Reflections on the NCCN

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Welcome to Value-Based Voices, a podcast from the Association for Value-Based Cancer Care.
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Each episode dives into the shifting terrain of cancer care in the United States, exploring what value means in today's clinical policy and patient-centered environments.
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Our mission is to spark informed dialogue, promote transparency, and equip every stakeholder, from providers to payers to patients, with the insights they need to navigate cancer care with clarity, confidence, and purpose.
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Let's get into it.
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My name is Nick Ferreros, and I'm managing director at the Community Oncology Alliance, and I'm going to be your host today.
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With me today is Bill McGivney, and uh today we're going to be talking about the NCCN, which uh I think is a very exciting topic for us to learn a little bit more about.
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Um, and uh thank you very much for joining us today.
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Let's level set a little bit for everyone here.
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Tell us what is the NCCN.
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I mean, I I obviously we are in oncology, so we understand it, but I I even those who have spent a lot of time here may not really get the distinction of what NCCN may be versus other centers.
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Yeah, well it's good to be here.
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The NCCN uh is is the the real name is the National Comprehensive Cancer Network.
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And it's an alliance now of 33 of the leading cancer centers in the United States and really in the world.
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And its basic mission is to improve the quality and the value that is uh available in cancer care, especially treatment to patients in need with cancer.
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And the major way it really does that and contributes to uh accessibility and availability of new healthcare technologies is through a very various processes specifically.
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And the the major process is the establishment of guidelines that make recommendations about what appropriate care is for over 99% of cancer patients out there.
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So if you can imagine 70 different committees, guideline panels with say 30 to 33 world experts sitting on them, looking at the data, relying on their basic experience and all their experience and years and years of you know providing good treatment and care to patients and coming up with the recommendations about appropriate treatment of the various tumor types, lung, breast cancer, colorectal, multi myeloma, et cetera, et cetera.
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That is the basis, basic product that the NCCN has created.
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And it's critically important out there.
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And one of the things that's uh pretty amazing about the process at NCCN and continues today is the fact that there is just tremendous updating of uh of those 70 different guidelines, some of which, the whole guideline, including the discussion, runs close to 400 pages.
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So there's continuous updating specifically.
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Uh, for example, the non-small cell lung cancer guideline last year in 2024 had eight different versions.
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And that's because, as we all know, the advances in the diagnostics and in the treatments for cancer care patients is just coming at a rapid rate.
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And uh we have the FDA to approve, say, drugs and biologics, but interestingly, as you well know, there are a lot of label off-label uses, so that's indications for use in treatment that go well beyond what the FDA uh you know has uh ruled specifically to introduce the product to market.
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So, and then another product specifically uh is the uh a derivative product of the NCCN guidelines, and it's really focused and directed more towards payers, although clearly, especially community practices have to use it to make determinations and make sure they know what's going to be covered by payers, which we'll discuss in a few minutes.
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But that's the NCCN Drugs and Biologics Compendium.
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And as I say, it's a derivative work of the NCCN guidelines in the sense that basically what it does, it takes all the indications for use of the drugs and biologics that are recommended in the guidelines and translates and transposes those recommendations consistently and accurately into a listing of indications that's easily accessible, especially by payers.
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Because payers, they don't want to go through the guidelines and try and find all the indications listed in the guidelines.
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This is a direct listing of the appropriate indications as adjudged and recommended by the NCCN guidelines panel.
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And it's critical because obviously payer coverage, as you well know, uh and an expert are uh you're an expert in this, but payer coverage is critical to again availability of drugs for use by uh clinicians and prescribing for patients.
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Yeah, there's no coverage, there's no access, right?
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Exactly.
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Um I I'm gonna say this a little facetiously because uh I know who you are.
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Um, but uh, you know, I I kind of feel like you should be hosting this podcast and I should be the guest in a way, because you are a legend within our world.
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We've we've known each other for years through AVBCC.
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Give the audience a little bit of like who you are and what what what's your background about NCCN?
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Because you know, just listening to you for the last couple of minutes, I mean, I think you're gonna forget more about NCCN than any of us are gonna be able to learn in our lifetimes.
