A Trial-Based Economic Evaluation Comparing Spinal Cord Stimulation With Best Medical Treatment in Painful Diabetic Peripheral Neuropathy

Published:December 12, 2016DOI:


      • Painful diabetic peripheral neuropathy carries a high (economic) burden.
      • Spinal cord stimulation is not cost-effective at the short term due to substantial initial investment.
      • Extended follow-up and a decision model are needed to estimate long term cost-effectiveness.


      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.

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        • Alleman C.J.
        • Westerhout K.Y.
        • Hensen M.
        • Chambers C.
        • Stoker M.
        • Long S.
        • van Nooten F.E.
        Humanistic and economic burden of painful diabetic peripheral neuropathy in Europe: A review of the literature.
        Diabetes Res Clin Pract. 2015; 109: 215-225
        • Bala M.M.
        • Riemsma R.P.
        • Nixon J.
        • Kleijnen J.
        Systematic review of the (cost-)effectiveness of spinal cord stimulation for people with failed back surgery syndrome.
        Clin J Pain. 2008; 24: 741-756
        • Barrett A.M.
        • Lucero M.A.
        • Le T.
        • Robinson R.L.
        • Dworkin R.H.
        • Chappell A.S.
        Epidemiology, public health burden, and treatment of diabetic peripheral neuropathic pain: A review.
        Pain Med. 2007; 8: S50-S62
        • Council for Public Health and Health Care
        Sensible and Sustainable Care [in Dutch].
        Den Haag, The Netherlands2006
        • daCosta DiBonaventura M.
        • Cappelleri J.C.
        • Joshi A.V.
        A longitudinal assessment of painful diabetic peripheral neuropathy on health status, productivity, and health care utilization and cost.
        Pain Med. 2011; 12: 118-126
        • Daousi C.
        • Benbow S.J.
        • MacFarlane I.A.
        Electrical spinal cord stimulation in the long-term treatment of chronic painful diabetic neuropathy.
        Diabetes Med. 2005; 22: 393-398
        • de Vos C.C.
        • Meier K.
        • Zaalberg P.B.
        • Nijhuis H.J.
        • Duyvendak W.
        • Vesper J.
        • Enggaard T.P.
        • Lenders M.W.
        Spinal cord stimulation in patients with painful diabetic neuropathy: A multicentre randomized clinical trial.
        Pain. 2014; 155: 2426-2431
        • de Vos C.C.
        • Rajan V.
        • Steenbergen W.
        • van der Aa H.E.
        • Buschman H.P.
        Effect and safety of spinal cord stimulation for treatment of chronic pain caused by diabetic neuropathy.
        J Diabetes Complications. 2009; 23: 40-45
        • DiBonaventura M.D.
        • Cappelleri J.C.
        • Joshi A.V.
        Association between pain severity and health care resource use, health status, productivity and related costs in painful diabetic peripheral neuropathy patients.
        Pain Med. 2011; 12: 799-807
        • Dolan P.
        Modeling valuations for EuroQol health states.
        Med Care. 1997; 35: 1095-1108
        • Drummond M.
        • Sculpher M.J.
        • Torrance G.W.
        • O’Brien B.J.
        • Stoddart G.L.
        Methods for the Economic Evaluation of Health Care Programmes.
        3rd ed. Oxford University Press, Oxford2005
        • Dworkin R.H.
        • Panarites C.J.
        • Armstrong E.P.
        • Malone D.C.
        • Pham S.V.
        Health care utilization in people with postherpetic neuralgia and painful diabetic peripheral neuropathy.
        J Am Geriatr Soc. 2011; 59: 827-836
        • Dworkin R.H.
        • Turk D.C.
        • Wyrwich K.W.
        • Beaton D.
        • Cleeland C.S.
        • Farrar J.T.
        • Haythornthwaite J.A.
        • Jensen M.P.
        • Kerns R.D.
        • Ader D.N.
        • Brandenburg N.
        • Burke L.B.
        • Cella D.
        • Chandler J.
        • Cowan P.
        • Dimitrova R.
        • Dionne R.
        • Hertz S.
        • Jadad A.R.
        • Katz N.P.
        • Kehlet H.
        • Kramer L.D.
        • Manning D.C.
        • McCormick C.
        • McDermott M.P.
        • McQuay H.J.
        • Patel S.
        • Porter L.
        • Quessy S.
        • Rappaport B.A.
        • Rauschkolb C.
        • Revicki D.A.
        • Rothman M.
        • Schmader K.E.
        • Stacey B.R.
        • Stauffer J.W.
        • von Stein T.
        • White R.E.
        • Witter J.
        • Zavisic S.
        Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations.
        J Pain. 2008; 9: 105-121
        • EuroQol Group
        EuroQol–a new facility for the measurement of health-related quality of life. The EuroQol Group.
        Health Policy. 1990; 16: 199-208
        • Feldman E.L.
        • Stevens M.J.
        • Thomas P.K.
        • Brown M.B.
        • Canal N.
        • Greene D.A.
        A practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy.
        Diabetes Care. 1994; 17: 1281-1289
        • Goossens M.E.
        • Rutten-van Molken M.P.
        • Vlaeyen J.W.
        • van der Linden S.M.
        The cost diary: A method to measure direct and indirect costs in cost-effectiveness research.
        J Clin Epidemiol. 2000; 53: 688-695
        • Gordois A.
        • Scuffham P.
        • Shearer A.
        • Oglesby A.
        • Tobian J.A.
        The health care costs of diabetic peripheral neuropathy in the US.
        Diabetes Care. 2003; 26: 1790-1795
        • Gore M.
        • Brandenburg N.A.
        • Hoffman D.L.
        • Tai K.S.
        • Stacey B.
        Burden of illness in painful diabetic peripheral neuropathy: The patients’ perspectives.
        J Pain. 2006; 7: 892-900
      1. Hakkaart-van Roijen L, Tan SS, Bouwmans CA: Manual for cost research. Methods and standard cost prices for economic evaluations in health care [in Dutch]. Diemen, ZiNL, 2010

