Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for proton beam therapy. Proton beam has unique properties compared to standard photon or x-ray beam in its ability to deposit radiation doses. The use of proton beams potentially results in fewer areas of low scattered radiation dose as fewer proton beams may be used to achieve a dose distribution similar to standard photon beams. While proton therapy is currently indicated in settings where severe toxicities would result if normal tissue constraints cannot be met by photon beam, Corbin and Muter note that there has not been a demonstrable clinically significant improvement in either quality of life or reduction of high grade toxicities in the setting of intact whole breast treatment. Chowdhary and colleagues report that limited data exists demonstrating the clinical benefit of proton radiotherapy in early breast cancer. The authors conclude that proton radiotherapy is not associated with overall survival and that further studies are required to determine benefits other than overall survival of proton radiotherapy. Proton therapy may hold some benefit in certain cases of very advanced disease or cases of re-irradiation, as locally advanced breast cancers often require irradiation of a large area of tissue in addition to the chest wall. These additional areas may include the axillary chain of lymph nodes and the supraclavicular fossa, leading to greater difficulty in avoiding the adjacent organs. In this case, the treatment region is to the left breast alone. The patient has appropriately been recommended a course of adjuvant radiation treatment following her lumpectomy, as recommended by National Comprehensive Cancer Network (NCCN) guidelines. While a treatment plan comparison between proton beams and photon beam reported that the photon plan showed heart doses exceeding the typical QUANTEC acceptable dose constraints, it is highly unusual to see such a high mean heart dose of 18 Gy in the setting of a left breast radiation treatment. Cross-sectional imaging did not show that left breast was attached or closely plastered to the chest wall, which would indicate difficulty in avoiding dose to the heart. Duma and colleagues note that based on available findings, the best heart-sparing technique is the use of breathing techniques such as deep inspiration breath-hold. The authors note that standard radiation techniques that may be utilized to avoid a heart dose include volumetric modulated arc therapy (VMAT) radiation therapy. Given this patients anatomy and the lack of evidence in current medical literature demonstrating a clinically significant reduction in toxicity with the use of proton beams in early stage breast cancer, the requested services are not medically indicated. Therefore, proton beam therapy is not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested services are not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in radiation oncology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.