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

Physician 1The patient is a 55-year-old woman diagnosed with stage IIB (T2N1) breast cancer in June 2002. She was ultimately treated with a modified radical mastectomy and immediate reconstruction using a TRAM flap. Final pathology documented a 3cm (T2) grade III tumor with angiolymphatic invasion with 2/10 modes positive. The tumor was ER (+) PR (-) HER2/neu (-). The patient received six cycles of TAC adjuvant chemotherapy and hormonal therapy of letrozole. She also received Zometa as part of a clinical trial.In May 2004, the patient was found to have locoregional recurrence involving the supraclavicular nodal basin as well as a large chest wall recurrence with direct rib invasion. She was started on Xeloda therapy following staging studies of a CT chest and PET scan. On examination, the mass in the upper chest was noted to decrease in size and become softer. Repeat CT chest after Xeloda therapy has demonstrated a decrease in size of the chest wall recurrence. Planning for external beam radiation therapy has been initiated. A follow-up PET scan has been requested to evaluate the patients response to therapy. The Health Plan has denied authorization for the requested PET scan on the basis that it considered experimental in this clinical setting.The patient is a 55-year-old woman diagnosed with recurrent breast cancer having been previously treated with modified radical mastectomy, adjuvant chemotherapy, and hormonal therapy. The recurrence involves the supraclavicular nodal basin as well as a large chest wall recurrence with direct rib invasion. Standard imaging for the evaluation of bone metastases (i.e., bone scan) or liver metastases (i.e., liver ultrasound or CT abdomen) was not performed and only a PET scan was used to evaluate for distant disease. She has been treated with Xeloda and both clinical and radiographic (CT chest) response has been demonstrated. A follow-up PET scan has been requested to evaluate response to therapy. The utility of PET scans in breast cancer remains uncertain. There are reports that it may be helpful in the evaluation of patients with recurrent or metastatic disease to identify the sites of disease. In addition, there are limited reports describing the utilization of PET scans to assess the response of primary intact breast cancers to neoadjuvant chemotherapy. However, in both of these scenarios, there does not yet appear to be clear evidence that PET scans are superior to currently available methods for evaluation of breast cancer. Furthermore, there is no data available on the utility of PET scans to assess response of recurrent or distant breast cancer to systemic therapy that is either better than current methods or has clinical benefit (i.e., selection of appropriate therapy based on efficacy or prediction of responders/nonresponders that correlates with survival outcome). To date, the efficacy of PET scans in this clinical context has not been established.Based upon the information set forth above, I have determined the requested PET scan is 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.Physician 2The patient is a 55-year-old female who was diagnosed with breast cancer and underwent a right modified radical mastectomy in July 2002. The patient was treated with chemotherapy. A CT scan of the chest performed in May 2004 showed a new mass in the right anterior chest wall destroying adjacent bone consistent with recurrent tumor. A PET scan performed in May 2004 showed increased activity corresponding to the mass. In addition, there was a small focus of activity in the right supraclavicular region. CT-guided, percutaneous biopsy of the mass confirmed recurrent breast cancer. Follow-up CT performed in August 2004 after therapy showed decrease in the chest wall mass with a mass still present. A PET scan was ordered to assess the metabolic activity of residual tumor. The Health Plan denied authorization for the PET scan stating that PET scan is considered investigational for breast cancer.Over the last decade, there have been many studies showing the efficacy of PET scan for staging breast cancer. In October 2002, the Centers for Medicare and Medicaid Services (CMS) approved PET scans for breast cancer staging/restaging of local/regional recurrence or distant metastases.PET scan has been shown to be more sensitive and specific than CT scans for detection of mediastinal and internal mammary lymph node metastases. In addition, PET scan has been shown to be more sensitive, specific, and accurate and to have better positive and negative predictive values than conventional imaging for detecting local recurrence or distant metastases. Furthermore, PET scan has been shown to have a significant impact on the management of breast cancer patients, influencing both clinical stage and management.Moreover, two more recent articles continue to support the role of PET scan in evaluating patients with breast cancer. One study by Van der Hoeven and colleagues found the addition of FDG PET to the standard work-up of patients with locally advanced breast cancer may lead to the detection of unexpected distant metastases. Another study by Eubank, et al., concluded the sensitivity and specificity of PET for recurrent/metastatic breast cancer is high, 94% and 91% with the results of the PET scan altering the therapeutic plan in 32% of patients.In the case of this patient, she had a prior PET scan that can be used for comparison adding more value to the follow-up exam. PET scanning will clearly be useful in this patients follow-up and is medically reasonable. 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.Physician 3The patient is a 55-year-old female who is post adjuvant chemotherapy for a T2 poorly differentiated carcinoma of the right breast failing locally on the right chest wall while on continued adjuvant Femara. CT scan showed a mass with lytic bony destruction. Restaging with PET scan was strongly positive at the site of the mass and suggested adjacent nodal metastasis. The patient has received additional chemotherapy with apparent response. CA 27-29 marker studies do not appear reliable in this patient. A PET scan has been recommended for restaging purposes. The Health Plan has denied authorization for the requested PET scan on the basis that it is considered investigational.PET scans have broad utility in the management of multiple cancers. PET scans are of recognized value in restaging of relapsed breast cancers. This patients breast cancer is FDG-18 avid. Tumor masses may persist post successful chemo-radiotherapy. Distinguishing residual disease short of surgical excision with pathology may