Wider access to test can improve cancer treatment

[00:00:00] Host Amber Smith: Upstate Medical University in Syracuse, New York invites you to be "The Informed Patient" with the podcast that features experts from Central New York's only academic medical center. I'm your host, Amber Smith. New York Governor Kathy Hochul signed a bill just before Christmas that requires health insurers to cover life-saving cancer biomarker testing, which allows for targeted treatment. To understand more about how this bill will help people, I'm talking with Dr. Thomas VanderMeer, the medical director of the Upstate Cancer Center, and Mr. Michael Davoli, who is the American Cancer Society's senior government relations director for New York. Welcome to "The Informed Patient," Dr. VanderMeer and Mr. Davoli.

[00:00:42] Michael Davoli: Thank you, Amber. Thank you.

[00:00:44] Host Amber Smith: Let's begin please with a description of what cancer biomarkers are and how they differ from genetic testing and why this has become important in cancer care. Dr. VanderMeer?

[00:00:57] Thomas VanderMeer, MD: There's lots of different kinds of biomarkers, but in general, a biomarker is a test to measure something that's happening in our bodies. In cancer, biomarkers are molecules that indicate if cancer is present, what abnormality is causing the cancer to grow, how active it is, and how it will respond to different types of treatment.

In the past few years, there have been major breakthroughs in our understanding of how cancer works and how to design treatments that target specific molecules and spare the rest of the body the toxicity of conventional chemotherapy. Some biomarker testing is done with blood tests and some requires tissue from a biopsy.

Genetic testing refers to, generally, a blood test that looks at what genetics we're born with. We call that germline testing. That differs from this type of testing, which evaluates the specific molecular alterations in the cancer cell.

[00:01:55] Host Amber Smith: So this sounds like it's fairly new. How long has it been that biomarkers have been a tool for cancer care providers?

[00:02:04] Thomas VanderMeer, MD: We go back to 2001 when the FDA (Food and Drug Administration) approved the first drug called Gleevec, that is designed to target a specific protein on a cancer cell. This was very new at that time. That drug was incredibly effective against a couple of rare cancers, but the concept was so exciting that the FDA approved it in about two and a half months.

Since then, molecular targets and their biomarkers have been identified in many different cancers with numerous new drugs created to interfere with cancer cell growth. And now there are so many potential molecular targets for treatment that testing is done on a panel of over 300 molecular alterations.

[00:02:44] Host Amber Smith: So at this point, which cancers is biomarker testing used in the most?

[00:02:50] Thomas VanderMeer, MD: Well, it's increasing. All cancers have, or can have molecular targets for treatment. They're most commonly seen in non-small cell lung cancer, melanoma, breast and colorectal cancer. But 37 of those 62 anti-cancer drugs launched in the past five years, require bar biomarker testing to determine effectiveness, and increasingly we're finding that these new drugs work against more and more types of cancer.

[00:03:17] Host Amber Smith: Do you ever have patients who need this, who need biomarker testing or would benefit from it, but whose insurance companies won't pay for it? Do you see that happen?

[00:03:27] Thomas VanderMeer, MD: Oh, definitely. And that's why this is so exciting.

My practice focuses on pancreatic cancer. And the typical policy for insurance companies is that they only cover biomarker testing for patients with metastatic disease. But as a surgeon, I see early stage pancreatic cancer, and we've had a number of patients where we wanted to get biomarker testing, and we figured out how to do it one way or another. And they received targeted treatment, which would be different than the treatment that they would receive if we didn't know about the specific molecular alteration in their cancer. And we've had patients who had the cancer completely eradicated, and there was none seen on surgical specimen.

[00:04:12] Host Amber Smith: Wow. So when you say targeted treatment, can you describe what is meant by targeted treatment and how it compares to, I guess, traditional treatment?

[00:04:23] Thomas VanderMeer, MD: Well, traditional chemotherapy agents interfere with cell growth throughout the body. They focus on growth patterns that tend to be more common in cancer cells. But all cells get affected, so there can be significant toxicity. These newer targeted treatments modify specific molecular processes that are unique to cancer cells and interfere with cellular signals that cause cancer cells to grow or limit our own body's immune response to fight the cancer. So as a result, there's much less collateral damage to normal cells because the activity of these drugs is so much more specific and limited.

