Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate cancer
Treatment: Proton beam therapy (PBT)
The insurer denied coverage for proton beam therapy (PBT).
The denial is upheld.

In the documentation given for review, it shows that this male patient has a history of high-risk prostate cancer. The request is for approval of proton beam radiation therapy. The request for proton beam radiation therapy for the treatment of prostate cancer was previously denied by the plan as not medically necessary.

Present data have demonstrated that proton beam therapy is safe and effective compared with the standard treatment options for prostate cancer. While dosimetric studies suggest lower whole-body radiation dose and a theoretically higher relative biological effectiveness in prostate cancer compared with photons, no studies have demonstrated a clear benefit with protons.

Evolving trends in proton treatment delivery and proton center business models are helping to reduce costs. Introduction of existing technology into proton delivery allows further control of organ motion and National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer (2021) 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. Conventionally fractionated prostate proton therapy is considered a reasonable alternative to an X-ray based regimen at clinics with appropriate technology, physics, and clinical expertise in addressing organs-at-risk. Finally, the much-awaited contemporary studies comparing photon with proton-based treatments, with primary endpoints of patient-reported quality-of-life, will help us understand the differences between proton and photon-based treatments for prostate cancer in the modern era." (Kamran, S. C., et al, 2019).

National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer (2021) refer to American Society for Radiation Oncology's (ASTRO) current position which states that "proton beam therapy for primary treatment of prostate cancer should only be performed within the context of a prospective clinical trial."  

"Men diagnosed with localized prostate cancer have many curative treatment options including several different radiotherapeutic approaches. Proton radiation is one such radiation treatment modality and, due to its unique physical properties, offers the appealing potential of reduced side effects without sacrificing cancer control. In this review, we examine the intriguing dosimetric rationale and theoretical benefit of proton radiation for prostate cancer and highlight the results of preclinical modeling studies. We then discuss the current state of the clinical evidence for proton efficacy and toxicity, derived from both large claim-based datasets and prospective patient-reported data. The result is that the data are mixed, and clinical equipoise persists in this area. We place these studies into context by summarizing the economics of proton therapy and the changing practice patterns of prostate proton irradiation. Finally, we await the results of a large prospective randomized clinical trial currently accruing and also a large prospective pragmatic comparative study which will provide more rigorous evidence regarding the clinical and comparative effectiveness of proton therapy for prostate cancer." (Royce, et al, 2019).                                                         

The health plan acted reasonably, with sound medical judgment, and in the best interest of the patient.

The insurer's denial of coverage for proton beam therapy (PBT) is upheld. Medical necessity is not substantiated.