Invasive Ductal Carcinoma Of The Breast denials in California external review

What the reviewers wrote

Where the denial was 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 patient’s 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.

Physician #1: The patient is a 59-year-old woman diagnosed with breast cancer in February 2005. At that time she was found to have a 1.4cm invasive ductal carcinoma with negative axillary nodes. Her estrogen receptor was positive and HER2 was negative. She underwent an Oncotype DX assay and was found to have a low recurrence score. On the basis of that assay the decision was made to forgo adjuvant chemotherapy.At issue is whether the use of the Oncotype DX assay was likely to be more beneficial for evaluation of the patient’s medical condition than any available standard therapy.Oncotype DX assay is a relatively new assay wherein 21 genes are analyzed in a breast cancer, allowing for the development of a prognostic score. This score then allows one to place a patient into a risk category for recurrence (low, intermediate, or high).

Where the denial was upheld

Physician 1: This patient is a 55-year-old woman diagnosed with breast cancer in September 2005. At that time she was found to have a 1.5 cm invasive ductal carcinoma, intermediate grade, with negative nodes. The estrogen receptor was positive and HER2 was positive. Her tissue was submitted for “Oncotype DX” assay. This assay gave her a risk of recurrence of 34%. Accordingly, she underwent adjuvant chemotherapy. The Health Plan deemed the diagnostic procedure experimental/investigational and denied her request for reimbursement.The decision as to the appropriateness of adjuvant chemotherapy is a difficult one in Stage I breast cancer. The “Oncotype DX” assay does appear to add meaningful prognostic information in this situation.

Physician 1: The patient is a 52-year-old female who was diagnosed with invasive ductal carcinoma of the breast found to be T2N0M0, ER positive, PR positive, and HER2 positive. The Oncotype DX assay was performed to help guide her choice of therapy. The patient now requests reimbursement for the diagnostic procedure. The Health Plan considers the Oncotype DX experimental/investigational and has denied reimbursement and coverage.There are no prospective clinical trials that have demonstrated that this assay can be used to select a specific therapy that will provide the individual patient with a better therapeutic outcome than would be achieved with the current guidelines for selection of therapy. Such studies are currently in progress, and until such data are available, use of this test is investigational.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving invasive ductal carcinoma of the breast, then check the rights and deadlines that apply to your plan.