In an important decision announced late on Friday last week, the Centers for Medicare & Medicaid Services (CMS) announced that it had agreed to cover costs associated with genetic/genomic testing for Medicare patients with many advanced forms of cancer.
Specifically, according to a report on the Reuters web site, CMS has made a “national coverage decision” that diagnostic laboratory tests using what is known as “next-generation sequencing” or NGS would be covered. This includes tests like the FoundationOne CDx test and other analogous tests that have:
- FDA-approved uses in detection of mutations in a patient’s cancer and
- When tests results are provided to the treating physician with a report that specifies FDA-approved treatment options
As an example, the FoundationOne CDx test is able to detect mutations in > 300 genes and gene mutations associated with 15 approved, targeted cancer drugs.
This is an important decision by CMS for all sorts of reasons, but most importantly because it will help to increase the application of personalized or precision medicine in the management of cancer.
At present, there is only one drug that has been approved for treatment of a specific subtype of prostate cancer and for which there is an FDA-approved test that shows a specific mutation: that drug is pembrolizumab (Keytruda), which is approved for treatment of patients with any form of advanced or progressive cancer shown by a laboratory test to be caused by what are known as microsatellite instability-high (MSI‑H) or a mismatch repair deficient (dMMR) genetic defects. This is an extremely rare form of prostate cancer. However, we can also expect such testing to be usable in testing to see whether the PARP inhibitors might be potentially effective in some patients with advanced prostate cancer as well in the near future.
The approval of coverage for this type of testing by CMS is also likely to
- Accelerate coverage of such testing by commercial insurers
- Increase the opportunity for developers of pharmaceutical and biopharmaceutical therapeutic agents to appropriately define the utility of their products in genomically characterized subsets of patients
Filed under: Diagnosis, Drugs in development, Living with Prostate Cancer, Management, Risk, Treatment | Tagged: approval, coverage, genetic, genomic, next generation, NGS, sequencing, test |
THE "NEW" PROSTATE CANCER INFOLINK 
This CMS guideline was actually issued on Friday, March 16. I have been following this closely along with Foundation Medicine and submitted published comment on behalf of Answer Cancer Foundation.
The good news is that CMS softened up the regulations and included all solid tumors without patients having to jump through clinical trial hoops.
The bad news is that this is still a once in a lifetime test — a requirement many objected to. So it does not recognize that cancers like prostate cancer can morph.
Right now there is a work-around per Foundation Medicien — the once in a lifetime is per actual test, not per NGS. So if you were to order FoundationOne now, you could order FoundationCDx or FoundationAct (liquid) in future.
Foundation Medicine does plan to phase out FoundationOne and FoundationFocus fairly quickly, so some may want to order FoundationOne now. It is not clear to me how tests from other providers like Guardant fit in.