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Perspectives in the Treatment of Colon Cancer with Leonard Saltz, MD

Perspectives in the Treatment of Colon Cancer with Leonard Saltz, MD

AJMC®: What are some of the advantages of doing a broad assay if one is able to and how does that data potentially help inform future treatment?
Saltz: A lot depends on what you know before you get your NGS assay. Our approach here is to use our NGS assay to get the standard information and we are also able to get the mismatched repair deficiency information or the microsatellite instability from the NGS assay. So, we can do one assay where we get microsatellite instability, we get KRAS, NRAS, and BRAF. That’s is what I can say is useful and that I can say is standard practice. To prescribe appropriate medicine and meet standard expectations, you need that information. The other information that we can use in the context of being a research center with a robust drug development program is to try to pair people with rare mutations to drugs we have in development to match them, but I can’t say it’s part of standard practice. 
 
AJMC®: What standard setting organizations are most important in determining coverage of treatment?
Saltz:  FDA approval or NCCN compendium listing is where you have the option to proceed. Going beyond that, you would need a third-party payer to approve it. The reality is that, the newer drugs are extremely expensive. We can’t ignore that reality. That is a factor that undoubtedly would be considered under the third party that would be considering paying for it, and it is highly prohibitive to any individuals choosing to pay out of pocket, because most people simply don’t have that much money. If you take a look at the idea of treating a BRAF mutated colon cancer with a commercially available BRAF inhibitor plus MEK inhibitor plus EGFR inhibitor, realistically you will be in the drug cost range of $35,000 to $40,000 a month. I think that “wow” is the usual response to that fact that people choose not to look at, and it is naïve of us to pretend that numbers like that are not going to go into factor in terms of consideration. Another very important thing for people to understand is, if you are treating a Medicare patient and you send in a bill and Medicare pays it, that doesn’t mean that Medicare approved it. The approval process and the paying process are siloed separately, so they can come back and audit that at any time and determine that that was inappropriate, and call back the payment to cause damages.
 
AJMC®:What are some key takeaways that managed care professionals need to take into consideration to help oncologists and patients?
Saltz: We want to make sure that we use the drugs that we have responsibly and appropriately to optimize care for patients. We have to be aware that we don’t have the option to simply pick any drug we want and use it because we think it makes sense if it’s not an approved indication, unless someone is able to absorb the substantial financial consequences of that. So, when we talk about the use of NGS assays and targeted therapies, we need to realize that outside of an experimental trial, that kind of thing is not something we practically can do, nor do I think we necessarily should because we don’t know if it’s the right answer. When you look at the published reports of the identification of actionable mutations, many of them, which are being published often by the companies that are providing and marketing the assays, define RAS mutation as actionable. I think that’s not an appropriate way to define them. They are a bad thing to find, and we don’t have an effective treatment for patients with RAS mutated tumors. We can say that we thought that MEK inhibitors were going to help, but the data don’t support that. So, if we look for other putative actionable mutations; let’s say we found a mutation for a particular gene, and there’s a drug out there, for instance, I found a CDK mutation, and I had a hypothesis that palbociclib would be a useful treatment. There are no data, so the assumption that just finding the target means that I can use a drug and that drug will be meaningfully beneficial to the patient is incorrect. This would only be appropriate in a clinical trial that would generate data. Ultimately, we have to have data to tell us where drugs with significant toxicity and significant cost are appropriate to use in a patient and where they are not.
 


 
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