Episode 41 – The Latest in GLP-1s for Employers and Consultants

Released February 16, 2024 

Mike Stull (0:08)   

Hey everyone, and welcome to this episode of HR Benecast, your source for expert commentary and insights on current health benefits related news and strategies. This is your host, Mike Stull. I can’t believe it, this is the first episode of 2024. 2023 was a tremendous year, and we are extremely excited to see what this year has in store. Each year, the team at Employers Health makes it our mission to provide all of you with exclusive access to valuable in person events and online resources, with this year being no exception. We have multiple webinars and events taking place in the next few months. Head to employershealthco.com/events to see a full list of upcoming events and details.  

Before we get started, I’m excited to share that registration for our biggest in-person event of the year, our Annual Benefits Forum, is now open. Bigger and better than ever. Join us for this new two-day event, March 5th and 6th in Columbus, Ohio. Attendees will hear from seasoned pharmacy consultants, benefits professionals and clinical management specialists who will share, among other topics, real life solutions to today’s benefits issues, cost reduction methods through high quality digital care, current congressional initiatives and their effects on your plan, risk management solutions for high-cost claimants, how to enhance productivity and workplace satisfaction for working caregivers, healthcare price transparency and its impact on employee benefits, the impact of biosimilars on planned performance, and of course, the latest developments in weight loss and diabetes drugs. Register and view the full agenda at employershealthco.com/ABF24. We hope you’ll join us.  

All right. Let’s get started. Today, I’m joined by Courtney Keefe, our resident expert on all things GLP-1’s. Courtney began her work at Employers Health as a managed care pharmacy resident and today serves clients as a clinical advisor. In this role, Courtney serves as a resource to Employers Health clients and its team members to make plan design recommendations and provide information on new drugs and overall trends. I hope you enjoy my conversation with Courtney. Welcome, Courtney. To get us started here, can you tell the audience a little bit about yourself?  

Courtney Keefe (2:49) 

Absolutely. So, like Mike mentioned, my name is Courtney Keefe. I’m one of the 10 clinical advisors here at Employers Health. So being a clinical advisor, I’m a pharmacist by training. I am originally from Minnesota, which is where I got my pharmacy degree, and then was lucky enough to find all the unique things that we’re doing here at Employers Health. So moved from Minnesota to Columbus, Ohio, where I’m now in our Columbus office, and have been here for a little over two and a half years now. 

Mike Stull (3:21)   

I talked in my intro that you are our resident GLP-1 and anti-obesity drug expert. How’d you get that lofty designation? 

Courtney Keefe (3:31)   

Well, that is not a self-designated title. Whoever gave me that kind title, I’m not sure, but I think it was all about right time, right place. So, when I started here at Employers Health, a little bit over two and a half years ago, like I mentioned. So, when I started, it was July 2021 and Wegovy was launched June of 2021 so just a month before I started here. When I came on board, I mentioned that I was interested in digging a little bit further into this topic. And right when I started, I wrote an article alongside Matt Harmon, our Vice President of Clinical Solutions here at Employers Health, and it was titled, Is It Time to Rethink Obesity Drug Coverage? So pretty ironic, thinking about all the discussions that have happened ever since July 2021, and all the questions that plan sponsors are asking us for their plans. Should they be covering obesity?  

Then that led me to completing a research study that very year and following into the subsequent year on obesity drug coverage under the pharmacy benefit. I looked into employer opinions via a survey that was sent out to current clients of ours, and we looked into per member per month cost breakdowns, the designations between utilization management strategies and other various cost metrics. So, I’ve been digging into the data ever since then, and something that is just a hot topic, so it’s not going away anytime soon. But, there is another one of my colleagues actually doing a research study this year, also on obesity, because there have been such advancements since then. So, who knows? I might be giving that title away to her, passing along those reigns here soon.  

Mike Stull (5:15) 

I don’t know about that, but certainly what I do know is that GLP-1’s are consistently making headlines, and every meeting we’re in employers, consultants, industry analysts, they want to know what are employers doing about GLP-1’s? So, let’s just start with the baseline. What should employers know about?  

