Eye care experts review differences between branded and generic medications and their relevance for patient care.

Hello and welcome to the discussion presented by 

, titled “Branded vs. Generic: You Make the Call,” focusing on dry eye. As with all therapeutic areas with prescription drug therapies, ophthalmic medications have branded and generic medications. Doctors have choices in what to prescribe. Our expert panel will address the cost question specifically, the cost difference between branded and generics, and the impact on patients, and share some personal clinical experiences. Finally, we will dive deeper into the treatment and technician roles for the management of dry eye.

I’m Dr Marguerite McDonald, a board certified ophthalmologist specializing in cornea, cataract, and refractive surgery at OCLI [Ophthalmic Consultants of Long Island] in New York. I am also a clinical professor of ophthalmology at NYU [New York University].

Today I am joined by Dr Eric Donnenfeld, who performs cataract and refractive surgery at OCLI in New York, and is also a clinical professor of ophthalmology at NYU in New York, and Dr Richard, or Rich, Mangan, an assistant professor at the University of Colorado School of Medicine in the ophthalmology department in Boulder and Aurora, Colorado. 

Let’s start by talking about the landscape of generic ophthalmologic medications. Have you ever had a patient who developed a problem that you thought was related to the use of a generic medication?

 I can say it’s happened multiple times and from different products. One that comes to mind is, I’ve had a patient where I gave them a sample of Zirgan, for example, for herpes simplex keratitis, and because of cost issues, they switched to a generic, Viroptic. The next thing you know they’re having to come to my office for multiple visits because of the ocular surface inflammation irritation it caused. That’s one example that comes to mind.

 The literature has multiple cases, probably the most famous is the use of generic nonsteroidals in which there were a series of corneal perforations in the patients who got generic nonsteroidals. These are big problems. And the compounding issue with generic medications is when you take a patient who has a generic medication and you add dry eye, it adds a level of insult to the ocular surface that’s going to make almost all these medications problematic. 

Generic medications are not a panacea. There are risks associated with them, and I think as clinicians, we have to be aware of [them and] do what’s best for the patient, specifically however, in dry eye patients who have the highest risk for having ocular problems. 

Also there is a lower bar for generic companies. The branded medications have gone through incredible testing. And not only are generic medications less scrupulously studied, there are all sorts of things that can change-the excipients, the base, the pH. And there are many generic medications that are made by 11 or more companies. So if the patient is doing fairly well on one generic, the next time they go to the store they might get one made by a different company and have a completely different outcome.

That actually happened to my dearest friend, who has glaucoma. She lives far from me. Her care is delivered by someone else, and she was switched from one generic latanoprost to another. And her excellent outcome suddenly tanked, and she was losing field and her OCT [optical coherence tomography] changed till she got back on the original generic.

 Well, I think it’s worth discussing the difference in approval process for branded versus generic. When you have a branded medication that’s approved, you go through a multimillion dollar evaluation with phase 1, phase 2, and phase 3 trials where they’re looking really not only at the efficacy, but the safety. Safety is an enormous concern of the FDA when evaluating a new product. So the safety evaluation of these new medications is really significant. And they look at a lot of different things. If you’ve ever been involved in an FDA trial...it’s extraordinarily rigorous. They look at everything.

On the other hand, when you look at a generic medication they’re looking for bioequivalence. They don’t even look at patients. They just look to show that in a laboratory, in vitro very commonly, that the medications look very similar on paper. So you don’t know about things like particle size, pH, excipients.

 Exactly. They all play significant roles. There are significant differences. Now there are generic medications that are wonderful. They do a great job. The problem is, how do you decide which are good and which are not good, because the FDA doesn’t really give you guidance on which is the best medication to use, generically or not.

 I think for latanoprost alone there are at least 7 companies making them, and even if your patient is on a generic that happens to be pretty good that month, what’s the next bottle they’re going to get from the pharmacy a few months later, and how is that going to be different? Trust is the difficult thing with generics.

I think the main thing is consistency. We know it’s already been well studied and gone through the FDA trials and rigorous testing on things. So we usually feel good about the branded product. The thing for me is just consistency. I want to know that whatever my patient is picking up from the pharmacy is repeatable and reliable. We can’t always say that about generic products, especially when there’s more than 1 pharmacy in the game.

As we mentioned before, the excipients, the packaging, the size of the drop that comes out, there are a host of variables and there’s really no control over them in the generic world. How about the options in the branded world for choosing formulations that are non-BAK [benzalkonium chloride] preserved, or preservative-free. Are there more options in the branded world?