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So what what how did you how did you come to be associated with NCCN?
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What's your history with it?
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Oh, first of all, you're very kind because obviously you're a wicked spot, as we say up in Boston.
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But anyway, but uh with respect to uh how did I get to NCCN?
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Well, interestingly, my career, I kinda I never planned anything out uh specifically.
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My first real job, as I mentioned before we even started, was at the American Medical Association.
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Then I was recruited to run national coverage policy at Aetna Health Plans, which at the time was the second largest uh commercial payer, private payer in the United States.
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Uh and I ended up setting up, obviously, running national coverage policy both on the medical benefit side and on the pharmacy side, which was unusual then and is unusual now, and ran a bunch of different areas.
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But uh I guess it was in uh late September, October of uh 1996, I got a call from an executive recruiter who said, you know, would you be interested in talking to me about a position as the CEO of this new organization, NCCN?
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I have to say I'd barely heard of it.
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And so I said, Well, what you know, tell me what it is.
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And so we went into it.
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And so I was modestly interested, you know, but when I went down and interviewed with the people and started, you know, talking with the docs and the experts and the administrators and saw their enthusiasm and what they were trying to do, you know, and my background with being a liaison to the FDA for the AMA and just everything being involved and clinical guideline development in my career, kind of fit in.
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So I ended up taking the job.
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It was a surprise to a lot of people from their academic positions that NCCN, this new organization, as I say, based with at the time only 13 academic centers as members, I would reach out and pluck somebody, if you will, from Aetna in Connecticut.
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But uh that's how I got there.
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And so uh my role and function was obviously to focus on expanding the organization.
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The organization, interestingly, was interested in becoming uh a national cancer care centers of excellence program for uh you know for insurers, because that was happening in different therapeutic areas.
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Uh interestingly, from my experience running centers of excellence programs at that, I knew that, for example, if you had a member institution like MD Anderson, they would not want Bill McGivney negotiating their reimbursement rates for their specific services.
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So the second major program was the guideline effort.
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And uh and again, obviously that has uh turned out to be tremendously important, influential, and essential, if you will, to access and availability.
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And I need to just shout out for the the father of NCCN guidelines, was a great physician from MD Anderson who was recruited by MD Anderson from his you know community practice, Roger Wynne, community practice in New Jersey down to Houston.
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And he just had this great view of uh basically that you know clinicians needed to have, you know, cancer was moving so fast in the community, as you well know, they're treating so many different types of cancer.
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They need recommendations from a national organization that was authoritative, and the recommendations were evidence-based.
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But you didn't need some ornate, complex methodological process uh that would take a lot of time.
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He knew that the docs that would sit around the committee tables uh basically they had the data in their heads.
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They understood it.
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In many instances, they were the investigators, the principal investigators that created it through clinical trial process.
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So, anyway, so I kind of got down to Philadelphia and ran with it, and things turned out pretty well.
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So you've talked a little bit about the guidelines and how they came to be and their establishment.
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I want to talk about what maybe sort of isn't on paper, right?
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A little bit of a little bit about the behind the scenes how because it's everything's inherently political, especially when you talk about guidelines, right?
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Because you're you're starting to fence off and and sort of navigate the steer the system in a direction, right?
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Particularly around drug policy.
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How did that come to be?
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What was the uh what was the guiding principle and and sort of what barriers or challenges did you face when guidelines were starting?
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Great question.
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I mean, the you know, the the the first barrier was I mean, it's just was making sure that they were evidence-based.
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I mean, we were in a um in an era where obviously everyone was talking, and it keeps changing year by year, but outcomes-based decision-making, evidence-based decision-making.
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And so that was the key.
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And as I say, Dr.
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Wynne, Roger Wynn, you know, understood that the docs who were going to sit around the NCCN panels, as they call tables, under understood uh, you know, basically what what was uh what was important, what was going to drive, if you will, decision-making and policy setting.
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The other thing, obviously, was to organize.
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You know, at the beginning, you know, we had the breast cancer guideline.