Courtney Keefe (5:39) 

Yeah, absolutely. So, like I mentioned, with Wegovy being launched just a few years ago, there have now been additional medications that have been approved by the FDA, one of the most notable and most recent ones is called Zepbound. So, this has been gaining traction online and social media, direct to consumer advertising, you name it. And this is one that I think will be another blockbuster medication going forward, especially when in comparison to Wegovy.  

So, looking in clinical trials, this medication Zepbound has been showing even greater double digit weight loss within those patients in those trials. And it’s something that, in comparison to Wegovy, so that having the same active ingredient as Ozempic, this Zepbound has the same active ingredient as Mounjaro that’s already been on the market. So, we’ve already seen that it has those results for patients. 

It’s currently under new to market block. So, something to know for plan sponsors that you might not see that drastic utilization right now, but it’s something that’s right around the corner, depending on when and if it’ll be put on formulary. I’m willing to bet it will be on formularies here soon, but a lot of the big PBMs currently have it on what I mentioned as new to market blocks. So, it’s currently considered excluded, but when it gets on formulary again, we’re expecting drastic increase in utilization. But also, with that, I just read an article that drug shortages are still a problem within this space. Wegovy, those haven’t even subsided, and it’s been a few years now. Same with Zepbound. We’ve heard from the manufacturer Eli Lilly, shortages aren’t stopping, which means off label utilization for the anti-diabetic medications will still continue, at least for the time being. And then lastly, the only other thing I mentioned is that, again, considering these new medications, the pipeline is strong within this area, both for diabetes and obesity, but there’s also going to be novel mechanisms. One unique one is that they’re combining a GLP-1 with an insulin. Originally, they’re seeking an indication for diabetes, but who knows for the additional indications past that. And then it’s interesting, these GLP-1’s are being studied for other things like fatty liver disease and even addictions like alcohol, drug and gambling addiction. I know that’s something that I’ve seen in the news, but again, it’s just to the point that these medications are not going away, and we’ll see additional indications and additional commercials with all these medications.  

Mike Stull (8:21) 

 We know that there are a number of different GLP-1’s. Let’s talk about the side effects, efficacy, discontinuation rates among these. Are there differences? 

Courtney Keefe (8:36) 

Yeah. I would say overall the side effect profile, they’re pretty similar because all these medications are in the same therapeutic class of GLP-1’s. So again, the side effect profile is pretty similar, where the most common side effects that we see are those gastrointestinal or GI side effects. So, think of things like nausea, vomiting and diarrhea. Definitely not pleasant, and one of the most common reasons why patients have discontinued these medications in trials and in real life. But then, when we want to compare them side by side, looking into those clinical trials, we’ve seen that Wegovy has the highest rates of gastrointestinal side effects when compared to the other GLP-1 anti-obesity medications like Zepbound and Saxenda.  

And then, when we’re thinking in the diabetes space, for example, Mounjaro that has actually shown the highest efficacy, or a little bit better, in both A1C reduction and weight loss. And then lastly, when we’re considering Zepbound, again on the anti-obesity space, this actually had the lowest rate of discontinuation due to side effects. When prescribers are putting patients on these medications, it’s really a balance of both that efficacy, side effect profile and that discontinuation. And when we talk about discontinuation, of course, there’s a lot that goes into it, one of the reasons being side effects, but also cost. If a patient doesn’t have coverage under their plan and they can’t afford it, that might be something that leads to discontinuation as well.  

So, a lot goes into this, but when we are talking about these GLP-1’s, again, we’re really talking about that high efficacy in comparison to other anti-obesity medications in the past, where we traditionally saw about 3 to 5% weight loss consistently. But when we’re talking about efficacy for these newer agents, this is the first time we’ve seen the double-digit weight loss. And even with these newer ones like Zepbound, we’re seeing even more than 20% which, again, is just something we’ve never seen in the past.  

Mike Stull (10:53)  

So, for the audience, this is like the fourth or fifth time I’ve heard Courtney give her talk on GLP-1’s in the past couple weeks. And every time I hear the side effect profile in terms of nausea, vomiting, diarrhea, I think I’m listening to a Pepto Bismol ad. And I just wonder, is there any chance that we could get a compounded version of one of these GLP-1’s with a little bit of the pink stuff? 

