Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Non-Hodgkins Lymphoma
Treatment: Radiation Therapy
The insurer denied: Radiation Therapy
The denial is overturned.

This is an adult male patient with stage III diffuse large B-cell (white blood cell) lymphoma in the mediastinum status post rituximab-cyclophosphamide-hydroxydaunorubicin-Oncovin-prednisone (R-CHOP) chemotherapy with partial response. Proton beam therapy is planned to deliver consolidation radiation therapy of 30.6 gray (Gy) in 17 fractions to the involved sites in 
the mediastinum on a multi-institutional registry trial.

The proposed radiation therapy is medically necessary.

Currently, peer reviewed publications on proton beam therapy for non-Hodgkin's lymphoma demonstrate that that proton beam therapy offers superior dosimetry to photon radiation treatment dosimetry, and side effects of proton beam therapy may offer potentially less local side effects compared to photons for mediastinal lymphoma. 
Radiation treatment fields to encompass large mediastinal adenopathy will include large volumes of heart and lung with significant risks of radiation induced complications to the heart and lung especially after chemotherapy. Due to synergistic cardiotoxic effects of radiation and chemotherapy, the risks of radiation complications (radiation pericarditis, coronary artery 
disease, radiation pneumonitis) to the heart and lung will increase substantially. Proton beam therapy with its unique highly conformal dose distribution can decrease the radiation dose to lung and heart compared to photon radiation therapy such as intensity modulated radiation therapy and, thus, minimizes risks of these cardiac and pulmonary complications in this patient with good prognosis.
Medical documents provide the comparison of intensity modulated radiation therapy (IMRT) plan and proton beam therapy plan which demonstrated significant reduction of radiation dose to the heart and lung with proton beam therapy plan compared to the intensity modulated radiation therapy plan.
The 2022 American Society for Therapeutic Radiology and Oncology (ASTRO) model policy on proton beam therapy states that based on the medical necessity requirements and published clinical data that meets the selection criteria above, disease sites that frequently support the use of proton beam therapy (PBT) include the following: mediastinal lymphoma. 
The National Comprehensive Cancer Network (NCCN) guideline for non-Hodgkin's lymphoma 2023 states advanced radiation therapy technologies such as intensity-modulated radiation 
therapy (intensity modulated radiation therapy [IMRT])/volumetric modulated arc therapy (VMAT), proton therapy, breathhold or respiratory gating, and/or image-guided therapy may offer significant and clinically relevant advantages in specific instances to spare organs at risk (OARs) such as the heart (including coronary arteries and valves), lungs, kidneys, liver, spinal cord, esophagus, bone marrow, breasts, stomach, muscle/soft tissue, and salivary glands to decrease the risk for late, normal tissue toxicity while still achieving the primary goal of local tumor control. The National Comprehensive Cancer Network guideline states that reducing dose to normal tissues reduces the risk of late complications. Achieving highly conformal dose 
distribution is especially important for patients who are being treated with curative intent or who have long life expectancies following therapy. The National Comprehensive Cancer 
Network guideline also states randomized studies to test these concepts are unlikely to be done since these techniques are designed to decrease late effects, which take 10-plus years to evolve. In light of that, the modalities and techniques which best reduce the doses to the organs at risk (OARs) in a clinically meaningful way without compromising target coverage should be considered. The submitted comparison of intensity modulated radiation therapy (IMRT) and proton beam therapy plan demonstrates that proton beam therapy delivers lower dose to the coronary artery, aorta, esophagus, heart, larynx, liver, lung, spinal cord and thyroid. Thus, the requested proton beam therapy in this case is consistent with the 2022 American Society for Therapeutic Radiology and Oncology (ASTRO) model policy on proton beam therapy and the National Comprehensive Cancer Network (NCCN) guideline on B-cell lymphoma 2023.