Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is a 57-year-old male with Gleason score of 3+3=6 adenocarcinoma of the prostate, which was confirmed with biopsies after the patients PSA rose to 6.3. The results of the first biopsy in December 2003 revealed prostate adenocarcinoma at left base. A second biopsy performed in April 2004 revealed prostate adenocarcinoma at left mid-gland. The patient has had heart valve surgery and wishes to avoid major prostate surgery. He believes cryosurgery is the best alternative for treatment of his prostate cancer. The Health Plan has denied authorization for cryosurgery on the basis that it is considered experimental for treatment of prostate cancer.The use of cryosurgery in treatment of prostate cancer is evolving as techniques improve and morbidity (except for erectile dysfunction) has decreased. However, long-term survival data comparing its efficacy to that of other, more standard treatments such as radical retropubic prostatectomy and various forms of radiation therapy (brachytherapy and/or external beam radiation) is lacking. To date, there is not sufficient evidence in the peer-reviewed literature to demonstrate that cryosurgery of prostate adenocarcinoma is comparable in terms of efficacy to these other modes of treatment. 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 2The patient is a 57-year-old man with a stage T1, No, Mo moderately differentiated adenocarcinoma. He has a Gleason score of 3+3=6 and a PSA of 6.3. Only 1 of the 12 biopsied specimens contained 8% of cancer in the tissue, a relatively small volume. The patient has had a history of heart valve replacement. He is concerned about the risks of surgery and wishes to undergo cryosurgery. The Health Plan indicates cryosurgery is considered investigational for treatment of prostate cancer.Cryosurgery treats a limited volume of the prostate. In addition, general anesthesia or a spinal anesthesia is required with cryosurgery. The expected survival at seven years with a PSA of less than one is 76%. The complications associated with cryosurgery include fistula formation (recto-urethra); outflow obstruction; scrotal swelling; and penile numbness. Based on Partins Tables, this patient has a 23% chance of prostate capsular involvement and a 2% chance of seminal vesicle involvement. Thus, cryosurgery will not control this patients entire cancer risk. In addition, the patient will lose his potency. Given his low volume of cancer, even conventional radiation therapy will offer the patient a better control without the many side effects and complications of cryosurgery. 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 3The patient is a 57-year-old male with localized prostate cancer. He has investigated the options for definitive therapy including surgery, radiation, and cryosurgery (freezing of the tumor). The patient prefers cryosurgery because of his history of heart valve replacement and his desire to avoid the potential complications of more invasive or aggressive treatments. The Health Plan has determined cryosurgery is considered investigational for treatment of prostate cancer.Cryosurgery 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. There is a body of evidence demonstrating the efficacy and safety of cryosurgery as the technique has improved significantly in the last several years. Cryosurgery 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 cryosurgery 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.