The Centers for Medicare & Medicaid Services (CMS) has widened their Medicare coverage for next-generation sequencing (NGS) tests that can delineate treatments for patients with metastatic, recurrent, relapsed or stage 3 or 4 cancers. Under the finalized National Coverage Determination (NCD) publised last week, tests approved by the FDA as companion diagnostics will automatically receive full coverage. In addition, this final determination covers all solid tumors, as well as repeat testing if the patient has a new primary cancer diagnosis.
“It really establishes that broad-based genomic profiling is here to stay, said Vince Miller, Foundation Medicine’s chief medical officer, in a phone interview. “It’s mainstream, it’s central to the acceleration and adoption of precision medicine across advanced cancer. So, the third-party payers who were sitting on the sideline, kicking the proverbial can down the road. I think they’re going to be urged to address this.”
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Two of the main beneficiaries of the NCD are Foundation Medicine and Thermo Fisher Scientific, which have both invested significant effort into NGS panels. The FoundationOne CDx test assesses 324 genes in multiple solid tumors and received parallel approval from both CMS and FDA late last year, to some degree blazing the trail for the new NCD.
CMS has also approved Thermo Fisher’s Oncomine Dx, which tests 23 genes and 600 DNA and RNA markers for non-small cell lung cancer, though that could be broadened to other cancers in the near future.
The coverage decision should be a great benefit for patients, giving them greater access to comprehensive molecular panels that could provide much more information about their tumors than single-gene tests – and do it much faster.
“The turnaround time is very important,” said Joydeep Goswami, Thermo Fisher Scientific’s president of Clinical NGS and Oncology. “These patients have stage III or stage IV cancer. They often only have a few months to live if they’re not immediately put on the right treatment.”
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In addition, these panels can be expanded. As new drugs are developed to target specific tumor mutations, NGS diagnostic developers can add those genetic variations to their panels once their approach is validated.
This final determination has significant refinements over the draft version, adding stage 3 cancers, covering all solid tumors (rather than a select five) and covering repeat testing. Still, the field is growing and there are other areas where expanded coverage could help patients.
“Clearly, there are newer tests on the immuno-oncology aspect, where you’re trying to figure out how the immune system is responding to the tumor,” said Goswami. “CMS should be thinking about those and how they could advance patient care.”
Eventually, liquid biopsies could also be added to the reimbursement mix, giving clinicians better tools to monitor patients for relapse or – in the more distant future – detect earlier stage cancers. But perhaps the greatest long-term benefit is setting up a more collaborative structure between CMS and the FDA.
“The closer relationship with FDA is helpful to all involved,” said Miller. “The parallel review process was a good experience – the relationships that were built, the transparency and the responsiveness of the folks on the other end.”
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Correction: An earlier version misstated the number of genes tested in ThermoFisher’s Oncomine Dx test. It’s 23.