Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for proton radiation therapy and SpaceOAR treatment in conjunction with the proton radiation therapy. The Health Plan has denied this request indicating that the requested services are not medically necessary for treatment of the patients prostate cancer. The submitted documentation supports the medical necessity of a portion of the requested services. Currently, there is insufficient clinical data to discern whether treatment with proton beam radiation offers a clinical benefit compared to conventional radiation therapy techniques in the treatment of prostate cancer. A Surveillance, Epidemiology and End Results (SEER)-Medicare analysis evaluated the comparative effectiveness of intensity-modulated radiation therapy (IMRT,) proton therapy, and conformal radiation therapy for prostate cancer. In the comparison between IMRT and proton therapy, IMRT patients had a lower rate of gastrointestinal morbidity. The analysis indicated that there were no other significant differences regarding toxicities between IMRT and proton therapy. Another analysis of early toxicity compared 421 patients treated for prostate cancer with proton therapy and 842 matched case controls treated with IMRT within the SEER-Medicare database. There was a statistically significant decrease in genitourinary toxicity at six months with proton therapy. However, this difference disappeared by one year. The analysis proved that there were no other significant differences in toxicity between the two techniques. A position statement released by The American Society of Radiation Oncology (ASTRO) in 2013 stated that at the present time, ASTRO believes the comparative efficacy evidence of proton beam therapy with other prostate cancer treatments is still being developed. Thus, the role of proton beam therapy for localized prostate cancer within the current availability of treatment options remains unclear. The National Comprehensive Cancer Network guidelines (v1.2018) endorse the position statement by ASTRO and state that no clear benefit of proton therapy has been demonstrated over standard treatment with photons and IMRT technique.  Furthermore, there is a lack of data to suggest that patients with ulcerative colitis derive a greater benefit from proton radiation over standard photon techniques. With regard to the request for SpaceOAR, this therapy was evaluated in a randomized study and found to significantly improve gastrointestinal symptoms in patients undergoing radiation therapy. Given this patients history of ulcerative colitis, SpaceOAR treatment  can help minimize the side effects of radiation therapy and therefore is medically necessary for the treatment of this patient. However, proton radiation therapy is not medically necessary for this patient.Final Result: The reviewer determined that a portion of the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be partially overturned.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.