Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 79-year-old man who had an elevated PSA of 12. On 1/14/05, he underwent a prostate biopsy. Of six core biopsies, only the one from the left apex was involved with a Gleason score of 3+3 with 50% involvement. The patient was placed on hormone ablative therapy by his urologist. On 3/11/05, the patients PSA dropped to 3.8. A repeat PSA on 3/14/05 was 2.2. With this good response, the patients urologist recommended the patient undergo cryoablation. The Health Plan has denied coverage for cryoablation on the basis it is considered investigational for treatment of prostate cancer.Based on Partins Tables, the patient has 62% chance of having the cancer limited to his prostate. In addition, he has a 32% chance of having the cancer extended to his capsule, a 4% chance of having the seminal vesicles involved, and a 2% chance of having it spread to the pelvic lymph nodes. The response of the hormonal ablative therapy was very good with a significant drop of the patients PSA. Nevertheless, while the volume of the tumor has diminished there still remains a chance for involvement by the tumor at these specified sites.Cryoablation, while having a destructive capability, is effective in a very localized tumor. To date, there is insufficient data in peer-reviewed literature demonstrating clinical outcomes of cryoablation. This patient will be better served by conventional radiation therapies, both in terms of survival and quality of life. Conventional radiation offers better control without the many side effects and complications of cryoablation. Therefore, I have determined that the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2:  The patient is a 79-year-old male who underwent a prostate biopsy in January 2005, which revealed adenocarcinoma. Gleason grade was 3+3 (total =6) in the core from the left apex. In February 2005, the patient obtained a second opinion and cryoablation was recommended.  The patient was started on hormonal therapy for prostate adenocarcinoma and his PSA fell from 12.6 on 2/15/05 to 2.2 on 3/18/05. The Health Plan has denied coverage for the requested prostate cryoablation on the grounds that the safety and efficacy of cryoablation for the treatment of prostate cancer has not been established in peer-reviewed medical literature.This patient is a 79-year-old man with a clinically localized prostate adenocarcinoma, currently on hormonal treatment with a parenteral LHRH antagonist, Zoladex. The patients urologist has requested authorization to treat the prostate cancer with freezing therapy (alternatively referred to as cryoablation, cryotherapy, and cryosurgery). Standard treatments in this situation are radiation therapy, including external beam and/or brachytherapy (which would be potentially curative), hormonal therapy (which the patient is currently receiving) and watchful waiting.Relevant medical literature reveals increasing support for cryoablation. As indicated in the Horger and Clark article referenced above, morbidity associated with cryoablation, with the exception of erectile dysfunction, has improved to a level comparable to other therapeutic options. The authors concluded, while long-term data and randomized prospective trials comparing cryoablation with other forms of treatment for prostate cancer are still lacking, the advances of recent years have improved the efficacy and safety of cryosurgery. Thus, improved techniques and experience with cryosurgery of prostate cancer have led to decreased morbidity from the procedure itself. However, at this time there is insufficient evidence in peer-reviewed medical literature to demonstrate that cryoablation for prostate adenocarcinoma is comparable in terms of efficacy to other modes of treatment.Based upon the information set forth above, I have determined that the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3: The patient is a 79-year-old male who has prostate cancer with a Gleason score of 3+3 in the left apex. He has been receiving hormone treatments. The patients physician has recommended the patient undergo cryoablation of the prostate. The Health Plan indicates there is insufficient evidence of the efficacy of cryoablation for treatment of the patients condition.Cryoablation is one of a number of definitive therapies for prostate cancer with curative potential. It is not more commonly applied because its availability is relatively scarce due to the lack of trained physicians in the technique. Review of the medical literature reveals the technique has improved significantly in the last several years. Cryoablation for prostate cancer has been approved by the Centers for Medicaid and Medicare as primary therapy for prostate cancer since 1999. The body of literature regarding cryoablation is substantial and adequate to support its use in this clinical setting. Based upon the information set forth above, I have determined that the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.