Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Physician 1The patient is a 62-year-old male who has recurrent prostate cancer with a PSA of zero currently. In addition, the record indicates the patient is status post prostatectomy. The patient underwent a Prostascint scan on 11/6/03 at the direction of his oncologist. He is requesting authorization and coverage for the Prostascint scan.In this patient the Prostascint scan performed on 11/6/03 detected metastatic prostate adenocarcinoma in two areas, the prostatic fossa and left iliac node region, which were not identified on the CT scan performed on 10/29/03 or the bone scan performed on 11/6/03. While the prostatic fossa was already noted to be abnormal on digital rectal examination, the left iliac lymph node region abnormality was not otherwise identified. The findings of the Prostascint scan were used to determine the need for a boosted dose of radiation therapy given in the pelvis to the prostatic fossa and to the left iliac lymph node regions.Thus this study, the full indications for which still remain to be determined in this patient, in this situation did play a significant role in deciding on the most appropriate treatment.Prostascint scanning does not yet have a routine role in the evaluation of prostate adenocarcinoma; however, in this patient at the particular stage in the evaluation of his recurrent prostate adenocarcinoma two years post radical retropubic prostatectomy, the Prostascint scan did have a valuable role, providing useful information that was not otherwise available. Therefore, I have determined that the Prostascint scan was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 2The patient is a 62-year-old male who is status post radical prostatectomy for locally advanced prostate cancer (several vesicle involvement). The patient has been evaluated for possible radiation therapy and/or hormonal therapy. He is requesting reimbursement for a Prostascint scan that was performed for evaluation of his condition.Elevated PSA following radical prostatectomy for prostate cancer remains to be a difficult clinical problem. Treatment is selected according to the disease recurrence site. Local recurrence carries a better prognosis compared to distant spread. PSA score is useful for evaluation but very inaccurate for staging. Bone scan, CT scan, MRI, and ultrasound have significant false response. Prostascint scan can be useful in this patients setting. Although its false positive rate is high the false response rates are less. Because the Prostascint scan is the only available diagnostic tool with sensitivity after prostatectomy it is frequently employed in similar situations. Based upon the information set forth above, I have determined that the Prostascint scan was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.Physician 3The patient is a 62-year-old man who underwent radical retropubic prostatectomy with curative intent. During his postoperative follow-up, his prostate specific antigen (PSA) began to rise. A rising PSA after radical prostatectomy indicates recurrence of disease. The initial Gleason score was 7. He had a bone scan performed to look for bone metastasis, which was negative. A CT scan of the abdomen and pelvis was also negative for metastatic disease.He then has a Prostascint scan (radioimmunicintigraphy with IN 111 capromabpendetide) to look for soft tissue recurrence of disease in the prostate bed or lymph node tissue. The scan was positive for low-grade uptake in prostate bed and intense uptake in left mid and lower pelvic areas suspicious for left internal iliac nodes. The patient was treated with hormone ablation - Lupron and then with radiation therapy with an extended field to radiate lymph nodes as well as the prostate bed.The Health Plan has denied reimbursement for the Prostascint scan.The medical problem in following patients who have a rising PSA after radical prostatectomy is determining the site of the recurrence. Bone scans only find disease in the bone, which is a relatively late finding. CT scans of the pelvis and abdomen are also too insensitive to determine early and possibly curable disease.The only potentially curable modality for salvage is radiation therapy the only disease that can be cured with radiation therapy is recurrence in the prostate bed itself. JAMA (March 2004) has the most up to date article on the use of salvage radiation therapy for prostate cancer. The article underscores that salvage radiation is valuable if given before the PSA rises above 1.0 ng/ml, and generally not valuable if the PSA rises much higher. The hope of the Prostascint scan was to identify soft tissue recurrence and thus identify those patients who would benefit from salvage radiation therapy. The literature cited above clearly shows the lack of value of salvage radiation for those patients with positive nodes on Prostascint.This patient had a positive scan and was then treated with hormone therapy and then radiated despite his positive scan. There is no demonstrated value in giving radiation to a patient with disease recurrent in the lymph nodes, even when a patient has been primed with hormone therapy. Although the scan may have been helpful in treating the patient, the results of the scan were ignored therefore, negating any benefit the scan may have had.Based upon the information set forth above, I have determined the Prostascint scan was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.