Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1: The patient is a 59-year-old woman diagnosed with breast cancer in January 2005. She was found to have a 1.1 cm high-grade invasive ductal carcinoma. Estrogen receptor was positive, progesterone receptor was borderline, and HER2 was overexpresed. Axillary nodes were negative. Apparently, the tumor was sent for Oncotype genomic analysis; the results indicated the patients recurrence score was 54, which places her predicted rate of recurrence by 10 years at 34%. The patient was then treated with adjuvant chemotherapy including cycles of Adriamycin/Cytoxan and then Taxol. It has now been proposed that the patient also be treated with Herceptin. The Health Plan has denied authorization and coverage for Herceptin on the basis that its use is considered investigational in this clinical setting.Herceptin is an antibody that is very useful in the treatment of HER2 positive breast cancer. Most of the data has been in women with metastatic disease, but recently very important data has been reported using Herceptin in the adjuvant situation. At least two recently presented studies have demonstrated very significant decreases in the rate of recurrence in the patients who were randomized to one year of Herceptin (started during or after their chemotherapy). Apparently these trials were initially designed to include only node-positive disease, but soon both allowed node-negative cancers if they were felt to be at sufficient risk of recurrence. One study required the cancer be greater than 2 cm in size. It is very likely that Herceptin will become standard practice in the near future.  The issue in this case is whether the patient is in a high-risk category despite the fact that she is node negative and has a small cancer (1.1 cm). The submitted records include the results of a genomic assay (Oncotype), which suggest that the patient is at high risk with an estimated chance of recurrence of 34%. Although the Oncotype assay is new and does not appear to have been used in the Herceptin adjuvant trials, it seems to be reliable and useful. Based upon the evidence provided, the patient is at sufficient risk to justify the use of Herceptin and it is quite likely the drug will be beneficial in her case. Therefore, I have determined that the requested medication 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 59-year-old woman with biologically high-risk stage 2 node negative breast cancer. She has completed a chemotherapy regimen of Adriamycin/Cytoxin and Taxol. The patients provider has recommended a course of Herceptin. The Health Plan has denied coverage for Herceptin on the basis it has not been established as efficacious for the treatment of patients such as this patient.The data from three recent trials strongly supports the addition of Herceptin to this patients regimen. The data suggests it is probably best to start Herceptin simultaneously with Taxane, but those data emerged after the patient had already received Taxol. While the patients tumor does not fall within the size or nodal category of patients in these trials, it is biologically similar by virtue of HER2 amplification, and biologically aggressive by Oncotype diagnosis. Therefore, it is highly likely that this patient can similarly benefit from the addition of Herceptin at this point in her treatment regimen. As such, I have determined that the requested medication 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 59-year-old postmenopausal female who has poorly differentiated infiltrating ductal carcinoma of the left breast. The tumor was HER-2/NEU positive at 3+ IHC and sentinel lymph node biopsy was negative. The patient is status post four cycles of dose dense Adriamycin/Cytoxin chemotherapy followed by dose dense Taxol with concurrent regional breast radiation. The patients left ventricular function is normal. Herceptin adjuvant treatment has been recommended. The Health Plan has denied authorization and coverage for Herceptin citing a lack of proven efficacy of the drug in cases such as this.The proposed adjuvant Herceptin therapy is entirely appropriate and is now state of the art treatment for this patients breast cancer. Three randomized trials, two of which are NCI approved, have demonstrated Herceptin therapy added to conventional chemotherapy provides superior relapse free results. There is no reason to infer that Herceptin therapy given adjuvantly would be less beneficial for patients such as this with tumors less than 2 cm in size. 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.