 Of course there are. The branded medications have been studied, and it’s not only about safety, it’s also about efficacy. And it’s the combination of both that really are very important. But you want to use a medication, optimally for most patients, that is used [as infrequently] as possible. If you have a medication that can be used once a day rather than twice a day, that is an enormous benefit for patients. Certain nonsteroidals are used 4 times a day generically or used once a day when you use a branded. What an advantage to the patient to use a once-a-day drop. In addition to that, you can have the advantage of using a preservative-free medication, and I think that’s really important, especially for a dry eye product like lifitegrast or like a cyclosporine, having a nonpreserved medication really plays a significant role in improving the efficacy and safety of the medication.

Generic vs. Branded Ophthalmic Medications

Eye care experts compare the direct and indirect costs of branded and generic medications. Dr Donnenfeld discusses his solution for minimizing concerns related to generic substitution at the pharmacy.

 Let’s talk about the cost difference between branded and generics. Are generics always that much cheaper?

 The answer is sometimes actually branded are cheaper than generics. I’ve had that happen many times where a patient comes back and they have paid 50% more for generic medication than they would pay for the branded. You have to be aware of that, and there’s a lot of concern now among the pharmaceutical makers to make certain that drugs are available to our patients. Cost has become a major issue. We’re all aware that our patients sometimes have limitations on what they can spend for their medications. 

With different insurances, these branded medications can actually be a lot less costly. It’s almost like an IQ test. You have the ability to give a patient the FDA-approved, evaluated, safe medication that costs less than the generic medication with unknown excipients. Why would you not use the brand under those circumstances?

 A few years ago a lot of the insurance companies said, “Our patients can only have generics.” When that started to be the case, the companies that made generics said, “Well, that’s fine, that’s fine, let’s raise the prices.” So that was an unintended outcome, of course, of that.

 I think also some of these pharmacies that are making the generics are also getting hit with increased regulation, and they’re having to pass those costs upward as well. It’s kind of hitting from all areas there.

 Eric, you mentioned some of the manufacturer rebates and coupons and such. Let’s talk about some of the direct and indirect costs of care. In other words, there are dollars and cents, but there’s also time, employee time, phone calls, prior authorizations, all that sort of thing. It’s very hard to put a finger on it, but it’s a big issue. A lot of the bigger practices have full-time people doing nothing but prior authorizations. Have you noticed, is that getting to be a bigger and bigger part of your life, Rich?

 It is, and we are one of those places that have someone full time to do that. Thankfully, we have someone really dedicated to that. But as I speak around the country to my colleagues, I hear that’s still one of the barriers for them to sometimes get in the game on some of the newer products. I’d be curious to know what you do in your practice with that, Eric.

 Rich, it’s an amazing problem. Not only is it tedious but it’s expensive, and it really limits our ability of our staff to do their jobs because we have a number of staff members who spend most of their time calling back pharmacies and patients and making certain that the medications that are prescribed are given to them, or arguing with pharmacies. This is not what I went into eye care to do. It’s not why you became an optometrist. It’s not why Marguerite and I became ophthalmologists. We don’t want to be talking to insurance companies and pharmacies about the medications. What we want is to give a patient something that we think is best for the patient; we want to be sure the patient gets that medication.

 We’ve come up with some solutions that work fairly well, and we use some pharmacies now that have become the intermediary for this. These pharmacies are springing up around the country. I’ll mention we use a company named Orphan Pharmacy [Services], and we contact them, and all of the patients’ medications go through that pharmacy and if there’s a problem or a callback, it goes to the pharmacy. And the pharmacy knows what I consider to be a reasonable substitute, if needed, because we don’t want a patient paying out-of-pocket enormous sums of money. They know what I will consider reasonable, and they will make sure the patient gets that medication.

They’re working on behalf of the doctor, and on behalf of the patient. They’re not working on behalf of the pharmacy that has in mind, what can I give to the patient that will give me the most profit? So again, as an eye care professional, my major concern always has to be the same thing—what is best for my patients? And what’s best for my patients is very many times making certain the patient gets the medication that I think is in their best interest.

 Do you find that even though you check the right box on the prescription pad sometimes, or sign on the right line, do you find that they still don’t come back with the prescription you prescribed?

 Absolutely I find that. And I find that there are some drugstores, especially some of the bigger chains, that will actually do the substitution without calling, which is very distressing.

Cost and Substitution Issues

Eye care experts share their approaches for counseling patients about generic versus branded medications.

 As far as patient education, do you provide any information to the patients about brand versus generic?

