Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate Cancer
Treatment: Proton Beam Therapy
The insurer denied coverage for Proton Beam Therapy
The denial is upheld.

This is the case of an adult who presented with a rising prostate-specific antigen (PSA). Biopsy established a diagnosis of T1C (cancer size) N0 (cancer in lymph nodes or not) prostate cancer. The patient is being evaluated for proton beam treatment.

Proton beam therapy has a typical physical characteristic called "Bragg peak," by which most of the radiation dose is delivered at a prescribed depth in and near tumor. Proton beam delivers less radiation to organs and tissues in the path of radiation compared to conventional photon beam radiation therapy (RT). Because of this characteristic, proton beam has been utilized to treat several benign and malignant clinical conditions including prostate cancer.

Protons has been used to treat prostate cancer for last several years. There are several clinical publications for safety and efficacy of proton beam RT for prostate cancer. However, there is no randomized trial suggesting superior clinical outcome of proton beam for prostate cancer over commonly used intensity-modulated radiation therapy (IMRT). Most investigators recommend additional study for long term safety and efficacy of protons compared with photons before adopting protons as medically necessary treatment for prostate cancer.

Protons are currently evaluated in several ongoing National Cancer Institute (NCI)-approved clinical trials. The National Comprehensive Cancer Network (NCCN) guideline regarding proton therapy for prostate cancer refers to American Society for Therapeutic Radiology (ASTRO's) 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 or within prospective registries." The NCCN panel believes there is no clear evidence supporting a benefit or decrement to proton therapy over IMRT for either treatment efficacy or long-term toxicity (2017).

For health benefit plans that contain such language, charged particle irradiation with proton beams for treatment of prostate cancer would be considered not medically necessary because, based on the limited clinical evidence available according to current published medical literature, established and less costly radiotherapy modalities are at least as effective as proton beam therapy for treatment of prostate cancer.

There is emerging data suggesting that proton therapy is safe and effective for prostate cancer. However, there is lack of clinical outcome evidence (local control, disease free survival, and toxicity) of proton beam therapy relative to available standard therapies including surgery, brachytherapy, photon beam therapy such as photon IMRT for prostate cancer, by well- conducted, randomized controlled trials or well-conducted cohort trials from more than one institution. Without published clinical outcome evidence (local control, disease free survival, and toxicity) of proton beam therapy relative to available photon beam therapy such as IMRT, proton beam therapy for the treatment of this patient's prostate cancer is not the standard of care or medically necessary at the present time.

This is a young patient with early stage, prostate cancer. The patient has several treatment options including surgery and radiation treatment for curative intent. Radiation treatment of such patients includes conventional Intensity Modulated Radiotherapy (IMRT), brachytherapy, proton beam therapy, stereotactic body radiation therapy (SBRT), etc. Therefore, Proton Beam Therapy is not considered medically necessary for this patient.

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 Proton Beam Therapy services is not substantiated.