Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for proton beam therapy to a high dose of 50.4Gy in 28 fractions, in a post-surgical setting. The utilization of proton beam in treating the post-mastectomy chest wall is an area of active investigation. Proton beam has unique properties compared to standard x-ray, or photon, therapy in its ability to deposit radiation doses. Often, fewer proton beams can be utilized to achieve a dose distribution similar to a standard x-ray beam, potentially resulting in less radiation exposure to critical organs. The National Comprehensive Cancer Network (NCCN) guidelines currently support the use of proton beam in clinical settings where a reduction in dose to organs at risk is required that cannot be achieved by other radiation techniques. The primary organs at risk when treating the left breast are the adjacent heart and lung. The rate of secondary lung cancers, pneumonitis, and major coronary events is correlated with the amount of radiation exposure to these organs. Pasalic and colleagues report that proton beam therapy is a maturing treatment option with exceptional heart and lung sparing effects. The properties of proton beam also allow for a steep dose gradient, meaning that there is a rapid fall off of the dose outside of the intended target. There is also a dose-dependent risk to the nearby exposed organs with higher radiation dose exposure to the heart and lung resulting in higher risk of late lung and cardiac related morbidities. Proton beam therapy can achieve high dose homogeneity, reducing hot spots of dose deposits to nearby organs. Aside from cardiopulmonary toxicities, a reduction in long term scarring and radiation-related skin changes leads to higher quality of life and fewer medical visits in the future. Teichman and colleagues report that proton beam therapy is associated with improved overall quality of life, including low rates of permanent skin changes such as telangiectasias. In this case, a comparison plan of proton beam and standard radiation therapy techniques included in the providers letter showed less integral dose delivered to adjacent organs in the proton beam plan. Some key dosimetric parameters were met with the proton plan but not in the standard plan. For example, the accepted Quantitative Analysis of Normal Tissue Effects in the Clinic (QUANTEC) dose constraint for lung V20 is less than 30%. In this case, the photon plan noted lung V20 of 10.2%, while the standard plan noted lung V20 of 30.7%. The typical accepted mean heart dose constraint is less than 4 Gy. In this case, the proton plan showed a mean heart dose of 0.3 Gy whereas the standard plan had a mean heart dose of 8.4Gy. In this clinical setting, given the significant difference in critical organ exposure, proton beam therapy is likely be more beneficial than standard radiation therapy. Therefore, proton beam therapy to a high dose of 50.4Gy in 28 fractions, in a post-surgical setting, is likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Three of the three physician reviewers found the requested proton beam therapy to a high dose of 50.4Gy in 28 fractions, in a post-surgical setting, is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested service is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in radiation oncology and are actively practicing. The reviewers are experts 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.