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AJMCtv® Interviews, August 2018
Produced by Mary Caffrey, Jaime Rosenberg, and Samantha DiGrande

AJMCtv® Interviews, August 2018

Produced by Mary Caffrey, Jaime Rosenberg, and Samantha DiGrande
Precision medicine is a term that we’re still working on defining, and to some degree, these next-generation sequencing assays are what most people have in mind when we talk about precision medicine. One of the points I tried to make in the session we had this afternoon is that we’re not talking about the precision use of accepted targets. We’re talking about trying to use NGS to open a new therapeutic option for a patient [who] otherwise might not have it.

What we’re finding, and what the data I went through this afternoon show, is that, unfortunately, that happens in a very small minority of patients. So, as we work to move this field forward, we have to keep a certain balance between optimism and realism and help patients understand that this is not going to help everyone. In fact, it’s not going to help a very substantial percentage of patients. Arguably, the substantial majority. There’s a limited number of people for whom it’s going to be helpful, and that’s going to be very useful.

I think it’s also going to become more important as we start to see some therapies become available that are highly effective with a very rare target, and it’s not going to be practical, I don’t believe, to go searching for multiple targets separately when we’re looking for the needle-in-the-haystack kind of patient.

But if we can assemble an NGS assay that looks for a lot of different rare possibilities, that may be a more practical way to bring those therapies to patients.


Hope Rugo, MD, director of the breast oncology clinical trials program at the University of California at San Francisco

Do you plan to prescribe Mylan’s biosimilar trastuzumab to patients? Would you switch patients from the reference product to the biosimilar, or just begin new patients on the biosimilar, and will payer coverage decisions affect provider and patient choices?

There’s always a big question about whether or not you would—okay, now the biosimilar is available, are you going to use it in your patients? In everybody? Are you going to switch patients who are on the originator to a biosimilar?

I think that there are a number of issues that we need to understand. In the [United States], that’s very much driven by insurers and what insurers are going to mandate. For example, with biosimilars for the filgrastim, the insurers, very quickly, many of them said, “you have to use the biosimilar because it’s cheaper.” And then what happens is, the institution—I work at an academic institution—changes over wholesale to say, “Okay, that’s what we’re going to give people,” so [that] you don’t have to worry about what the insurance said beforehand.

So that’s one thing that I think often happens, and with the trastuzumab—and we also switch people because, you know, supportive care it comes and goes, right? With the trastuzumab biosimilars, I think it’s going to depend on the price points and what the insurers and institutions say about if there is a real cost savings, and then they will want us to switch over to the biosimilars, which I am very happy to do.

I think these are agents which are biosimilar, so I don’t have a problem switching over. And I don’t have a problem switching a patient either, I just took a patient off trastuzumab who has been on it for 17 years and has no evidence of disease. We had a big conversation about stopping the trastuzumab and I said, “I really would’ve stopped you at 10 years, but you said no,” and she’s moving away now. But that’s a patient where you may have a patient on it for so many years; if you could have a drug that’s 20% or 30% less, that’s a huge savings over time, so it’s possible that those people who are on forever-maintenance trastuzumab in the metastatic setting, that that will be a situation where patients are switching or switched.

I don’t think that I would switch anybody that was in the neo-adjuvant or adjuvant setting on short-term exposure to the drug. It’s going to be an interesting time to see what happens. 

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