CMS Final Coverage Policy for NGS Cancer Assays May Boost IVD Development

Regulatory NewsRegulatory News | 20 March 2018 |  By 

The Centers for Medicare and Medicaid Services’ (CMS) recent move to finalize a national coverage determination (NCD) for next generation sequencing (NGS) cancer panels underscores an emerging trend across the US expected to broaden patient access to targeted therapies.

CMS’ decision to extend reimbursements to a substantial portion of the US population was informed by the parallel review process in which the US Food and Drug Administration (FDA) approved an NGS-based test from Foundation Medicine with breakthrough medical device designation.

FoundationOne CDx became the first FDA-approved comprehensive genomic profiling assay for all solid tumors, featuring a set of companion diagnostics, in November 2017. It is only the second firm to have receive FDA-approval via the FDA/CMS parallel review pathway, with the first being Exact Sciences.

Foundation’s approval sparked a shift away from oncology testing based on a single gene, toward using a single test that looks at multiple biomarkers associated with a disease to then “stratify the treatment of the patients’ tumor and get to the right treatment,” Joydeep Goswami, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific, told Focus.

Thermo Fisher is among the manufacturers of NGS-based oncology testing assays and its Oncomine Dx Target Test is designed to evaluate 23 genes clinically associated with non-small cell lung cancer.

According to Goswani, the change in the space is occurring simultaneously with the growing awareness on the value in NGS-based tests because these allow for a holistic view of the clinically-actionable markers that may be present in a patients’ tumor, which in turn enable faster, less expensive results.

But CMS was not the first to issue a coverage decision for NGS tests. Private insurance companies, including Cigna and UnitedHealthcare, have issued positive reimbursement decisions as well. However, the discussion around CMS coverage aligned with FDA approvals further legitimizes NGS, Goswami said.

It also provides incentives to medical device companies like Thermo Fisher, Qiagen and Illumina, among others, to continue to develop more in vitro diagnostic (IVD) tests that can be used as companion diagnostics, Goswami added.

“It’s encouraging to see the distinction that was made between FDA approval and CMS coverage and that gives a lot of hope to us that the system is being streamlined,” he said.


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