Clinical Progress and Coverage Policies in Immuno-Oncology - Episode 11
Benjamin P. Levy, MD: I think clinical pathways are going to be important. Medicine is getting very complex, and we have to have pathways that are driven in to institutions that are flexible. I think pathways that are based on evidence, but that are flexible, is really where we need to go. And they also have to be updated because there’s so many competing standards. It’s important that if we institute a pathway within an institution, that pathway is adaptable—but it also drives in some flexibility. Younger doctors are doing fine with this. People are coming up and understand having pathways may help save dollars in the end. But I think there’s also some reluctance, that it basically drives you in and won’t allow you to think on your own if there’s a special circumstance.
So, I do believe that pathways need to be instituted, but it has to be realistic; they have to be flexible and they have to be updated. And if that’s going to be done right, it’s going to have to be done by a third-party vendor; it can’t be done internally within the institution. There are third-party vendors that are coming out and saying, “We can do this for you. We can develop a pathway system for each disease state, for each stage within each disease state,” which are reasonable. I think that can help guide young practitioners, but also avoid the people who are just doing things that have no evidence to support. Because there are, I’m sure, a lot of physicians who may be practicing medicine and that are not up-to-date on a lot of things, given how rapid things are coming.
There’s some real benefits to this in terms of cost saving, in terms of aligning treatment patterns. But the caution is that I think there needs to be some flexibility; it needs to be updated. We’ve got 10 new lung cancer drugs approved in the past 4 years. It is getting complicated. And that means that there are competing strategies. So, I think we need to be realistic.
This is a case-in-point about flexibility, of pathways when it comes to immunotherapy. Where we sit right now, nivolumab is approved for all patients, regardless of histology, after they fail platinum chemotherapy. So, if I were developing a pathway, I would certainly say nivolumab is a consideration or an option for patients that have progressed on chemotherapy irrespective of PD-L1, given that it’s a complimentary test, not a companion diagnostics test.
But, I may also, in the theme of flexibility, consider pembrolizumab or Keytruda, if PD-L1—positive. That would be my pathway. I think that that, at least, sets expectations. If you want to use nivolumab, you can use it. But if you’re going to use pembrolizumab, you need that PD-L1 testing. I don’t think there’s any pathway where you should say you can just use nivolumab. We’ve decided the pathway’s going to employ nivolumab only and we’re going to ignore PD-L1. There’s competing strategies. And, again, it speaks to theme and the need and the desire for flexibility with these.
And things are only going to get more confusing. If you’re at ASCO this year and seeing how many different competing strategies are coming out, how many immunotherapy trials they are, my voice and my advice is, get ready. It’s going to get really complicated as these drugs get moved to the first-line. And given how many trials there are, we may have a situation and a scenario where there’s six or seven different options first-line in immunotherapy. Then, I think the pathways are going to maybe have to be restrictive. I don’t think a pathway can include seven different options.
So, immunotherapy right now is firmly cemented as a second-line treatment option for our patients. It needs to be in the pathways. PD-L1 testing should be a part of that pathway. If you’re going to use pembrolizumab, nivolumab should be a part of that pathway if you’re not going to PD-L1 test.