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Wui-Jin Koh: NCCN Guideline Updates and Consideration of RWE

November 19, 2019

Journal of Clinical Pathways spoke with Wui-Jin Koh, MD, senior vice president and chief medical officer, NCCN, at the Oncology Clinical Pathways Congress (October 11-13, 2019; Boston, MA) regarding the importance of interoperability between pathways and EHRs as well as whether NCCN is considering real-world data as an evidence source in the guidelines.

The importance of keeping NCCN guidelines up to date with the most recent clinical data...

Dr Koh: The reason why we really want to keep guidelines up to date is because, number one, it's used by a lot of clinicians to guide them. Also because the guidelines, or at least the compendia, are used for coverage determination. If it isn't in the guidelines, there are many payers, especially if it's an off‑label use, that won't cover that.

We actually have a mechanism that, if there is new data, or a new FDA‑expanded indication, or a new study that suggests appropriate off‑label use, we want to make sure that that gets into the guidelines and into the compendia within 2 weeks. Literally, that cycle is a very quick cycle because one of our key points is to say, "We want patients to have access to appropriate medications."

To get it into the compendia allows physicians to order that regimen, which is acceptable to many payers.

The importance of interoperability between clinical pathways and EHRs...

Dr Koh: That remains a challenge because unfortunately, most of the EHRs want to have their own proprietary systems. NCCN and another organization, ASCO for example, have argued for EHR systems to be able to talk to one another here. Relative to pathways, it is difficult for any organization to keep pathways up to date unless you have enough resources – the expertise, the time to do it, etc.

One of the suggestions that perhaps I shared is that, if NCCN is able to keep the guidelines up to date and the pathways derived from guidelines are linked to guidelines, then you don't have to have the additional resources at a particular institution. That's what we have with McKesson. When our guidelines get updated, they immediately look to update their pathways in a linked form.

Whether clinicians are generally supportive of pathway integration into the EHR...

Dr Koh: In general, they are. It's interesting. I see that perhaps in academic centers, there's a greater resistance to pathways partly because you have the luxury of super‑specialization.

You have people who deal with one cancer, or even a subset of cancers. You might deal with EGFR‑positive non‑small‑cell lung cancer, and that's all you do, or something like that. That is a little bit of exaggeration.

Where pathways are particularly helpful, it is helpful in academic center, but we do know that the majority of cancer care is given in the community.

I have great respect for community oncologists, but they may be seeing someone with triple‑negative breast cancer at one point, and then someone with endometrial cancer, someone with central nervous system cancer. They don't have the luxury necessarily to say, "I am going to specialize in one thing." The pathways or guidelines are much more useful to those individuals.

Whether NCCN is considering real-world data as an evidence source in the guidelines...

Dr Koh: Yes, actually we are. It is a nascent effort, but we have collaborated with a couple of health information technology companies. I think I'm allowed to say that we are collaborating with Flatiron for the NCCN institutions, and while it has not yet been analyzed, data is being collected so that we can evaluate outcomes.

For example, if we say it's a preferred surgery, how often is that preferred surgery actually being done? Then we would like to track issues such as outcomes, and do pharmacovigilance.

With FDA approving drugs so rapidly, what are some of the long‑term toxicities, immunotherapies? We're realizing that there are different toxicities the further out you go, that perhaps have not been captured in the original registration studies.

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