And with newer targeted treatments coming down the line, they're using the molecular profile of a person's individual cancer to design custom vaccines or to reprogram a patient's own immune cells to kill their cancer.

[00:05:13] Host Amber Smith: Mr. Davoli, do I understand correctly that this bill was needed because only about a third of health insurers in New York were paying for biomarker testing?

[00:05:23] Michael Davoli: Yeah, that is correct. While all insurance plans in the state cover some biomarker testing for some patients, only around 31% of commercial plans cover what is considered comprehensive testing. And in addition, Medicaid does not cover comprehensive testing either. So Medicaid covers some testing for some patients.

So for example, a commercial plan or Medicaid may cover testing for, say, breast cancer only, but no other cancer. But they also may say we're going to cover it if it's a stage three or stage four diagnosis, but we're not going to cover it for an earlier stage. So comprehensive biomarker testing, which is what this bill would achieve, requires coverage for all testing for all diseases and at all stages when medically appropriate.

[00:06:21] Host Amber Smith: You mentioned Medicaid. What about Medicare, for seniors? Does that cover biomarker testing?

[00:06:28] Michael Davoli: Yeah, luckily Medicare already covers comprehensive biomarker testing. Since that's governed by the federal government, they established this in law several years ago. But Medicaid, on the other hand, the rules are governed sort of on a state-by-state basis.

And so Medicaid only covers some testing for some patients, similar to the way the commercial market. And in a state like New York, when you've got around 8 million people that are on Medicaid, that is so critically important.

[00:06:59] Host Amber Smith: Do you know if biomarker testing is covered in other states?

[00:07:03] Michael Davoli: Well, so New York State just became the 13th state in the nation to enact comprehensive biomarker testing. New York joined states like California, Texas, Rhode Island, even Arkansas and Louisiana. So it's a real mix of sort of larger and smaller states that have done this. And I do know that there are efforts underway in all 50 states to establish comprehensive biomarker laws similar to the one we now will have here in New York.

[00:07:32] Host Amber Smith: Are you familiar enough with the language of this bill to tell whether does it account for the advances in biomarker testing that are bound to happen in this field?

[00:07:42] Michael Davoli: It does. And and that's one of the exciting things about the bill is it's really a, it's not a cancer bill per se, it's a science bill. It's a pro-science bill that sets out a set of criteria that says if different tests for biomarkers meet these different sets of criteria, then they must be covered. And there's a list of different types of criteria, and as long as the test meets one or more of those sets of criteria, it would be covered.

So for example, if something is an FDA-approved test for that disease, it would be covered. Or if there are national guidelines, set out for a certain type of disease and a test, it would be covered. If there is a Medicare approval already for that type of test, it would be covered. And so a test that, say, didn't exist 10 years ago, or even five years ago, but that is developed in the future, as long as it meets those criteria in the bill, it would be covered.

And a perfect example of this is, as the doctor mentioned, you know, you have individual tests for individual biomarkers that have been going on for 20 years where we've been able to sort of, say, test one biomarker at a time. But increasingly, we have companies that are developing these biomarker tests that are these multi-panel tests that really look for every known biomarker that exists within a patient's own blood sample. And the bill allows for coverage of that, if it's medically appropriate and if it meet one of those standards. So, like I said, it really is a pro-science bill that's going to evolve with the science as it develops moving forward.

[00:09:33] Host Amber Smith: Does the bill say anything about whether insurers need to pay for genetic testing to see if a particular cancer gene runs in family members, for instance?

[00:09:43] Michael Davoli: That's the one area where there is a lot of confusion. So this bill specifically does not deal with genetic testing and whether or not someone is likely to develop a disease in the future. It is focused exclusively on biomarker testing for the purposes of treatment rather than looking to see if someone is predisposed for cancer. So it does not cover that type of genetic testing for predisposition.

[00:10:08] Host Amber Smith: You're listening to Upstate's "The Informed Patient" podcast. I'm your host, Amber Smith. I'm talking with Dr. Thomas VanderMeer, the medical director of the Upstate Cancer Center, and Michael Davoli from the American Cancer Society. He's the senior government relations director for New York. We've been talking about a new law in New York requiring health insurers to pay for biomarker testing.

How soon does the bill take effect, and how quickly would patients who need biomarker testing have it covered?

