Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is a 60-year-old man with a PSA of 4.7 who had a Gleason score of 3+3=6 prostate carcinoma on prostate biopsy performed in June 2004. This was present in cores at the right mid-apex and lateral areas, and the left apex and lateral areas. This is an extensive prostatic adenocarcinoma and should be viewed more as a T2b lesion than a T1c lesion. The chance of the carcinoma being organ confined is probably closer to 50% than 80%. The patient has medical problems including diabetes mellitus, hypertension, and hypercholesterolemia. He wishes to undergo cryosurgery. The Health Plan had denied authorization for cryosurgery on the basis it is considered investigational.This patient has a mid-grade prostate adenocarcinoma, which is bilateral in extent. He wishes to undergo cryosurgery. The Health Plan has recommended alternative curative treatments of external radiation, brachytherapy, or radical retropubic prostatectomy. These are considered first-line curative therapies.Cryosurgery of prostate carcinoma is evolving as techniques improve and morbidity (except for erectile dysfunction) decreases. However, long-term survival data comparing the efficacy of cryosurgery to that of other, more standard treatments such as surgery or radiation is lacking. There is not sufficient evidence in peer-reviewed literature to demonstrate 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 60-year-old man who was diagnosed with prostate cancer in June 2004. His PSA was 4.7 and the clinical stage was T1c with a Gleason score of 6. Based on Partins Tables, the patient has an 80% chance of confinement to the prostate and a 19% chance for capsular penetration. Biopsy results revealed 3 out of 4 needle cores positive for over 30% of the gland on the right side of the prostate, and 2 out of 4 needle biopsies for 10% of the gland on the left side of the prostate. On the extreme right, 50% of the tissues were involved with cancer. The patient has a significant volume of cancer on both the right and left sides. The patient wishes to undergo cryosurgery. The Health Plan indicates cryosurgery is considered investigational for treatment of prostate cancer.Review of the scientific literature does not demonstrate cryosurgery of prostate adenocarcinoma is superior to other modes of treatment. As set forth in the Bahn article cited above, the seven-year outcome with cryosurgery for patients with a PSA less than one is 76%. The Martinez article indicates the 10-year outcome with high-dose rate (HDR) brachytherapy for cause specific survival is 92%. In addition, cryosurgery will cause the patient to become impotent while HDR brachytherapy will preserve potency. Other complications associated with cryosurgery include fistula formation (recto-urethra); outflow obstruction; scrotal swelling; and penile numbness. The complications associated with HDR brachytherapy can be controlled with medications and do not occur as frequently. Given the patients high volume of cancer as well as the presence of cancer in both prostate lobes, HDR brachytherapy in combination with external beam irradiation is likely to result in a better outcome with significantly less complications than 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 60-year-old male with a history of prostate cancer. His Gleason score is 6 with a PSA of 4.7. The patient wishes to undergo cryosurgery rather than brachytherapy or surgery. The Health Plan has denied coverage for the requested procedure indicating it is considered experimental.There is no evidence establishing the long-term effectiveness of cryosurgery in the treatment of prostate cancer. This patient is a candidate for either brachytherapy or surgery. Both brachytherapy and surgery are well-established and effective modalities for treatment of prostate cancer. Therefore, I have determined that cryosurgery is not likely to be more beneficial for treatment of the patients condition than any available standard therapy. The Health Plans denial should be upheld.