The U.S. government said on Friday it will pay for certain genetic tests for Medicare-eligible patients with advanced cancer, in a bid to help match patients with the drugs most likely to provide benefit.
The Centers for Medicare & Medicaid Services (CMS) said that diagnostic laboratory tests using Next Generation Sequencing (NGS) would be covered by the government healthcare program.
The National Coverage Determination (NCD) is an important step in the advance of so-called personalized medicine and follows U.S. Food and Drug Administration approvals of the tests.
“We want cancer patients to have enhanced access and expanded coverage when it comes to innovative diagnostics that can help them in new and better ways,” CMS Administrator Seema Verma said in a statement.
With the decision, one small test sample from a Medicare patient with advanced breast cancer, for example, could be simultaneously screened for all known gene mutations associated with potential treatments.
When a known cancer mutation cannot be matched to an approved treatment, results from the test using NGS can help determine a patient’s candidacy for clinical trials linked to their specific mutation.
The decision covers Foundation Medicine Inc’s FoundationOne CDx in vitro diagnostic test that can detect gene mutations associated with 15 already-approved targeted cancer drugs, such as Pfizer Inc’s Xalkori for lung cancer, as well as mutations in 324 genes and two genomic signatures in any solid tumor, CMS said.
It also covers other FDA-approved in vitro diagnostics if the test has an FDA-approved use in a patient’s cancer and results are provided to the treating physician with a report to specify treatment options.
Thermo Fisher Scientific said its approved NGS, called Oncomine Dx Target Test, will be covered under the CMS decision. The test screens for a wide variety of biomarkers and gene mutations associated with non-small cell lung cancer.
Tests that gain FDA approval or clearance as an in vitro companion diagnostic in future will automatically receive full coverage under this final NCD, CMS said.
The decision also extends coverage to repeat testing when a Medicare patient has a new primary diagnosis of cancer.
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