On Aon Podcast: Look at the Rise and Risk of Weight Loss Medications

Intro:
Welcome to “On Aon,” an award-winning podcast featuring conversations between colleagues on, well, Aon. This week, we hear from Michael Manolakis for a discussion on the rise and risk of GLP-1s. And now, this week’s host, Tracy Spencer.

Tracy Spencer:
Hi, there. I'm Tracy Spencer and I serve as the national practice leader at Aon in the pharmacy space. I've been in this industry for 25 years and I've held positions at National Pharmacy Benefit Managers, as well as various pharmacy consulting firms. I would say, over the last 25 years, I've never seen a pharmacy industry as dynamic as it is today. That's saying a lot because I generally feel like I learned something new every day in the pharmacy space ever since I've started my career. I'd say our clients are really at a crossroads right now in understanding how to treat certain disease states and how to address the spikes they're seeing in utilization and cost.

I've asked Michael Manolakis to join me today, and he's a senior vice president on our pharmacy practice team. He's part of my leadership team and serves as our clinical innovation leader for the pharmacy practice here at Aon. Michael and I are going to be discussing GLP-1s and the current and future state of the pharmacy challenges faced by plan sponsors in relation to GLP-1s. Thank you for joining me, Michael.

Michael Manolakis:
You're welcome, Tracy, and thank you so much for having me today. It's really a pleasure to be here and to have this opportunity, to have this discussion. As you mentioned, I've been with Aon now for four and a half years, but I've been a pharmacist for a long time. I've worked as a community pharmacist at the beginning of my career and then spent a long time in managed care pharmacy with a number of different PBMs. I'm actually frightening to say that it's been 30 years or so at this point in time. I've worked in just a variety of different capacities and I'm just really excited to have this conversation today with you about the GLP-1 drug class.

Tracy Spencer:
Drugs that treat diabetes and weight loss aren't new and they've been around for a really long time, but something that is obviously new is the GLP-1 dynamic. Can you talk about that a little bit further?

Michael Manolakis:
Let's take a step back to take a whole bunch of steps forward. I love how you set this up as looking ahead and based on what we've learned, because we've learned so much. We are dealing with the drug class, the GLP-1s, that has been around for a while. It basically helps the body. It mimics a hormone in the body, it helps for treating diabetes, and it helps for managing weight loss and treating obesity by lowering blood sugar as one of its effects. It makes us feel full. We don't get hungry. And those two effects, when you blend them together, they help us treat diabetes and they help us to treat obesity.

For diabetes, this has really become a standard of care that the 2023 guidelines focus primarily on the use of GLP-1s for treating Type 2 diabetes, unless there are other comorbid conditions in place, but they have become a standard of care. Interestingly and, I think, appropriately, employees are not questioning the use of GLP-1s for treating diabetes, where the challenge becomes the cost associated with them.

And then, of course, the other challenge is the cost associated with GLP-1s for folks that do not have diabetes and perhaps they don't qualify for a weight loss version of these drugs.

Employers, over the course of the last year, have been wrestling and raising some very challenging questions about how to manage the drugs, how to pay for them, how to allocate these drugs to individuals that are managing obesity. We talk about breakthroughs in drug therapy and, in a way, this breakthrough... It's transformational. The breakthrough piece is the fact that we now have in clinical practice a drug that, by all measures, is safe and effective for treating obesity. We're helping individuals with this condition.

Now, there's chapters probably still to be told about an adverse effect, but we'll see, and we continue to gather real world evidence. But we seem to have a safe and effective drug, and that's really good news, because arguably we've never really had a safe and effective drug for treating obesity like the efficacy that the GLP-1s show. But there's an overlay here. There's cost and there's prevalence concerns and they're interrelated in a very interesting way.

The drugs are expensive, absolutely flat out expensive, and it can be a thousand dollars a month. You read that number, it's pretty accurate. It can vary a little bit if you're insured or underinsured or lack insurance, but it's that prevalence piece that adds the layer of complexity because we've got so many people that are either overweight or are obese as measured by body mass index.

