Appeal type: Medical Necessity
Decision: Upheld

A 60-year-old male has requested approval for past stereotactic body radiation therapy (SBRT) with CyberKnife for treatment of his prostate cancer.   Findings:  The physician reviewer found that standard therapies for early stage prostate cancer include prostatectomy, interstitial brachytherapy, and IMRT delivered over seven or more weeks. SBRT, delivering high fractional doses to the prostate in 4-5 fractions is an emerging approach to the treatment of prostate cancer. CyberKnife is a delivery system which allows for SBRT delivery, using real time monitoring of fiducials, coupled with robotically controlled tracking of these fiducials. The technology of CyberKnife is superior in many respects to other LINAC based radiation delivery systems in that using robotic technology the head of the LINAC follows the patient movements in real time. This allows for accurate delivery of radiation which is a necessity with large fractional doses in such a critical area between the rectum and bladder. Although CyberKnife is a treatment option, it is not the most standard means for delivering radiation therapy for prostate cancer. In an initial study, King and colleagues acknowledged that their results were premature. A more recent publication from the same group on 67 patients, the authors reported low rates of toxicity and a four-year PSA relapse free survival of 94%. In a paper from the CyberKnife Centers of Tampa, 112 patients were treated with CyberKnife treatment to a dose of 35 Gy in 7 Gy fractions (Friedman, et al). In most patients, PSA levels declined after radiation with median follow-up of two years. Despite these encouraging results, the American Society of Radiation Oncology (ASTRO) position statement regarding SBRT for prostate cancer states that, There is not sufficient or mature data to demonstrate equivalency to existing standard treatment modalities and, in our view, SBRT for prostate cancer patients does not represent a standard of care. SBRT for early stage, low-intermediate risk prostate cancer should be further tested within the context of appropriately designed clinical trials. Preliminary results, primarily available only in abstract form and consisting of reports of clinical experiences from single institutions, show that SBRT for the prostate is technically feasible, with little reported acute morbidity. Very early results, of limited statistical power, suggest that treatment will induce an initial PSA response of a magnitude equivalent to that seen with conventionally fractionated radiotherapy. Data are not available regarding long-term disease control, survival, and chronic toxicity. In the absence of randomized trials and mature, long-term follow-up data, a conservative estimation of consequences of non-use of SBRT would be a continuation of treatment following standard, accepted fractionation schemes, with realization of the associated tumor control and normal tissue complication probabilities. In addition, SBRT is not included in the National Comprehensive Cancer Network (NCCN) treatment guidelines for early stage prostate cancer. External beam radiation is an accepted alternative to more invasive approaches such as high dose rate (HDR) brachytherapy, permanent seed implant, or prostatectomy. However, SBRT for prostate cancer does not provide any known benefit over standard therapy. There is no compelling reason for the patient to have been treated with SBRT with CyberKnife over standard approaches. There is no proven benefit of CyberKnife treatment over standard prostate radiation therapy options including IMRT, IGRT or 3D-conformal radiation therapy. All told, the SBRT with CyberKnife technology was not medically necessary for treatment of this patients medical condition.