Impact of National Comprehensive Cancer Network Guidelines Inclusion of Level 1 Evidence on Insurance Denial for Randomized Controlled Trial Patients with Metastatic Spine Disease.

Abstract

Background: The primary treatment of metastatic spine disease is radiation therapy (RT), traditionally conventional external beam RT (EBRT) or stereotactic body RT (SBRT). Until recently, there had been no Level 1 evidence supporting SBRT over EBRT, which has led to difficulties obtaining insurance approval. Publication of the first randomized controlled trial (RCT) comparing SBRT to EBRT for spine metastases [Canadian Cancer Trials Group (CCTG)] helped change this. The results showed superiority of SBRT in pain response; however, the results were not cited by The National Comprehensive Cancer Network (NCCN) until March 24, 2023. We present results from an ongoing RCT to assess the impact of this NCCN inclusion on insurance denials for trial-eligible patients.

Materials and methods: The ongoing SPORTSMEN RCT randomizes metastatic spine cancer patients to SBRT versus EBRT. Trial-eligible patients during the first six months were examined to assess if SBRT was denied by insurance before March 24, 2023, versus afterwards. Fisher's exact test was used to assess for statistical significance.

Results: Prior to CCTG NCCN inclusion, 25% of 12 trial-eligible patients experienced SBRT insurance denial. Following NCCN inclusion, of 8 patients, one (12.5%) has undergone insurance denial of SBRT. These differences were not statistically significant.

Conclusions: The inclusion of Level 1 evidence in the NCCN guidelines has resulted in a numerical halving of spine SBRT insurance denials on a RCT, with the small sample size likely the largest culprit of not meeting statistical significance. These findings illustrate the importance of generating high-quality evidence, followed by timely inclusion into the NCCN guidelines.