The CDC numbers become a pretty common number. We know 42 percent or so of US citizens fall into those categories. And then, comes the third challenge: the ethical concern. This is where we say... The employer is asking us, "How do we do this fairly? How do I treat people fairly? How do I allocate funds for these drugs fairly? How do I make decisions about who gets the drug?" That's what the cost has created for employers. That's the challenge, it's that convergence of a therapy that works, prevalence numbers that are incredibly high, cost that's incredibly high, and then this ethical question about fair distribution. It is really a conundrum for our clients today.

Tracy Spencer:
Michael, let's talk about the prevalence piece a bit more. You stated a number of 42 percent and that number continues to rise every year. Obesity is not new in this country. We know Aon's clinical perspective is that obesity is a disease and it should be treated, but then we have to look at what has happened with social media and the utilization associated with these drugs. To be clear, Michael, some of these drugs are not approved by the FDA for weight loss. Is that correct?

Michael Manolakis:
That's absolutely correct. Tracy, that's a really important distinction to be made, that they can be the same chemical ingredient but the approval of the GLP-1 may be for treating diabetes, but the approval could also be for treating weight loss. You have to qualify for each based on your condition and comorbid conditions that you may have. But, yes, there are drugs not approved by the FDA for weight loss and they're just for diabetes.

Tracy Spencer:
Then you can pound that with we have drugs that have been made household names by social media and various news agencies and so forth. From your perspective, Michael, how do employers balance this with fairness of coverage when they are seeing inappropriate utilization happening?

Michael Manolakis:
It's an interesting question about inappropriate utilization. I think, before we jump into that and we talk about those elements, let's spend a second just on the utilization that's happening. Tell us about, from our pharmacy data, what are we seeing in terms of utilization over the course of the last year?

Tracy Spencer:
Aon's data tells us that from '22 to '23, and this is just through the third quarter of '23, that utilization and costs of GLP ones across for treatment of diabetes and obesity are on track to triple what they were in '22, and that's with only nine months worth of data.

Michael Manolakis:
The numbers are astounding and, of course, our clients know this. When you asked me before about inappropriate utilization and fairness of coverage, we have to look at the drivers of that utilization. Direct to consumer advertising has become a force.

The impact of unofficial celebrity endorsements via social media has been astonishing, particularly as we look at the utilization rise of GLP-1s. We can look back at our data to November of '22, pretty much a year ago at this point in time in the beginning of December of '22 when the drugs absolutely took off. We know that that aligned with social media impact at that particular time.

It has a really interesting effect and a concern on safety because we also ask, "Where are folks receiving these drugs? Are they getting them from the manufacturer? Are they getting them from some other source?" That's concerning.

Tracy Spencer:
Yeah. I think it's interesting, Michael, because the direct to consumer advertising, as it is out there today across different mediums, is so different than when the FDA first approved direct to consumer advertising. You take that with the prevalency of the weight loss concept in this country, along with the obesity rates that you mentioned. But the social media posts by celebrities that aren't actual direct to consumer advertisements by the manufacturers have just brought a different level of awareness and demand of these medications.

Michael Manolakis:
It is indeed a very different day. It's perhaps we call it our new normal. It is part of the vaccine problems that occur with this drug class in the associated challenges. We have advantages and we have all the gains that are made by this therapy class in terms of managing these conditions, but then we have the risk on the other side that can follow when people are starting to use products off label. It's a very different day.

Tracy Spencer:
From my chair, the employers that I speak to, they discuss constantly that they've got to be doing something different here in order to make sure that they're managing the appropriateness of these drugs and the protocols associated with these drugs, including appropriate prescribing. Michael, again, you've seen our data. There's different types of provider specialties in our data and ones who historically would not necessarily be providers of care in the diabetes or obesity management space. That's one of the reasons that our employers and plan sponsors are struggling with the utilization of these drugs and really trying to understand how should they best manage them.

