Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Prostate Adenocarcinoma
Treatment: SpaceOAR, perirectal spacer, procedure code 55874
The insurer denied the SpaceOAR, perirectal spacer), procedure code 55874
The denial was overturned.

This patient has an intermediate risk stage T1cN0M0 prostate cancer Gleason 3+4=7 and prostate specific antigen (PSA) of 10.47. He was treated with intensity-modulated radiation therapy (IMRT).  Transperineal placement of Space OAR was performed for sparing of rectum.

Based on the published evidence and Food and Drug Administration (FDA) approval, Space OAR implantation into peri-rectal space prior to IMRT is commonly performed standard procedure for prostate cancer.  Therefore, the scientific evidence in peer-reviewed literature does support a result of improvement in health outcome.

A prospective multicenter randomized controlled pivotal trial (NCT01538628) was performed to assess outcomes following absorbable spacer (SpaceOAR system) implantation (Mariados N, et al., 2015).  This trial, Evaluation of SpaceOAR System When Used to Create Space Between the Rectum and Prostate in Men Undergoing IGRT-IMRT for Localized Stage T1-T2 Prostate Cancer: A Randomized, Multicenter, Parallel Arm Controlled Clinical Study enrolled 222 patients with primary end points being 1.Proportion of subjects achieving a reduction of 25% or greater in percent volume of the rectum receiving at least 70 Gy measured from CT scans acquired pre and post SpaceOAR hydrogel injection [Time Frame: 3 months post index procedure]. Proportion of subjects experiencing a Grade 1 or greater rectal adverse event or procedure adverse event in the 6 months following treatment. Patients were treated with IMRT to 79.2 Gy in 1.8Gy per fraction X 44 fractions with daily IGRT. With the median follow-up of 3 years, the 3-year incidence of grade =1 (9.2% vs 2.0%; P=.028) and grade =2 (5.7% vs 0%; P=.012) rectal toxicity favored the spacer arm. Grade =1 urinary incontinence was also lower in the spacer arm (15% vs 4%; P=.046), with no difference in grade =2 urinary toxicity (7% vs 7%; P=0.7). From 6 months onward, bowel QOL consistently favored the spacer group (P=.002), with the difference at 3 years (5.8 points; P<.05).  This trial demonstrated that prostate-rectum hydrogel spacer application is a relatively safe technical procedure which is well tolerated and has a high technical success rate.  Spacer application significantly reduces rectal radiation dose, and results in long-term reductions in rectal toxicity as well as improvements in bowel, urinary and sexual QOL [quality of life]. 

Per Karsh L, et al. (2017), "Spacer application was well tolerated with a 99% technical success rate. The mean additional space created between the prostate and the rectum was just over 1 cm, which allowed significant rectum and penile bulb radiation dose reduction, resulting in less acute pain, lower rates of late rectal toxicity, and improved bowel and urinary quality of life (QOL) scores from 6 months onward.  Improvements in sexual QOL were also observed at 37 months in baseline-potent men, with 37.5% of control and 66.7% of spacer men capable of "erections sufficient for intercourse."'

Based on the published evidence and FDA approval, SpaceOAR can improve sparing of rectum during external beam radiation treatment in this patient.  

The carrier's denial of coverage for (SpaceOAR, perirectal spacer), procedure code 55874 should be overturned.