Cost-Effectiveness of Total Disc Replacement Versus Multidisciplinary Rehabilitation in Patients With Chronic Low Back Pain: A Norwegian Multicenter RCT

Study Design. Randomized clinical trial with 2-year follow-up. Objective. To evaluate the cost-effectiveness of total disc replacement (TDR) versus multidisciplinary rehabilitation (MDR) in patients with chronic low back pain (CLBP). Summary of Background Data. The existing studies on CLBP report cost-effectiveness of fusion surgery versus disc replacement and fusion versus rehabilitation. This study evaluated the cost-effectiveness of TDR versus MDR. Methods. Between April 2004 and May 2007, 173 patients with CLBP (>1 yr) were randomized to TDR (n = 86) or MDR (n = 87). Treatment effects (Euro Qol 5D [EQ-5D] and Short Form 6D [SF-6D]) and relevant direct and indirect costs at 6 weeks and at 3, 6, 12, and 24 months after treatment were assessed. Gain in quality-adjusted life years (QALYs) after 2 years was estimated. Cost-effectiveness was expressed as an incremental cost-effectiveness ratio. Results. The mean QALYs gained (standard deviation) using EQ-5D was 1.29 (0.53) in the TDR group and 0.95 (0.52) in the MDR group, a significant difference of 0.34 (95% confidence interval 0.18–0.50). The mean total cost per patient in the TDR group was &OV0556;87,622 (58,351) compared with &OV0556;74,116 (58,237) in the MDR group, which was not significantly different (95% confidence interval: −4041 to 31,755). The incremental cost-effectiveness ratio for the TDR procedure varied from &OV0556;39,748 using EQ-5D (TDR cost-effective) to &OV0556;128,328 using SF-6D (TDR not cost-effective). The dropout rate was 20% (15% TDR group, 24% MDR group). Five patients moved from the MDR to the TDR group, whereas 9 patients randomized to TDR declined surgery. Using per-protocol analysis instead of intention-to-treat analysis indicated that TDR was not cost-effective, irrespective of the use of EQ-5D or SF-6D. Conclusion. In this study, TDR was cost-effective compared with MDR after 2 years when using EQ-5D for assessing QALYs gained and a willingness to pay of &OV0556;74,600 (kr500,000/QALY). TDR was not cost-effective when SF-6D was used; therefore, our results should be interpreted with caution. Longer follow-up is needed to accurately assess the cost-effectiveness of TDR. Level of Evidence: 2

[1]  M. Grotle,et al.  Comparison of the SF6D, the EQ5D, and the oswestry disability index in patients with chronic low back pain and degenerative disc disease , 2013, BMC Musculoskeletal Disorders.

[2]  A. Sadosky,et al.  The Burden of Chronic Low Back Pain: Clinical Comorbidities, Treatment Patterns, and Health Care Costs in Usual Care Settings , 2012, Spine.

[3]  G. Andersson,et al.  Management of degenerative disk disease and chronic low back pain. , 2011, The Orthopedic clinics of North America.

[4]  P. Paquis,et al.  Medicoeconomic evaluation of total disc replacement based on French National Health Care System data. , 2011, Orthopaedics & traumatology, surgery & research : OTSR.

[5]  J. Clarke,et al.  What is a systematic review? , 2011, Evidence Based Nursing.

[6]  Leiv Sandvik,et al.  Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study , 2011, BMJ : British Medical Journal.

[7]  T. Solberg,et al.  Would loss to follow-up bias the outcome evaluation of patients operated for degenerative disorders of the lumbar spine? , 2011, Acta orthopaedica.

[8]  H. Tropp,et al.  Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-year follow-up , 2010, European Spine Journal.

[9]  Bart W. Koes,et al.  A systematic review on the effectiveness of physical and rehabilitation interventions for chronic non-specific low back pain , 2010, European Spine Journal.

[10]  R. Ostelo,et al.  Total disc replacement surgery for symptomatic degenerative lumbar disc disease: a systematic review of the literature , 2010, European Spine Journal.

[11]  D. Moher,et al.  CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials , 2010, Trials.

[12]  S. Kurtz,et al.  National Revision Burden for Lumbar Total Disc Replacement in the United States: Epidemiologic and Economic Perspectives , 2010, Spine.

[13]  D. Brunenberg,et al.  The impact of differences in EQ-5D and SF-6D utility scores on the acceptability of cost-utility ratios: results across five trial-based cost-utility studies. , 2010, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[14]  J. Doctor,et al.  Health Utility Bias: A Systematic Review and Meta-Analytic Evaluation , 2010, Medical decision making : an international journal of the Society for Medical Decision Making.

[15]  J. Caro,et al.  Can cost utility evaluations inform decision making about interventions for low back pain? , 2009, The spine journal : official journal of the North American Spine Society.

[16]  Xiong Guo,et al.  Clinical diagnosis for discogenic low back pain , 2009, International journal of biological sciences.

[17]  K. Muir,et al.  Comparing Cost-Utility Estimates: Does the Choice of EQ-5D or SF-6D Matter? , 2009, Medical care.

[18]  M. Kenward,et al.  Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls , 2009, BMJ : British Medical Journal.

[19]  C. Bünger,et al.  Interchangeability of the EQ-5D and the SF-6D in long-lasting low back pain. , 2009, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[20]  Roger Chou,et al.  Surgery for Low Back Pain: A Review of the Evidence for an American Pain Society Clinical Practice Guideline , 2009, Spine.

[21]  J. Cairns,et al.  SF-6D versus EQ-5D: reasons for differences in utility scores and impact on reported cost-utility , 2009, The European Journal of Health Economics.

