Addressing the Root Cause of a Common Ocular Condition: A Virtual Roundtable

View a roundtable discussion on Demodex blepharitis, a prevalent ocular condition that often goes undiagnosed in patients. Full transcript below. 

Table of Contents:

1. What is Demodex Blepharitis? (00:10)

2. Historical Treatment Landscape of Demodex Blepharitis (18:32)

3. Payer, Provider, and Patient Perspectives on Lotilaner for Demodex Blepharitis (29:58)

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Mile Brujic, OD, FAAO

Dr Mile Brujic is a partner of Premier Vision Group, a successful 4-location optometric practice in Northwest Ohio. He practices full-scope optometry with emphases on ocular disease management of the anterior segment and specialty contact lenses. Dr Brujic graduated from the New England College of Optometry in 2002, and he is active at all levels of organized optometry. He has published over 450 articles and has given over 2100 lectures, both nationally and internationally, on contemporary topics in eye care. Dr Brujic is also on the editorial board for a number of optometric publications. 

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Craig Mattson, MS, MBA, RPh 

Craig Mattson is the president of Mattson Consulting. He has been a pharmacist for more than 45 years. Prior to his retirement from Prime Therapeutics, Craig was the senior director of formulary development for over 14 years. He led the clinical evaluation of new drugs and the critical positioning of all drugs within their therapeutic class or indication. Prior to Prime, Craig held a similar role at AdvancePCS and all its iterations for 9 years. He also worked for 20 years in hospital pharmacies at Tufts Medical Center in Boston, Massachusetts and the Mayo Clinic in Rochester, Minnesota. Craig earned his Bachelor of Science in Pharmacy at the University of Minnesota and his Master of Hospital/Clinical Pharmacy at the University of Iowa’s College of Pharmacy. He completed a residency in hospital pharmacy at the Veterans Administration Hospital in Iowa City, Iowa. His Master of Business Administration was awarded from the University of St Thomas in St Paul, Minnesota. Craig continues to be an active member of the Academy of Managed Care Pharmacy. 

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Dan Sontupe

Dan Sontupe is the president of The Value Builders, an agency of The Bloc. After joining The Bloc in 2010, Dan was tasked with leading the Payer Marketing Group in early 2012. He has overseen tremendous growth in the market access space, including the launch of The Value Builders internally in 2014 and then externally in 2021. As the president of The Value Builders, Dan continues to provide strategic and tactical leadership for the group while also supporting a number of traditional payer marketing engagements and building a practice in patient services and reimbursement. Dan has spent his entire professional career in the healthcare industry, focusing on managed markets and market access. His career has been defined by building culture and delivering innovation and results. Prior to leading The Value Builders, Dan was the director of client services for Ogilvy CommonHealth Payer Marketing. Additionally, he spent 7 years working with managed care prescription benefit manager Medco Health and served in several sales and marketing roles for both Sanofi and Watson (now AbbVie) Pharmaceuticals.  

Transcript: 

Chapter 1: What Is Demodex Blepharitis?  

Dan Sontupe (00:15):

Thank you very much for joining us here today. We are about to launch the First Report Managed Care roundtable discussion, and this is going to be on addressing the root cause of a common ocular condition. It is known as Demodex blepharitis. No, that's not a spell from Harry Potter. That is a condition that affects your eyelashes, and I'm not going to be the person that's going to talk about that. My name's Dan Sontupe. I'm the president of The Value Builders. We are a market access promotional advertising agency, agency of the year in a couple different areas, and I'm here to help guide the discussion. With me today is Dr Mile Brujic, a partner with Premier Vision Group. Dr Brujic, would you like to introduce yourself?

Mile Brujic, OD, FAAO (01:01):

Yeah, thanks, Dan. Like you said, partner of a 2-location practice in northwest Ohio. We just care and see a lot of patients, and this is actually becoming an increasingly important topic, so I'm glad that you're bringing this up to the forefront here to the individuals that can really affect patient care.

Dan Sontupe (01:22):

That's great. Also, joining me today is someone I've worked with quite a bit in the market access space, a former formulary decision maker, and now the principal for Mattson Consulting. Craig, why don't you introduce yourself?

Craig Mattson, MS, MBA, RPh  (01:35):

Thanks, Dan. Yes, I spent over 20 years in managed care and many years before that in hospital pharmacy. In my role in managed care, I was primarily on the clinical side, where I would head up a group that reviewed all new and existing drugs in terms of evaluating their clinical safety and efficacy. And so, as we will proceed through the discussion here, there is a drug now that has been recently approved for Demodex blepharitis that we will discuss. So, this really fits into what I enjoy doing and have done for many years. So, look forward to the discussion today.

Dan Sontupe (02:13):

Great. And the reality is, Craig and I had a conversation as we were preparing for this. Had he ever heard of this disease? Was he worried about it? And we're going to get into that as we get going. But before we start, let me go to Dr Brujic. Tell us a little bit about Demodex blepharitis.

