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Transcription:

Hillary: Hello, and welcome to another episode of the Avalere Health Essential Voice Disease Education Series. In this series, we will be covering topics on a wide range of therapeutic focus areas.

My name is Hillary Stires, and I am a Consultant in the Market Access practice at Avalere Health. I am joined today by Amy Schroeder, who is a Senior Consultant in Market Access, and Casey Hopkins, who is a Senior Associate in Market Access, both of whom are trained as pharmacists.

In today’s episode, we will dive into major takeaways from the 2021 National Comprehensive Cancer Network (NCCN) annual conference that featured challenging case reviews, updates to NCCN clinical practice guidelines in oncology, supportive care topics, and best practices in oncology.

To get us started, we wanted to provide some background about the value of guidelines in oncology. Amy, what are guidelines and how did they come to be?

Amy: Great question. So, guidelines are recommendations for optimizing patient care. If you think about guidelines, it’s about compiling all those modalities in an organized fashion so that providers can use that information to decide what is best for a patient, while taking into consideration that this is a population-based document. They can use that information when they are also using patient-specific information and determine, based on what is recommended for a population, whether that applies to the patient, and then also take in those other considerations.

Clinical guidelines can be very broad and comprehensive. They can include things from diagnosis through to survivorship. For instance, we know that in NCCN, we have disease guidelines for prostate cancer, so those cover a patient from the point of diagnosis all the way through the patient journey.

We can also have clinical guidelines that are very specific to a certain setting of care, such as post-transplant for a patient who has diffuse large B-cell lymphoma.

With that in mind, I also want to mention that clinical guidelines are a little bit different than compendia, and we know that payers and providers use both. Guidelines are considered a more comprehensive document that can later inform more specific documents like clinical compendia that speak to one modality of care, such as drugs and biologics or imaging or surgery. So, the compendia take individual pieces of guidelines and focus their attention there.

Returning to guidelines, I think one of the most important things is that these have been developed over time by providers who are treating patients in this space, looking at the evidence, deciding what is the best care for patients, and then putting together this document that is a recommendation of what to do for a population. This really helps providers around the country and around the world see what is available to patients and how they can use that information when treating a patient today.

Hillary: Thanks, Amy. It sounds like they’re really helpful in getting different oncologists on the same page. It’s a guide to move them all in a similar direction and support their decisions, while understanding that patients are individual.

Would both of you provide us with some background about how payers and providers use guidelines?

Casey: Yeah, absolutely, Hillary. So as Amy mentioned, providers use it to direct their treatment choices and diagnosis choices throughout the patient journey. Whether they’re looking at the guidelines for diagnostic purposes, molecular testing purposes, or treatments for different subtypes, providers can really utilize the guidelines and feel confident that they’re making the right treatment choices for their patients. They know that these NCCN guidelines are updated frequently. They know that the data in the guidelines is reviewed by an expert panel. Whenever possible, they try to use randomized control trials to pull the data from meta-analysis. So, they are a really valuable source for providers to use and feel confident when they’re treating patients.

By that same token, payers use the guidelines to establish coverage decisions for their plans. NCCN guidelines are recognized by CMS and any commercial plans that are contracted with CMS. Commercial plans will especially utilize the NCCN guidelines for off-label coverage decisions, which isn’t available in many sources.

Anything to add there, Amy?

Amy: Yeah, I think that’s a really great point. We know that CMS and payers may go back to the guidelines and reference them when making coverage decisions, or else they may use the compendia, which remember, are like that little single modality version of guidelines. So, we know that all of this really rolls up to guidelines and their importance in payer and provider decisions.

Hillary: Thank you both. We know that there was a lot of discussion at the conference this year about updates to guidelines and the clinical and scientific side of things. Were there any discussions about how payers or providers use guidelines?

Casey: Yes, Hillary. One conversation that stands out to me was surrounding Car T therapy, which we know has a very hefty price tag and has faced coverage decisions in the past. Dr. Schuster from the Abramson Cancer Center was discussing it with a moderator and said they no longer face coverage decisions for CAR T therapy. That’s not to say that a unique patient case couldn’t pop up with some obscure health plan, but for the most part, now that Car T therapy is recognized in the NCCN guidelines, providers have not experienced any problems with coverage for their patients. The moderator had the same experience at his practice. That was nice to hear and goes to show the weight that having approved therapy in the guidelines carries and how that’s affected coverage from payers.

Amy: Adding to that, in a different session about prostate cancer, it was basically the opposite situation. When something isn’t supported by NCCN, or we don’t see something supported by evidence, there can be pushback. In this particular situation, one of the providers on the panel commented that there has been pushback in non-metastatic prostate cancer when thinking about all the options to give a patient.

The provider stated that when it comes to Sipuleucel-T as well as PARP inhibitors, there had been some pushback from providers about sticking to using those 2 products in the metastatic setting of disease because there isn’t the evidence behind it in the non-metastatic setting. If you go back and look at NCCN, that is true. NCCN does recommend them for metastatic disease, so you can understand that pushback from payers if you try to use it in non-metastatic setting.