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It was the first one, and gradually, obviously, we had to add panel after panel and staff up to manage all this.
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The important thing was obviously to have it out there for practitioners to use.
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And NCCN guidelines, I'd say within two to three years became the standard of care out there in the United States.
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But importantly, having moved from Aetna to NCCN, I understood that it's nice to have the standard of care.
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But as you indicated, if you don't have the payers basically having a coverage policy that says, you know, that is consistent with the recommendations of your NCCN guidelines, then there are going to be a lot of big problems and fights out there.
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So we were very fortunate in the early 2000s.
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I started to see uh actually my old company would email me every once in a while and say, hey, Bill, there's this recommendation in the guideline that says this.
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So what does that mean?
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Now, having run that area, and when I was at Etna, I had a lawyer attached to my hip for my uh full six years there and understood the liability issues, I knew what they wanted.
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They wanted in writing, Bill McGivney telling them what this recommendation means so that they could be consistent and you know be able to defend their actions and their policies.
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But what that told me in the early 2000s was the payers want this, they need it, or whatever.
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And so we began to work.
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And the story of the drug and biologics compendium, you know, started to formulate in my mind, and I founded that.
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And the key was uh we walked the halls of Congress for two years to try to get Medicare recognition.
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But in January, and I had lots of connections because I had been in that great people like Lee Newcomer at United, January of 2008.
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United Healthcare put out a press release that says we are gonna base our coverage policy in cancer for drugs and biologics totally on the NCCN Compendium specifically.
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In June, June 4th, 2008, at 4:30 p.m., uh uh Medicare announced that they were gonna recognize the NCCN compendium.
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So that whole, it was obviously that was a space of 11 years, but that whole process gradually evolved from making it the standard of care in the United States, basically having the payers start to recognize it.
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And after United and Medicare, all the other payers followed, and uh, you know, that's that's kind of history.
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Uh, you know, it's as you well know, it's much more complex than that.
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But but anyway, it took a lot of work and just the aggregate work of all the the key opinion leaders that we had at the centers, the administrators, the NCCN staff, just everybody, you know, contributed to us achieving those main goals.
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Yeah, so guidelines, compendium, standards.
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You sat on all sides of the table uh over your career.
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Right.
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And I, you know, in my day job, I do policy and advocacy uh for you know most of the time.
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And uh one of the one of the issues that that we run into frequently is, you know, it's all well and good that it's in the NCCN guidelines, but sometimes you can have payers who just decide, oh, we're gonna make alternative decisions or we're not gonna cover that.
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Um and I wanted sort of, you know, what's the point of having all of this evidence?
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You you described a very rigorous, researched, consensus-based process with recognition from different players.
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Um, and yet you still have, and I'm there are probably edge cases.
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I doubt they're it's a regularity, but it's still at the end of the day, there's a human life at the end of that decision.
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Um what's your perspective on when a payer decides that they're not gonna they're not gonna follow the guidelines?
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So so the payers basically you know began to, well, as you well know, so payers have to file with state insurance commissioners kind of how their processes and decisions are made.
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So once you file with a state insurance commissioner basically and say that, okay, we're gonna use the NCCN guidelines as the basis for coverage decision making, saying cancer care, you don't want to go back and say, oh, we're gonna kind of back off that and blah, blah, blah, blah, blah.
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So as you know, interestingly, the way to get around it is the wrong way to describe it.
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But the base the way to address it from the payer issues so that they're have slightly more control is the establishment of prior authorization, the establishment of step therapy, the establishment of formularies.
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Now, a lot of these, for example, criteria that you have in prior auth basically uh you know are derived from the NCCN guidelines.
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And NCCN has preferred status for agents.
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So those contribute to deciding, you know, what's number one therapy or the the first therapy you need to use in step therapy.
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But but at the same time, the payers you know have kind of taken back a little autonomy and and self-decision making about you know how they're gonna actually cover in in real-world situations for an individual patient, you know, a drug or a biologic.
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So you're absolutely right.
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That's why, you know, as as we get towards the end, you know, when when the question becomes, so where are we going from here?