 I know some practices actually hand out literature, and I think that’s a great idea. That is something I’d like to incorporate. But I do definitely take the time to explain the pros and cons about this issue, and why I feel this product is really best for them. And what’s interesting is just by taking a few minutes to give that explanation, it’s amazing how many all of a sudden really feel that the branded is best for them too. It’s not like I’m having to twist too many arms on this. It’s just educating them about what the real differences are. Many feel that a generic is exactly the same as the branded, that it’s just been reduced in cost. So when they hear about these variances, it’s important to them.

 Especially surrounding surgery you can say, “I really feel drug X is much better for you than drug Y. You only have 2 eyes. This is not a long-term situation.” It is possible I think in just a few sentences to impart that information.

 I can believe it, Marguerite. In all of medicine, generics are used very commonly. But in eye care, optometry and ophthalmology, we use the highest percentage of branded medications of any specialty. And there’s a very good reason for that. When you give a medication orally, it’s digested. It goes through the GI [gastrointestinal] tract. It hits the acid in the stomach. It’s purified. The waste is excreted. There’s no mucous membrane that’s involved here. When you give a topical drop, it’s applied to the ocular surface, it’s the most vital substance of the body. It’s incredibly sensitive to changes in pH, in chemistry. And a small problem in drug delivery applied to the ocular surface can have an enormous impact upon medication effectiveness. That’s why I think that branded [medications] are more important for what we do than for really any other specialty.

 Yes, the pharmacokinetics are completely different. And the drug companies will have teams that do systemic medications, and then ophthalmic teams only, for that reason.

How do you respond when a patient says, “Doctor, I just can’t afford that,” and they ask for a generic, if you are really convinced that the branded medication is the best?

 Right. In all of our practices we deal with comorbidity of dry eye and glaucoma all the time. One thing we know is that too much BAK [benzalkonium chloride] load to the ocular surface not only has some immediate effects, but long term, it can have effects on surgical outcomes, etcetera. 

I just had a patient recently who, she told my technician before I even walked into the room, “If the doctor is going to prescribe a drop, can you prescribe me a generic?” Well, this is a patient who already has ocular surface disease. She’s maybe a year or two away from cataract surgery. And one of the things that she loves to do is read. And she talked about how her reading has been affected by her dry eye. So I took the time to explain, “Look, if we go with a branded product, a glaucoma product that has a preservative that’s friendly to the ocular surface, or preservative-free, we may find that this helps extend your ability to read more comfortably over time.”

And as soon as she realized that reading is her passion, she didn’t want to do anything to rock that world, so to speak. In her mind it made more sense to then consider the branded product over something that may not be as good to the ocular surface.

 It’s a very sensitive and important topic to talk to patients about the cost of medication. I think as doctors we have an obligation to do what’s best for our patients, but also to understand their financial limitations. I will very commonly prescribe a generic medication to a patient if I think it’s a reasonable alternative. They don’t have to get branded, unless I think it’s in their best interest to get the branded. And if it’s a significant financial concern, one of the nice things about branded medications is you’re dealing with big companies, and they almost always provide samples to you. Generics don’t provide samples. When you prescribe a branded you can always have that backup plan that you’ll have some generics. Or, they have a pathway through the company to provide medications at no cost to truly indigent patients who need the medications.

Corporate eye care is actually very sensitive to the fact that they need to provide medications to these patients. You brought up before about dry eye, and I want to reiterate that. There’s nothing more frustrating to me as a clinician than when I do a surgery or I manage a complex case, and the patient has a bad outcome because they have the wrong medications. At the end of the day, you’re the captain of the ship and you have to make certain that your patient gets the medication that’s going to give them the best chance of a good clinical outcome. And if that’s going to be a branded medication, then my patient is going to get a branded medication if we have to find a way of getting it for that patient.

Dry eye patients are the most difficult to manage and the ones who have the most complications with generic medications because their ocular surface is more compromised. And you brought up a very good fact, these patients have more sensitivity to BAK, to pH, to excipients, to drug absorption, so the patients for whom it’s most critical to get branded medications are the dry eye patients. Those are the ones I particularly look out for.

Patient Counseling on Generic vs. Branded

Eye care experts review the epidemiology of dry eye disease and why it is changing.

 Let’s talk about dry eye. How common is dry eye? Who’s at risk?

 Who’s at risk for dry eye? Well, I’ll tell you this. I moved to Colorado 3 years ago from Kentucky. I don’t think I have a single patient who’s come across my chair who doesn’t have some level of clinically significant dry eye. We certainly know there are risk factors, there are plenty of them.

 Depending on the study, you’re right, there’s one study that shows that half of Americans have clinically significant dry eye. Another study says there are 30 million in the United States but only 16 million have been diagnosed. So it’s ubiquitous.