Mile Brujic, OD, FAAO (02:30):

Yeah, so thank you Dan, and I think this is so important to understand before we get started because this will set the basis for everything else we talk about. So, let's first talk about blepharitis. I think it's important to really understand this term. “Blephar” describes anything referring to the lids, and “itis” simply describes an inflammation of the lids. So, when you're talking about inflammation, that's something that's not necessarily specific to an infection. Those 2 words sound a lot alike, but they're very different, but they're oftentimes associated. Infection is when you have an infestation in an area or a tissue where that microorganism isn't supposed to be there. If you get a bacterial infection, that's what that term means. Inflammation is what happens secondary to the infection when the tissue gets red, sore, irritated, but you can also have inflammation without an infection. Take, for example, if you did 50 pushups yesterday and your elbows are sore, you have inflammation in the tissue, but the tissue is not infected.

Mile Brujic, OD, FAAO (03:39):

So again, you oftentimes have inflammation associated with an infection, but not necessarily an infection with an inflammation. So again, because of that, we're thinking about an inflammation of the lids. When you talk about Demodex blepharitis, you are now talking about a microbe that actually infests the lash follicles. And in doing so, what actually ends up happening is it creates characteristic clinical signs that we see in our offices – things like red lid margins, things like collarettes. These are actually small waxy buildup at the base of the lashes as the eyelash comes out of the lash follicle that are pathognomonic for it, which means when you see a collarette, you know it's because of Demodex overpopulation, but it can also cause a lot of symptoms for patients. It can cause things like itchy eyelids. It can cause things like things that mimic dry eye symptoms, things like dryness, irritation, blurry vision, or fluctuating vision. So, all these things can be associated with it, but ultimately, this is all caused by an overpopulation of this one little parasite, Demodex, in the hair follicle of the lash margin. It can cause all of these other issues.

Dan Sontupe (05:04):

So, this little mite that lives on our body congregates and has a little party on our eyelashes and causes all these issues, essentially wax buildup, itchiness, all these other things.

Mile Brujic, OD, FAAO (05:15):

Dan, it is interesting. You described that very well. And the other interesting thing about it as well is people always wonder, “Well, how did I get this infestation?” And the reality is, everybody has a certain level of Demodex all over their body, but it's usually at very, very low concentrations. So, it doesn't cause issues when they start coming together. When they start forming this party, so to speak, when they start overpopulating, that's where the problems actually start to arise.

Dan Sontupe (05:45):

So, Craig, let me talk to you about this for a second, right? Did you ever care about Demodex when you were thinking about coverage in a formulary?

Craig Mattson, MS, MBA, RPh  (05:57):

Certainly not. And, quite honestly, blepharitis was not, broadly speaking for many causes, was not on our radar at all. And so, much less this very specific type of blepharitis, I had not heard of prior to our initial conversation.

Dan Sontupe (06:19):

But, or yes and, it sounds like dry eye is something you probably deal with quite a bit on a formulary.

Craig Mattson, MS, MBA, RPh  (06:26):

Oh, very much so. It was a very competitive market for many manufacturers around dry eyes, but that's a very non-specific symptom that can be attributed to many disease states.

Dan Sontupe (06:40):

So let me go back to you, Dr Brujic. So, how common is Demodex blepharitis?

Mile Brujic, OD, FAAO (06:48):

Very common. So, in a recent study, they showed that over 50% of individuals that come into eye care practices actually have a certain level of blepharitis. The caveat is, Dan, and the challenge that’s been up until relatively recently, is we didn't really have a good fix for it. I'll give you a perfect analogy. In the primary care space, if somebody is overweight and holding more body weight than they're supposed to be, the best solution for that individual is to lose weight. That is also one of the most difficult things for patients to do. It's the same thing in blepharitis because what we used to do is we used to have these patients manually clean their eyelids, and what starts to happen is people just stop doing it over time because it's a habit that needs to be built that's very, very difficult to do so. So unfortunately, it's very, very common, and we see it a lot in primary care practices.

Dan Sontupe (07:47):

So, how much prescribing might have been done that wasn't necessarily for the blepharitis, but for things like the dry eye or other issues that it's causing that maybe someone like Craig could benefit from those prescriptions never happening again once there's a treatment?

Mile Brujic, OD, FAAO (08:08):

So, Dan, that's an insightful question, and Craig, your perspective on dry eye was spot on because it's oftentimes the symptom that can be brought on by several things. So clinically, what we're trying to do is look at the patient, assess the lid margin. We have certain diagnostic tests, and through all the information that we collect and capture, we're trying to figure out what the main culprit is to these symptoms. When you don't have a solution for something, it's very, very difficult to actually attribute the symptoms to that because even if you do, you can't effectively treat it. But I'll tell you, anecdotally, what we found in our office is we've actually been able to pull patients off of some of these chronic prescription dry eye medications by a simple 6-week course of a medication that's specific for Demodex blepharitis. So, to answer your question directly, Dan, I think there's more than we suspect.

