Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Adenocarcinoma of the prostate.
Treatment: Proton beam radiation therapy (procedure codes 77522, 77523, 77525 and 55874).
The insurer denied coverage for proton beam radiation therapy (procedure codes 77522, 77523, 77525 and 55874). The denial is upheld.

This is a male patient with high risk adenocarcinoma of the prostate with Gleason 8 and a Prostate-Specific Antigen (PSA) score of 9.56. Proton beam therapy was delivered to treat this claimant's prostate cancer. 

Current published data does not support improved outcomes with proton beam radiation therapy for prostate cancer, when compared with other approaches such as intensity-modulated radiation therapy. A review of published peer-reviewed literature on proton beam radiation therapy shows insufficient high-grade evidence of proton beam radiation therapy over photon radiation therapy in clinical outcomes, such as survival, tumor control, or toxicity. Published studies suggest that proton beam radiation offers superior dosimetry to photon radiation treatment dosimetry, and side effects of proton beam therapy appear to offer potentially less local side effects compared to photons. However, no randomized studies of proton versus photon have been published to conclusively state any advantage of protons to the current standards that exist. Review of literature on proton beam therapy for prostate shows several studies which includes over 1000 patients all together. However, most of these studies are retrospective studies from single institutions and with heterogeneous patient population. These studies report that proton therapy is effective therapy for localized prostate cancer with minimum side effects.

National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer (2020) states that "The NCCN panel believes there is no clear evidence supporting a benefit or decrement to proton therapy over intensity-modulated radiotherapy (IMRT) for either treatment efficacy or long-term toxicity..." In summary, there is lack of clinical outcomes evidences (local control, disease free survival, and toxicity) of proton beam therapy relative to available photon beam therapy such as IMRT from comparative controlled cohort trials in the prevailing peer reviewed medical literature. Proton beam therapy at the requesting facility is Food and Drug Administration (FDA) approved for treatment of prostate cancer. This patient is not a good candidate for proton beam radiation therapy. Proton beam radiation therapy is not the best available treatment for this patient at this time.

Current published data does not support improved outcomes with proton beam radiation therapy for prostate cancer, when compared with other approaches such as intensity-modulated radiation therapy. A review of published peer-reviewed literature on proton beam radiation therapy of prostate cancer showed insufficient high-grade clinical outcome evidence as measured by survival, tumor control, or toxicity either from meta-analyses of randomized trials or from randomized controlled trials.     


Proton radiation therapy for prostate cancer is currently under review in phase II and III trials. Without published clinical outcomes evidences (local control, disease free survival, and toxicity) of proton beam therapy relative to available photon beam therapy IMRT with or without brachytherapy, proton therapy is not likely to be more beneficial than any other standard treatment/procedure.

The denial of proton beam radiation therapy (procedure codes 77522, 77523, 77525 and 55874) is upheld.