        • Happich M.
        • John J.
        • Stamenitis S.
        • Clouth J.
        • Polnau D.
        The quality of life and economic burden of neuropathy in diabetic patients in Germany in 2002–results from the Diabetic Microvascular Complications (DIMICO) study.
        Diabetes Res Clin Pract. 2008; 81: 223-230
        • Kemler M.A.
        • Furnee C.A.
        Economic evaluation of spinal cord stimulation for chronic reflex sympathetic dystrophy.
        Neurology. 2002; 59: 1203-1209
        • Kemler M.A.
        • Raphael J.H.
        • Bentley A.
        • Taylor R.S.
        The cost-effectiveness of spinal cord stimulation for complex regional pain syndrome.
        Value Health. 2010; 13: 735-742
        • Koopmanschap M.A.
        PRODISQ: A modular questionnaire on productivity and disease for economic evaluation studies.
        Expert Rev Pharmacoecon Outcomes Res. 2005; 5: 23-28
        • Koopmanschap M.A.
        • Rutten F.F.
        • van Ineveld B.M.
        • van Roijen L.
        The friction cost method for measuring indirect costs of disease.
        J Health Econ. 1995; 14: 171-189
        • Kumar K.
        • Toth C.
        • Nath R.K.
        Spinal cord stimulation for chronic pain in peripheral neuropathy.
        Surg Neurol. 1996; 46: 363-369
        • Lamers L.M.
        • McDonnell J.
        • Stalmeier P.F.
        • Krabbe P.F.
        • Busschbach J.J.
        The Dutch tariff: Results and arguments for an effective design for national EQ-5D valuation studies.
        Health Econ. 2006; 15: 1121-1132
        • Manca A.
        • Hawkins N.
        • Sculpher M.J.
        Estimating mean QALYs in trial-based cost-effectiveness analysis: The importance of controlling for baseline utility.
        Health Econ. 2005; 14: 487-496
      2. Nederland Z: Guideline for conducting economic evaluations in health care [in Dutch]. Diemen, ZiNL, 2015

      3. Statistics Netherlands (CBS): Consumer prices; price index 2006 = 100, 1996-2015. Available at:

      4. Medtronic: 2013 Product Performance Report: Spinal Cord Stimulation Systems. Available at: Accessed February 12, 2017.