Mile Brujic, OD, FAAO (09:05):

We've only had access to the treatment option for Demodex blepharitis for about a year. That actually means we only have about 9 to 10 months of experience with it because the first few months people are using it, we don't see them back for that few months, but we're already seeing that we may be, in some instances, misdiagnosing patients with dry eye symptoms where they're taking medications that are essentially alleviating a downstream symptom of what may be a totally different etiology. It may not necessarily be dry eye; it may actually be blepharitis that's the underlying etiology causing these symptoms.

Dan Sontupe (09:43):

Totally makes sense to me. And Dr Brujic, you're getting to our conclusion before we're ready to get there. So, I know that it's great we have an opportunity to talk about a solution, but let's still go back to some of the issues. We know there's a solution, and I'm excited to talk about that. And then there's going to be the challenge of, "How do we make sure it's available?" How do we make sure all of the patients, or, in our language, Craig, the members, have the appropriate access to it? Right? So, let's start with, "If we left this condition untreated, what happens?"

Mile Brujic, OD, FAAO (10:20):

So, that's one of the most concerning things, Dan, and I'll be very frank on this next statement. I am charged with caring for an individual's most valued sense, their sight. When you ask people in any type of survey, "Of your 5 senses, which one do you have most value in, and which one would you be most concerned about losing?" sight is always an issue. For that fact, we are always very aggressive and making sure we're doing everything we possibly can to keep the eye and the supporting structures in a healthy state because if we compromise that at all, we can actually put the eye at risk – in a worst-case scenario, of causing permanent, unrepairable damage to that individual through infectious etiologies or through inflammatory etiologies. So, that's a worst-case scenario. The best-case scenario is a patient is asymptomatic. We see some of these individuals that come into the office, and we ask them about symptomology and the standard symptoms, and they don't really respond to any of these issues or they're not reporting any of these issues.

Mile Brujic, OD, FAAO (11:38):

But we've had some of these patients go through the 6-week course of the treatment, and they've come back. And you know what they've told me, Dan, they said, "Doc, I'm so glad you are persistent on making me use this medication. I actually didn't realize what I started to get used to." The back pain that you wake up with in the morning may be age-related, but there may be something else that's underlying it, but we just kind of get used to it. It's a product of time, and there are several things that we just start to get used to over time. And when you remove the insult to what's starting to happen, these people actually report all of these symptoms that they just attributed to time or age that aren't there anymore. But Dan, to give you very specific examples, this can, over time, cause itchy, inflamed eyelids. This can actually cause damage because the more somebody itches the eyes, the more they actually make themselves susceptible to outside infections, just from their hands being this close to the eyes.

Mile Brujic, OD, FAAO (12:36):

They can stretch the fine tissues of the skin. They can actually cause premature aging of the skin because the elastin in the eyelid tissues is actually so fine that it's not equipped to actually handle the same type of elasticity stressors that our hands go through or that skin on the rest of our body does. It's very, very thin. So again, you can prematurely age, you can cause premature ptosis when you're starting to itch the eyelids. That's just things that can happen from mechanically itching the eyes or working with the symptoms that are most common with it, but you can also cause dryness in patients. You can also cause what's referred to as corneal staining, which is a compromise of the corneal structure over time that looks almost identical to dry eye in these individuals. You can actually compromise meibomian glands, which produce the oily layer of the tear film. And again, like we said earlier, at its worst-case scenario, you can actually cause blindness in these individuals, allowing the inflammation, the overpopulation to continue untethered.

Dan Sontupe (13:42):

So, I'm going to move to Craig and talk about what this all means to him. Before we do that, what I'd like to know from you—one last question here—is how many people have this and need to be treated? What percentage? Is it 10% of the population? Is it 5% of the population? Is it 20% of the population? What are we looking at here if they're trying to make a decision?

Mile Brujic, OD, FAAO (14:07):

So, when you look at recent studies, it's over half of patients walking into eyecare offices that actually have Demodex blepharitis. Now saying that, that population's a little bit skewed, they're already coming into our offices for reasons associated with their eyes. So, the actual prevalence may be a little bit lower than 50% of the population, and I would estimate it at about 20% to 30%. Saying that, what's interesting is with the appropriate treatment, you can actually cure it, you can fix it, you can get rid of the agent on 1 course. So, that's something that should always be top of mind in a payer's perspective because again, it's not something that can manage it, it’s something that actually can fix it.

Dan Sontupe (14:53):

Okay. So, Craig, you heard a lot about all of the issues, the health issues, the issues around the eye, the potential maybe for taking people off of other drugs. What do you want to hear? What does the impact of this mean to you as you're making formulary-type decisions?

Craig Mattson, MS, MBA, RPh  (15:12):

Well, I think the first thing that we would look at is, what is that drug doing for the disease? And so, as Doctor said, I mean the potential for a cure, I mean, that's ultimately what we want every drug to do rather than to ameliorate the disease or just prevent it from progressing or anything like that. So, we're not talking about that. So, if we're truly able to cure a disease with the drug, with the background that has been presented where, in fact, we are just treating symptoms and not really addressing the cause, then that's pretty very impactful in terms of how we would look at addressing the drug from a formulary perspective.

