> Medicare Will Cover FDA-Approved Genomic Tests

Medicare Will Cover FDA-Approved Genomic Tests


Testing can help some people with metastatic breast cancer get matched with targeted therapies, immunotherapies and clinical trials that may help them

In March, the Centers for Medicare & Medicaid Services announced it would cover all current and future FDA-approved next-generation sequencing tests in people with certain advanced cancers, including metastatic breast cancer. The results of these tests can sometimes be used to make treatment decisions.

What Are Next-Generation Sequencing Tests?

Next-generation sequencing tests are a newer type of genomic test. Genomic tests look for mutations, or errors, in tumor DNA that occurred on their own, unlike genetic tests, which look for mutations in your DNA passed on to you from your parents. Many genomic tests look at a single gene in a tumor in the hopes of finding something in that gene that suggests one certain medicine would work well for you.

Instead of looking at one gene at a time, next-generation sequencing tests can look at hundreds of genes at once. The results can show whether any of an assortment of medicines will work well for you based on features of the disease. You may then be able to get a medicine approved for breast cancer or being studied in a clinical trial. The tests might also show that the cancer might respond to treatments available in other cancers but not in breast cancer. In this case, it might be possible to get that medicine in a clinical trial.

The Medicare decision to cover next-generation sequencing tests came after the FDA approved Foundation Medicine’s FoundationOne CDx test in November 2017. Genomic tests have been used for years, but until recently, it wasn’t common for them to receive approval from the FDA. There are many NGS tests already in use that don’t have FDA approval that your doctor can order from other labs or academic institutions. You may have had genomic testing in the past with a test that does not have FDA approval. Don’t worry — your results are just as accurate. If you’re concerned, talk to your doctor.

About FoundationOne CDx

The FoundationOne CDx test can find mutations in 324 genes and two genomic signatures in any solid-tumor cancer. Solid-tumor cancers include breast and ovarian cancer, non-small cell lung cancer, colorectal cancer and melanoma, among others. To date, this test looks at the largest number of genes out of all approved next-generation sequencing tests. It is also the only one approved for use in all solid tumors, including breast cancer. Foundation Medicine estimates that a mutation that could affect treatment decisions is found in 10 percent of people with breast cancer who get their test.

FoundationOne CDx can show if the cancer may respond to FDA-approved HER2-targeted therapies trastuzumab (Herceptin), ado-trastuzumab-emtansine (Kadcyla) or pertuzumab (Perjeta). It can also suggest whether the FDA-approved immunotherapy medicine pembrolizumab (Keytruda) could treat the cancer.  It may also identify a pathway that can be targeted in a clinical trial.

If there is a mutation identified with no FDA-approved therapy, there may be clinical trials for medicines that target that pathway you could be eligible for. For example, Massimo Cristofanilli, MD, FACP, professor of medicine and associate director of translational research and precision medicine at the Robert H. Lurie Comprehensive Cancer Center in Chicago, says if the test shows you have a mutation in the PIK3CA or ESR1 gene, it is possible that standard therapy won’t work as well for you as it does for others, so your doctor may recommend a clinical trial instead.

The genomic testing process works like this:

  • If you have advanced cancer, you and your doctor talk about genomic testing.
  • Your doctor orders the test, uses an existing tumor sample or does a biopsy to get a new sample, and sends the sample to the genomic testing company.
  • The company analyzes the sample.
  • A trained professional looks at the results and in about 2 weeks, the doctor who ordered the test gets a report about it.

    • For the FoundationOne CDx test, the report includes information about mutations or targets that were found. FDA-approved treatments or clinical trials that you may be eligible for based on those findings may be recommended based on the results.

What This Means for You

Without insurance coverage, genomic tests can cost thousands of dollars.

“One of the barriers that we see [to people getting these tests] is the cost [and] the coverage,” Dr. Cristofanilli says.

If you have metastatic breast cancer and get your insurance through Medicare, this approval may give you more access to next generation sequencing than you would have in the past. It’s important to know that the decision does not require Medicare to pay for genomic testing more than once, so if you’ve had testing in the past, FoundationOne CDx may not be covered. If you’re unsure, talk to your care team to find out what tests you’ve had and if any are considered genomic tests. If you have private insurance you may still benefit from the Medicare decision: Private insurance companies often follow Medicare’s lead on what they cover, so major companies are more likely to start covering next-generation sequencing in the future.

If you already know you have HER2-positive breast cancer, you had tests at diagnosis to determine the need for treatments with trastuzumab, pertuzumab or ado-trastuzumab emtansine. Since these older, less expensive tests can already show the cancer is HER2-positive your doctor isn’t likely to order a next-generation sequencing test to learn whether a HER2-targeted treatment could help you. But the test could help you find a clinical trial you qualify for, or get you access to a medicine that’s approved to treat a different type of cancer. Also, tests like FoundationOne CDx look at hundreds of genes at the same time that may let you avoid future biopsies or trips to the doctor if more testing is required.

Doctors will still be able to order genomic tests that aren’t FDA approved, including the kind that are often created and used by large cancer centers. Some of these tests are already covered by Medicare, even though they aren’t FDA approved, and other tests may be covered by Medicare on a case-by-case basis. If you have questions or are interested in this type of testing, be sure to talk to your healthcare provider.