 Well, let’s get right to the chase. As an eye care professional, optometry, ophthalmology, it makes no difference. The single most common reason why patients come into our offices by Medicare designation is dry eye. It’s by far the most common problem we see in our office. And I will add to that, it’s probably also the most difficult problem we treat.

 Right, and the face of dry eye used to be the perimenopausal female, but the face of dry eye is changing with the use of digital devices, and the normal blink rate of 20 times a minute drops to 3 times a minute. One of our offices is the Manhasset office in New York, which is very close to one of the [military] academies, and the cadet academies’ students are on digital devices all day long, and they come streaming into that office. The Merchant Marine Academy is sending 18- to 22-year-olds every single week, and their problem is dry eye because of digital devices.

 If you want to do something really interesting, and this may define a little bit of my personality, what I consider interesting, is go to a Starbucks and watch a millennial look at a screen. They’ll go minutes, literally minutes without blinking. It’s actually extraordinary, and we’re inducing an entire generation of dry eye patients because they’re not blinking, and they're not getting the normal effects of lipid flow, aqueous turnover. Dry eye used to be the 60-, 70-year-old woman, now it’s 15- and 25-year-olds.

 Yes, and the American Academy of Optometry and the American Academy of Ophthalmology have recommended the 20-20-20 rule. Every 20 minutes, stand up for at least 20 seconds, and look at least 20 feet away. It’s good for your posture and your circulation to stand up. You relax the muscles of accommodation briefly as you look far away, and it of course allows your blink rate to recover. I tell people that all day long. That makes a difference. And of course, we know the impact of hormones and menopause, well documented. But for the reasons we just discussed, there are a whole lot of men, especially young men, who have it too, and we’re all living much longer and we’re on more medicines that help us live much longer, and they have an impact on dry eye.

Dry Eye Disease Epidemiology

Eye care experts discuss the impact of dry eye disease on surgical outcomes and their approaches for screening patients for dry eye disease.

 We touched on this before, but patients with glaucoma are certainly at increased risk for dry eye.

The preoperative measurements for cataract surgery and corneal refractive surgery are vastly impacted by dry eye. Do you want to say a word or two about that?

 Yes. Marguerite, you’ve been an expert in this area for a long time, and you know as well as I do that the cornea is not the refractive surface of the eye, it’s the tear film. And without adequate tear film, we don’t know how to treat these patients effectively. Tear film affects biometry, it affects keratometry, it affects wavefront aberrometry, it affects topographic-guided ablations. Every aspect of refractive surgery is impacted by dry eye. And one of the caveats I have for all of my patients is that when they come in, I want to make sure the dry eye is well managed, so I won’t do a preoperative evaluation until I do a dry eye evaluation. If the eyes are dry on my initial consultation, I tell the patient, we’re not going to do the evaluation today. You need to go back, get the proper therapy, improve your ocular surface, and that gives me a better chance of giving that patient the visual outcome they’re looking for.

 Yes. I have trained the technicians who work with me. If they see a tear osmolarity score of 317 mOsm/L or greater, or they do a topography map and they see it’s all broken up, and they recognize that as a sign of dry eye, they stop the preoperative cataract or refractive evaluation and come show it to me. I come in, meet the patient, say hi, do a quick slit lamp examination, stop it; no dilation, no IOLMaster, stop it right there. Tell them it’s important to treat the dry eye, and then have them come back a few weeks later and then I do it. And that’s also why I won’t let people come in from out of town, have the exam, and have surgery all in 1 week because often you find someone who needs a month or more of ocular surface treatment, and now you’re stuck. They’re there with their children. The son took a week off of work, and now you’re between a rock and a hard place. So you don’t let them come from out of town, even if it’s a good referring physician who sent them in, until you see them.

 You’re absolutely right about that. And dry eye is so ubiquitous. One of the common concerns is if the patient comes with preoperative dry eye, we know very well that any surgical intervention is going to worsen that dry eye. And the unhappiest patients in my practice are not the patients who have dry eye, but the patients who have borderline dry eye who are not treated before therapy. Because if you take patients with borderline controlled dry eye who are functioning normally, you do surgery on them, and you convert them from a borderline dry eye to an overt clinically significant dry eye; you know what they do, they blame you because your surgery caused their dry eye. So diagnosing dry eye before surgery is extraordinarily important for not only good outcomes, but to make sure the patient isn’t going to come back to you blaming you for something that you did to cause their dry eyes to worsen.

 And as they say, if you diagnose it preoperatively, it’s their problem. If you diagnose it postoperatively, it’s our problem.