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The question is NCCN has to maintain and enhance its focus on payers as an important user of the NCCN and guideline and compendium recommendations.
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Well, I would argue also NCCN needs to advocate for it to be the law of the land.
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Because if not, what is what is the point?
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Right?
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What what is the point?
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It's all well and good when you say these are the these are the guidelines of the road.
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I would say rules of the road, although they're not rules because you they no one's bound to follow them.
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But when science and evidence and uh it dictates that this is how you treat this type of cancer, and you have individuals with different uh different goals and and reasons for uh controlling that access and those bump up against each other, um, you're creating a system that is inherently going to leave everyone unhappy.
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And that's what we have seen over the last couple of decades.
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You know, I I don't think I realized how young NCCN, I mean relatively young NCCN is and the guidelines are until this conversation.
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And I always look back two decades or so and the tremendous transformation in our cancer care system, especially from a community oncology lens.
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And the the the rise, the the entire ecosystem has changed with the way the money flows, with the rise of PBMs, the rise of 340B, the large consolidated health care systems, the consol, even the consolidation within the payer market, um, and and all of the you know, the Affordable Care Act, medical loss ratios, like everything has changed how everyone plays the game here.
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And so within that backdrop, you have NCCN, which was trying to take a little bit of the scientific chaos and organize it so that people had rigorous decision making there.
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Um and and here we are now where we're sort of at this precipice, and this does lead into the next good question of you know, people need to follow these guidelines.
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Otherwise, otherwise, what is the point of this?
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And so where where do we go from here?
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What's the future for NCCN?
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So let me yes, let me just address uh so first of all, your organization, the Community Oncology Alliance, has been tremendously it's been a champion, if you will, uh, you know, for the author authoritative and kind of autonomous, and autonomous is not the right word, because you know, clinicians don't have that great autonomy.
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They should be clinician-driven decision making.
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Yeah, but your organization has been a tremendous champion.
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And your point, actually, I always used to say to myself, I usually don't say it publicly, but um I will hear.
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But so I always used to think, you know, coming from the real world, okay, so be have being the standard of care, oh, isn't that a nice thing to have to say?
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It's it's nice.
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It is the standard of care, it's important.
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But if you don't have, you know, the way through payers and be able to influence payers to help assure access and availability to patients who need it, who need those treatments, then yeah, what have you accomplished?
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It's kind of an empty empty word if you don't have that, you know, influence on the payers to say, oh, we're the standard of care.
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And and and the payers just, you know, kind of brush that aside a little bit.
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So that's a critical component that you and your organization have championed in terms of, you know, for patients or for your practices.
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Trevor Burrus, Jr.
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And drug drug pricing control advocates will always say, you know, it's all well and good to have a standard of care or this new innovative treatment, but if you can't pay for it, you may as well not exist.
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And there there is a balance of trying to figure out this system.
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But I do think when you have standard of care that is going to save a life, and we're seeing everyday new innovative treatments that are truly saving lives, um, we have to, you know, how we have to we have to be able to, you know, we've people have paid for insurance, they have paid for coverage.
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We need to be able to ensure that they have some level of access to it.
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And not just, you know, uh after three rounds of fail first step there in utilization management and suffering through six months uh of of of you know the different challenges that they face there.
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So all the different times of therapy that are coming on the market, the buy-specifics, the ADCs, the CART CART T, etc.
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You you know them all.
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So there are all sorts of options as you proceed through the lines, lines of therapy.
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But so where does NCCN go from here?
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Well, hopefully NCCN goes.
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As I say, I left NCCN in 2011 after 15 years being the CEO.
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But hopefully NCCN you know has an eye, and I think it does, to maintaining and even enhancing the position of the guidelines as the standard of care.
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Okay, because you get in all all sorts of uh issues about how is that important?
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Well, if it's recognized standard of care, then you know if you're a payer in issues of liability and ended up in court and saying, what do you base your decision on?
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This NCCN that all these great uh academic centers belong to, they say this, and so uh that that tends to force payers to follow NCCN.
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But so that's that's one thing.
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Just keep your eye on the ball there.