Dan Sontupe (16:03):

So, the goal here, if you can identify these patients appropriately and treat them appropriately, if there was a drug that could cure them—again, we're getting to that, Doc, we're going to be there soon—that's a win for a health plan?  

Craig Mattson, MS, MBA, RPh  (16:22):

Correct, correct. And as has been alluded to, you know, that these patients are being treated with other expensive… because again, they're treated for sustained periods of time, perhaps years, with minor improvements and only improvement in symptomatology.

Dan Sontupe (16:44):

So today, we're trying to understand what might actually be the economic burden, right? So, you have to make a population decision. If it turns out that 1 of every 3 patients in your health plan needs this, how easy is the decision to say, "Yes, it should be a preferred product," or how do I manage that?

Craig Mattson, MS, MBA, RPh  (17:13):

Well, interesting. In my previous PBM, we did have access to medical claims, and so there, we would have to look at the ICD-10 to identify, okay, how many patients actually had Demodex blepharitis. As Doctor said, it might be underdiagnosed. So, that number may be an underestimate. And as a result of that, we would work with our downstream plans to identify, okay, you have so many patients that would be eligible for a new drug, and then, you know, we would take an estimate of the potential cost of that. And then, because this would be potentially new drug spend for the health plan, although it would be potentially again, an offset because if it could come off some of the other ones, then the net cost to the health plan may be close to zero with obviously a much better result. So, we would look at that. I mean, quite honestly, I doubt that we would do that health economic approach around blepharitis, but certainly, given a much larger population, it's possible to do that. But I think resources would be devoted elsewhere.

Chapter 2: Historical Treatment Landscape of Demodex Blepharitis

Dan Sontupe (18:40):

So, Dr Brujic, one of the things I want to talk about is basically patients’ daily lives and maybe even some of the psychosocial experiences, where on Craig's side, there's a debate on whether or not the health plans will actually take some of that into consideration. How does this disease affect daily life, the psychosocial or mental health of patients today?

Mile Brujic, OD, FAAO (19:08):

Well, Dan, I would actually throw that back to you as a question. What if every morning you woke up, or every time you looked in the mirror, or every time you did a Zoom call for that matter, you were reminded about an inflammation on your eyelids because you could actually see the outer rim of your lids? And certainly, that's a more severe form, but that has tremendous psychosocial challenges for patients. Again, especially with the amount of screen time we have now, especially with the amount of things that we're doing. And it's remarkable, Dan, the females and what they're doing to their eyes to actually try and cover this up sometimes because they don't know what the etiology of it is, they just know that it's happening. So, that's one aspect.

Dan Sontupe (19:52):

So, let me ask you this.

Mile Brujic, OD, FAAO (19:53):

Go ahead, Dan.

Dan Sontupe (19:54):

The demographics of this—and we probably should have gotten into this earlier—age, is there a gender proliferation… who's dealing with this the most?

Mile Brujic, OD, FAAO (20:09):

So, this is the interesting part of it as well too. So, what I tend to see in clinical practices, the younger patients actually are affected by this. Then it kind of dips a little bit in the mid-years, the twenties and the thirties, and then it kind of spikes back up into the forties, where we see more patients that actually have it. You were talking about males and females, really no differences between the 2. Studies have shown that it's actually pretty similar between the 2 populations.

Dan Sontupe (20:37):

Craig, let me turn that back to you. If they presented that as part of the data with a potential cure, is that something you even will look at on the payer side? Is that something that, from a population perspective, has value as part of a value story or a value proposition that they might bring to you?

Craig Mattson, MS, MBA, RPh  (20:57):

Honestly, we recognize, or certainly I recognize, that physicians are treating one patient at a time, and they deal with those patients and what they present with. But on aggregate, honestly, those don't have a lot of impact on a formulary decision-making because the payers, or the health plans, and the employer groups, or even the individual, they're looking at granted their out-of-pocket costs and the overall cost to that company for their health benefits. We will weigh that, but it is typically further down on the scale of assets that we would take into account when reviewing a new drug.

Dan Sontupe (21:48):

So, for you, when reviewing something in this space, you're going to want to see things like, "How much dry eye medication are we now not paying for?" Or, because it's a cure and you're only able to use 1 cycle for 6 weeks, what are the downstream costs that we were talking about earlier that now you no longer have an impact? So, Dr Brujic talked about the potential of the corneal issues or some of that stuff, if they share that with you, does that have an impact?

Craig Mattson, MS, MBA, RPh  (22:26):

It can, but I think the real benefit that has already been presented is that we have the ability to cure. So, it's much like hepatitis C. Prior to that, we never had a cure for that, and now we do, and potentially we have a cure here. I guess the 1 question that comes up in my mind is, "Is there any recurrence?" It is a 6-week cycle. Obviously, we're getting a little ahead of the game here, but will these patients likely re-present, and are there individuals that are predisposed, if you will, to recurrent courses of or exposure to Demodex blepharitis?