[22]  J. Katz,et al.  Cost-Effectiveness of Spine Surgery: The Jury Is Out , 2008, Annals of Internal Medicine.

[23]  Michael Kropf,et al.  Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc®-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease , 2007, Spine.

[24]  M. Mugford,et al.  Exploring the cost effectiveness of an immunization programme for rotavirus gastroenteritis in the United Kingdom , 2007, Epidemiology and Infection.

[25]  S. Kurtz,et al.  Polyethylene Wear Debris and Long-term Clinical Failure of the Charité Disc Prosthesis: A Study of 4 Patients , 2007, Spine.

[26]  J. V. van Eijk,et al.  The Long-term Effect of Multidisciplinary Back Training: A Systematic Review , 2007, Spine.

[27]  E. Carragee.  Surgical treatment of lumbar disk disorders. , 2006, JAMA.

[28]  T. Stijnen,et al.  Review: a gentle introduction to imputation of missing values. , 2006, Journal of clinical epidemiology.

[29]  F. Christensen,et al.  Health economic evaluation in lumbar spinal fusion: a systematic literature review anno 2005 , 2006, European Spine Journal.

[30]  I. Holm,et al.  Lumbar instrumented fusion compared with cognitive intervention and exercises in patients with chronic back pain after previous surgery for disc herniation: A prospective randomized controlled study , 2006, PAIN.

[31]  H. V. van Stel,et al.  Health and Quality of Life Outcomes , 2006 .

[32]  J. Katz,et al.  A Review of the 2001 Volvo Award Winner in Clinical Studies: Lumbar Fusion Versus Nonsurgical Treatment for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial From the Swedish Lumbar Spine Study Group , 2006, Spine.

[33]  N. van der Roer,et al.  What is the most cost-effective treatment for patients with low back pain? A systematic review. , 2005, Best practice & research. Clinical rheumatology.

[34]  John E. Brazier,et al.  Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D , 2005, Quality of Life Research.

[35]  B. Koes,et al.  Exercise therapy for treatment of non-specific low back pain. , 2005, The Cochrane database of systematic reviews.

[36]  R. Delamarter,et al.  Clinical results of ProDisc-II lumbar total disc replacement: report from the United States clinical trial. , 2005, The Orthopedic clinics of North America.

[37]  Jeremy Fairbank,et al.  Surgical stabilisation of the spine compared with a programme of intensive rehabilitation for the management of patients with chronic low back pain: cost utility analysis based on a randomised controlled trial , 2005, BMJ : British Medical Journal.

[38]  R. Collins,et al.  Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial , 2005, BMJ : British Medical Journal.

[39]  J. Brazier,et al.  A comparison of the EQ-5D and SF-6D across seven patient groups. , 2004, Health economics.

[40]  A. Nordwall,et al.  Cost-Effectiveness of Lumbar Fusion and Nonsurgical Treatment for Chronic Low Back Pain in the Swedish Lumbar Spine Study: A Multicenter, Randomized, Controlled Trial From the Swedish Lumbar Spine Study Group , 2004, Spine.

[41]  Inger Holm,et al.  Randomized Clinical Trial of Lumbar Instrumented Fusion and Cognitive Intervention and Exercises in Patients with Chronic Low Back Pain and Disc Degeneration , 2003, Spine.

[42]  Inger Holm,et al.  The Effect of Comprehensive Group Training on Cross-sectional Area, Density, and Strength of Paraspinal Muscles in Patients Sick-Listed for Subacute Low Back Pain , 2003, Journal of spinal disorders & techniques.

[43]  Andrew Briggs,et al.  Missing... presumed at random: cost-analysis of incomplete data. , 2003, Health economics.

[44]  W. Jacobs,et al.  Total disc replacement for chronic low back pain: background and a systematic review of the literature , 2003, European Spine Journal.

[45]  H. Bleichrodt.  A new explanation for the difference between time trade-off utilities and standard gamble utilities. , 2002, Health economics.

[46]  N. Zethraeus,et al.  Definition, interpretation and calculation of cost-effectiveness acceptability curves. , 2000, Health economics.

[47]  S. Hallan,et al.  Quality of life after cerebrovascular stroke: a systematic study of patients’ preferences for different functional outcomes , 1999, Journal of internal medicine.

[48]  H. Ursin,et al.  Five‐Year Follow‐Up Study of a Controlled Clinical Trial Using Light Mobilization and an Informative Approach to Low Back Pain , 1998, Spine.

[49]  J. Brazier,et al.  Deriving a preference-based single index from the UK SF-36 Health Survey. , 1998, Journal of clinical epidemiology.

[50]  P. Dolan,et al.  Modeling valuations for EuroQol health states. , 1997, Medical care.

[51]  R. Brooks.  EuroQol: the current state of play. , 1996, Health policy.

[52]  A. Indahl,et al.  Good Prognosis for Low Back Pain When Left Untampered: A Randomized Clinical Trial , 1995, Spine.

[53]  S. Wilson.  Methods for the economic evaluation of health care programmes , 1987 .

[54]  Annett Wechsler,et al.  Applied Methods Of Cost Effectiveness Analysis In Healthcare , 2016 .

[55]  B. Koes,et al.  Outcome of invasive treatment modalities on back pain and sciatica: an evidence-based review , 2005, European Spine Journal.

[56]  I. Holm,et al.  Intensive group training versus cognitive intervention in sub-acute low back pain: short-term results of a single-blind randomized controlled trial. , 2003, Journal of rehabilitation medicine.

[57]  A. Witzmann.  [Acupuncture and other forms of treatment for patients with chronic back pain]. , 2000, Wiener medizinische Wochenschrift.