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Medicare Contractor Issues Draft LCD on Breast Cancer Tests for Predicting Chemotherapy Benefit

NEW YORK (GenomeWeb) – Medicare contractor Noridian has issued a draft local coverage determination limiting coverage for a number of biomarker tests to guide decisions about adjuvant chemotherapy in breast cancer patients.

According to the draft LCD, Noridian proposes to cover Genomic Health's Oncotype DX, NanoString's Prosigna, Sividon Diagnostics' EndoPredict, BioTheranostics' Breast Cancer Index, as well as tumor-associated proteolytic factors uPA & type 1 inhibitor PAI-1 for breast cancer patients who are estrogen or progesterone receptor positive, HER2 negative, and whose disease hasn't spread to the lymph nodes. Though these same tests are not covered for ER/PR positive, HER2 positive, node-positive, or triple-negative breast cancer, Noridian said.

"In addition, none of these tests are not covered for ER/PR positive/HER2 negative, node negative breast cancer patients who have had 5 years of endocrine therapy without tumor recurrence to guide decisions for extended endocrine therapy," the contractor added. "Testing is not covered for ductal or lobular carcinoma in situ."

In March, Noridian issued a favorable final LCD for NanoString's Prosigna assay for predicting recurrence in node-negative patients, which becomes effective May 3.

With regard to Genomic Health's business, specifically, Cowen and Company analyst Doug Schenkel pointed out in a note to investors that the node-positive market is one-third the size of the node-negative market, and likely represents around 4 percent of the firm's US product revenues and total test volume. Medicare had previously extended coverage for Oncotype DX for predicting recurrence in node-positive breast cancer and ductal carcinoma in situ. The test has been covered by Medicare in the node-negative population for a decade.

Noridian further said that it will not cover Agendia's MammaPrint, NeoGenomics' Mammostrat, IHC-4, tumor infiltrating lymphocytes, circulating tumor cells, and Ki67 for "any reason."

The draft LCD is based on the latest guidelines from the American Society of Clinical Oncology's Biomarker Expert Panel. Schenkel pointed out that the guidelines don't reflect the latest published data from the large, prospective TAILORx trial involving Oncotype DX, and wrote that Genomic Health "is working with CMS and ASCO to resolve the proposed change in coverage based on critical data not incorporated into this decision."

Similarly, researchers in April presented data from the prospective, large MINDACT trial involving MammaPrint, which showed that among women who have early-stage breast cancer and are high risk by clinical parameters, using the test could reduce the use of chemotherapy by half.

The public has until Aug. 8 to comment on the draft LCD.