Dan Sontupe (23:11):

That's a great question. So, I'll pass that right over to you, Dr Brujic.

Mile Brujic, OD, FAAO (23:16):

Yeah, so that is a good question, Craig. It's interesting. As a clinical scientist, it's the first question I had when I looked at the clinical data. I always think, well, this is great if you can fix it, but what is the reoccurrence, and what can I expect too? Because I need to be able to set expectations for patients as well too. And they actually followed individuals for about a year after the study. So, after going this 6-week course, then they asked themselves, "How many patients were still essentially cured from Demodex blepharitis?" They found approximately 85% of patients were still essentially cured. So, because of that, we now know how to set expectations for patients. So, I tell them, I say 85% of the people in the study 1 year out didn't have this come back, but that means 15% of patients did have a comeback.

Mile Brujic, OD, FAAO (24:05):

I'm not sure what category you're going to fall into, but we're going to make sure we see you in a timely manner. Or, if any symptoms recur, you just let me know before the next time I'm scheduled to actually see you. And we're just starting to now see this, because again, we just started prescribing when the medication was approved, so we're just going to start seeing these patients now on a year out basis. And although I value the clinical data, I truly do, and I think the clinical scientists that put these things together are magnificent, efforts shouldn't be minimized clinically. We always put a sense of value on what we're actually seeing with our patients as well too. And time will tell on this one in the offices.

Dan Sontupe (24:46):

Well, Dr Brujic, we've been tiptoeing around the subject. Craig, thinking about making a decision. So, let's go deeper, right? What are the treatment options today for Demodex blepharitis?

Mile Brujic, OD, FAAO (25:01):

Yep. Well, I'll start with the traditional ones prior to lotilaner being approved. And then I think it's important to understand those because you'll hear how people have been managing this on their own prior to the advent of this. So, what we used to do traditionally—I graduated 22 years ago—and what we were taught was take baby shampoo, dilute it 1 part, baby shampoo, 4 parts water, take a Q-tip, a cotton tip applicator, dip it in there, and clean your eyelash margin. Now, for people that are used to applying makeup, that might not be a big deal, but if you've never applied makeup to your eyes or if you've never worn contact lenses, you're getting very, very close to the eye in a lid margin. It's just a difficult thing to do, even at a slit lamp for me. So, we then had commercially available wipes.

Mile Brujic, OD, FAAO (25:50):

These wipes contain antimicrobial agents. They sometimes contain moisturizers, but they're literally meant to be used once. You tear it open, you rip it open, and the patient cleans their eyelid margin; they flip it over, and they do the same thing on the other side. The intent is to actually remove some of the collarettes or that buildup at the base of the eyelashes along with microbes that we at one point thought were the reason for these collarettes because we only learned that it was Demodex mites about 12 years ago. Then we had hypochlorous spray. Hypochlorous spray does a phenomenal job on bacteria, and it actually has strong antimicrobial and anti-inflammatory effects. The challenge is it never gets to the root cause. So, it can really halt those microbial populations, but never gets to the root cause. We've also had antibiotic steroid combinations work relatively well.

Mile Brujic, OD, FAAO (26:44):

So, if somebody comes in inflamed, there's 2 primary products, 1 that's a combination of loteprednol etabonate and, excuse me, tobramycin. So, it's an antibiotic steroid combination where we attempt to reduce the concentration of the microbial load and also reduce inflammation. There's also another that has dexamethasone and tobramycin. The problem is, again, they're antimicrobial agents, so they don't get to the parasite, essentially, the Demodex mite. So, these patients always come back, and we need to retreat these individuals. One of the basic tenets within eyecare is we can treat with steroids, but we don't want to continue to retreat with steroids. We want to use those as minimally as possible.

Dan Sontupe (27:27):

So, let me pause there for a second and turn it to Craig. So, Craig, you're hearing about a lot of these treatments. Nothing in those treatments sounded expensive to me. How do you respond to that when you think through your populations and what your colleagues on the financial side would be thinking?

Craig Mattson, MS, MBA, RPh  (27:47):

Well, again, and I think many of those don't even cross our radar screen, I think are over-the-counter, maybe dispensed through physicians’ offices, and that's perfectly fine. But as Dr Brujic explained, I mean these are, again, primarily cosmetic that only remove the superficial manifestations of the Demodex blepharitis and don't attack the mite population that is brewing under the skin, so to speak. So, those don't really bother me. Those obviously had no primary financial impact. The only other question I would ask Dr Brujic is the fact that when I did a little bit of research on this, they were talking about ivermectin, a topical application, and just curious if he had used that prior.