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Secondly, I think, and this is a real challenge because you've got 70 different guidelines, you've got, you know, what, over 2,000 panelists, and you have this torrent of uh new technologies, drugs, devices, procedures, and techniques flooding into cancer care for a diagnosis, for treatment, et cetera, et cetera.
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You have to keep it up to date.
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At the beginning, I mentioned the lung cancer guideline last year at eight different versions, and that's tremendously taxing and a tremendous challenge.
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But you have to keep having these versions and these meetings that look at the latest data and be able to update uh, you know, what's already in the guidelines in terms of potentially new indications and things like that, and and make it public so that then everybody is aware of it, including you know all stakeholders, including uh including the payers.
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So that's important.
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One thing we haven't touched upon, uh I haven't mentioned it yet, and I'm closing here, but it is specifically the fact that NCCN, one of my goals was to make NCCN the gateway to off-label use.
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And what's off-label use?
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FDA approves drugs biologics, as you well know for certain indications.
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But I'll give you an example.
00:21:19.839 --> 00:21:33.599
The great advance of the PD, the anti-PD ones and the anti-PDL ones, basically immunotherapeutic agents, in the NCCN guidelines, the first 88 indications for those agents, 51 of those were off-label.
00:21:33.680 --> 00:21:37.359
So 67% of those were off-label uses, critically important.
00:21:37.519 --> 00:21:42.400
And the payers basically covered those uses because they were NCCN recommended.
00:21:42.640 --> 00:21:43.519
So that's important.
00:21:43.680 --> 00:21:44.640
Two more points.
00:21:44.880 --> 00:21:54.160
One, basically, you know, in addition to maintaining and enhancing a position of standard of care, just maintain your focus on payers.
00:21:54.319 --> 00:22:05.920
Understand this is for NCCN, understand the implications of everything you do, whether it's the recommendations, whether it's the preferred status versus unpreferred, versus all the categories that I won't explain.
00:22:06.160 --> 00:22:26.640
And then I guess thirdly, or whatever it is, I feel like the government of Texas, you know, how many points do they make or not make, but you know, thirdly specifically, understand that the biopharma industry and all the companies that are helping to advance uh, you know, new technologies, especially drugs and biologics, into the cancer care system.
00:22:26.799 --> 00:22:28.319
You know, they're collaborators.
00:22:28.480 --> 00:22:44.079
You need to collaborate more and more because not to get wonky, but there's a process of technology transfer with all sorts of stakeholders and shareholders to help facilitate the entry of advancements into the cancer care system so they're available to patients who need them.
00:22:44.559 --> 00:22:46.799
I mean, it moves so fast they need to be at the table.
00:22:46.960 --> 00:22:56.559
Like that it does it does not help anybody to push the stakehold certain stakeholders out of the room just because I mean that we are all everyone has a voice.
00:22:56.640 --> 00:22:58.240
I often say that in advocacy, right?
00:22:58.319 --> 00:23:00.559
Everybody has a valid voice at the table.
00:23:00.799 --> 00:23:07.200
Um, and hopefully, you know, those voices can collaborate together successfully for patients and to make the cancer care system better.
00:23:07.759 --> 00:23:08.640
You're absolutely right.
00:23:08.880 --> 00:23:15.359
So uh you know, it was a privilege to work with the great doctors, physicians uh at NCCN.
00:23:15.519 --> 00:23:30.000
NCCN is an essential critical institution on behalf of shared decision making, decision making, you know, by doctors and and their patients to make sure the patients have available the best treatment, you know, that they can access.
00:23:30.319 --> 00:23:30.960
Well, thanks, Bill.
00:23:31.039 --> 00:23:38.640
This has been well that wraps up this episode of Value Based Voices brought to you by the Association for Value-Based Cancer Care.
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A heartfelt thank you to Bill McGivney for sharing his insights and to you, our listeners, for joining the conversation.
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If you found today's discussion thought provoking, be sure to subscribe to Value Based Voices wherever you get your podcast.
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Stay tuned for more episodes that spotlight the voices shaping the future of oncology.