 That’s right. And that’s one of the reasons why I was brought on to the department, to help with surface optimization prior to surgery. So I could work with these patients, get their ocular surface optimized and then get back to the surgeon at that point for the measurements and treatment at that time. And I’ve been trying, as I’ve lectured around the country, I've really impressed upon my optometric colleagues to pay attention to that before you even refer them over to your surgeon. Is that surface truly ready for them to get measurements? And so I think we’re starting to see some improvements in that area, too.

 And you know Rich, I think you really made an important comment here. I think that the common ground for optometry and ophthalmology to work together is dry eye. That’s a place where we need each other to manage our patients appropriately, and I think that’s a place where we really need to spend more time and effort, as our professions, to increase the quality of care we provide to our patients. And we work with a lot of optometrists in our practice who do a great job of working with us to make sure the patient gets the right treatment.

Impact of Dry Eye on Surgical Outcome; Patient Screening

Eye care experts highlight the impact of glaucoma medications on dry eye disease and strategies for management.

 The dry eye patient who’s on a glaucoma medication, Rich, you touched on it before. There are quite a few peer-reviewed publications indicating that that leads to noncompliance and loss of visual field, etcetera, because of the terrible discomfort of putting a glaucoma drop on a dry eye.

 Yes, and I see that unfortunately a lot as well. And I hear arguments on both ends, that lowered cost should lead to greater compliance. At the same time, if it’s a product that’s not beneficial to the ocular surface, they oftentimes won’t use it and sometimes stop more than just 1 offending agent. They’re not sure which 1 it is.

 They’re less compliant with all of them, and again, that’s where patient education is very important about if there’s any concern about how a drop is feeling on the eye, that they need to let us know.

 Does that lead you more toward non-preserved unit dose BAK [benzalkonium chloride]-free medicines?

 Of course you want to minimize the number of drops the patient receives, so a once-a-day glaucoma drop is better than a twice-a-day glaucoma drop, which is of course better than a three-times-a-day glaucoma drop. Limit the BAK. For patients who have significant dry eye problems, you can start them on non-preserved drops. But very commonly when I have a patient who has dry eye to start with and we’re starting glaucoma therapy, I think it’s really a good idea to manage their dry eye at the same time that you manage their glaucoma. Putting patients on immunosuppressive therapies concomitantly with glaucoma management I think does a great job in assuring patient satisfaction and making sure the medications stay where you want them to go. The use of lifitegrast or cyclosporine I think are really important for our glaucoma colleagues to use to make certain our patients get the right outcome.

Glaucoma Medications and Dry Eye Disease

Eye care experts offer their perspectives on initiating anti-inflammatory/immunomodulatory treatment for dry eye disease.

 When do you decide it’s now time for a prescription medication for dry eye? What are your [considerations]?

 I’ll tell you what I look at. If there is any kind of surface staining whatsoever, I feel that artificial tears are not going to get the job done. At that point, [I prescribe medication]. Then I look at risk factors. I’ve had some patients who have been diagnosed with Sjögren syndrome, yet they haven’t really shown the ocular surface issues yet, but I’m proactive with it there as well. How about you, Eric?

 For me it’s an informed consent decision when I talk to patients with dry eye. When I talk to patients, I say, “We can treat you palliatively—I can give you a drop that will make you feel better—or I can treat the disease. Would you rather have something that makes you feel better or something that actually treats the disease process?” I’ve come to learn that when patients come to see an eye doctor, they’re not there because they want to be there. They’re there because they have a problem. These patients [who come because of dry eye] usually have at least level 2 dry eye. Otherwise they wouldn’t bother to be coming in.

So, I’m very proactive about using immunosuppressive therapy. It’s effective. It’s [used] twice a day. Whatever artificial tear you use cannot in any way come close to matching the quality of tears that the human produces. There are over 200 proteins in a human tear. You don’t get that with an artificial tear.

I like to manage patients with dry eye aggressively. I believe in immunosuppressive therapy. I think it’s the core of managing these patients, and I have no problem with starting level 1 patients on [an] immunosuppressive [agent]. We have 2 that are available right now. We have lifitegrast. We have cyclosporine. Both work very effectively. There’s no head-to-head studies that show one is better than the other. They both work very well. But we do know that lifitegrast works more rapidly. We like that aspect of it, that it’s a more rapid onset of action, and I think that is really important to patients that they get relief sooner rather than later.

 I think what you brought up was key. They did a poll years ago and they found that by the time patients actually come in to your office, they’ve already tried 3.5 different types of over-the-counter products, artificial tears. If all we do is hand them an artificial tear sample from the cabinet, they’re just going to think, this is what it’s all about, this is what dry eye is, you just have to live with it. Yes, keep in mind if patients are coming to your office, it’s really bothering them.

