual analogue scale.

The target population was derived mainly from people with back and/or leg pain as a result of FBSS. Results of this study should not be extrapolated to people with neuropathic pain of the head, neck, or arm, or to people with CRPS.

Both CNR-SCS and CR-SCS were defined as low-frequency (up to 1.2 kHz).

Clinical parameters considered in model: pain scores (e.g., VAS score), duration of pain relief, patient satisfaction (e.g., relating to frequency of battery recharging), health-related quality of life, functional disability measures (e.g., disability index score, Oswestry Disability Index, and functional improvement, including ability to drive and perform work-related activities), opioid and other analgesic use, device-related adverse events, incidence of paresthesia, and reason for implant removal.

The transition probabilities informed by clinical parameters in the decision tree (initial 6 months) included probabilities of trial success leading to permanent implantation, probability of achieving optimal reduction in leg pain, and probability of nonserious complications; the transition probabilities informed by clinical parameters in the Markov model (beyond 6 months) included probability of nonserious adverse events (beyond 6 months) and probability of serious adverse events (i.e., ineffective pain control, intolerable paresthesia, and other adverse events, such as surgical site infections, or patient falls).

Dominant = lower cost and higher QALYs.

Reported reference case results also included mean and incremental QALYs for CMM and reoperation, not summarized in this table.

Reported reference case results also included mean and incremental costs for CMM and reoperation, not summarized in this table.

The cost of Senza HF10 SCS was assumed to be the same as for conventional rechargeable SCS, at £4,442 for the SCS trial procedure, £15,056 for the device, £1,720 for additional CMM as needed in first 6 months, £860 for additional CMM as needed per 3 months from the first year and onwards, £622 for implant-related complications, and £1,800 for device explantation (i.e., implantable pulse generator).

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Reported reference case results also included ICERs for CMM and reoperation versus comparators, not summarized in this table.