[00:10:39] Michael Davoli: So the bill takes effect on January 1st, 2025. So it'll be next year. However, we do know that putting this bill in place, a lot of insurance plans are already starting to add this comprehensive testing. So like I mentioned, 31% of commercial plans were not covering comprehensive testing. Well, that does mean that the majority were covering testing already, voluntarily. And so what we believe this is going to do is ensure that everyone's covering it beginning January 1st, but in the meantime, we do believe more and more insurance companies are going to add this coverage benefit because they see the value of it.

And now that they see the law that's on the books, they're going to recognize that they might as well start doing this for the benefit of their patients.

[00:11:29] Host Amber Smith: Dr. VanderMeer, can you walk us through how a hypothetical person might learn that they would benefit from biomarker testing?

[00:11:37] Thomas VanderMeer, MD: The most common gene panel that's looked at is called FoundationOne. And on their website there's a table that shows based on what type of cancer, what different molecular alterations there might be, and it even says which drugs are available too,to treat those. There's also guidelines published by the National Comprehensive Cancer Network, for each type of cancer, and so people can get information about that.

Generally just medical oncologists are very aware of this, that they are really enthusiastic about all these targeted therapies and the rapid growth and their ability to use targeted therapies. So, usually just talking to your medical oncologist will be probably the easiest and best way to do it.

[00:12:30] Host Amber Smith: So is this what happens almost immediately after you learn that you have cancer? Is this the next step is to find out whether a biomarker test could help?

[00:12:40] Thomas VanderMeer, MD: It hasn't been, because we haven't been able to get it approved. But I think with this bill, especially in the states where it's being enacted, that will increasingly be the case.

[00:12:53] Host Amber Smith: So is it like going to a lab for blood work, generally? I know you said sometimes there's a biopsy, but often is it a blood draw, and then you wait a certain amount of time to get the results?

[00:13:06] Thomas VanderMeer, MD: There are blood tests. What we find more useful, though, is a test on the biopsy specimen itself, because the alterations are frequently different in the cancer itself compared to what we see in the blood. All cancers are diagnosed with a biopsy. So if it's a solid tumor, like, say, lung cancer, then there's a biopsy of that. But even leukemias, there's a bone marrow biopsy. And so, these tests can be run on any specimen.

[00:13:38] Host Amber Smith: Is this a test where the results come back either yes or no, or is there more interpretation needed?

[00:13:46] Thomas VanderMeer, MD: The tests come back, and it'll say which molecular alteration is present and give you a lot of specific information about that. And the gene panels are really targeted to what would be actionable in terms of treatment. So they're all set up with a specific goal of identifying changes that would impact treatment.

[00:14:12] Host Amber Smith: So is treatment sort of put on hold until you get the results back, or are there certain parts of treatment that you would start ahead of time?

[00:14:21] Thomas VanderMeer, MD: Yeah, well we like to get the results back as quickly as possible. It usually takes from the time of the request, the tissue has to be sent out to another lab. Once that lab gets it, it takes about 10 days to get the information back. So it's usually about two weeks. So it depends on the severity of the cancer. If people can wait those two weeks without much harm, then a lot of times we would wait to get that information back.

Increasingly, larger institutions are trying to bring those tests in-house. So that we get the information more quickly.

[00:15:00] Host Amber Smith: If a person finds out they have a particular biomarker, does that mean that their children or other family members will have the same biomarker?

[00:15:10] Thomas VanderMeer, MD: No. The biomarker on the tumor is typically unique to the tumor. The germline testing, which is what we're born with and is the composition of all of our cells, that is heritable. And so if you take, say, like a BRCA mutation that may be in your gene line. That would be passed on to your children. That runs in your family. That's also going to be present on your tumor cell, most likely, but there may be other changes in the tumor cell that have occurred during your lifetime and have caused that cell to change from a normal cell to a cancer cell. And that's why the most important testing is done on the biopsy specimen itself.

[00:16:00] Host Amber Smith: And BRCA, that's the breast cancer gene?

[00:16:03] Thomas VanderMeer, MD: Yeah. The BRCA mutation put you at risk for other cancers too.

[00:16:07] Host Amber Smith: Okay. Gotcha.

Now, when this bill passed, there was talk that it was going to help reduce health disparities. Can you explain how?

