Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Prostate Cancer.
Treatment:  Treatment: IMRT (intensity-modulated radiation therapy) - 45 treatments.

The insurer denied the IMRT (intensity-modulated radiation therapy) - 45 treatments.  The denial is overturned. 

The patient is a male with a diagnosis of prostate cancer.  Definitive radiation therapy was recommended, and IMRT (intensity-modulated radiation therapy) with 45 fractions was requested.

Yes, the IMRT (intensity-modulated radiation therapy) - 45 treatments is medically necessary.

There are several peer-review literatures that showed that IMRT (intensity-modulated radiation therapy) is as effective, and safer compared to conventional conformal radiation therapy for the treatment of prostate cancer.

In a study from Memorial Sloan-Kettering Cancer Center, a comparison was made for 1,100 patients with prostate cancer treated with 3-D (three dimensional) conformal or IMRT (intensity-modulated radiation therapy).  The authors concluded, "Treatment with IMRT [intensity-modulated radiation therapy] significantly decreased the incidence of late grade-2 rectal toxicity," and furthermore, that, "IMRT [intensity-modulated radiation therapy] is associated with minimal rectal and bladder toxicity, and, hence, represents the treatment delivery approach with the most favorable risk-to-benefit ratio."

Another study from Washington University School of Medicine evaluated 763 patients with prostate cancer treated with IMRT (intensity-modulated radiation therapy) vs 3D (three dimensional).  The authors concluded, "Intensity modulated RT [radiation therapy] is associated with a significant reduction in acute G2+ [grade 2 or more] GI/GU [gastrointestinal/genitourinary] toxicity. There is a trend for a clinically meaningful reduction in late G2+ [grade 2 or more] GI [gastrointestinal] toxicity with IMRT [intensity-modulated radiation therapy]."

A more recent study from Viani et al. reported on a pseudorandomized trial (sequential allocation) that compared toxicity levels between IMRT (intensity-modulated radiation therapy) and 3D-CRT (three dimensional conformal radiation therapy) in 215 men who had localized prostate cancer.  The 3D-CRT (three dimensional conformal radiation therapy) group reported significantly more incidence of acute and late GI (gastrointestinal) and GU (genitourinary) toxicity, with similar rates of biochemical control. The combined incidence of acute GI (gastrointestinal) and GU (genitourinary) toxicity was 28% for the 3D-CRT (three dimensional conformal radiation therapy) group compared with 11% for the IMRT (intensity-modulated radiation therapy) group. Prostate-specific quality of life was reported to be worse in the 3D-CRT (three dimensional conformal radiation therapy) group at 6, 12, and 24 months but not at 36 months post treatment.  The authors concluded, "IMRT [intensity-modulated radiation therapy] 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 [gastrointestinal] and GU [genitourinary] toxicity for IMRT [intensity-modulated radiation therapy] compared with 3D-CRT [three dimensional conformal radiation therapy]."

With regard to the number of fractions requested, according to NCCN (National Comprehensive Cancer Network) guidelines, conventional fractionation of 1.82 Gy (gray) x 37-45 fx (fractions) is recommended for the definitive treatment of prostate cancer.  The requested 45 fractions of IMRT (intensity-modulated radiation therapy) is within the recommended dose regimen per NCCN (National Comprehensive Cancer Network) guideline.  Therefore, the requested IMRT (intensity-modulated radiation therapy) for 45 fractions, is considered medically necessary.

Forty-five fractions of IMRT (intensity-modulated radiation therapy) for the definitive treatment of prostate cancer is considered within the standard of care per NCCN (National Comprehensive Cancer Network) guidelines.