Hillary: So, we know that payers and providers are using guidelines. Why should manufacturers care about guidelines?

Casey: It’s important for the manufacturers to care about the guidelines because payers care about the guidelines and manufacturers want their drugs to be covered. If a drug isn’t covered, it won’t be utilized by providers or patients. So, the NCCN guidelines and their acceptance by CMS and other commercial plans should definitely be a concern for all manufacturers of oncology drugs. They want to see their product in those guidelines, and they want to see them ranked favorably.

Amy: We know that guidelines really support coverage in an off-label setting, but we also know that some payers broaden that and state that they are also looking to NCCN to support their on-label coverage decisions. We definitely know of payers that are doing that. But there’s also a lot of off-label use that is covered in guidelines, and because the panels and the different entities that are represented by NCCN are testing these different modalities of care and then rating them, we know that the evidence and support is behind the NCCN guidelines. With a lot of our clients, a big part of understanding their product and how it’s being used is what’s listed in guidelines.

Hillary: Makes a lot of sense. Thanks.

NCCN is one of the most common guidelines. We know that there are others, but since this was the NCCN conference, we wanted to move into some of the findings. But first, what was the goal of this conference, which was held March 18-March 20?

Casey: The goal of this conference, as well as previous NCCN conferences, was to align the medical oncology community on current standards of care, how to improve them, and what providers are seeing. They walk through unique and challenging case studies for different cancer types, which is helpful for providers to see what their peers are facing, what diagnostic choices and treatment choices they’re making in those case studies, and what the results of those choices were. Providers discuss what patients are facing and what the oncology community can do to help improve the cancer experience from the patient side as well.

This year, obviously, the pandemic was a big concern.

Amy: I think it’s a really great opportunity to network and pull people together. NCCN has done a nice job of creating this virtual setting where we can do this, where we can hear from experts in these different cancer types about how the guidelines have been updated, which is great because as a pharmacist, I have a difficult time keeping up with everything. It’s really nice to have it brought to your attention—this is what’s new, this is what’s different.

There’s also an opportunity to ask questions and present cases and say, “How would you handle this situation?” So, it’s also an opportunity to share. This is just one of the ways for all of us to benefit from what NCCN panels and those institutions do every day internally.

Casey: Yeah, that opportunity to interact with and ask questions during these presentations as an attendee is so valuable. When you’re doing research on your own, you might not have that direct access.

Hillary: It was definitely a wonderful conference. All 3 of us were able to attend and split up the different meetings on specific cancers.

Today, we’re going to walk through our 3 key takeaways from the conference.

The first key takeaway is the use of diagnostics or other methods of tumor analysis in supporting cancer treatment decisions. What were some of the specific conversations that you all heard?

Casey: There were 3 different presentations concerning lung cancer. One was a case study, and 1 focused on new targeted therapies and immunotherapy. The final presentation concerned biomarker testing. Molecular testing is a huge component of lung cancer and it was interesting to hear the providers go back and forth and explain some different case studies.

One unique thing that stood out to me, and I think you picked up on it too, Amy, was if a case of non-small cell lung cancer is severe enough, and treatment is urgent, they’ll often just start a round of chemo while waiting for genetic testing results to come back. The providers were also discussing different labs that they use for testing, whether an in-house laboratory or outsourcing to one laboratory or even multiple laboratories, depending on the type of test. It was interesting to hear their perspective there. I’m sure they faced some pandemic-related challenges with shipping samples and whatnot.

Hillary: Related to that, what are some things that manufacturers or test developers can do to ensure patients receive the most optimal care as we see more and more testing developing in this space?

Amy: One thing I heard, which was also in a lung cancer session, was, we know that there are a lot of manufacturers that have targeted therapies, and Casey mentioned the importance of waiting for those test results, but also understanding that a patient might want to be treated. There’s a lot of data out whether there are safety concerns in doing that. There was one mention about treating an epidermal growth factor receptor (EGFR)-negative patient with an EGFR tyrosine kinase inhibitor (TKI). What are the harms of that?

Casey mentioned that while you’re waiting for test results, maybe starting with a round of chemo, but then there were also a lot of questions that came up during the presentations and in the commentary afterward about, in non-small cell lung cancer, we have chemo plus immunotherapy up front. If you’re waiting for test results, is it really safe to do both of those? Just based on data, at least try the round of chemo, hold the immunotherapy, wait for the test result, and then decide what to do.

I think an interesting thing that manufacturers that have these targeted therapies can do is work on technology. Over and over again, especially in the lung sessions, we heard that doing broad panels up front is most informative to providers, but if it takes 3 weeks to get that, what do you do in the meantime?

