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

Physician 1: The patient is a 64-year-old male who was diagnosed with a well-differentiated adenocarcinoma of the pancreas on 7/22/04. The mass was in the head of the pancreas measuring 2.5cm in diameter and had encased the superior mesenteric artery. Following evaluations, the patient was given chemotherapy followed by conventional radiology as a step towards a definitive surgery. Since November 2004, the patient has been evaluated by various cancer centers and has been found to have a surgically unresectable tumor. It has been recommended the patient undergo intensity-modulated radiation therapy (IMRT) as a step towards a definitive approach. The Health Plan has denied authorization and coverage for IMRT on the basis it is considered experimental. It is well known and accepted that cancer of the pancreas carries a reputation of poor prognosis. This patient has a well-differentiated adenocarcinoma that continues to be well localized and he has exhausted conventional therapies. IMRT remains the only treatment option available to the patient. Though IMRT is limited to 7600-8200 cGy, it can be utilized in a confined volume, unlike any conventional equipment. This patient with a localized cancer of the pancreas has received all available conventional therapies and continues to have a progressive tumor. Therefore, 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 64-year-old male with locally advanced pancreatic cancer, diagnosed in early 2004. He had appropriate workup before starting chemotherapy. It was determined the patients cancer was unresectable so he received three cycles of chemotherapy, which included Gemzar, Taxotere and Xeloda. The patient then received 4500 cGy external beam radiation with gemcitabine. Radiation was poorly tolerated by the patient. He was subsequently evaluated by oncologic surgery and his tumor was found to be unresectable. An MRI showed lymphadenopathy suggesting progressive disease. The patient was seen again by a radiation oncologist who recommended intensity-modulated radiation therapy (IMRT). The Health Plan has determined IMRT is considered investigational for treatment of the patients medical condition. The patient has locally advanced pancreatic cancer. He has received neoadjuvant chemotherapy followed by a combination of chemotherapy and radiation therapy. Unfortunately, the patients tumor was not resectable even after neoadjuvant chemotherapy and combined chemotherapy. He did not tolerate radiation very well. Considerable time has lapsed since the patients last radiation treatment. IMRT is only likely to increase acute toxicity and will not achieve cure or local control. Therefore, 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. Physician 3: This case involves a 64-year-old male diagnosed with pancreatic cancer deemed unresectable due to encasement of the celiac and superior mesenteric artery. Combined chemotherapy and radiation was recommended and gemcitabine, Taxotere, and Xeloda was initiated in July 2004 and completed in early September 2004. The patient was then evaluated by a radiation oncologist and 45 Gy delivered in 25 equal fractions over five weeks was initiated. Evidently, the patient had difficulty tolerating the combined treatment and therefore, radiation had to be interrupted for 10 days. 45 Gy was delivered however, initiated on 9/16/04 and completed on 11/3/04 for a total overall time of 48 days. A repeat CT of the abdomen on 11/3/04 at the completion of the pre-operative course of radiation therapy demonstrated minimal change in the size and prominence of the mass with continued evidence of invasion of the celiac and superior mesenteric artery. The scans were reviewed by a surgeon and it was deemed that the tumor was not resectable. The patient was re-evaluated by the radiation oncologist regarding further management and the recommendation was to use intensity-modulated radiation therapy (IMRT) with or without chemotherapy. A note from the radiation oncologist dated 12/28/04, stated that the patient accepted the fact that the tumor could not be resected and he returned for additional treatment. The recommendation again was to use IMRT administered in 20 fractions over two weeks. Treatment planning was initiated to include the pancreatic region and adjacent lymph nodes. The Health Plan has denied coverage for IMRT indicating it is considered experimental in this clinical setting. Initially, the patient was deemed unresectable and therefore, a course of neoadjuvant chemotherapy/radiation was initiated in an attempt to shrink the tumor so that a surgical resection could be performed. Unfortunately, after pre-operative therapy was delivered the tumor still could not be resected and therefore, the patient returned for additional therapy. Additional radiation therapy using IMRT treatments is medically appropriate and warranted in this case. The patient has exhausted all other treatment modalities and therefore, further attempts at standard therapy are not likely to benefit the patient. Therefore, 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.