Objectives:

The primary treatment of metastatic spine disease has involved radiation therapy, traditionally conventional external beam radiation therapy (EBRT) or more recently spine radiosurgery/stereotactic body radiation therapy (SBRT). However, until recently, there had been no Level 1 evidence supporting SBRT over EBRT for these patients, which has led to difficulties in obtaining insurance approval for SBRT over EBRT in some instances. Completion and publication of the first published randomized controlled trial (RCT) comparing SBRT to EBRT for symptomatic spine metastases [Canadian Cancer Trials Group (CCTG), PMID: 34126044] helped change this, however the results of this trial were not included into the National Comprehensive Cancer Network (NCCN) guidelines 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.

Methods:

The ongoing Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Phase II randomized clinical trial (NCT05617716 on clinicaltrials.gov) randomizes symptomatic metastatic spine cancer patients to spine SBRT versus EBRT. Trial-eligible patients during the first six months of enrollment were examined to assess whether the option of SBRT was denied by their insurance. The rate of insurance denial before 3/24/23 versus afterwards was assessed and compared to examine the impact of NCCN inclusion of the CCTG RCT on insurance denial. Fisher’s exact test was used to assess for statistical significance, set at p< 0.05.

Results:

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

Conclusion(s):

The inclusion of Level 1 evidence in the NCCN guidelines for treatment of metastatic spine disease has resulted in a numerical halving of spine SBRT insurance denials (25% to 12.5%) on an ongoing RCT, with the small sample size likely the largest culprit of this difference not meeting statistical significance. These findings illustrate the importance of generating and publishing high-quality evidence, followed by timely inclusion of this evidence onto the NCCN guidelines. Such timely inclusion optimizes the likelihood of patients receiving insurance approval for optimal care.