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Comprehensive Genomic Profiling and Clinical Actionability


Payer response to supporting decisions for coverage of comprehensive genomic profiling in oncology.

Bruce Feinberg, DO: Eugean, are you taking notes?

Eugean Jiwanmall, MPH, MBA: I’m taking notes. I like that Kenna and Mark [Kris] speak, and I have a chance to respond. That brings a comprehensive picture to all of this. Going back to Mark, I’ll start with that then I’ll come to the points that Kenna has made. Clinical actionability is what we’re looking for. I’d hate to spend time on this because I don’t want to paint the picture that panel size matters. I’m going to bring it from a different perspective because there may be a 25-marker panel that doesn’t make clinical sense.

Let’s talk about the clinical actionability of the makeup of your test. I won’t even call it a panel. How many pieces that you’ve combined together are truly clinically actionable? It’s not going to be the case, despite some of the examples that Kenna has brought up. Depending on the situation—I’m just making this up Kenna, so don’t think I’m specifically thinking about that—microsatellite instability may not be clinically actionable, but the makeup is such that you’ll bring it in.

Kenna R. Mills Shaw, PhD: It’s a tumor-agnostic biomarker.

Eugean Jiwanmall, MPH, MBA: It is.

Bruce Feinberg, DO: Eugean, that wasn’t the best example, but I know where you’re going.

Eugean Jiwanmall, MPH, MBA: That’s why I started with the disclaimer. But don’t pick on what I’m doing. With the example that I’m using, I’m trying to build out the case, so give me the chance. Here’s what we’ll be looking for. If you pick a particular variation within the markers that you have, how likely is this is going to be coming back? Or are you going to use that variation and devise a patient-management protocol based on that? But who has the time or resources to go through these huge profiles? They’re going to differ from Duke to Georgetown. You do, but I’m not speaking from an academic perspective. I’m speaking from my industry perspective, where it’s not just testing that folks have to worry about. You have to worry about all the services out there and the variations that you’re picking up. The tests are going to differ from 1 institution to the next. The makeup of the markers is going to differ from 1 to the next. Kenna is disagreeing.

Kenna R. Mills Shaw, PhD: The reality is, at the end of the day, if I run an exome, if I run a whole genome, if I run MSK-IMPACT or if I run my assay or a foundation’s assay or KRAS’s assay, etc, there are about 150…

Bruce Feinberg, DO: You didn’t mention Tempus. Do you want to mention a few more?

Kenna R. Mills Shaw, PhD: All of them. At the end of the day, there are about 150 actionable genes. Meaning if my clinicians, if Mark’s clinicians, if any clinician has a mutation in that gene, there’s a possibility that we need to explore it further for biological function. It’s only about 150. There across the board. They’re in every assay.

Eugean Jiwanmall, MPH, MBA: I got you. I’m going to try to be a little forceful in my answers now because of the disagreement. Let’s talk about this. You’re stating and so did Mark. I’ll go back to Mark, and then come to you. Bruce was asking about a 500-gene panel. Give me a chance to explain because I’m trying to answer these questions. I’m going to get to the point of how reimbursement has changed, but let me build up the case because I’m an evidence-first guy. I’m going to explain from that perspective first because I don’t want to paint an incorrect picture down the line, before it doesn’t matter. I’m not going to get the evidence for this. I’m not going to get it peer reviewed. I’m not going to get it published. I’m just going cover the test because the insurance is going to pay for it. Let me build up that case.

Going back to Mark’s example, with the 500 that Bruce was asking about. I don’t want to misquote, but it was like, “Would you use a 30-gene panel vs the 500? What about the other 470?” If I have the quote correctly, Mark attested to the fact that they’re not going to pay attention to the 470 out there. Even 30 within that 500-gene panel are going to give you certain information that this is clinically actionable. Either there’s a therapy associated with it, because it was a companion diagnostic designation that happened to be part of the panel, or there are other decisions that you’re going to have to follow through with.

Coming back to your point, Kenna, if there are about 150-plus markers out there, from a payment perspective—and I’m going to stratify the 150—why should there be something that’s 151 when you talk about actual clinical practice? I’m not talking about the information that you have. At this point, we’re not funding research. We have to care about the premiums and the money coming into the pot for everybody. If somebody wants gene therapy, that’s billions of dollars. Why do you care about a couple of thousand dollars, Eugean? Because I have to worry about the medical necessity and safety and effectiveness of that gene therapy for a situation such as SMA [spinal muscular atrophy]…. That’s millions of dollars per pop. As stewards of the finances that are coming in, we have to establish certain ground rules based on evidence. Not to pick on the 150, but why is there something beyond 150? From an academic perspective, I get it. But professionally speaking, from an industry perspective, the case that’s being presented to us at prior authorization is that all of those 150…

Kenna R. Mills Shaw, PhD: But no one is billing you for the other 350 that I know of.

Eugean Jiwanmall, MPH, MBA: Let me build the evidence case. I’m going to come to the billing part.

Bruce Feinberg, DO: Hold on.

Kenna R. Mills Shaw, PhD: I’m waiting for the evidence part.

Eugean Jiwanmall, MPH, MBA: You’re waiting for the evidence part.

Kenna R. Mills Shaw, PhD: No one is asking for the 151st. We need the other landscape for TMB [tumor mutational burden].

Eugean Jiwanmall, MPH, MBA: Yes, we’re getting bills for this comprehensive genomic profile.

Kenna R. Mills Shaw, PhD: What’s the bill? We can’t bill for it. We have to bill on a biomarker-specific basis.

Transcript edited for clarity.

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