ABSTRACT
BACKGROUND CONTEXT: Randomized trials have demonstrated the superiority of intraosseous basivertebral nerve ablation (BVNA) compared with sham and standard care in terms of improvements in pain, disability, and health-related quality of life in patients with vertebrogenic chronic low back pain (cLBP). PURPOSE: To assess the cost effectiveness of BVNA in patients with vertebrogenic cLBP compared to standard care alone. STUDY DESIGN/SETTING: A model-based economic analysis. PATIENT SAMPLE: Base case analysis used INTRACEPT, a randomized trial comparing BVNA with standard care in 140 patients with vertebrogenic cLBP, recruited from 23 sites across the United States, with a follow-up, up to 5 years. Scenario analyses compared data from the Surgical Multi-center Assessment of Radiofrequency Ablation for the Treatment of Vertebrogenic Back Pain (SMART) randomized trial against a sham control, and a single-arm study. OUTCOME MEASURES: Costs and quality-adjusted life years (QALYs) were calculated to determine the incremental cost-effectiveness ratio (ICER). METHODS: A cost-effectiveness model was built in Microsoft Excel® to evaluate the costs and health outcomes of patients undergoing BVNA using the Intracept Procedure (Relievant Medsystems) to treat vertebrogenic cLBP from a US payor perspective. Alternative scenario sensitivity analyses and probabilistic sensitivity analyses were conducted to assess the robustness of the model results. QALYs were discounted at 3.0% per year. RESULTS: Base case analysis showed that BVNA relative to standard care alone was a cost-effective strategy for the management of patients with vertebrogenic cLBP, with an ICER of US$11,376 per QALY at a 5-year time horizon from introduction of the procedure. Modeling demonstrated a >99% probability that this was cost effective in the US, based on a willingness-to-pay threshold of US$100,000 to US$150,000. Various sensitivity and scenario analyses produced ICERs that all remained below this threshold. CONCLUSIONS: BVNA with the Intracept Procedure offers patients with vertebrogenic cLBP, clinicians, and healthcare systems a cost-effective treatment compared to standard care alone.