Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Breast Cancer

Treatment image guided radiation therapy (IGRT); proton beam; special physics consult; special treatment procedure (PBT)

The insurer denied coverage for image guided radiation therapy (IGRT); proton beam; special physics consult; special treatment procedure (PBT).

The denial is overturned.

This is the case of an adult female with history of cT3N1M0 (cancer staging), ypT0N0 (cancer staging) triple negative right breast cancer status-post neoadjuvant systemic chemotherapy, followed by breast conserving lumpectomy and nodal dissection. She was randomized on the Radiotherapy Comparative Effectiveness (RADCOMP) trial. Request is for approval of postoperative proton beam radiotherapy with curative intent.

Per Kammerer, E., Guevelou, J. L., Chaikh, A., Danhier, S., Geffrelot, J., Levy, C., Saloux, E., Habrand, J. L., & Thariat, J., "Radiation therapy plays a major role in the management of adjuvant breast cancer with nodal involvement, with an iatrogenic increase of cardio-vascular risk. Photon therapy, even with intensity modulation, has the downsides of high mean heart dose and heterogeneous target coverage, particularly in the case of internal mammary irradiation. Proton therapy reduces mean heart dose in breast cancer irradiation, probably reducing late cardio-vascular toxicity."

Per National Comprehensive Cancer Network (NCCN) Guideline for management of breast cancer (see principles of radiation therapy) Version 1.2021: "The adolescent and young adult (AYA) Oncology patient is defined as individuals aged preteen to adulthood at the time of the initial cancer diagnosis. This definition is based on the National Cancer Institute (NCI) Progress Review Group recommendations for a national agenda to advance AYA oncology, a patient population that saw little to no improvement in cancer survival for decades compared with younger and older adults."

The treating provider supplied the results of a proton/photon plan comparison, which revealed that the patient could not be treated safely with the use of photon- based intensity-modulated radiation therapy (IMRT), as this modality resulted in excessive exposure to the patient's right lung and cardiac tissue, which would lead to an unacceptable risk for cardiopulmonary morbidity/mortality. The proton radiation therapy plan was able to significantly reduce the heart/lung exposure to within known safe tolerance limits, thereby minimizing the risk for high grade toxicity.  

Furthermore, the American Society for Radiation Oncology (ASTRO) Model Policy supports its use in the member's setting, since the patient is randomized on the RADCOMP trial, which will allow her clinical outcomes to contribute to the future peer reviewed medical literature and help define the role of proton beam radiotherapy for management of breast cancer.

The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.   

Proton radiotherapy on the RADCOMP trial is standard of care and supported by the ASTRO Model Policy for proton radiation. IGRT; proton beam; special physics consult; special treatment procedure (proton beam therapy [PBT]) to treat breast cancer is considered medically necessary for this patient.  

The insurer's denial of coverage for image guided radiation therapy (IGRT); proton beam; special physics consult; special treatment procedure (proton beam therapy [PBT]) to treat breast cancer is reversed. Medical necessity is substantiated.