Mile Brujic, OD, FAAO (28:45):

So, that's such a good question. So, we don't use ivermectin. There are clinicians that have used ivermectin in the absence of anything else. We've also used things like tea tree oil for terpineol, [which] we actually know is toxic to Demodex mites as well too in high enough concentrations. The challenge is getting these agents to the site because it's so close to the lash margin for terpineol, or the active ingredient in tea tree oil, for example. If you've ever had tea tree oil shampoo, it kind of stings your scalp. It unfortunately does the exact same thing to the eye. So, you have to apply it very, very carefully. And unfortunately, there's always a little bit that gets on the eye. And there's actually studies, mind you, these were in vitro trials, so not in patients, but in an experimental setting. But there's question marks around the effects of terpineol on the meibomian glands, which actually produces the oily layer of the tear film. So, we as a professional society have pulled back just a little bit from the tea tree oil wipes just because of those reasons.

Chapter 3: Payer, Provider, and Patient Perspectives on Lotilaner for Demodex Blepharitis

Dan Sontupe (30:05):

Well, it sounds to me as we go through this, lots of treatments, symptomatic ways to do some removal, ways to make it feel a little bit better with some challenges, but the root cause, the Demodex is the issue. Is that fair to say?

Mile Brujic, OD, FAAO (30:24):

That is correct.

Dan Sontupe (30:26):

Okay, so let's talk about it. Xdemvy. So, Dr Brujic, tell us a little bit about what Xdemvy is and why it's something that Craig and all of his former peers and colleagues should be thinking about when they're building out their formulary.

Mile Brujic, OD, FAAO (30:46):

So, the first part of this is going to be a little bit selfish. And the reason why I say that is because there's nothing more frustrating clinically for me as a clinician treating patients to identify something that doesn't have a treatment. That's a frustrating thing for the patient. I'm describing the etiology of the condition, I'm telling them all about it and I'm leading them on, and then I'm saying, but we can't really fix it, so we're going to manage it as best as we can. Here's how we're going to manage it. Collarettes at the base of the eyelashes are one of the most difficult things to clean just mechanically. There's actually a tool that we have. It has a small surgical micrograde sponge on the end of it. It spins very, very quickly. We can actually clean the eyelid margin as well too. It's about the only way that we can get rid of these collarettes that start forming at the base of the eyelashes.

Mile Brujic, OD, FAAO (31:41):

But the reality is the Demodex is still in the follicle. So, they come back every 3 to 6 months, we see them grow back. We've done this for years for patients. So now we talk about the FDA approval of lotilaner 0.25% or what's commercially available is Xdemvy. I'll tell you that clinically, I had some doubts when I saw the data initially because the company shares with us the data, and they say 60% of individuals essentially have no collarettes in a 42-day time period. Well, okay. They said 85% of patients have 10 or less. And just to put things into perspective, we have about 150 eyelashes along our upper eyelid in a normal healthy individual. It's oftentimes a little bit less in patients with Demodex blepharitis because we know that Demodex blepharitis actually causes lashes to fall out. But again, having collarettes of 10 or less at the end of a 43-day time period is pretty significant.

Mile Brujic, OD, FAAO (32:47):

So, when I asked the company, I said, well, "How do people use the drop?" I thought they were going to describe something that the patient has to put the drop in and then wipe the excess into their lash margin. They said, "Nope, the patient just uses the drop." I said, "Well, how does it get into the hair follicle?" And they said, "We engineered it so that it's in a lipophilic solution." Essentially, it seeks out the hair follicle. And then I repeated my question again. "So, wait a second. A patient just has to use the drop, and that's it, with no mechanical rubbing." They said, "Uh-huh," and I said, "This is your data?" They said, "Uh-huh," and I thought, "Alright, I'm going to prescribe this. I'm going to trust the data, but I'm also going to check on this as well too." So, my first 5 patients that I prescribed it to, I remember I said, "Take 2 drops for the next 6 weeks.

Mile Brujic, OD, FAAO (33:37):

I'm going to follow up with you in 2 months." I said, "But what I want you to do is when you use the drop, if you have a little bit of extra drop, and you might just wipe it away from your eyes with a tissue or something…" I said, "Just take a clean finger and rub it into your lash margin just to make sure it's getting to the site where it needs to be." Every patient came back, every single patient came back, and their lash margin was clear. And we have dozens upon dozens of pre- versus post-treatment photos of these patients. And I asked the patients, I said, "Oh, did you rub the drop in your eyelash?" Every single one of them said, "Dr. B, I completely forgot to do that." And as soon as they told me that they weren't doing that, and I clinically saw the results of this, I realized there was something in this formulation that made it very, very different.

Mile Brujic, OD, FAAO (34:27):

Lotilaner 0.25%. We know that that's has strong anti-Demodex effect. We even know that from the veterinarian world. But what we didn't know is how it would get and how it would actually function on the eye. And when we saw it clinically, that's when we realized there is something here. And we can't say this about most medications, but I can actually tell if somebody's compliant with their medication just because if they've used it, it's gone when they come back. If they still have collarettes at the base of their lashes, they haven't been using it compliantly.

