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

Physician 1: The patient is a 60-year-old man who underwent a Whipples procedure for a well-differentiated pancreatic cancer stage T3, N1, M0 in March 2005.  The tumor extended into the peripancreatic fat and all gross tumor was removed.  The 3.5 cm tumor was associated with the involvement of 8 of 13 lymph nodes.  The patient next underwent chemotherapy, which was completed at the end of November 2005.  He is now ready for radiation therapy and there is a dispute on the method: intensity modulated radiation therapy (IMRT) versus conventional radiation therapy.  The Health Plan has denied authorization and coverage for IMRT based upon their determination that it is an investigational therapy in the treatment of pancreatic cancer.The patient has a defined chance of local recurrence because of the extension of the cancer into the peripancreatic fat and the lymph node involvement. Radiation therapy is clearly indicated.  IMRT is a useful tool in destroying bulky tumors when compared to conventional radiation. However, following successful surgery, IMRT has not been shown to be superior to conventional radiation for microscopic tumors. There is no evidence that the use of IMRT in this patient, who may have at most microscopic tumor cells, will be of greater benefit than conventional radiation therapy. Based upon the information set forth above, 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 2: This case pertains to a 60-year-old male patient diagnosed with pancreatic cancer in early 2005. A Whipple procedure was performed in March 2005, showing a well-differentiated adenocarcinoma 3cm in size with extension into the peripancreatic fat.  Eight of 13 lymph nodes were involved, there was extensive lymphovascular and perineural invasion and there were positive margins. Chemotherapy was initiated postoperatively with the last dose in October 2005. Chemotherapy drugs included Gemzar, Cisplatin, and Xeloda. The patient consulted with a radiation oncologist in November 2005. CT scans after chemotherapy revealed no definitive evidence of active disease. The initial consult stated I plan to use the IMRT technique to deliver approximately 6,000 cGy to the tumor bed and at least 4,500 cGy to the regional lymph nodes at risk. Additionally, the note states that the case requires IMRT due to the fact that IMRT is the optimal option to cover the volume of interest with narrow margins and adequately protect the immediately adjacent structures. The treating radiation oncologist ran dose volume histograms, as well as a comparison of an IMRT isodose to a 4-field conformal approach. According to the note on the side, it states that there is a significantly lower dose to the stomach and right kidney with IMRT. The DVH sheet notation states that there is better coverage and fewer doses to the stomach, intestine, and right and left kidney. The Health Plan has denied authorization for IMRT on the basis it is considered experimental/investigational. At issue in this case is the plan to deliver 60 Gy to the tumor bed with 45 Gy to the regional nodes. This is in excess of the current NCCN guidelines (maximum dose of 54 Gy). According to the national clinical practice guidelines, this dosage is not considered the current standard of care. No clinical rationale is provided for varying from the standard dose in this case. The records do not mention a specific need to treat above the standard dose and conventional conformal radiation treatment with a dose of 50.4 to 54 Gy would give similar results. 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: The patient is a 60-year-old male who was diagnosed with locally advanced pancreatic cancer in early 2005. He underwent surgery in March 2005. The pathology report showed T3 N1 well-differentiated pancreatic cancer. The patient then received six months of chemotherapy. He is now scheduled to receive radiation to the tumor bed and the lymph node areas using the IMRT technique.  The Health Plan considers IMRT experimental/ investigational in the treatment of pancreatic cancer, and has denied coverage.Following surgery and chemotherapy, adjuvant radiation therapy using the IMRT technique was recommended for this patient. Based upon a review of the literature and the above referenced article, it appears that many radiation oncologists have used IMRT for gastrointestinal malignancies, especially pancreatic cancer because the pancreas is surrounded by sensitive organs like the kidneys, bowels, and liver, etc. With IMRT the radiation dose is better directed to the targeted area than with conventional 3D radiation therapy. IMRT could potentially reduce toxicity to the surrounding organs. 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.