 It’s interesting in that, Marguerite and I are both very busy surgeons, we do a lot of surgery. But to me, the greatest opportunity that I have to impress a patient is managing those with dry eye because many have had a problem for years, if not decades. They haven’t gotten relief. No one they’ve spoken to has really gotten to the base of what’s happening and why there is a problem. They pass the buck. They give them 3 different tears, and they say pick the 1 you like best.

When you can take a patient who’s had 3 or 4 different eye care professionals managing them but have not gotten relief and you can make them better, those become very important referrers to your practice. I think dry eye is a very important way of growing a practice.

 You mentioned, Rich, central or any kind of corneal staining is a trigger for a prescription medication. I agree with you. Also, conjunctival staining in the classic pattern.

 What stains do you use for conjunctival staining?

 Lissamine green. Between fluorescein and lissamine green, you learn so much, with the classic complaints to catch the borderline dry eye that’s going to decompensate right after your cataract or LASIK [laser-assisted in situ keratomileusis] surgery.

I also like the tear osmolarity test. I like objective tests because you can say to someone, “You have dry eye.” “No, I don’t. No, I don’t, I have no symptoms.” “Well, your tear osmolarity is supposed to be between 290 and 295 [mOsm/L] and it’s 350.” “Oh.” The numbers impress them. The InflammaDry test is very impressive as well for showing the MMP-9 [matrix metalloproteinase 9] increase that you see in dry eye patients.

 I was asked a while ago if I were on a desert island, what 1 test would I do for my patients. It would have to be either LipiView or slit lamp photography because we’ve all had those cases where there is florid ocular surface staining, yet because the nerve function is so deteriorated, the patients are not really feeling all that bad. And to try to get someone to buy in to a branded medicine or therapy, it can be really challenging. But when you can show them the photograph of the ocular surface of their eye or show how their meibomian glands have atrophied, all of a sudden you’ve got their attention. Compliance goes way up.

 Documentation, numbers, and images—showing them, “This is what your glands are supposed to look like with meibography, and this is what yours look like.” It’s like a brick in the face.

Initiating Anti-Inflammatory/Immunomodulatory Therapy

Dr Donnenfeld reviews the challenges of formulating topical cyclosporine.

 Let’s talk about the challenges of formulating generic cyclosporine. What comes to mind when you hear about all the new ones coming down the pike?

 Cyclosporine is arguably one of the most difficult medications we’ve ever tried to formulate. Allergan did this about 15 years ago, and it was difficult because cyclosporine is very lipophilic. The tear film is obviously aqueous. To provide a medication that’s going to penetrate into the eye, you have to have it be biphasic. It has to be both lipophilic and hydrophilic. They [Allergan] created an emulsion that brings the best of both together. Usually a lipid and an aqueous component don’t work together, but due to proprietary technology, they’ve been able to do this.

Cyclosporine has been around for a long time. We’ve tried various different ways of getting it into the eye. Here’s a case where the vehicle is extraordinarily important, maybe even as important as the molecule itself. What was done with cyclosporine really made an enormous difference in efficacy. If you don’t have the right formulation, it’s not going to be bioavailable. It’s going to be uncomfortable, and it won’t be therapeutic.

 Some companies have tried to compensate by going extremely high in concentration, which is ineffective, actually, or far less effective.

Cyclosporine Formulation Challenges

Experts discuss their experience with lifitegrast and share their patient counseling conversations.

 Let’s talk a little about lifitegrast and its role in your practice. Are you using it?

 I use it quite a bit, actually. I have to say overall, it’s been well received by my patients. It has a couple extra [adverse] effects we are aware of, like dysgeusia and blurred vision. I find that those are real in my practice, but again, by educating patients ahead of time on these, I’ve yet to have any patient stop the medicine because of the dysgeusia. I think I’ve had 1 out of many patients stop it because of extended blurred vision. I don’t know if you’ve experienced that in your practice. But comfort wise, it’s been overall really positive.

 In the FDA trials, dysgeusia, bad taste in your mouth, was a pretty common complaint. In my clinical practice, it really hasn’t been that much of an issue. I really haven’t seen it that commonly. I tell patients about it sometimes, but I haven’t really worried about it.

Like all dry eye medications, when you’re putting a medication onto an ocular surface that’s been traumatized by dry eye, you’re going to have [adverse] effects because this eye doesn’t react normally. You’re going to have more irritation, more redness, and very commonly, the first stage of return of tear film function is a return of innervation and return of corneal sensation.

Dry eye patients are anesthetic. When they start getting better, it’s like when your foot goes numb and you don’t feel anything, that’s the dry eye state. Then the sensation starts coming back and you start getting pain. That’s what happens in your eyes. You have to live through that for a couple weeks and you come out the other side.