Dan Sontupe (35:03):

So, Craig, turning it over to you. This comes to you from an account director, or maybe even Dr Brujic on behalf of the manufacturer shares this story. How do you react?

Craig Mattson, MS, MBA, RPh  (35:19):

Well, my initial reaction is always with skepticism. Everybody's got the latest, greatest drug to meet the unmet need that has been established. So, I'm always a cynic, but honestly, the more I dug into this, I think just a couple of emphasis points because the mechanism of action is really important because I think that explains why the drug works so well. It actually paralyzes the mite itself, and then it eventually dies. But because we treat for 6 weeks, the lifecycle of a mite I think is like a couple of weeks. So, if we don't catch 'em the first round, we can catch 'em the second or the third because we're now medicating continuously for 6 weeks. So, I think that's why they came up with the 6-week cycle. And I honestly think the cure rate is obviously highly significant, even those that got down to less than 10 collarettes being over 80% in the 2 randomized clinical controlled trials.

Craig Mattson, MS, MBA, RPh  (36:34):

So, this was well done, obviously approved by the FDA, a placebo-controlled trial. But quite honestly, that's kind of what we were treating with in the past was placebo, if you will. So, the more I spent digging into this, the more I became a proponent of it. So, I looked through the FDA review, the CDER review. So, this was based on the data that typically doesn't come to light, if you will, because when the manufacturer is submitting data to the FDA, it's up to the manufacturer to publish it. The FDA doesn't disclose it, but they do describe their review of the submission package, and it was all very favorable. And the other thing that it showed was the drug is well-tolerated. We would always look at peer review literature. And so, both of the clinical trials, called Saturn-1 and Saturn-2, have been published.

Craig Mattson, MS, MBA, RPh  (37:37):

So, that's always important. Peer review, let's put it out for examination and review by ophthalmologists, optometrists to see if in fact this will hold muster. And so, it did. And so, I think all the clinical pieces are in place. The other thing that wasn't just briefly addressed was the safety, and it's well-tolerated. It's a BID 1-drop, and only about 10% of them expressed any sort of itching or burning in the eyes. And I think the discontinuation rate, which I would always look at, is well, okay, so the drug works, but if they don't take it because of a side effect, that's not going to be any benefit. And I think that was in single digits, 3% to 5%. So, given my inherent skepticism, I have slowly come to be a convert towards this drug. I mean, it actually cures the disease.

Dan Sontupe (38:42):

Okay, safe, effective. It's a 6-week period of time, so it's actually got a day supply limit. So, you're only going to be, you can either prior authorize this or put some other rules around it. As a payer, what are the patients saying, Dr Brujic? Are they happy with it? Is it like, "Oh, this is very difficult," or "This is kind of easy." They're obviously using other drops for dry eye or the simplicity of things. What are they saying to you?

Mile Brujic, OD, FAAO (39:15):

Dan, to answer that question, you have to understand that eye care in general, optometry and ophthalmology, we're starting to dig deeper, and we're starting to get to the root causes of some of these things and trying to not treat based on symptoms, but trying to figure out what's causing this stuff and how can we fix this with patients. So, with that said, when you have a treatment that's a drop that you use twice a day… and personally, I just tell patients use it twice a day until the bottle's gone. That usually ends up being a little bit more than 6 weeks, but 6 weeks I find is just a difficult timeframe for patients to remember. Using it till the bottle's done, we'll get them at least 6 weeks, and there's no adverse effects that I've run into with patients taking it longer than 6 weeks.

Mile Brujic, OD, FAAO (40:03):

So, it's easy. And the most important thing—and Craig, you hit on a few of these points—the installation site irritation, or what's commonly referred to as, "Oh, the drop bothers me a little bit." That was only about 10% in the clinical trials. So again, again, just to hit on a few points. One is patients, it's tolerable and it's effective. And that's really ideally what we want in eye care. We want something to be utilized that's very, very easy, and we want it to lack any side effects, and we want it to be effective. And that's really what we have as close as we can with this medication.

Dan Sontupe (40:43):

It sounds like Xdemvy is a product that's long been needed for these patients. Some of the challenges with products that are long needed for patients becomes PBMs and health plans and coverage decisions. So, Craig, the Xdemvy team comes to you, and they want to make sure your organization, or your former organization, or the next organization, they said, "How do we make sure this gets covered?" What do they need to do?

Craig Mattson, MS, MBA, RPh  (41:13):

So, we would bring them in to help us understand Demodex blepharitis. So, as I started earlier, say that I never even heard of it. So, we would want to understand the disease in which we're treating, how the drug works, and all that. Then we would, and I really see this as an opportunity to have a dialogue with the manufacturer. So, it would be great if they brought in optometrists and ophthalmologists so we can understand all the things that Dr Brujic has been talking about and his limited experience with the drug too. Because on the PBM side, as a clinical pharmacist, I always say I know a little bit about a lot of drugs and disease state. So, the more I need to dig into about an individual disease state and drug, we need to do that when a new drug comes out. So, we would have this dialogue and go on that. But again, from my clinical assessment of the drug, I can't see any reason to keep it off of the formulary.

