Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for proton beam therapy with a high dose of 70 Gy in 28 fractions and hydrogel spacer. While the use of proton therapy is an accepted radiation technology, with proven efficacy and tolerability, whether it affords any benefit over conventional radiation therapy is controversial. Several studies note that patients treated with proton therapy fare comparably and/or better to patients treated with photon radiation. In a comparative study on patient-reported quality-of-life (QOL) between different treatment modalities for prostate cancer, Hoppe and colleagues conclude, There were no differences in QOL summary scores between the intensity-modulated radiation therapy (IMRT) and proton therapy cohorts during early follow-up up to two years. Response to individual questions suggests possible differences in specific bowel symptoms between the two cohorts. These outcomes highlight the need for further comparative studies of proton therapy and IMRT. In a comparison of proton radiotherapy versus IMRT in the treatment of prostate cancer, Yu and colleagues found no difference in toxicity one year post-treatment. While Xiang and colleagues report that proton therapy may be associated with a lower risk of a second cancer diagnosis, the authors note that that future work is warranted to determine the cost-effectiveness of proton therapy and to identify the population best suited for this treatment. The need for future study is indicative of the unknown benefit from proton therapy with retrospective analyses. There are also compelling data showing worse outcomes with proton therapy. Sheets and colleagues conclude that patients treated with IMRT had a lower rate of gastrointestinal morbidity when compared to those treated with proton therapy. Coen and colleagues report, High dose proton radiation was associated with small increases in bowel dysfunction and incontinence, with more pronounced changes in sexual dysfunction. The National Comprehensive Cancer Network (NCCN) note that there is no clear evidence supporting a benefit or decrement to proton therapy over IMRT for either treatment efficacy or long-term toxicity. Therefore, proton beam therapy with a high dose of 70 Gy in 28 fractions and hydrogel spacer is not 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 with a high dose of 70 Gy in 28 fractions and hydrogel spacer is not 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 not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. 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.