Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Prostate Cancer
Treatment: Additional 16 Fractions of Modulated Radiation Therapy (IMRT) for a total of 44 Fractions
The insurer denied the additional 16 Fractions of IMRT for a total of 44 Fractions.
The denial is overturned.

The patient is an adult male with a diagnosis of localized, unfavorable intermediate risk prostate cancer, Gleason score of 7.  Definitive radiation therapy was recommended and intensity modulation radiation therapy (IMRT) to 7920 centi-gray (79.2 gray) in 44 fractions was requested.  The health plan approved 28 fractions; the remaining 16 fractions are under review.

The proposed additional 16 fractions of IMRT for a total of 44 fractions are medically necessary.

In this case, definitive radiation therapy was recommended, and 44 fractions of IMRT was requested.  The definitive dose required for prostate cancer is at least 75 gray (Gy).  In cases where the surrounding critical structures cannot be spared with standard conformal radiation, IMRT may be the only option for a safe delivery.   

In this case, the planned dose of 79.2 gray (Gy) is significantly higher than the tolerance doses of the surrounding critical structures such as rectum, small bowel, and bladder.  

There are several peer-review literatures that showed that IMRT is as effective and safer compared to conventional conformal radiation therapy for the treatment of prostate cancer.  In a 2001 study from Memorial Sloan-Kettering Cancer Center, a comparison was made for 1,100 patients with prostate cancer treated with three-dimensional (3-D) conformal or IMRT.  The authors concluded that "treatment with IMRT significantly decreased the incidence of late grade-2 rectal toxicity," and concluded that "IMRT is associated with minimal rectal and bladder toxicity, and, hence, represents the treatment delivery approach with the most favorable risk-to-benefit ratio."  

Another 2013 study from Washington University School of Medicine evaluated 763 patients with prostate cancer treated with IMRT versus three-dimensional.  The authors concluded that "Intensity modulated RT is associated with a significant reduction in acute G2+ (grade 2 plus) gastrointestinal (GI)/genitourinary (GU) toxicity. There is a trend for a clinically meaningful reduction in late G2+ GI toxicity with IMRT."  

A more recent 2016 study from Viani, et al reported on toxicity levels between IMRT and three dimensional - conformal radiation therapy (3D-CRT) in 215 men who had localized prostate cancer.  The 3D-CRT group reported significantly more incidence of acute and late GI and GU toxicity, with similar rates of biochemical control. The combined incidence of acute GI and GU toxicity was 28% (percent) for the 3D-CRT group compared with 11% for the IMRT group. The authors concluded that "IMRT reduced the delivery of significant radiation doses to the bladder and rectum using a similar target volume.  This dosimetric advantage resulted in a lower rate of acute/late grade 2 GI and GU toxicity for IMRT compared with 3DCRT."

In regard to the dose-fractions, standard fraction of up to 45 fractions is one of the standard radiation regiments.  According to the National Comprehensive Cancer Network (NCCN) guideline, the standard dose fraction regimens include moderate stereotactic body radiation therapy (SBRT), hypofractionation of 2.5-3.0 gray per fraction to 20-28 fractions and standard fractionation of 1.8-2.0 gray for 37-45 fractions.  The proposed 1.8 gray for 44 fractions, therefore, would be considered one of the standard regimens and is medically necessary.