Then we hear about whether there might also be liquid biopsy. So, there might also be EGFR, ALK, ROS-1 testing individually. Well, how much sample do you have? We kept hearing over and over again that knowledge is power, but can we get that quickly? Is there a way for manufacturers to work on it? Is there any way they can help us get faster technology? We have good technology, but can we get faster?

Casey: Yeah, the turnaround time for the tests was discussed. You obviously want the test to be recommended by the guidelines, and as with the drugs, you want the payers to cover the test to enable the best treatment decision possible.

Hillary: Yeah, making the best treatment decision. One of the next takeaways that we discussed is the holistic view of cancer treatment delivery. The patient as well as their various disease attributes should be considered. So, thinking about the molecular testing that exists or some of the comorbidities that might be there for the patient, but also that the patient might respond differently to the treatment and might have some side effects or other considerations that play a role.

Can you provide us with some examples of the conversations you heard about the holistic approach to cancer treatment throughout the conference?

Casey: So, one session that was particularly interesting was a session on oncofertility and how important that is to patients. You might think of a cancer patient as being older and fertility is not a concern, but I believe they said 46% of new cancer diagnoses are between the ages of 20 and 64. That’s a significant portion. Having their own biological children is important to these patients. The takeaway from this session was that oncologists are not discussing fertility preservation options to the extent that they should be with their patients. They really need to bring that up and refer patients to specialists if that is a concern for the patient.

Another interesting thing that the session touched on was fertility for children. You might not think of fertility as much of a concern for the child with diagnosed cancers, but it is. In that circumstance, the physician would need to consider, maybe not discussing fertility options with the patient, but maybe with the parents.

There’s a lot that goes into those discussions. Cost is a huge issue in oncofertility, especially with women. I think sperm banking might have been $160 to $400, whereas freezing eggs or embryos is $10,000 to $15,000. So, females face a very significant out-of-pocket cost if they want to preserve fertility and it’s affected by the cancer treatment.

Hillary: I listened to a few conversations where they were talking about some of the side effects that drugs might cause and then ultimately, how that influences the decisions that providers are making because they want to ensure that their patient’s side effects are considered. Were there any discussions about patient-reported outcomes (PROs) or side effects being incorporated into guidelines?

Casey: Yes. Panelists discussed how important it is to incorporate patient-reported outcomes into clinical practice guidelines. An interesting perspective touched on utilizing technology to interact with patients and gather that data. Studies have shown that patients don’t think the surveys and questionnaires are quite as burdensome as we may think. They want to be heard and they want to have a voice. Quality of life is important, and patients want that to be taken into consideration with their cancer treatment.

Hillary; Thank you. So, the last key takeaway was about how the pandemic has influenced cancer care. Can you elaborate on some of the ways that this has happened? Also, talk through a few of the future implications or the future changes that might either change or stay around as a result of the pandemic?

Amy: One of the sessions talked about advanced care providers, and it was really focusing on how, especially with physician shortages, we’ve focused more on nurse practitioners and physician assistants for care. I had always thought about those 2 roles as being more of someone who works under a physician, so the physician is going to duplicate that.

What I learned in this session was that there is so much trust that’s been enlisted with these individuals to take the reins and oversee care. Physicians really trust them, and this is really an opportunity to provide more comprehensive care for patients, highlighting the importance of nurse practitioners and physician assistants. I came out of this session with a whole new perspective. I definitely appreciate them, but even more so after hearing all that they do, and all that they’re trusted to do because there are not enough physicians and physicians don’t have enough time to see every patient. So, just understanding that nurse practitioners and physician assistants are trusted to do this was actually very helpful to hear.

That can also help us because we’re always doing primary research with providers. We can go back to our teams and tell them we need to expand our provider pool and make sure that we are including these other 2 as well because they’re treating patients at the same level as physicians. That was a big takeaway for me.

Casey: Likewise, for me, if there is any bright side of the pandemic, it would be healthcare workers receiving a little more credit. Some other COVID-related topics during the conference focused on the uptick in telehealth. Providers have been forced to virtually interact with their patients, and there was discussion surrounding licensing restrictions. Physicians were frustrated that their state licensing requirements restricted the care of their patients. I think there’s some opportunity there in the future. Maybe licensing restrictions will become a little bit more flexible around delivering telehealth services to patients.

During COVID, there was also an increase in home infusion services and a decrease in buy-and-bill practices because physicians’ offices are not buying the drug to stock it to the extent that they were because patients are looking to receive more care in their home.

Hillary: Absolutely. It seems like those are going to be opportunities for the future, continuing to learn about the most effective way to provide treatment and some of the barriers that can be overcome with policy changes and/or conversations in this space. It will be great to continue tracking these over the next few years.

We’re out of time, so I just wanted to say “thank you” to Amy and Casey. Your insights are invaluable to our listeners. Thank you all for tuning in to Avalere Health Essential Voice. Please stay tuned for more episodes in our disease education series. If you’d like to learn more, please visit us at avalare.com/ podcasts.