Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Breast Cancer
Treatment: Proton Beam Radiation Therapy (PBRT)
The insurer denied: Proton Beam Radiation Therapy (PBRT)
The denial is overturned

This is an adult female with stage T1cN0M0 invasive carcinoma of the right breast status post lumpectomy and sentinel node biopsy. Proton beam therapy is being requested to deliver accelerated partial breast irradiation (APBI) of 40 gray (Gy) in 10 fractions on phase II PCG BRE 007-12 clinical trial.

The proposed treatment is medically necessary.

Currently, there is no peer reviewed publications on the long-term clinical outcome of proton beam therapy for accelerated partial breast radiation therapy (RT) compared to other standard partial breast irradiation (APBI) techniques such as photon external radiation therapy or high dose rate (HDR) brachytherapy in peer reviewed literature. A few published studies on proton radiotherapy for accelerated partial breast irradiation (APBI) are dosimetric/physics studies and single institutional phase II studies with a small number of patients. These publications do not provide clinical evidence on tumor control or toxicities of proton radiotherapy compared to photon radiation therapy (RT) or high dose rate (HDR) brachytherapy accelerated partial breast irradiation (APBI). Physical and dosimetric advantages of proton beam radiation therapy (RT) in the delivery of more precise radiation dose distribution to the tumor with sparing of normal tissues compared to photon beam have been well studied and published in peer reviewed literature. However, the long-term clinical efficacy of proton beam therapy relative to the standard modalities from a prospective study for accelerated partial breast irradiation (APBI) is lacking in the peer reviewed literature at the present time.
A search in www.clinicaltrials.gov showed a phase II trial presently recruiting patients for accelerated partial breast radiation therapy with proton therapy. 
The American Society for Radiation Oncology (ASTRO), which contributes to establishment of standards of care in radiation oncology, has issued an update to its recommendations for medical insurance coverage regarding the use of proton beam therapy to treat cancer.
The updated 2017 American Society for Radiation Oncology (ASTRO) Proton Beam Therapy Model Policy states that proton beam therapy is an advanced type of external beam radiation therapy that uses proton rather than photon beams to deliver radiation doses to a tumor. Proton therapy offers a high degree of precision, which allows radiation oncologists to target an escalated dose of radiation directly on a tumor and spare nearby healthy tissue. Proton therapy is particularly beneficial for patients with tumors that are near critical structures, such as lung tumors near the heart. Based on new evidence published since the original policy was issued in 2014, the updated model policy outlines two categories of appropriate clinical indications, or diagnoses, for proton beam therapy. For indications in Group 1, coverage is recommended; for Group 2, coverage is recommended if additional requirements (outlined below) are met. Disease sites were assigned to one of the two categories based on evidence in published clinical data and current Medicare coverage.
Medical documents indicate that the proton beam therapy for accelerated partial breast irradiation (APBI) is provided on a phase II PCG BRE 007-12 clinical trial. Thus, the requested proton beam therapy for this patient's breast cancer is consistent with the 2017 American Society for Radiations Oncology (ASTRO) policy for proton beam therapy and it is considered medically necessary.