Next generation sequencing (NGS) test receives both FDA approval and proposed medicare coverage by the CMS for patients with advanced cancer


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UPDATE 4/19/18:  On April 2, it was announced that Next Generation Sequencing (NGS) tests will be covered in all states throughout the US, and that they are reasonable and necessary tests to make available to Medicare beneficiaries. This announcement means NGS tests are now available to all cancer patients with solid tumors. One such test is FoundationOne CDx which received FDA approval in November 2017, and in March 2018 the Centers for Medicare and Medicaid Services (CMS) declared it would be available to all medicare beneficiaries. During the public comment period, the Fight CRC team, with advisement from representatives of the Medical Advisory Board, requested clarification on several areas, including the requirement that “patients have not been previously tested using the same NGS test.” CMS addressed this in the final national coverage decision and while they still do not allow patients to have the same NGS test repeated, (i.e. patients can’t receive FoundationOne CDx twice) different NGS tests will be covered allowing CRC patients and clinicians to utilize these tests to determine future treatment options. You can read the public comments and responses here. Fight CRC stays at the forefront of the latest policy issues, provides input and keeps an eye on the outcomes that will result in the most efficacious treatments for patients. We are dedicated to keeping the patient’s best interest at the center of our work. Ultimately, the final coverage announcement was in line with the comments and clarifications we requested. This decision will improve access to precision medicine, identifying the best treatment options for patients.

The Announcement

In November, the Federal Drug Administration (FDA) approved a breakthrough next generation sequencing (NGS) test for tumor-gene profiling in patients with recurrent, metastatic or advanced stage IV cancer known as the FoundationOne Companion Diagnostic (F1CDx) test. In a parallel review process, the Centers for Medicare & Medicaid services also proposed coverage of FD1CDx in order to provide quicker access to Medicare beneficiaries. Prior to this announcement, it was very difficult for patients covered under Medicare to receive access to NGS testing. This decision will allow for increased access to healthcare coverage for a large portion of the US population.

What is a companion diagnostic test?

Companion diagnostic tests are tests that are typically linked to a specific drug for therapy. These diagnostic tools help clinicians decide if a particular drug or treatment will be efficacious and benefit the patient while mitigating risks and serious side effects.

How will this test help CRC patients?

The newly-approved NGS FD1CDx test can distinguish mutations in over 300 genes at once in any of the 5 solid tumor types. Not only do results from the breakthrough genetic profiling test help determine which of the 15 FDA-approved targeted treatment options will then be most beneficial to a patient, but it only requires one tissue sample to do so. Results from these tests will provide insight into eligibility and clinical trial enrolment, guiding a patient’s treatment decisions.
According to Dr. Dusty Deming from the University of Wisconsin, “in the ever expanding era of precision medicine, molecular testing is critical to determining the best treatment strategies for patients with cancer. In order to make this a possibility for more patients, improved coverage of this type of testing is essential."
Among the numerous genetic mutations that the FD1CDx test can detect are molecular changes that are a result of microsatellite-instability (MSI- H). Findings from the Fight CRC/ CI Immunotherapy workgroup blueprint, published in November 2017, determined that biomarkers and identified treatment methods need to be integrated into the routine management of CRC. NGS tests such as FD1CDx can help make targeted treatment a more viable option for clinicians and patients, using biomarkers to guide these decisions.
Do you know your biomarker? Check out our Biomarked campaign and resources!

Fight CRC’s Public Comment

In light of this monumental announcement from the FDA and CMS, Fight CRC took advantage of the public comment period, with help from members of our Medical Advisory Board and patient advocates, to support the proposed decision memo with requests for clarification before finalization of the guidelines. Highlights from our letter included:
  • Clarification on the requirement that “patients have not been previously tested using the same NGS test”. (This implies that a patient tested with one NGS test would be excluded from future tests, but it wasn’t clear whether a patient could be tested with a different brand of a NGS test.)
  • Additionally, we emphasized our support on the requirement that the NGS test be covered if data is gathered, helping to assess the clinical validity of the tests.
  • We noted however, that it is necessary to find an efficient collection and entry method so it doesn’t become a burden on physicians.
Take a look at the proposed memo here You can read our public comment in full here: PDF File You may exclusively donate to colorectal cancer research at Fight CRC: [button] Make a donation [/button]