Unscripted Podcast - National Comprehensive Cancer Network Guidelines for Lung Cancer & Managed Care

Welcome to Unscripted, the AMCP podcast, a look inside managed care pharmacy

Steve: The National Comprehensive Cancer Network, or NCCN guidelines, are probably the most widely used oncology guidelines within the payer community, but they're not written for payers, and that creates challenges with interpretation and application, which can ultimately impact patient access. Welcome to Unscripted, the AMCP podcast.

I'm Steve Kheloussi. I'm the principal consultant with Kheloussi Consulting and a managed care pharmacist by background In this episode, we'll be discussing recent efforts by AMCP to contribute stakeholder perspectives for consideration in the NCCN non-small cell lung cancer guidelines. I'm joined today by Tianyi Wang, consultant at Omnicom Health Market Access, where she specializes in precision medicine, oncology diagnostics, and market access strategy, with a focus on biomarker testing and payer medical policy analysis.

I'm also joined by Irvin Molina, director of clinical pharmacy at IPD Analytics. Irvin is a board-certified oncology pharmacist with extensive experience in managed care, specialty pharmacy, utilization management, and precision medicine. He works closely with payers to translate rapidly evolving oncology evidence into formulary strategy and clinical policy.

Welcome to both of you.  

Tianyi: Thank you, Steve. Great to be here. Thanks for having me.  

Irvin: Thanks, Steve. It's great to be here.  

Steve: So I gave a short introduction, but can you tell the audience a little bit more about yourselves? Tianyi, we'll start with you.  

Tianyi: So at Omnicom Health Market Access, my team worked extensively on biomarker testing strategy across multiple tumor type.

We regularly evaluate coverage policy across payers. We look at medical necessity criteria, reimbursement requirement, claim submission to understand where patient encounter barrier to access. We also conduct primary research with different stakeholders payer, LBM provider, to understand how biomarker testing is implemented in practice.

So we've developed a strong understanding of how biomarker testing is adopted across the healthcare system. I'm very excited to be part of the discussion today.  

Steve: Fantastic, and we're lucky to have you. Thanks so much. Irvin, how about you?  

Irvin: In my role at IPD Analytics, I help translate rapidly evolving oncology insights into practical payer strategy, clinical policy, and formulary decision-making for payers and pharma.

So like you said, throughout my career, I've seen a lot of different fields of oncology, like managed care, utilization management, specialty pharmacy, always focused on oncology. So those experiences have given me the opportunity to see firsthand how clinical evidence and treatment guidelines are translated into real-world coverage decisions.

I'm looking forward to discussing how biomarker testing fits into that process and why it matters for both patients and payers.  

Steve: Excellent. Yes, as am I. And so, let's start at the beginning. I think it's a very logical place to start is the beginning. Tianyi, can you talk to us a little bit about the AMCP Precision Medicine Initiative?

Tianyi: Of course. So the initiative really started with trying to understand where the biggest barrier exists. AMCP brought together stakeholder from across the healthcare system to build consensus around what good biomarker testing should look like and where there were opportunity to improve consistency.

And from, from there, we've developed a number of practical resources which includes a roadshow to raise awareness across the managed care system a shared lexicon to help standardize terminology, a clinical utility checklist to provide a more consistent framework for evaluating biomarker test.

Also coverage principle, aligning best practices for payer policy design, and also NCCN guidelines submission to help improve alignment between clinical recommendations and payer interpretation. More recently, we've launched the quarterly bulletin, with the first one being in quarter three this year, to keep AMCP members and sponsors informed on the latest development across all of these initiative and continue the conversation as the thoughts evolves.

And the goal is really to create more consistent coverage policies, reduce unnecessary variation in care, and ultimately improve access to the right test and the right treatment to the right patient.  

Steve: Excellent. Yeah. Thanks so much for that. I've been involved in this work as well. I know it's been a very heavy lift, and you and your organization have been instrumental in that.

