Diagnosis: Right breast DCIS (ductal carcinoma in situ)
Treatment: OncotypeDX Breast DCIS Assay Genetic Testing (0045U)
The insurer denied the OncotypeDX Breast DCIS Assay Genetic Testing (0045U).
The denial is upheld.

The patient is a female with DCIS (ductal carcinoma in situ). Her provider performed OncotypeDX testing.

No, the health plan should not cover the OncotypeDX Breast DCIS Assay Genetic Testing (0045U).

No, the OncotypeDX Breast DCIS Assay Genetic Testing (0045U) is not more beneficial.

The benefit of RT (radiation therapy) for DCIS (was shown in a meta-analysis of RT compared with no further treatment following lumpectomy. Compared with lumpectomy alone, RT resulted in a reduction in the risk of all ipsilateral breast events. This translated into a number needed to treat of nine women to prevent one ipsilateral breast recurrence. As in the treatment of invasive breast cancer, the standard of care for patients undergoing BCT (breast-conserving therapy) is to deliver adjuvant whole-breast radiation therapy (WBRT), typically within eight weeks of surgery. Conventionally dosed WBRT consists of 1.8 to 2 Gy (gray) daily fractions over 4.5 to 5 weeks to a total dose of 45 to 50 Gy, often followed by a boost to the surgical bed.

RT reduces the odds of in-breast recurrence but likely does not change the odds of distant recurrence or decrease mortality. For patients with low-risk disease that has been fully resected with widely negative margins, the absolute reduction of in-breast recurrence may not be large enough to justify the risks associated with RT. In such patients, it is reasonable to omit RT, especially in the setting of comorbidity, advanced age, or patient preference. Results from the NSABP (National Surgical Adjuvant Breast and Bowel Project) B-17 trial have been used to argue for RT in all women who undergo lumpectomy for pure DCIS.

Gene expression analysis such as the OncotypeDX DCIS recurrence score has been studied as a tool for identification of patients for whom post-lumpectomy RT may reasonably be omitted, but data regarding its utility are still limited. At this time, the NCCN (National Comprehensive Cancer Network) does not support the routine use of this testing to guide management in women with DCIS and feels that universally all women with DCIS should be offered adjuvant radiation.