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CMS Issues Positive Draft LCD for NanoString's Prosigna

NEW YORK (GenomeWeb) – CMS has issued a positive local coverage determination (LCD) for NanoString's Prosigna breast cancer recurrence test.

The draft document outlines coverage for testing when it is performed for post-menopausal women who have estrogen receptor-positive, early-stage breast cancer that hasn't spread to the lymph nodes, or for stage II disease that has spread to as many as three nodes.

The Prosigna assay runs on NanoString's nCounter platform and yields a recurrence score based on the PAM50 gene signature; the score denotes the risk that a woman's breast cancer will recur 10 years after diagnosis. The US Food and Drug Administration first cleared the test in 2013, and updated its label last December to provide additional information on the risk of 10-year distant recurrence.

The coverage criteria outlined in the draft LCD, issued by Medicare contractor Palmetto, tracks with Prosigna's FDA-approved indication. "Claims for Prosigna testing will be denied when testing does not meet [this] criteria," the draft LCD states.

To garner FDA clearance, the Prosigna test was validated in a study involving more than 1,000 cases from the TransATAC trial. The findings of that study were replicated in an independent cohort of 1,600-patient samples from the ABCSG-8 trial. Then, a third analysis combining data from TransATAC and ABCSG-8 showed Prosigna can assess distant recurrence between five and 10 years after initial diagnosis.

A clinical utility study on the test has shown that doctors change their decisions for or against adjuvant chemotherapy for 20 percent of 200 newly diagnosed breast cancer cases. In this analysis, doctors considered Prosigna test results after factoring in all other clinical data.

"The net rates of selecting adjuvant chemotherapy for low, intermediate, and high-risk cases was similar to that observed in a meta-analysis of Oncotype DX decision data," the draft LCD notes. Another study showed a strong link between Prosigna scores and neoadjuvant chemotherapy response, with low-scoring cases having limited chance of achieving a complete pathologic response and high-scoring patients approaching a 50 percent chance of having a complete pathologic response.

Stakeholders have from June 9 to August 24 to comment on the draft LCD.