Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate Cancer

Treatment: Radiation therapy for prostate adenocarcinoma

The insurer denied coverage for radiation therapy for prostate adenocarcinoma

The denial is upheld 

This is the case of a patient who presented with T2cNo Stage IIc (2c) prostate cancer. Metastatic work up was negative. The plan is to treat with proton beam therapy (PBT) with curative intent. This is the subject of review.

This patient has localized cancer which can be treated with standard of care (SOC) intensity modulated radiation therapy (IMRT).

The appealer has provided dose-volume histogram (DVH) comparison of IMRT and proton beam treatment. The dose to bladder, rectum and bowel from IMRT are within acceptable limits, so patient can be treated with IMRT.  The appealer also mentioned that bowel and bladder complications from IMRT and proton beam are not significantly different.

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 patients that have shown worse gastrointestinal (GI) side effects as compared to photon beam radiation therapy with IMRT. There is 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 investigational and not medically necessary and should be denied.
 
National Comprehensive Cancer Network (NCCN) guidelines version 3.2023 mentioned that proton and photon beam radiotherapy are both effective at achieving highly conformal radiotherapy with similar  biochemical control and long-term side effects profiles.

The following statement is endorsed by The American Society for Radiation Oncology (ASTRO): "Don't routinely recommend proton beam therapy for prostate cancer outside a prospective clinical trial or registry." It is advised that prospective clinical trials are necessary to establish the potential advantage(s) of this treatment over other therapies prior to wider adoption of this form of treatment.

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.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for radiation therapy for prostate adenocarcinoma is not substantiated.