Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1:  The patient is a 54-year-old female diagnosed with breast cancer in 2004, treated with mastectomy, chemotherapy, and localized radiation.  At present, she has been diagnosed with isolated liver metastasis with documented growth despite chemotherapy. According to the submitted notes, the treating oncologist has identified one main lesion putting pressure on the nearby biliary ducts and recommended a consultation for consideration of stereotactic body radiosurgery. The Health Plan indicates stereotactic body radiosurgery is considered investigational and therefore, is not a covered benefit.Treatment options in cases such as this include clinical trial with Phase 1 chemotherapeutic drugs, ablative treatment (radiofrequency, cryotherapy, microwave, or high dose rate brachytherapy), chemoembolization, radiation therapy (conformal or stereotactic), or supportive care.  In this case, consideration for stereotactic radiosurgery has been proposed.  Stereotactic body radiosurgery enables a higher dose of radiation therapy to be delivered in a few fractions (typically five or less) whereas conformal therapy is typically given over a period of weeks. The procedure itself is not considered investigational and is no longer under active clinical research; it essentially allows for highly conformal irradiation to be delivered over a shorter timeframe. Given the information provided, stereotactic body radiosurgery is a medically reasonable and appropriate option 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. Physician 2:  The patient is a 54-year-old woman with metastatic breast cancer. She has received post-operative radiation therapy to her chest in addition to chemotherapy in two sessions, beginning in 2004. In October 2006 a PET scan showed tiny retroperitoneal lymph nodes and a 5.8cm mass in the left lower lobe of the liver. Thus, it appears that within two years she has exhausted all available chemotherapeutic agents and her tumor is not in control. The patient has requested authorization and coverage for a consultation for possible stereotactic body radiosurgery. The Health Plan considers this procedure investigational and therefore, has denied the patients request.Stereotactic radiosurgery is a method used to deliver high dose radiation to a specific target. It is primarily used for curative purposes and in patients with localized disease. It can also be used for palliation of symptoms, i.e., brain metastases. The procedure requires immobilization for accurate targeting. In light of the patients widely metastatic breast cancer it is not likely her condition is curable. Additionally, because of the small size of the lesions in the liver and retroperitoneum she is asymptomatic. Furthermore, it is not clear where the beam will be delivered for effective targeting. Moreover, immobilization of the liver will make this modality unpractical. 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 3:  The patient is a 54-year-old woman who was diagnosed with breast cancer in 2004. She then received systemic chemotherapy followed by local radiation to her spine and ultimately mastectomy in December 2004. The patient developed liver metastatic disease and received multiple courses of chemotherapy. The liver metastases responded initially, but later progressed under chemotherapy. The patient was evaluated for possible treatment using radiofrequency ablation. This treatment was unfortunately technically difficult and was ruled out by the radiologist. It has been recommended that the patient see a radiation oncologist for possible stereotactic body radiosurgery. The Health Plan indicates the proposed procedure remains investigational for patients such as this patient.The patient developed liver metastatic disease under chemotherapy. She is not a candidate for radiofrequency ablation treatment due to technical difficulty in administering the treatment. However, based on the submitted information, the patient appears to be a good candidate for stereotactic body radiosurgery. It is likely that the proposed procedure will be more beneficial than other available standard therapy. There is sufficient evidence supporting the efficacy of stereotactic body radiosurgery and it has been proposed in this setting as an interventional technique. For the reasons 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.