        • Pluijms W.A.
        • Slangen R.
        • Joosten E.A.
        • Kessels A.G.
        • Merkies I.S.
        • Schaper N.C.
        • Faber C.G.
        • van Kleef M.
        Electrical spinal cord stimulation in painful diabetic polyneuropathy, a systematic review on treatment efficacy and safety.
        Eur J Pain. 2011; 15: 783-788
        • Slangen R.
        • Schaper N.C.
        • Faber C.G.
        • Joosten E.A.
        • Dirksen C.D.
        • van Dongen R.T.
        • Kessels A.G.
        • van Kleef M.
        Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: A prospective two-center randomized controlled trial.
        Diabetes Care. 2014; 37: 3016-3024
        • Streiner D.L.
        The case of the missing data: Methods of dealing with dropouts and other research vagaries.
        Can J Psychiatry. 2002; 47: 68-75
        • Taylor R.J.
        • Taylor R.S.
        Spinal cord stimulation for failed back surgery syndrome: A decision-analytic model and cost-effectiveness analysis.
        Int J Technol Assess Health Care. 2005; 21: 351-358
        • Taylor R.S.
        • Taylor R.J.
        • Van Buyten J.P.
        • Buchser E.
        • North R.
        • Bayliss S.
        The cost effectiveness of spinal cord stimulation in the treatment of pain: A systematic review of the literature.
        J Pain Symptom Manage. 2004; 27: 370-378
        • Taylor R.S.
        • Van Buyten J.P.
        • Buchser E.
        Spinal cord stimulation for complex regional pain syndrome: A systematic review of the clinical and cost-effectiveness literature and assessment of prognostic factors.
        Eur J Pain. 2006; 10: 91-101
        • Tesfaye S.
        • Selvarajah D.
        Advances in the epidemiology, pathogenesis and management of diabetic peripheral neuropathy.
        Diabetes Metab Res Rev. 2012; 28: 8-14
        • Tesfaye S.
        • Watt J.
        • Benbow S.J.
        • Pang K.A.
        • Miles J.
        • MacFarlane I.A.
        Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy.
        Lancet. 1996; 348: 1698-1701
        • Tolle T.
        • Xu X.
        • Sadosky A.B.
        Painful diabetic neuropathy: A cross-sectional survey of health state impairment and treatment patterns.
        J Diabetes Complications. 2006; 20: 26-33
        • van Asselt A.D.
        • van Mastrigt G.A.
        • Dirksen C.D.
        • Arntz A.
        • Severens J.L.
        • Kessels A.G.
        How to deal with cost differences at baseline.
        Pharmacoeconomics. 2009; 27: 519-528
        • van Beek M.
        • Slangen R.
        • Schaper N.C.
        • Faber C.G.
        • Joosten E.A.
        • Dirksen C.D.
        • van Dongen R.T.
        • Kessels A.G.
        • van Kleef M.
        Sustained treatment effect of spinal cord stimulation in painful diabetic peripheral neuropathy: 24-Month follow-up of a prospective two-center randomized controlled trial.
        Diabetes Care. 2015; 38: e132-e134
        • van Hout B.A.
        • Al M.J.
        • Gordon G.S.
        • Rutten F.F.
        Costs, effects and C/E-ratios alongside a clinical trial.
        Health Econ. 1994; 3: 309-319
        • Zucco F.
        • Ciampichini R.
        • Lavano A.
        • Costantini A.
        • De Rose M.
        • Poli P.
        • Fortini G.
        • Demartini L.
        • De Simone E.
        • Menardo V.
        • Cisotto P.
        • Meglio M.
        • Scalone L.
        • Mantovani L.G.
        Cost-effectiveness and cost-utility analysis of spinal cord stimulation in patients with failed back surgery syndrome: results from the PRECISE study.
        Neuromodulation. 2015; 18 (discussion: 276): 266-276