Dan Sontupe (42:29):

So, Craig, great feedback on trying to understand the coverage decision, things like that. But I do want to understand guidelines. So, a lot of times, Craig, one of the things you're going to look at when making decisions, are there standard guidelines for treatments? Because if your organizations, Dr Brujic, aren't saying Xdemvy should be part of it, there's a reason. So, what are the guidelines today with Demodex blepharitis?

Craig Mattson, MS, MBA, RPh  (42:58):

So yeah, in my review, we would always look at guidelines to treat a disease. And yes, there are... I have to look at my notes here because I know there was a 2023 Blepharitis preferred practice pattern guidelines. And so, I did review those, and as we started out, blepharitis could be caused by many things, be it bacterial and parasitic as we're talking about now. So, they're broadly speaking, they do make reference in the guidelines on Demodex, and they do make reference to Xdemvy, but they don't give an algorithmic approach. So, they just merely mention it without a lot of clinical detail. So, the other thing that then I always think of is, okay, these were brought out in 2023. That's really great. Not all disease states have relevant or timely guidelines.

Dan Sontupe (44:10):

So Craig, since this is the sort of first and only product that might be on the market for this, does that allow a payer a health plan, a PBM, to cover it without much of an issue knowing that it's the only thing really, it's the only game in talent for Dr Brujic and his peers to use here?

Craig Mattson, MS, MBA, RPh  (44:32):

Well, right, and I think health plans are somewhat cynical like myself. How well does the drug perform in the real world? And so, I think what most plans are going to be doing in the near term is they are going to be putting some prior authorization in place for this drug. And I think what typically would be is that it's going to be prescribed by a specialist. They're going to probably make sure the diagnosis with an ICD-9 or a description of the inclusion criteria that were used in the pivotal trials. Again, what happens from a payer perspective and prior authorization, we want to make sure that our drug spend is going to the population for which the drug was initially studied. Now, I think we've talked about that quite a bit, and so I think that won't be a problem, but I think that is sort of the knee-jerk response for managed care and payers to put prior authorization in place for the first year. Then if what we see is that, oh yes, everybody is prescribing it appropriately, then likely those will be liberalized or even removed because, in fact, we've documented the fact that prescribers are using this appropriately.

Dan Sontupe (46:03):

I love that, Craig, and I think that's really important. So, Dr Brujic, I do a lot of work in this space and am trying to help physicians sort of guide themselves through the prior authorization process. And a lot of times, there's a resource and a willingness issue. How do you think you and your peers would respond to wanting to use this drug but having to jump through that extra prior authorization hoop, letter of medical necessity, that type of process for a payer?

Mile Brujic, OD, FAAO (46:35):

So, Dan, if you're asking me clinically, would I rather be able to prescribe a medication and have access to it for my patient or do extra paperwork to get it, the answer is option 1. I would rather just prescribe it and get it to the patient. Of course, we do understand that we're in a time now where everybody's held to a higher level of accountability, and because of that, we need to make sure clinically that we're equipped to make sure that we're answering questions in a timely manner that the healthcare provide or the healthcare insurers may need from us. So, a lot of us at this point have really kind of, we have the mindset that if there is a new medication, we know we're probably going to have to fill out a prior authorization. Again, to be clear, would I prefer not to do one? Yes, of course. But we now expect that with new medications. So, if we have something that we know will help patients, we know to expect some form of paperwork to be performed. And right now, we're already doing that with Xdemvy.

Dan Sontupe (47:35):

That's great. Well, that's all I have for this episode. Are there any questions that you 2 have for each other or anything else you'd like to add?

Mile Brujic, OD, FAAO (47:45):

Craig, I just wanted to share with you that it is really interesting to hear your perspective on those important points to understand when you're selecting things to be covered and how those things actually have access to patients or members. I do think that in addition to that, it's always important to hear the clinician's voice, which is what I'm here doing and sharing for you. So, I hope both of those things have been valuable for you.

Craig Mattson, MS, MBA, RPh  (48:12):

Oh, this has been great to hear from a practitioner and life on the front line, so appreciate your input as much.

Dan Sontupe (48:21):

I totally agree, and it's one of the things that we struggle to get together. You see 1 patient at a time, Craig's responsible for 20 million people. We have to think about how we manage through that. And let's be candid, our healthcare system is great, but it definitely has a lot of places to improve, and that's our objective down the line. But I want to thank you both. Craig, as always, great time talking to you. Dr Brujic, it was wonderful meeting you and having this conversation, and I found it enlightening. For everyone out there who got to spend this time with us, thank you for joining us for this episode of First Report Managed Care, a roundtable discussion. I think we really did a nice job of demystifying Demodex blepharitis and actually knowing it's time to really take an aggressive stance there. So, thank you very much, and have a wonderful rest of your day.