Comparative effectiveness research and policy: experiences conducting a coverage with evidence development study of a therapeutic device

BACKGROUND AND OBJECTIVE: The Washington State workers' compensation agency funded a coverage with evidence development study to evaluate spinal cord stimulation (SCS) for chronic back and leg pain after spine surgery (failed back surgery syndrome). We previously published the study outcomes. We now report results from a second patient cohort; study costs; and industry, provider, and payer responses.

RESEARCH DESIGN, SUBJECTS, AND MEASURES: This prospective cohort study compared patients with failed back surgery syndrome who received at least a trial of SCS (n = 51), Pain Clinic evaluation (n = 39), or Usual Care only (n = 68) on measures of pain, physical functioning, and opioid medication use at baseline and 6, 12, and 24 months. Between the end of subject enrollment and availability of final study results, a second SCS cohort (n = 30) was followed for 12 months.

RESULTS: SCS was associated with no benefits beyond 6 months and entailed risks, including one life-threatening event. After reviewing the results, the workers' compensation program decided to maintain its SCS noncoverage policy. SCS manufacturers and providers criticized multiple aspects of the study to policy decision-makers at all stages of the study. Accumulated evidence will be reviewed by the Washington State Health Technology Assessment Program to make decisions regarding all Washington State agencies' coverage for SCS.

CONCLUSIONS: Coverage with evidence development studies may yield important information not apparent from randomized clinical trials concerning long-term risks and benefits of a therapy in clinical practice for specific subpopulations, but are likely to be met with criticism from interested parties.