Appeal type: Experimental/Investigational
Decision: Upheld

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 no significant past medical history who was diagnosed with ductal carcinoma in situ (DCIS).  An OncotypeDX for DCIS test was performed on the tumor.

This test was denied by the health plan, as the plan's position is that this test is experimental/investigational. This denial was appealed as being medically necessary.

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

The patient had newly diagnosed DCIS. An OncotypeDX for DCIS test was performed on the tumor.

The OncotypeDX for DCIS test purports to provide an individualized assessment for the risk of local recurrence of DCIS. Performed on a tumor sample after a biopsy or surgery, the test looks at 12 cancer-related genes in the patient's tumor (OncotypeDX for DCIS 2021).

The first validation study of the OncotypeDX Breast Cancer Assay for DCIS was published (Solin). This study supports that the OncotypeDX Breast Cancer Assay for DCIS may have predictive value in quantifying invasive breast cancer risk, but does not show that making treatment decisions based on the OncotypeDX Breast Cancer Assay for DCIS assay will improve health outcomes.

A review of this publication comments the following:

"Although the information provided by the DCIS [ductal carcinoma in situ] Score may be useful in the correct setting and application, it is not a definitive guide. The study by Solin et al. (23) does not address the use or lack of RT [radiation therapy] and has not yet been validated against DCIS [ductal carcinoma in situ] treated with whole breast irradiation. The data used to develop the DCIS [ductal carcinoma in situ] Score may be affected by the low number of estrogen receptor (ER) negative and Her2neu (H2N) positive patients included, small subgroup sample sizes, the need to develop its algorithm based on mixed IBC [invasive breast cancer] and DCIS [ductal carcinoma in situ] samples, and limited patients who have taken tamoxifen. This is important because H2N [Her2neu]-positive DCIS [ductal carcinoma in situ] has historically been associated with high-risk DCIS [ductal carcinoma in situ] lesions..." (Duggal)

Subsequent studies have shown only that OncotypeDX for DCIS results may alter patient treatment, but do not demonstrate that this change will improve patient outcomes (Lin).

Recent reviews conclude the following:

"Given the relatively short period since the Oncotype DCIS [ductal carcinoma in situ] assay became commercially available and limited accessibility to cost coverage, there is limited experience with regard to the clinical utility of the Oncotype DCIS [ductal carcinoma in situ] Score." (Nofech-Mozes)

The OncotypeDX Breast Cancer Assay for DCIS is not recommended by the NCCN (National Comprehensive Cancer Network) Guidelines for the treatment of DCIS (NCCN Breast, page DCIS-1).

As the benefit of this testing is unproven, it is not medically appropriate. Therefore, 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 than any standard treatment for the insured's condition or disease.