Although it is not FDA approved, I very commonly will combine immunosuppression or immunomodulation with lifitegrast or cyclosporine with a topical corticosteroid. The topical corticosteroid is very rapidly acting, very efficacious. You can’t keep patients on it for a long time, but a month of combination therapy will very commonly get patients over that hump to become more comfortable so they can stay on immunosuppressive therapy for longer periods.

 I have a quick little lifitegrast speech that I give and that I’m convinced has increased compliance and prevented calls. I tell patients that the vast majority of people tolerate it beautifully. If you have a bad taste in your mouth 5 minutes later, nothing is wrong—it’s important to say that—just brush your teeth, use mouthwash, or chew a piece of sugar-free gum. I tell them if there’s a little discomfort on instillation, put the medication in the refrigerator. When it’s cold, it will feel much better. I say if it is still bothersome, first put in a cold preservative-free tear from the refrigerator followed immediately by the cold lifitegrast. If patients have blurring, I say, put the drop in your eye the minute you swing your feet out of bed in the morning and then go do some non-critical task like make breakfast or take a shower or whatever. By the time you go to work, you should be seeing well.

Rarely do you have somebody who has blurring for more than 30 minutes, in which case I say, okay, just use the medication at night. They’ll get their therapeutic effect but slower.

I really love lifitegrast because it is fast. The onset of action is fast enough that in a surgical practice you can really tune people up and get them ready for surgery pretty much faster than with any other prescription drug right now.

 The FDA trial showed the rapidity of action and that a number of patients actually showed clinically significant improvement in 2 weeks, which is really pretty extraordinary.

 I think Marguerite’s point is well taken. When patients come into a surgical practice, whether you’re co-managing it or doing the surgery yourself, the patient doesn’t want to wait 2 or 3 months before they’re ready for surgery. You want to make sure that patients can come back in 2 or 3 weeks and be ready to go.

Lifitegrast is part of my rapid action management for dry eye patients having surgery, so that I can get these patients into the operating room the same month.

Lifitegrast Experience and Patient Counseling

Experts discuss the value of utilizing technicians to screen for dry eye disease and the importance of educating all office staff who interact with patients about dry eye disease.

 Let’s talk about the role of the technician in a dry eye practice. What do you think the technician should do in the dry eye practice as far as screening and counseling? Do you rely on your technicians, Rich?

 I do. I have to say I was pretty spoiled for many years. I started my dry eye practice in 2006 when I carved out some dedicated time simply for this condition. I had the same technician ultimately for about 10 years, and it got to a point where she knew what I was going to say before I knew what I was going to say. It made the clinic very efficient, and it got to a point where she was even doing blood draws for me for serum tears. So, technicians can be very helpful. They can be vital to not only caring for the patient but in making you efficient. The one thing I hear from my colleagues about where they struggle with dry eye management is they feel that it bogs down their clinic. There are ways that you can really make it fun, make it efficient too, and still care for patients, and technicians are a big part of that.

 I find that you can have the technician do a lot, but some of the most critical stuff should come from the doctor’s mouth, and then you can transfer the rest of the learning experience to the technician. As far as technicians handling pharmacy requests to substitute for brand name products, Eric mentioned that with a specialty pharmacy like Orphan [Pharmacy Services], they’ve already interviewed you, they know what you consider to be a reasonable substitute. Do you do that, too, Rich?

 Do you let them substitute without talking to you because you’ve given them a list of what you will allow for substitution? Do you have that?

 If I document in the medical record that if this gets denied, it’s okay to do that, then yes.

 How do you keep your technicians up to date on the latest developments in pharmacology and the issues of generic and branded medications? Do you have team meetings?

 Yes, but more so in my previous practice. Where I am at now, we’ll probably need to have more of those. It’s not only important, in my mind, to educate your immediate technicians, but even the individuals answering the phone. I’ve had patients come to me from a colleague’s practice because the receptionist was making recommendations about artificial tear products over the phone. So, the patient thought, well, maybe that’s all they can offer me. I’ll go to practice B and get an opinion.

The doctor in the practice she came from was an excellent doctor, and I know if he had the chance to do a real dry eye assessment, he would have. So, it’s important to let all of the staff know that this is a real disease. It’s been compared to disabling hip fractures and angina, as far as seriousness, and so it needs to be treated that way. The goal is to get patients in and give them the attention they need.

 I think that the technician plays an extraordinarily important part in dry eye management. We empower our front office staff starting at the front desk. Patients fill out a questionnaire that looks at dry eye. If the patient checks off 2 positive comments for dry eye, it empowers my technicians who have been instructed by me that they can now do a dry eye work-up. That simplifies the dry eye management.

