title: A Trial-Based Economic Evaluation Comparing Spinal Cord Stimulation With Best Medical Treatment in Painful Diabetic Peripheral Neuropathy.
abstract: The objective was to perform an economic evaluation comparing spinal cord stimulation (SCS) in combination with best medical treatment (BMT) with BMT in painful diabetic peripheral neuropathy patients. Alongside a prospective 2-center randomized controlled trial, involving 36 painful diabetic peripheral neuropathy patients with severe lower limb pain not responding to conventional therapy, an economic evaluation was performed. Incremental cost-effectiveness ratios were based on: 1) societal costs and quality-adjusted life years (QALYs), and 2) direct health care costs and the number of successfully treated patients, respectively, both with a time horizon of 12 months. Bootstrap and secondary analyses were performed to address uncertainty. Total societal cost amounted to €26,539.18 versus €5,313.45 per patient in the SCS and BMT group, respectively. QALYs were .58 versus .36 and the number of successfully treated patients was 55% versus 7% for the SCS and BMT group, respectively. This resulted in incremental cost-effectiveness ratios of €94,159.56 per QALY and €34,518.85 per successfully treated patient, respectively. Bootstrap analyses showed that the probability of SCS being cost-effective ranges from 0 to 46% with willingness to pay threshold values ranging between €20,000 and €80,000 for a QALY. Secondary analyses showed that cost-effectiveness of SCS became more favorable after correcting for baseline cost imbalance between the 2 groups, extending the depreciation period of SCS material to 4 years, and extrapolation of the data up to 4 years. Although SCS was considerably more effective compared with BMT, the substantial initial investment that is required resulted in SCS not being cost-effective in the short term. Cost-effectiveness results were sensitive to baseline cost imbalances between the groups and the depreciation period of the SCS material.
  
  
  
  Painful diabetic peripheral neuropathy is a common complication of diabetes mellitus and the humanistic and economic burden is high. This article presents the cost-effectiveness of SCS in patients suffering from painful diabetic peripheral neuropathy from a societal and health care perspective with a time horizon of 12 months.
authors.affiliation: Department of Anesthesiology and Pain Medicine, Maastricht University Medical Centre+, Maastricht, The Netherlands. Electronic address: rachel.slangen@gmail.com.
authors.forename: Rachel
authors.initials: R
authors.lastname: Slangen
authors.affiliation: Department of Neurology, Maastricht University Medical Centre+, Maastricht, The Netherlands.
authors.forename: Catharina G
authors.initials: CG
authors.lastname: Faber
authors.affiliation: Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.
authors.forename: Nicolaas C
authors.initials: NC
authors.lastname: Schaper
authors.affiliation: Department of Anesthesiology and Pain Medicine, Maastricht University Medical Centre+, Maastricht, The Netherlands.
authors.forename: Elbert A
authors.initials: EA
authors.lastname: Joosten
authors.affiliation: Department of Anesthesiology, Pain, and Palliative Care, Radboud University Medical Centre, Nijmegen, The Netherlands.
authors.forename: Robert T
authors.initials: RT
authors.lastname: van Dongen
authors.affiliation: Department of Clinical Epidemiology and Medical Technology, Maastricht University Medical Centre+, Maastricht, The Netherlands.
authors.forename: Alfons G
authors.initials: AG
authors.lastname: Kessels
authors.affiliation: Department of Anesthesiology and Pain Medicine, Maastricht University Medical Centre+, Maastricht, The Netherlands.
authors.forename: Maarten
authors.initials: M
authors.lastname: van Kleef
authors.affiliation: Department of Clinical Epidemiology and Medical Technology, Maastricht University Medical Centre+, Maastricht, The Netherlands; CAPHRI School of Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands.
authors.forename: Carmen D
authors.initials: CD
authors.lastname: Dirksen
mesh_terms: D000368:Aged; D015331:Cohort Studies; D003365:Costs and Cost Analysis; D003929:Diabetic Neuropathies / Q000191:economics* / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012720:Severity of Illness Index; D062187:Spinal Cord Stimulation / Q000191:economics* / Q000379:methods*; D013997:Time Factors
keywords: Economic evaluation; cost-effectiveness analysis; cost-utility analysis; diabetic neuropathy; painful diabetic neuropathy; quality of life