[00:16:17] Thomas VanderMeer, MD: Yeah. Well, the out-of-pocket costs for the most commonly used panel is $3,500. And so, as was mentioned earlier, there's 8 million New Yorkers on Medicaid, and they probably don't have $3,500 to pay for this. So if you think about it, if you don't have access to biomarker testing, then you don't have access to these newer targeted treatments. And so every new advanced drug that comes out is widening healthcare disparities. Because there's more and more treatments that are unavailable to people in lower socioeconomic groups.

[00:16:55] Michael Davoli: When you look at who has access to biomarker testing currently in New York state and as well as nationwide, it's really fascinating. If you are a person of color or if you are lower income, but also if you are from a rural area, or if you get your healthcare from more of a community center as opposed to an academic center, you are less likely to get access to comprehensive biomarker testing. So, for example, if you get your cancer care, your medical care from an FQHC (federally qualified health center), maybe they do biomarker testing, but then they need to ship it out to a lab. It takes time. And then it comes back and everything. As opposed to if you are getting your treatment at a academic center where they literally do the biomarker testing right there in-house, and they and run it through their processes, it can speed up that process in order for getting you that care.

As well as, some of the larger cancer centers that have larger endowments and money will often cover the cost of biomarker testing for you as opposed to if you were in a community center where they just simply don't have those resources. So that's why this is so important that it really kind of levels the playing field and brings everyone up to that comprehensive level.

[00:18:13] Host Amber Smith: The Upstate Cancer Center is part of an academic medical center. You used the term FQHC. What is that?

[00:18:20] Michael Davoli: So that's a Federal Qualified Health Center. So these are the health centers that provide healthcare for a lot of our lower income folks, our Medicaid patients. They exist in New York City, but a lot of the urban areas across the country, and they provide treatment for millions of patients every single year. And they simply, they're not going to have the type of resources that a place like Upstate Medical would.

[00:18:46] Host Amber Smith: Now you both specialize in cancer, I realize, but biomarker testing is being used in other areas of medicine. Does this New York bill address any other diseases besides cancer?

[00:18:58] Michael Davoli: That is, again, that's one of the exciting things about this bill is that it's not a cancer bill, per se. It's actually disease agnostic. So, while biomarker testing is primarily being used in the treatment of cancer currently, there's research being done in a whole host of different medical conditions -- everything from mental health issues to heart disease, a lot of different neurological conditions, even Parkinson's and ALS (amyothrophic lateral sclerosis) there's research being done on biomarker testing and how they can be used for the treatment of those diseases.

What this bill explicitly says is, if the science shows that biomarker testing can be used to treat that disease, then it should be covered by the law, and the testing should be covered by your insurance.

Now, for example, just this past spring, a test for preeclampsia was approved by the FDA that would help doctors determine whether or not a patient of theirs needed to go on bed rest at home for a month, or if they needed to come to a hospital and spend potentially a month at the hospital prior to delivering their baby. And so you can imagine the mental and financial cost savings that would be if a patient could do bed rest at home versus having to spend a month in the hospital.

That test was just approved by the FDA back in April and now will be covered by this law because it meets that standard of FDA approved for the purposes of treatment. So that's just one example of how this law is going to go way beyond cancer in the future. As long as there is the medical science that sort of meets those standards laid out in the bill, the test would be covered regardless of what type of disease it is.

[00:21:03] Host Amber Smith: Well, that's good to know. I want to thank both of you for making time for this interview.

[00:21:07] Thomas VanderMeer, MD: Thank you, Amber.

[00:21:08] Michael Davoli: Thank you so much. Thank you, Amber.

[00:21:11] Host Amber Smith: My guests have been the medical director of the Upstate Cancer Center, Dr. Thomas VanderMeer, and the American Cancer Society's Senior Government Relations Director for New York, Mr. Michael Davoli. " The Informed Patient" is a podcast covering health, science and medicine, brought to you by Upstate Medical University in Syracuse, New York, and produced by Jim Howe. Find our archive of previous episodes at donvoyages.com/informed. If you enjoyed this episode, please tell a friend to listen too. And you can rate and review "The Informed Patient" podcast on Spotify, Apple Podcasts, YouTube, or wherever you tune in. This is your host, Amber Smith, thanking you for listening.