I don’t want to see patients and then send them out again for more testing once some tests were already done. I want them to be done when they first come in. Then they haven’t had medications put in their eye, and the tear film hasn’t been compromised in any way. So my technicians really play an important role. We empower them to allow us to manage dry eye more effectively.

A patient who’s positive, like Marguerite said, will get a tear film osmolarity test, a topography, and maybe a meibography as well. When the patient comes to me, I’m spending more time diagnosing the disease rather than ordering tests, and that lets me spend more time talking to them about therapy. I think if you are cognizant of the role that optometry, and front desk, and technicians can play, I think you can have a dry eye practice that’s extraordinarily effective, efficient, and seamless. And that’s where most doctors get caught up. They get bogged down. The patients are there for long periods. We can get our patients out very quickly with a rapid diagnosis that’s more accurate and therapeutic intervention that works more effectively.

 Yes. None of us wants to see our patients twice, see them, order more tests, go back in. And patients don’t like it either. They don’t like to be there a long time. Also, now with electronic medical records, everything is time stamped. Just as it is illegal to say everybody today gets a fluorescein angiogram, you have to have at least 1 check-off on the psychometric test for a symptom, or a well-known history of dry eye and you’re treating it and this is a follow-up, to go ahead with some of the testing. But it makes a big difference if they can go ahead [and have the testing] before you walk in.

Well, this has been fantastic. I really want to thank you, Dr Eric Donnenfeld and Dr Rich Mangan for your participation in this very insightful panel discussion. And thank you to our viewing audience for joining us during this 

presentation on branded vs. generics and the impact on ophthalmic medications

 We hope you found this discussion to be useful in your clinical practice.

Role of the Technician

Ileana Abreu describes approaches taken by OCLI technicians for dry eye screening, counseling patients about branded versus generic medications, and addressing medication cost and substitution concerns.

 My name is Ileana Abreau. I’m the technical supervisor at Ophthalmic Consultants of Long Island as a certified ophthalmic assistant, where I’ve been working for approximately 8 years.

Every patient who comes in the door gets screened for dry eye. We ask a series of questions such as, “Are you irritated? Do you feel foreign body sensation? Are your eyes tired throughout the day? Are they irritated? Is your vision blurry?” Depending on the answers, we’ll perform a series of tests, such as tear osmolarity, InflammaDry, a Schirmer test, to determine whether they have dry eye.

When a physician decides to start a patient on medication, we discuss the expectations with the patient, how long it’s going to take for them to feel some relief. Sometimes it can take up to 2 weeks. Sometimes it can take up to 3 months. We discuss with the patient the instructions for use—once a day, twice a day, 4 times a day—and how long to space [between drops]. Sometimes it’s important to space medications 5 minutes to 15 minutes between each drop. Some patients are on multiple medications.

We inform the patients of the importance of returning for their follow-up appointment to see their results and to make sure that they’re responding to the medication that the physician started them on.

With dry eye medication, one of the most important things is spacing the medication because there are multiple medications at once. If patients are putting in drops and putting in drops, they’re just washing one out with the other. With some medications, like Restasis, you have to wait 15 minutes in between before you administer another drop.

Brand name medication is a very important topic of discussion when it comes to patients because they [the clinician] wants to make sure that they’re getting the best medication that’s out there for them. [Practitioners] always start with prescribing the brand name medication versus the generic medication. We discuss with patients the importance of using the brand name medication versus the generic. We tell them that the studies have shown that for efficacy, the brand name medication has shown better results.

One concern for dry eye patients is the cost of their medications. We discuss with patients the options that they have. A lot of the pharmaceutical companies have patient assistance programs. We discuss GoodRx [website for tracking prescription drug prices and discounts]. We find samples to get patients started at least for the first month so they can start to see the results, and that will encourage them to want to pay for a medication.

There are also coupons available that we always have in the office. We give them to the patients, and we have rebates. We’re always searching or finding ways for patients to be able to afford their medications.

We frequently get calls from pharmacies attempting to switch patients from brand name medications to generics for multiple reasons. It could be cost, it could be that the prescription is not covered by the patient’s insurance. It could be that the pharmacy just wants us to encourage the patients to switch to a generic.

Unfortunately, dry eye medications don’t have generic substitutes, but a lot of other medications do. With glaucoma medications or a lot of our surgical drops, we’re often being encouraged to switch patients to the generic medications. We always encourage the patient to go for the brand medication first. But obviously based on the patient’s financial situation, we work to determine what the best course of action would be, whether it is a patient who we should switch to a generic or it’s a patient who we’ll encourage to get the brand name medication.

Branded vs generics: You make the call in dry eye