So thank you so much for all the contributions. And so this initiative, I would say, has really focused so far very heavily on increasing patient access to biomarker testing. And so, Irvin, I'm going to come to you next. Can you talk to us a little bit more about biomarker testing in oncology? What is it?

Why do we care? Why is this on payer's radar?  

Irvin: Yeah, no. Well, biomarker testing is the process of analyzing a patient's tumor to identify molecular alterations that can guide treatment selection. In diseases like non-small cell lung cancer, breast cancer, prostate cancer, those results help identify patients who may benefit from targeted therapy and are more likely to be effective based on the biology of the disease.

As our understanding of tumor biology continues to expand, biomarker testing has become a fundamental part of delivering personalized cancer care It helps ensure patients receive the most appropriate therapy based on their biomarkers, while avoiding treatments that are less likely to provide benefit.

Steve: Excellent summary. Thank you. And Tianyi, you mentioned the quarterly bulletin. So what was covered within that Q3 bulletin that we put out?  

Tianyi: In this first issue, we provided an update on the overall progress of the Precision Medicine Initiative highlighting several upcoming publications which I mentioned there are three piece and will be published in JMCP shortly.

We shared updates on ongoing research and educational activity such as webinars, podcasts, market research initiative. We also included a review of the latest NCCN guidelines for non-small cell lung cancer and discussed what those updates could mean from a payer perspective. And then one of the featured section was AMCP's recent submission to the NCCN guidelines.

We highlighted several recommendations aimed at improving the clarity and consistency of our market testing guidance particularly in area where ambiguous language may contribute to variation in payer coverage and in real-world implementation.  

Steve: Yeah, that's really interesting. And we're going to spend the bulk of our time talking about those recommendations.

I think it'll be helpful to set a little bit of a foundation here. And so Irvin, I'm going to come to you. How are the NCCN guidelines being used by payers today?  

Irvin: Well, the NCCN guidelines are one of the primary clinical references that payers use when developing oncology medical policies and utilization management criteria.

They provide an evidence-based framework for determining what constitutes appropriate guideline-concordant care. Because those guidelines often serve as a foundation for coverage policies, the wording of the recommendations matter. When recommendations leave room for multiple interpretations, implementation can vary across organizations, which may ultimately affect how patients access biomarker testing and targeted therapies.

Steve: Yeah, that's a, a really good point, and I would also consider the importance of that language with regard to the idea that if a certain payer policy, for instance, interprets the NCCN guidelines one way, but a provider interprets it a different way, that could lead to some friction there as well. Would you agree with that?

Irvin: Oh, yeah, definitely.  

Steve: Yeah, so I think that would, run into, you know, some conversations upon appeal and ultimately may lead to approvals for patients. But it will also potentially lead to some delays for appropriate care, depending on how the payers are interpreting that language. So certainly an opportunity there.

So, I said that we were going to get back to the guideline recommendations that we had, submitted. And so Tianyi, why don't you run us through what were those recommendations that were shared with NCCN? And what we'll do is we'll go one by one, and we'll get Irvin's reflections on each, and think about how the payer will consider that recommendation and the importance to the payer side of things.

So, why don't you go ahead and kick us off with the first recommendation?  

Tianyi: Sure. So the first recommendation, we really focused on broad panel testing, and coverage for that upfront. So the current NCCN language acknowledged that broad panel-based testing is commonly used in practice, but the wording it used is a bit ambiguous.

It says, "Biomarker testing may be performed." And using either a single assay or a combination of limited number of assays. So we actually don't know is it a single assay that it recommends or, you know, several smaller panels. So the language is blurred, and we actually see that reflected in payer coverage policy today.

So our recommendation to NCCN was to make the language more explicit by identifying broad panel-based testing as the preferred approach whenever feasible. And we recommended that because there are evidence supporting that broad panel testing identifies more actionable biomarkers. It increased the likelihood that patient receive biomarker-matched therapy.

