A cost-effectiveness analysis of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain.

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 Multicenter 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.