Courtney Keefe (11:22)  

Who knows? You know that could have some market share. You might be on to something. Let’s talk. 

Mike Stull (11:27) 

So, speaking of utilization, you mentioned in the beginning that utilization has certainly grown. Maybe dive into that a little deeper in terms of what have we seen so far? 

Courtney Keefe (11:40)   

Absolutely, this class is exponentially grown since back in 2021. When we’re looking into the actual numbers from 2022 to the first half of 2023, utilization of these GLP-1 products grew by a factor of 2.5 and this drove a 171% increase in gross costs per member over that same period. Now, when we’re thinking from 2021, to the first half of 2023, utilization grew by a factor of 3.9 and gross cost per member increased by 258%. 

So again, just astronomical numbers, something that we haven’t really seen with other therapeutic classes, especially within such a short timeframe. And like I mentioned before, it’s really because of essentially the pent-up demand, because this is the first time, we’re seeing that consistent double digit weight loss compared to the earlier products that we’ve seen on the market. 

So, the pent-up demand, the social media presence, we joke about how it was in the Academy Awards monolog, Ozempic was talked about. We’re just seeing it all over, but I would say that pent up demand is really what’s driving that utilization, and something that I don’t even think the drug manufacturers were prepared for because, again, we’ve seen those drug shortages, but we’ve seen those subside in the past year or so. Hopefully those will subside more, so that members that are trying to get these medications that really need them are able to get them. 

Mike Stull (13:14) 

So, we make the distinction between those being used for diabetes and when they’re being used for weight loss. The big decision I think that most employers are struggling with today are, do we cover these medications for weight loss? Can you share the coverage breakdown for this class, for that indication of weight loss among Employers Health clients? 

Courtney Keefe (13:40)   

Yeah, that’s a great distinction, because I think the talk gets a little murky. I hear a lot of clients are confused when this is talked about, because these medications are used for both indications. But when we do talk about coverage for the anti-obesity class, specifically, our clients are still shaking out to be about 50% coverage and 50% excluded. But when we look at the actual numbers, what that breaks down to be is about 51% are currently excluding, 31% of clients are covering with some sort of utilization management in place, and then about 16% have open coverage, meaning no utilization management in place and you might be saying, well, Courtney, that doesn’t add up to 100%. I still am able to do math, that 2% we consider that “other” because there are a few unique circumstances. For example, one of them, being a client is considered to have open coverage, but they have their members pay 100% of the cost share. So really, again, what it shakes out to be is about 50% cover and 50% exclude. 

Mike Stull (14:52)   

One of the other concerns that we’ve heard in the marketplace has to do with patients staying on the medication. So, you talked about the side effect profile. We know, even in the clinical trials, large portion of the population, about 20% discontinued the medication for one reason or another. When we look at our data, what are they telling us in terms of, are patients staying on the medications? 

Courtney Keefe (15:26)   

That has been one of the biggest questions I think that we’ve received, both from clients, consultants, brokers, you name it. It’s one of the biggest questions in the market. We’ve seen other studies say that about two thirds of patients were no longer taking a GLP-1 after one year. Excuse me, one year on these GLP-1’s. So, like you mentioned, we wanted to look into our membership. What are our members doing? Our clinical team at Employers Health have recently done a preliminary study looking into these discontinuation rates. And what we found is that it’s just under 50% of members are considered to have discontinued a GLP-1 within one year of taking the medication. So, the exact stat is 49% discontinuation rate.  

And when we break that down, we’ve seen for those that are considered to have discontinued their GLP-1, their average duration of use was actually only 80 days. But then when we consider all of the patients, so those that both discontinue and stayed on these medications, their average duration of use was just about seven to seven and a half months. So, it’s something that I know clients and plan sponsors are concerned about that continued use, because these are marketed to be chronic medications for chronic use. 

But what we’re really seeing in the data is members and patients are not taking this lifelong at least for now. So of course, there are other complications that come into that. What are the reasons why they’re discontinuing? We’re not exactly sure, because this study was just a claims analysis on the pharmacy side, so we’re really just looking at the numbers, but the actual patient experience, we’re not exactly sure, and something we’re hoping to get more data on that here in the future. 