Michael Manolakis:
The other part of that, and you think about it... Again, we talk about the ethical elements that are going on here. You focused us rightly so on the side of the ledger that's the prescribing side, the act of getting access to the drug. How are individuals qualifying for the drug? But then, there's another piece to this, which is what drug am I getting? And this moves us into a concern that's been raised by the FDA about compounding pharmacies and the actual product you're receiving. The FDA has addressed this issue head on. There's been some recent additional action by the FDA on a compounding pharmacy in one of our states, and they are very concerned about it.

They're taking action because we know that the product that's being distributed through the compounding pharmacies is not necessarily using the same ingredient that the manufacturer currently uses. For the FDA and what they do for drug safety and efficacy in this country, that's a concern. It's a safety concern and it's a quality concern and it ties directly to the product that somebody is injecting into their body or perhaps taking as a pill form. It is a serious, serious safety matter.

There's two pieces of concern going on here, but it hearkens back to what our clients are thinking about. It all goes back to this demand. We have half of our clients roughly that are not covering these products today, and we have half of our clients, again, roughly that are covering these products today. All have been thinking over the course of the last year and essentially asking the same question: "What do I do?" It's a great question. How do I manage these drug products? Some are saying I've been covering them for years.

In many instances, because these older drugs have been around for decades, they put them under coverage. They really didn't cost much, they raised no concerns, and they just really didn't even think about it until this year happened. Now, they have newer high cost drugs appearing. You've already commented on the data points that we're seeing and the escalation in pricing and associated utilization. They're saying, "Where'd this come from?"

There are those that aren't covering and they're feeling pressure. They're reading about how amazing these drugs are. They may be feeling pressure from their employee base about getting access to weight loss drug coverage under their prescription drug plan. They know it's a disease and these clients are saying, "What should we be doing?" And as you stated earlier, it's Aon's perspective that this is a disease and you should be covering this drug. The question then becomes, of course, how do you cover the drug?

All the worry points, the real safety risk points us right back to, "How do I do this right and how do I do it well?" That's what we've been thinking about over the course of this last year as the rise and the risks associated with this drug, the rise in utilization, the risk and financial exposure, the risk and safety... What do we do and how do we cover it? That's it. That's where we are today.

Tracy Spencer:
I completely agree with you. I think the struggle or the challenge that I consistently hear from employer groups in every one of these conversations is they understand that they're investing in benefits and investing in pharmacy benefits for their employees and their dependents, but their concern with this drug class comes into the fact that they don't have a good line of sight of the long-term clinical outcomes of these drugs. What is the patient experience? How long will patients have to be on these drugs? Will they have to be on them for the rest of their lives to maintain their lower weight? It's that unknown that is continuing to concern them.

With as much exposure that the social media has to the results of these drugs, I would say there's a rise in the articles and information that's coming about, saying that there are these side effects. And what are those long-term impacts of those side effects? All of those are creating these questions in the minds of employer groups as they're considering, again, these long-term investments. We know that there's no long-term data yet beyond five years of clinical outcomes for these drugs. We also know that there's been studies and some more recent studies related to patient adherence on these drugs. There really is no clear explanation as far as why patients become not adherent to these drugs or go off of these medications.

Do they go off because it has worked and they are now at a healthy sustainable BMI weight? However you want to classify it, but I think when there's broad exposure to studies from an employer chair where they're seeing that a third of... One of the studies in particular I'm thinking about is one that was published last summer, where a third of the patients stop being adherent within the first year of their treatment or they stop them because of side effects. Employers just look at that and say, "That's not an investment. How do we better curtail that? And what is the ROI on the investment that I'm making?"

Michael Manolakis:
Yeah. The question of adherence... We might even be able to think about it as persistence on therapy, right? Do I persist on the therapy? That's a fascinating question. There are some employers that are out there thinking, "Are my employees going to continue to take these drugs? Will the side effects become a burden? Will cost become a burden?" We have some studies that are out there showing a third are persisting on the therapy.

