Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement for proton beam radiation therapy (PBRT) high dose of 40 Gy in 15 fractions. Findings:  The physician reviewer found that 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, as in the setting of this patients post-lumpectomy breast. Chowdhary and colleagues report that limited data exists demonstrating the clinical benefit of proton radiotherapy in 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 the right breast alone. The patient appropriately received a course of adjuvant radiation treatment following her lumpectomy, as recommended by National Comprehensive Cancer Network (NCCN) guidelines; however, the radiation beam modality utilized was proton beam. While a treatment plan comparison between proton beams and photon beam reported that the photon plan showed heart doses exceeding the typical Quantitative Analysis of Normal Tissue Effects in the Clinic (QUANTEC) acceptable dose constraints, it is highly unusual to see such a high mean heart dose of 11 Gy in the setting of a right breast radiation treatment. Cross-sectional imaging did not demonstrate anatomy that would make it difficult to avoid irradiating the lung. 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. Given 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 services at issue were not medically indicated. Therefore, PBRT high dose of 40 Gy in 15 fractions were not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the services at issue were 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.