Mike Stull (17:18)  

And the shortages that you mentioned earlier, I’m sure can play into this a little bit as well. 

Courtney Keefe (17:27) 

They can. We tried to minimize that as best as we could. This study looked at the year of 2023. So, January 1st  to December 31st, 2023 and within that year, the manufacturers, especially Novo Nordisk in this space because they produce Wegovy and Zepbound, hadn’t been approved until the end of 2023. What we heard from Novo Nordisk is that they really limited use to new starts. So, we’re hoping that that meant that those patients were able to continue that medication within that year. But to your point, that is still a little bit of concern within this study. 

Mike Stull (18:11)   

Good point. So, we talk about discontinuation, what happens to patients when they discontinue use? 

Courtney Keefe (18:24) 

 Yeah, so I think it’s fair to assume that there will be some level of weight regain after a member or patient stops these medications, because it’s like any other chronic condition. When you think of diabetes, high blood pressure, high cholesterol, we’re not telling those patients to achieve a certain level or a certain goal and then stop those medications. We’re telling them that these are chronic medications, chronic conditions that need to be continually taken care of. So, when we think about stopping a medication for obesity again, it’s fair to assume that there will be some weight regain, and we have seen that in the data.  

So again, thinking of Novo Nordisk, of course, the manufacturer of Wegovy, they put out a study that showed patients regained about two thirds of their weight back after they stopped their medication. That leads into the point of hoping that lifestyle management modifications can help to a certain degree, and those changes can be in place so that it can mitigate some of that weight regain after a member stops that medication. I would say overall, the idea and hope is that obesity treatment, especially under the pharmacy benefit, will reduce costs under the medical benefit. So again, reducing comorbidities, anything like hospitalizations related to obesity or surgeries associated but again, we still need more data, because we’ve really only had data for about five years now.  

We’ve seen and some information. Again, Novo Nordisk released data that their medications, Wegovy, can reduce the risk of some heart events up to 20%. We still need more information on that as well. So again, I feel like I am a broken record sometimes where we have these medications, we have some data out there, but there’s definitely more that needs to come.  

Mike Stull (20:24) 

Yeah, you know, the recommendation I would give employers and consultants is, don’t be afraid to look into those studies. So, for example, the Novo Nordisk study select trial, where it looked at the cardiovascular outcomes. I think it’s interesting to just look at the study, look at the participation, the demographics of the participants. I mean, in that one, it was all individuals who had previously had heart attack, stroke or peripheral artery disease. And it was really looking at how long from the randomization point did people actually have a second event? So, it wasn’t about did people have or not have a second event, it was, how long did it take for people to have a second event? I think it’s just interesting to actually look at the studies for yourself, or have your consultant look at the studies, and then you can make an informed decision. But, you know, there’s so much information that comes from press releases put out by some of these companies, and it’s something that certainly we are doing in terms of looking at, how was this study constructed, and is it, you know, is an average age of 63 and a clinical study. You know, how does that compare to the average age within a commercial population, which I think for us, is around 47 so it certainly can have an impact. We may get to the point where the outcomes would be the same regardless. But we just want to make sure that we’re comfortable with those.  

Courtney Keefe (21:56) 

Yeah, completely agree, Mike. And just wanted to mention that’s just something that is a press release, so people are seeing that click bait article, the title saying the 20% decrease, and that’s fantastic. But what does that actually mean? Exactly to your point, and again, back to the discontinuation. What does that mean, if patients are only taking it for less than a year, only seven months, do we still see that 20% decrease, or do we still see that reduction? You know, what does that actually look like? So that’s what, while I was mentioning more data is still definitely needed to come.  

Mike Stull (22:38) 

So, let’s talk a little bit about management. Tell us how the PBMs are managing this class, and specifically, our contracts are with CVS and Optum. I’m sure you’re familiar with how they’re handling it.  

