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

Physician 1The patient is a 60-year-old female who was diagnosed with stage IV ovarian cancer in October 2003. The patient presented with a malignant pleural effusion and subsequently at laparotomy was found to have carcinomatosis. The patient completed six cycles of chemotherapy and has been followed with CA-125, CT scans, and PET scans.As of 10/14/04, the patients CA-125 increased to 47.6, which is elevated. A CT scan performed on 9/9/04 showed increased right hydronephrosis and a borderline enlarged left axillary lymph node. A PET scan in June 2004 showed right hydronephrosis with no other abnormal areas of increased activity. The initial PET scan in October 2003 showed increased activity to the right thorax and right pelvis corresponding to malignant disease.The patients oncologist has requested a follow-up PET scan to assess for recurrent disease and help determine the need for further chemotherapy. The Health Plan has denied coverage for the requested PET scan on the basis it is considered investigational.Review of the relevant medical literature reveals most of the published studies of PET scan and ovarian cancers are relatively small in patient numbers. To date, PET scan is not considered part of the standard diagnostic workup of patients with ovarian cancer. However, there is data to indicate the use of PET scanning in ovarian cancer is generally good with sensitivity of 83-100% and specificity of 67-100% for macroscopic disease. A study by Klipper, et al., suggests that at present the role of PET seems to be for problem solving and as a complimentary test in the patient with suspected recurrence. In addition, the sensitivity and specificity for CT scan and PET scan combined is higher than CT scan alone (83% vs. 70% for sensitivity and 92% vs. 83% for specificity). The negative predictive value is also higher for CT and PET vs. CT alone, 73% vs. 59%. Furthermore, the value of PET is also improved when the CA 125 tumor marker is greater than 30 U/Ml. In the case of this patient there are several reasons why a PET scan is likely to be beneficial. The patient has prior PET scans, which can be used for comparison. Additionally, the patient has a rising CA-125, now approximately 47 U/ml. Lastly, the patients oncologist plans to use the results of the PET scan to determine if the patient should be restarted on chemotherapy or undergo exploratory surgery. Therefore, in this particular situation, a PET scan in addition to standard non-invasive diagnostic tests is likely to be of greater benefit for evaluation of the patients condition. Based upon the information set forth above, I have determined that the requested PET scan is 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 2The patient is a 60-year-old female with a history of stage IV cancer of the ovary and fallopian tube that was poorly differentiated. She had an elevated CA-125 at diagnosis. She also had obstructive uropathy on the right side. She responded well to six cycles of standard carboplatinum/Taxol chemotherapy, which was completed in early April of 2004. Currently, the patient has worsening right side hydronephrosis and a rising CA-125 (47.6) in the abnormal range. There is also an abnormal (left) axillary lymph node on chest CT scanning. The patients provider has recommended the patient undergo a PET scan to re-evaluate her status. The Health Plan indicates a PET scan is considered investigational for the evaluation of ovarian malignancy.This patient has early relapsed ovarian and fallopian tube cancer, which was initially appropriately treated. The patients relapse within six months of completion of chemotherapy and poorly differentiated pathology indicates a poor prognosis regardless of end line treatment. The use of PET scanning in this setting will not result in an improved clinical outcome. Additional surgery will not be useful in a therapeutic sense. If further CA-125 evaluations show a continued rise, the decision to be made is what chemotherapy agent(s) to be used and when to initiate them. A PET scan is not likely to have a significant impact on the patients treatment regimen. Therefore, I have determined that the requested PET scan is not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3This patient presented with pulmonary symptoms and malignant pleural effusion in approximately September 2003. Diagnostic workup showed a pelvic mass on CT scan and a dilated right renal collecting system. A PET scan was performed, which showed clearly active metabolic FDG accumulation in the pelvic mass and in the pleura.Palliative and diagnostic surgery was performed in October 2003 and the patient was diagnosed with carcinoma of the ovary, widespread, stage IV. Following surgery chemotherapy was given. The patient has completed a full course of chemotherapy and her response has been assessed by repeated clinical evaluation, repeated CA-125 tumor markers, CT scans, and PET scan. The patients tumor marker went from a high of 89.8 in October 2003 to a low of 10.6 in June 2004 following therapy. CT scans showed only continuing right ureteral obstruction and the previously positive PET scan was negative in April 2004 and June 2004 after completing therapy. However, the patients CA-125 started to rise and was 23.8 in August 2004 (high normal) and was again high at 47.8 in October 2004. Clinically the patient has done quite well.At this point the patients treating physician has requested a repeat PET scan to assist in more definitive staging and critical therapeutic decision-making. The Health Plan indicates the requested PET scan is considered investigational for evaluation of metastatic ovarian cancer.An important factor in this patients tumor is that it has been clearly shown to actively metabolize FDG, which is a very good predictor of the future metabolic activity of its cell type. The request for a staging-restaging PET scan in this case is medically appropriate and reasonable. The use of PET scanning for patients such as this patient is an accepted approach and is within the current practice of oncologic and nuclear medicine. Therefore, I have determined that the requested PET scan is likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.