Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate Cancer
Treatment Proton Beam Therapy
The insurer denied the Proton Beam Therapy.
The determination is upheld.

The patient presented with a rising prostate-specific antigen (PSA). He  was diagnosed with favorable intermediate risk prostate cancer and was offered different treatment options. He is being evaluated for proton beam therapy. The medical necessity of the proton beam therapy is under review.
The requested health service/treatment of proton beam radiation therapy is not medically necessary for this patient.
Proton beam therapy is a type of particulate radiation therapy that differs from conventional electromagnetic and/or photon radiation therapy. The use of protons is produced by an accelerator (cyclotron, synchrotron, synchrocyclotron, or linear). This type of radiation is proposed to allow for minimal scattering as particulate beams pass through tissue disposing ionizing energy at precise depths (i.e., the Bragg peak) to minimize tissue damage in the surrounding area. The use of proton beam radiation therapy as definitive treatment for prostate cancer has medical literature with relatively short follow up with proton beam therapy as monotherapy for prostate malignancies. These studies show equivalent control rates to other types of radiation therapy for the shorter follow up periods. There are also retrospective studies with large numbers of patient that have shown worse gastrointestinal (GI) side effects as compared to photon beam radiation therapy with intensity modulated radiation therapy (IMRT). There are a lack of randomized studies regarding proton beam radiation therapy alone as treatment for prostate cancer that shows equivalent outcome or any improvement over other forms of radiation therapy such as photon IMRT. Until the current randomized trials ongoing are published in peer reviewed medical literature, this treatment for prostate cancer is considered not medically necessary.
Proton beam for prostate cancer is being evaluated under National Cancer Institute (NCI sponsored trials). Based on the limited clinical evidence available, according to current published medical literature, established radiotherapy modalities are at least as effective as proton beam therapy for treatment of prostate cancer. There is significant consensus among radiation oncologists that there is lack of comparative effectiveness research on proton beam radiation therapy (PBRT) for prostate cancer. Multiple evidence based reviews on this topic have concluded, that no clear evidence supports a benefit of proton therapy over intensity modulated radiation therapy (IMRT) in terms of efficacy or long-term toxicity.
The American Society for Radiation Oncology (ASTRO) maintains: "In the treatment of prostate cancer, the use of PBT is evolving as the comparative efficacy evidence is still being developed. In order for an informed consensus on the role of PBT for prostate cancer to be reached, it is essential to collect further data, especially to understand how the effectiveness of proton therapy compares to other radiation modalities such as IMRT and brachytherapy. There is a need for more well designed registries and studies with sizable comparator cohorts to help accelerate data collection. Proton beam therapy for primary treatment of prostate cancer should only be performed within the context of a prospective clinical trial or registry."
The body of evidence on proton beam radiation therapy (PBRT) for prostate cancer largely consists of retrospective studies performed at tertiary centers. The evidence quality is low and there is insufficient evidence to determine how PBRT compares to standard of care photon-based therapies, which are able to achieve outcomes with low toxicity. The use of proton beam radiation therapy (PBRT) in the treatment of prostate cancer is unproven.
Therefore, the proton beam therapy is not medically necessary.