It reduced the need for sequential testing and gets patient to the right patient faster. And that has been associated with improved clinical outcome compared with more limited testing strategy. So we really want NCCN to be clear on the recommendation for that.  

Steve: Yeah. You raised a really interesting point right at the end there that these are not just recommendations that we're pulling from thin air, right?

These are evidence-based recommendations that we're suggesting for NCCN to consider. And so, Irvin, I'll come to you for your reaction. From a payer perspective, why is distinguishing that language important?  

Irvin: Yeah. Historically, there's been variability in how organizations approach biomarker testing, with some relying on sequential gene, single gene testing, while others support broader panel-based testing upfront.

As the number of actionable biomarkers continues to grow, comprehensive genomic profiling can improve eff- efficiency by identifying clinically relevant alterations from a single specimen and reducing the need for repeat testing. So more explicit guideline language helps establish clear expectations around when broad panel testing is appropriate, which can support more consistent policy development and patient access.

Steve: Yeah, and I think that goes back to that earlier idea of consistent policies between organizations and consistent understanding from payer organizations aligning with a provider understanding is going to enhance patient access significantly, potentially. So, all right, Tianyi, how about the second recommendation that we've put forth?

Tianyi: Sure. So the second recommendation focused on completing molecular testing or biomarker testing before initiating a immunotherapy whenever clinically feasible. So the current guideline says that clinicians should consider holding immunotherapy while biomarker result are pending.

And the word consider may be interpreted differently by different people, and it could be interpreted as optional. So our recommendation was to use stronger language and maybe just remove the word consider. And there's also evidence showing that patient who receive biomarker-informed therapy as their initial treatment have better outcome than those who begin treatment before testing results are available, and they don't achieve the same overall survival even if they later switch to targeted therapy.

So there are benefits for patient there. And of course, we recognize that some cancer require very urgent treatment and don't allow the same opportunity to wait for biomarker testing result. And that's why we focus this recommendation on disease setting like non-small cell lung cancer, where the evidence supports waiting.

And we added that word, or, it's already in NCCN guideline, whenever it's clinically feasible.  

Steve: Yeah. It, you know, I would in some ways hate to be one of the authors of the guidelines because it's amazing how much emphasis is placed on even a single word like consider. And then you, you know, these guidelines are very extensive in their length and very in-depth.

And so, you know, hanging on to that one word is kind of what payers do from time to time, right? And we might think of something as optional because of that, that word consider. So that's a, a great point that you highlight there. So Irvin, I'm going to come to you. We know that biomarker testing can improve patient outcomes.

It reduces time to targeted therapy, avoiding inappropriate first-line treatment. It also limits exposure to therapies that might not provide benefit, but could potentially cause adverse events. So from the payer perspective, how would more guideline support on this topic impact payer policies?  

Irvin: Right. I think Tianyi said it perfectly.

Clearly defining expectations around biomarker testing really makes it easier for payers to align their coverage criteria with the guidelines, as well as their prior authorization requirements and the utilization management processes. You know, simple words just like, "when feasible" or "should," you know, they hold a lot of weight to it, and that's something that payers really take into consideration when developing these policies.

It also benefits providers by creating clear expectations about when and how biomarker testing should be incorporated into patient care  

Steve: Absolutely. And, Tianyi, why don't you take us to the third recommendation?  

Tianyi: So the third one was to add guidance on supporting workflow initiate initiated or reflex biomarker testing.

So this was actually one of the area where stakeholder consistently identified a gap. Currently there's no language in NCCN guideline regarding this. And right now, the pathology report is first sent to the treating oncologist who then will place a separate biomarker testing order which creates additional hands-off delayed testing and treatment decisions sometimes.

So our recommendation was for NCCN to consider maybe adding language supporting the test being automatically ordered once pathology confirm non-small cell lung cancer diagnosis. And also we find studies showing that this way it creates, it increases, biomarker testing rates, it shortens turnaround time, will identify more actionable mutation, and reduce time to treatment initiation.

