Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for (1) proton beam therapy given as 70 Gy in 28 fractions and (2) hydrogel spacer. 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. Proton therapy is currently utilized and strongly indicated in settings where severe toxicities would result if normal tissue constraints cannot be met by photon beam. However, in the setting of early stage prostate cancer there has not been a demonstrable clinically significant improvement in either quality of life or reduction of high grade toxicities. Sheets and colleagues report that among patients with nonmetastatic prostate cancer, intensity-modulated radiation therapy (IMRT) compared with proton therapy was associated with less gastrointestinal morbidity. Royce and Efstathiou report that the result of data on clinical evidence for proton efficacy and toxicity derived from both large claim-based datasets and prospective patient-reported data is mixed. There is a lack of evidence demonstrating a significant difference in overall survival or normal tissue toxicities over photon beam for early stage prostate cancer. While there are ongoing prospective trials investigating the potential benefits in disease outcomes and toxicities in this setting, no definite benefit has been demonstrated for proton beam in the setting of early stage prostate cancer. In this case, the patient has appropriately been recommended a course of definitive radiation treatment along with ADT for his intermediate risk prostate cancer, as recommended by National Comprehensive Cancer Network (NCCN). Given the lack of data supporting the utility of proton beam radiation for early prostate cancer, particularly for patients where the prostate and seminal vesicles rather than the comprehensive pelvic nodal chains are irradiated, (1) proton beam therapy given as 70 Gy in 28 fractions is not medically necessary for the treatment of this patient. One major concern during radiation therapy to the prostate is rectal toxicity due to exposure of the adjacent rectal wall. One method of reducing rectal toxicity is to create additional space and distance within the perirectum, which is the space between the prostate and the rectum. Certain rectal dose constraints must be met during the planning phase of radiation therapy before the treatment can be safely administered. Absorbable hydrogels have been created for this purpose to be placed in the perirectal space. The gel undergoes hydrolysis and dissolves six to twelve months afterward. There is strong evidence demonstrating decreased rectal toxicity when hydrogel spacers are used in the setting of external beam radiation treatment to the prostate. In a randomized, phase III trial of patients undergoing radiation therapy for prostate cancer, Hamstra and colleagues found a benefit in the use of a hydrogel spacer in reducing adverse effects, rectal dose, toxicity, and quality-of-life declines related to bowel and sexual side effects. In a systematic review, Armstrong and colleagues found that hydrogel spacers also demonstrated reduced late gastrointestinal and genitourinary toxicities. The rectal V70 is one of the key dosimetric parameters a treating radiation oncologist will look at while assessing the safety of a prostate radiotherapy plan. The V70 represents the volume of rectum receiving 70 Gy dose of radiation. This V70 parameter is defined by Quantitative Analysis of Normal Tissue Effects in the Clinic (QUANTEC) and is a widely followed guideline within the field of radiation oncology. Higher V70 values lead to a significantly increased risk of rectal toxicity. Given that placement of a hydrogel spacer has been shown to lower the V70 parameter and thus decrease the risk of both acute and late rectal toxicity, along with increases in quality-of-life following prostate radiotherapy, (2) hydrogel spacer is medically necessary for the treatment of 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.