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

Physician 1:  The patient is a 47-year-old male diagnosed with a high-grade pleomorphic sarcoma of the left supraclavicular fossa. The recommendation of the treating oncologist was for a dose of 60 Gy delivered in 30 fractions to the left supraclavicular area.  A post-treatment note from April 2005 indicated the PET and CT scan revealed no solid evidence of recurrence, however, a note dated July 2006 indicated a locally recurrent high-grade pleomorphic sarcoma interposed between the left scapula, clavicle and chest wall, occurring two years after neoadjuvant chemotherapy, surgical resection and post-operative radiation therapy. According to the radiation oncologist, the superior aspect of the patients recurrence was clearly within his prior radiation therapy portal, with the inferior aspect of it appearing to extend beneath the inferior margin on the portal.  Cyberknife therapy has been proposed, to be preceded by a conservative retreatment course of IMRT. The alternative treatment is a surgical approach, which would be a forequarter amputation.  The radiation oncologist acknowledged the significant risk of retreating this area.  The proposed treatment plan calls for IMRT plus 5 Cyberknife treatments with specific dosage deferred, but likely in the range of 40 Gy in 20 IMRT fractions, followed by Cyberknife radiosurgery consisting of 35 Gy in 5 fractions. The Health Plan has denied authorization for IMRT and Cyberknife stereotactic radiosurgery citing a lack of scientific evidence in the medical literature supporting the efficacy of the treatment.  IMRT and Cyberknife stereotactic radiosurgery is not considered standard of care for soft tissue sarcoma as initial treatment.  However, in this case the patient was initially treated according to standard of care, that being resection combined with chemo/radiation. Unfortunately, he has recurred two years later, and based on the location of the recurrence, his options are limited. The surgical approach would require forequarter amputation based on the information provided. Alternatively, retreating with chemotherapy or radiation therapy alone would carry with it a significant risk. One way of reducing this risk would be judicious use of conformal techniques. IMRT is the most appropriate option in this setting. In addition, given the volume of the tumor the use of Cyberknife stereotactic radiosurgery to provide an additional boost would be appropriate if tumor shrinkage is accomplished with the initial four to five weeks of IMRT treatment.  Further, the treating radiation oncologist states in his note that the specific dose regimen will be deferred until evaluation of the treatment plan following simulation. This approach is clinically appropriate and warranted under these circumstances.Based upon the information set forth above, I have determined that the requested therapy 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 47-year-old male who has a recurrent pleomorphic sarcoma. An MRI reveals an 8.9cm x 6.4cm x 10.6cm in cranio-caudal dimensions. It is posterior to the brachial plexus, elevating the scapula and interposed between the scapula, clavicle and chest wall. The patient has symptoms of severe pain. The mass was first resected in November 2004 at which time it was in the left supraclavicular region and extending to the lower neck. It was excised with positive surgical margins. 6000 cGy were delivered to the surgical bed in six weeks. The present recurrence borders the previously irradiated fields. The radiation oncologist has considered all available options and has recommended IMRT for the microscopic tumor around the recurring mass and the recurring mass in general followed by Cyberknife radiosurgery for the residual tumor after IMRT.Pleomorphic sarcoma is not sensitive to standard doses of radiation. A larger dose of radiation can be provided through brachytherapy plus interstitial hyperthermia, IMRT plus Cyberknife radiosurgery, or surgical excision followed by 6000 cGy post-operatively. The patient previously underwent surgical excision in 2004 and the present recurrence adjoins the previously irradiated field. As such, brachytherapy and IMRT/Cyberknife are the only remaining radiation options. The patients radiation oncologist has ruled out brachytherapy because of the association of the brachial plexus and its close proximity to the tumor. Accordingly, IMRT with Cyberknife therapy is the only suitable option remaining and is the most appropriate treatment in this scenario.For the reasons set forth above, I have determined that the requested therapy 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 3:  The patient is a 47-year-old male who presented with a neck mass in August 2004. Biopsy established a diagnosis of a high-grade sarcoma. The patient received chemotherapy followed by surgery and post-operative radiation therapy (6000 cGy). Unfortunately, he developed recurrent disease in the left neck area evidenced by PET and MRI scans, which revealed a large area of recurrence in the previously irradiated area. The patients surgical option is forequarter amputation. He was seen by a radiation oncologist who recommended IMRT followed by Cyberknife radiosurgery. The Health Plan has denied coverage for the proposed therapy on the basis that it is considered investigational.The patient received 6000 cGy of external beam radiation therapy in early 2005 to the left neck/supraclavicular area. This treatment delivered a significant dose of radiation to the left brachial plexus, probably exceeding its tolerance. The patient is at very high risk of brachial plexopathy if any kind of radiation is delivered to this area. The proposed IMRT and Cyberknife treatment is not likely to be beneficial and may cause significant morbidity in this case. Unfortunately, forequarter amputation is the only viable treatment option remaining.In conclusion, I have determined that the requested therapy 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.