After a year, we see another study that says 40 percent are persisting on therapy. After a year, we see another study that's part of that one study that focuses on the fact that it only used to be like 10 percent that persisted on therapy. Suddenly, 40 percent could look really good as opposed to it's not 100 or 90 that we might be hoping for. But it's another piece to the puzzle and it's something that we have to be thinking about. You raised the question about return on investment. Am I going to get a return on investment? That's kind of a key question here. It's that question on long-term gain.

When you start to think about long-term gain, and these are the questions that were really early on being able to bump into an opportunity to begin to measure. I'm going to lose weight, I'm going to assume efficacy there, but did my hypertension go down? Did my diabetes improve? Did my hemoglobin A1C go down along with my weight? Did my type two diabetes resolve itself because I lost the weight? Or perhaps, did I... This is an even longer term view that we don't have a window to open on yet. Was I able to avoid a knee replacement or a hip replacement? Was my musculoskeletal condition resolved and perhaps I didn't even need surgery?

That's certainly a hope here, and that's the return on investment. Because if I stayed in that obese state, I would've had the surgery, I would've had additional expense. Of course, that all ties into productivity as well.

Tracy Spencer:
Yep, absolutely. Let's dig into the fairness piece, if we could, a bit more, specifically related to weight loss. We know that Aon clients, about 50 percent of them are covering weight loss medication today in the weight loss class. The other 50 percent are not. I would say there's no doubt that 100 percent of those who aren't providing it today are considering what coverage they should provide and what that coverage should look like. Again, what are the short and long-term... I'll call them patient support elements to make sure that these drugs are successful and successful in the long-term, both short and long-term really. But they're inclusive of diet and exercise. What's that member [inaudible 00:20:15] look like? Really, all of the elements that played into the clinical trials of these drugs originally being approved. Our clients are asking, "What should they do? What pieces should I be considering? And, really, how do we do this holistically?" Fairness and equity needs to be, and generally is, part of those discussions.

Michael Manolakis:
The 50/50 number that you used is really a good accurate reflection. We've done some additional looking at the market space and looking across multiple PBMs. They've been shared information with us about coverage and we see a range of 30 percent, up to about 66 percent of plans that are currently covering these drugs. It just adds a little bit of additional context there. About 100 percent or nearly 100 percent of those lives under coverage are also being managed with prior authorization in place. Just a little bit of extra detail there, but if we turn to fairness and equity for a second, such an interesting question.

We'll take a really simple definition of fairness. You're going to treat someone as they deserve to be treated. I like that. We all live like that. What a better place the world would be. The person who has obesity, they have a disease. Okay, that's a fact. A person with hypertension, they have a disease. That's a fact. They have high blood pressure. If we leave them untreated, probably something a negative or a bad health outcome is going to occur, and that's going to occur secondary to a medical complication.

We ask the person with obesity, and this is what we're tending towards, and we're seeing this right now as sort of plan design elements begin to emerge. We say, "Enroll in a program," to help them with their treatment, but we don't ask anything of the person with hypertension. We just say, "Go get your drug, go to your doctor." We're saying to them, "You do this one way. But obesity person? You do this a different way. We're going to treat you differently." The question is, are we treating them in a way they deserve to be treated?

Tracy Spencer:
But let's look at the flip side of that, too, because there are disease categories that have programs associated with them that employers have adopted today and have had adopted for, again, over two decades that I've been doing this. Whether you call them compliance-based programs or compliance plan designs, one of the things that comes to mind, diabetes and the diabetes point solutions that are out there. Members have to be actively engaged. I think the definition of active engagement can vary between the plan sponsor, but they have to be actively engaged to receive something. They receive an electronic meter, they receive... That's fully electronic and Bluetooth. They receive free test strips that go along with that electronic meter on a monthly basis, based on their continued active engagement. And if they're not actively engaged, they don't get that. You also think about some, let's say, Healthy Mom or maternity programs, where somebody's actively involved in it and then there's additional benefits that they get by completing those programs. How are those potentially different than what you're referring to?