Courtney Keefe (22:52) 

 Absolutely. I think it’s important to differentiate between diabetes and anti-obesity management, because the management is different between these drug categories. So, when we’re thinking in the diabetes space, both are pretty similar. When we’re considering how or when would a member get on a GLP-1. From the CVS standpoint, they have what’s called the GLP-1 smart edit, or smart logic. So, if a member has tried any other anti-diabetic medication, if they have any other fills for those, or if they have fills for anything else that signifies that they are a “true diabetic”; you can think of things like test strips, meters, you name it. Or if they have an ICD 10 code on file, that signifies, again, that they’re a diabetic, they can get that GLP-1 right out the gate.  

Now, on the Optum side, they implemented and changed this a little bit throughout the year, but starting in May of 2023, they implemented that there would be a prior authorization for all of their members. So “traditional prior authorization”, not necessarily that claims analysis like CVS, but that prior authorization again is pretty similar. They’re looking at if a member has any other diabetic medication that they’ve tried on file, and if they are a true diabetic, which is signified by their A1C. Then they can get to that GLP-1 product.  

Now in the obesity space, again, CVS and Optum, their standards are pretty similar where they’re looking at BMI thresholds of 27 or comorbidities above 30 and iIf they qualify, or if they have those BMI’s then they are supposed to show 5% weight loss for continuation of coverage. Now just wanting to mention our custom strategy here at Employers Health, we also currently abide by those same BMI thresholds, because those are the ones that are studied in trials and on FDA labeling. But then we increase that weight loss threshold for continuation of coverage from 5% to 10% because we have the hopes that it is steering members to the best medication that’ll show the most or the highest efficacy, and then also hopefully that the clients will see a better return on investment in the long run.  

So hopefully a win, win. Also, I wanted to mention Optum’s custom strategy. You might hear it known as the risk managed strategy, because this targets higher risk adult patients, and they set that BMI threshold a little bit higher at the 35. There’s definitely various utilization management strategies out there. I really just encourage plan sponsors to talk to your team at Employers Health or your consultant and broker partners to figure out which strategy is best for you.  

Mike Stull (26:03) 

Yeah, it’s an interesting time, for sure. And certainly, employers are feeling the impact of this class of medications, regardless of whether they’re being used for diabetes treatment or for weight loss, for those who cover it. Anything else that you’d like to add Courtney? 

Courtney Keefe (26:22) 

 I would say this is an ever-changing landscape, like we’ve mentioned already. The launch of Wegovy back in 2021 really spurred this. But there is definitely more to come within this class. So, like I mentioned earlier, the FDA pipeline is strong. We’re seeing more drug approvals, new indication, new data out there, and new strategies to help manage this class. We know if you’re a plan sponsor, that pharmacy isn’t what you do 24/7 so we’d love to connect with you and walk you through these recent advancements, and again, to help you figure out the best way to help manage your plan going forward. 

Mike Stull (27:05)   

Excellent. I think the other thing that complicates it is these are highly rebatable drugs, and so anytime you deviate off of the label, it ends up costing you rebate dollars. So, figuring out if I increase, for example, the criteria for getting these medications, I’m going to give up some of the rebate. Am I actually going to make a big difference? And that’s where having your data, looking at your data, analyzing your data, and having people who can help, whether it’s your consultants or the team here at Employers Health really can help make a difference. Well, thank you for joining us. 

Courtney Keefe (27:44) 

 Thanks for having me.  

Mike Stull (27:45) 

We appreciate it, Courtney. If you’d like to hear more from her about how employers can proactively manage this growing drug class, she’ll be speaking at the 2024, Annual Benefits Forum in Columbus, Ohio. Again, that date is March 5th and March 6th , and Courtney’s specific session will be on March 6th. Visit employershealthco.com/ABF24 to learn more and register today. 

Before we go, I want to thank our sponsors for helping to not only make this podcast possible, but for supporting us and providing great employee benefits related content. A special thanks to our annual supporters, CVS Health and OptumRx and our executive supporters, Delta Dental, Employer Direct Healthcare, Johnson and Johnson, Pfizer and Quantum Health. Visit employershealthco.com/supporters for a full list of sponsors. 

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Be well and we’ll see you soon.