So this recommendation was really about closing a workflow gap, improving efficiency, and reducing unnecessary delay in care.  

Steve: Yeah, and I think this is also a sticking point for payers as well, right? In certain situations, pathologists may not be recognized as providers within the network, and that can create some challenges, you know, just in terms of additional delays before follow-up testing can be put into place.

So guideline support for pathologist-initiated or workflow-initiated or reflex testing, it goes by all sorts of names, right? I think there's, there's definitely an opportunity to enhance that from the payer side as well. So, Irvin, I'll come to you. How would providing guidance on workflow-initiated testing potentially impact payer practice and where is that gap today?

Irvin: Yeah. One of the biggest challenges today isn't necessarily deciding whether biomarker testing should occur. It's making sure testing happens early enough to help inform treatment decisions. You want to be able to make treatment decisions with a full patient profile and kind of know everything that's going on first.

So in many organizations, testing depends on multiple handoffs before it's ordered, which, like Tianyi was saying, can delay results. So supporting reflex testing workflows helps initiate testing earlier in the diagnostic process. Help ensure molecular results are available even before treatment decisions are made.

One example I like to use is HER2 testing. I think everyone knows that one. You get a IHC2 level, you know, but you can't really support it just with that alone. You need to do reflex testing to ISH or FISH. In situations like that, we would save a lot of time if it was with reflex testing, if that was made with other biomarkers or other types of testing.

Steve: All right. Well, thanks so much, Irvin, for that insight. And Tianyi, why don't you take us to our final recommendation?  

Tianyi: Sure. So the last one focused on RNA-based testing. So the current NCCN guideline recognize that RNA sequencing can improve fusion detection, but the language says it may increase detection and recommends RNA testing after DNA testing when no driver alteration is identified.

So our suggestion is to again, strengthening that language to better reflect the current evidence by positioning RNA-based testing as an important component and encourage concurrent DNA and RNA testing whenever feasible. Especially when many of the NGS panel available today are already capable of evaluating both DNA and RNA at the same time.

So similar to the other recommendation, this was really about making sure the strength of the guideline language reflects existing evidence and promotes more consistent implementation across clinical practice.  

Steve: So it sounds like there's an opportunity to strengthen some language similar to what we had talked about earlier and, certainly an opportunity there.

So, Irvin, from your point of view, if NCCN were to implement these changes, would these guideline updates meaningfully change payer practice?  

Irvin: The impact will likely vary across organizations because payer policy's already at different stages of adoption. Many have incorporated comprehensive biomarker testing into their coverage criteria, while others may have opportunities to further align with the evolving evidence and guidelines.

So where these updates can make the biggest difference is by reducing variation in how recommendations are interpreted and implemented across the healthcare system.  

Steve: Yeah, that certainly sounds like one of the themes from today is consistency. And so, as we are wrapping up here, I'd just love to get one final thought from each of you on this topic.

So Irvin, we'll start with you.  

Irvin: Yeah, I just want to say as precision medicine continues to evolve, greater consistency really helps align clinicians, laboratories, and payers, ultimately creating a more predictable pathway for patients to receive appropriate biomarker testing and those biomarker-targeted drugs.

I think that's the most important takeaway.  

Steve: Very nicely summarized. Tianyi, how about you?  

Tianyi: Yeah. I think like Irvin mentioned and like we discussed, words matters in guidelines. They don't just inform clinical practice, they also influence payer policy and how care is delivered every day. So how NCCN recommendations are interpreted has real downstream implications, and even relatively small refinement to the guideline language can shape coverage decisions and ultimately whether patient receive timely access to about her informed care.

So if we can improve that alignment, we can improve consistency across the healthcare system, and most importantly, improve patient access to precision medicine.  

Steve: Very well said. Thank you so much. And with that, we are out of time for today. I'd just like to thank Tianyi and Irvin for your insights today and for all the work that you do in this space.

And thank you for taking the time to listen to the AMCP Unscripted podcast. We'll see you next time.