Michael Manolakis:
It's different to me because it's somewhat of a precursor. I'm still going to get coverage under my plan for those other conditions. I don't necessarily know if I'm going to get coverage under the plan or if I'm going to get it at all, or if the plan is even going to make a decision to add coverage. We push it back further and we say, "Before the program..." We say, "We're not even going to give you the coverage under the plan because we don't yet know all the health outcomes. We don't yet know if people are really going to engage." These are just really challenging questions here about how we treat obesity and how we think about obesity in comparison to other disease states. The worry in my mind, and with just fairness in mind here, are we treating people in a way that we're trying to guide these individuals to success, to successful health outcomes?

Some of our employers maybe try to get them enrolled in a program that will work parallel with their drug treatment to position them for long-term sustained weight loss to get those really good positive outcomes that we hope will occur. Or are we setting ourselves up for a scenario as drug costs continue to rise and become more and more challenging, that we use that program requirement as a barrier for cost management purposes? That's the specter in my mind that looms out there. That creates the worry. It just goes to the challenge of, how is it that we define the ethical component as we manage the cost against the prevalence, as we try to account for the fact that these are new and they're amazing drugs and they really do work?

It's in that bundle, that convergence, that the questions all emerge in how we service, how we treat these people. And they're the questions, frankly, that I've been having great questions with my clients as they try to think through, "What is it that I do here and how can I do this right and well? That would be how I look back at your challenge about those other programs, Tracy.

Tracy Spencer:
We know that employers are just struggling with the complexity of these decisions and explaining it to their executives and so forth. I'm going to ask you to do something a little bit different here, Michael, for a second, and ask you to put this really at a high level summary for employers, for consideration. I guess let's imagine you're on an elevator and you're standing next to an employer plan sponsor and they happen to mention that they're just bewildered at this point and not sure what they should be doing to address these drugs.

Michael Manolakis:
I think you need to be thinking about cost, I think you need to be thinking about the prevalence of the condition, and I think you need to be thinking about fairness from a cost management perspective. We need to be thinking about, how do we manage utilization? What kind of purchasing power do we have? How can we optimize our discounts? When we start to think about our prevalence, we start to think about how can those criteria be managed. We start to think about bringing in that third party that comes alongside to manage both utilization and the lifestyle pieces.

You have to be thinking about, "Are we sensitive culturally? How are we taking into account racial preferences and body type differences and making sure that we're treating people in the population in a consistent manner?" That leads us right into the fairness piece. If you can sit back and when you make your recommendation, you're recognizing that your costs are going to go up, you're hoping for good positive outcomes in the out years, that you're accounting for the prevalence and that you're being fair about it. You feel good about what it is that you're doing because it's going to cost you more money in the short term and the doors open at 30. That would be my elevator pitch.

Tracy Spencer:
Again, I think it's that balance of costs and where are those costs. These costs would specifically be... The rising costs would be on the pharmacy side, but then with those longer term outcomes and financial benefits happen across the health plan in general. Well, you are such a critical part of this for our clients, Michael, so I thank you for that and appreciate the final insightful summary.

For those of you who are listening, if you'd liked what you heard, please feel free to follow us on LinkedIn. We also have a pharmacy page that's called Aon Pharmacy Solutions on LinkedIn, where members of our team share industry insights, address the challenges that are faced by clients in the pharmacy space, along with recommendations on how to address many of those challenges. That wraps up our discussion here for today. Thank you all so much for listening and look forward to the next episode of On Aon, coming soon.

Outro
This has been a conversation “On Aon” and the rise and risk of GLP-1s. Thank you for listening. If you enjoyed this latest episode, tune in soon for our next edition. You can also check out past episodes on Simplecast. To learn more about Aon, its colleagues, solutions and news, check out our show notes, and visit our website at Aon dot com.