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A FOCUS ON DRY EYE AWARENESS

As part of our continued commitment to dry eye awareness, we invite you to join us in learning more about dry eye disease through Dry Eye July & Beyond, with access to educational opportunities, training materials, and more!

Eye care technicians are one of the first lines of defense against dry eye disease, so we want to make sure you have the tools and resources necessary to help identify dry eye patients and set them up for success as they begin their journey with Xiidra.

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Identifying the Dry Eye Patient

Featuring: Maria Vasilopoulos, COA

Paid consultant for Novartis

Speaking with Patients About DED

Featuring: Lisa Jurgens, COT, OSC

Paid consultant for Novartis

Chapterized Indication & Important Safety Information

Xiidra is indicated for the treatment of the signs and symptoms of dry eye disease.

Please refer to the Important Safety Information and Full Prescribing Information regarding taking Xiidra that may include that it is contraindicated in patients with known hypersensitivity to lifitegrast or any other ingredients, as well as the common adverse reactions, such as instillation site irritation, dysgeusia, and reduced visual acuity.

Hello, my name is Maria Vasilopoulos. I am a Certified Ophthalmic Assistant at the Illinois Glaucoma Center in Mokena, Illinois.

Welcome to Tech Talks…DED De-TECHtive, Identifying the Dry Eye Patient. Today, I will be discussing the role of technicians in identifying patients with dry eye disease.

As a technician in a busy practice, I am often one of the first people to communicate with patients. This is why I consider my role to be part “De-TECH-tive” when it comes to assisting with the proper screening and identification of dry eye disease patients. In my opinion, this means that we should be very familiar with dry eye risk factors, as well as the appropriate questions to ask our patients, in order to effectively screen for dry eye disease.

Before we dive into screening, let's think about how many potential dry eye patients may already be sitting in our waiting rooms.

According to the Beaver Dam Offspring Study in 2008, it was found that approximately 14.5% of adults 21 to 84 years of age had symptoms consistent with dry eye disease.1

Using that prevalence and the estimated adult population from the US census in that same year, we extrapolated that approximately 30 million Americans had symptoms consistent with dry eye disease.1,2

Given that estimation, I believe that there are likely more dry eye patients in our offices than we think. In addition, dry eye disease is one of the most common reasons that patients seek medical eye care.3

At my practice, the first step in dry eye screening typically happens during the patient workup before the Ophthalmologist or Optometrist enters the room. During this time, a technician may perform the initial dry eye assessment, which includes a patient history. I’ve found that taking a thorough patient history provides certain cues and clues to be mindful of when assessing the patient.

There are several potential dry eye risk factors to look for when conducting a patient history. For example, age and gender are two of the potential risk factors for dry eye.3 The topical or systemic medications a patient is taking and their existing medical conditions are important to cover during the workup. For instance, epidemiological studies have identified anti-depressants and antihistamines as potentially increasing the risk of developing dry eye.3 Additionally, according to TFOS DEWS II, conditions such as diabetes and thyroid disease may be potential risk factors for dry eye.3

Certain disorders, such as meibomian gland dysfunction, blepharitis, and rosacea – which I commonly see in our practice – are also potential risk factors for dry eye.3,4 Finally, we should take note of any modifiable risk factors – these can include things like environmental conditions, contact lens wear, and digital device use – all of which may contribute to dry eye disease.3

As you can see, there are numerous risk factors associated with dry eye disease. In my opinion, our ability to uncover this information is an effective way for us to help screen patients during the preliminary workup. In my experience, this information may trigger the need for further evaluation of dry eye.

In our practice, we always look at a review of systems and medication. There could be other conditions or instances that may be contributing to the occurrence of dry eye disease – things like diabetes, can be part of the reason for dry eye disease. It is also important to closely review their medication list, so we always ask questions about any systemic medications or topical drops they are currently taking, as some can potentially cause dry eye.

Listening is an important skill when it comes to dry eye. I’ve found that asking the right questions can help to fully understand the patient’s ocular health.

Patients may not realize that the symptoms they are experiencing can be attributed to dry eye disease. I have had patients believe that their symptoms were just a “normal” and acceptable part of aging. This is where we come in. Asking the right questions during the patient workup can help us to tease out and identify potential symptoms. There are several ways to assess symptoms that may suggest dry eye. One of which can be a simple questionnaire at intake, such as the OSDI or SPEED questionnaires.3

There are several symptoms commonly associated with dry eye. When listening to the patient describe their eyes during the work up, you may want to be mindful of hearing things like: a scratchy or gritty feeling (like something in the eye)5, red or irritated eyes5, or burning feeling in the eyes5. Recognizing the symptoms of dry eye disease helps to identify dry eye patients and aids in a timely diagnosis.

In our practice, we first identify why the patient is coming in to the office. Then we continue with specific questions related to their complaint or symptoms. For example, we ask how many hours a day are you on the computer, use a smart phone or reading? If they are a contact lens wearer, we ask…“Do you sleep with contact lenses?” and “What is your average wearing time?”

Based on their symptoms, here are a few questions you may want to consider asking your patients. These questions are interpretations from various guidelines and questionnaires that help identify patients with dry eye disease:

How frequent and severe is your eye discomfort? Asking about symptom frequency and severity can give insight into the potential chronic nature of dry eye disease.3

How long have your symptoms lasted and was there a triggering event? Dry eye disease can be chronic, and may generally worsen by the end of the day.7 Additional follow-up questions can help identify the trigger.

Are you taking artificial tears to reduce symptoms? If yes, ask additional questions, including how often and document the answer.8 Artificial tear use is a mainstay of dry eye therapy and attempts to replace or supplement the natural tear film.8 In my opinion is it important to pay attention to specifics when asking patients about their artificial tear use. If a patient is not responding to their current therapy, another option may be needed, such as Xiidra.8

Another question you may consider asking…Is your vision affected and does it clear with blinking? Prolonged staring can dry eyes and reduce visual quality. Vision generally recovers with blinking.7

Do you wear contact lenses? Contact lenses may worsen dry eye disease.7

In my opinion, it is very important for us, as technicians, to document this information in the patient’s chart. Documenting potential dry eye risk factors and the answers to these questions allows me to not only accurately convey this information to the prescribing physician, but also serves as a record to detail what is happening with the patient.

Conclusion

In my clinical experience, knowing common dry eye risk factors, asking questions, and listening carefully are important components for screening patients for dry eye. Once you have identified a potential dry eye patient – what’s next? If dry eye disease is suspected during the workup through a questionnaire or patient history, this may trigger further evaluation.7 This evaluation is likely based upon what diagnostic tools are available in your practice and what the physician deems appropriate. Once the Ophthalmologist or Optometrist determines what tests should be performed, it is important to document the outcome clearly so a plan can be determined, and progress can be measured.

Speaking from my own experience, I think that these steps will pave the way for you to become an expert dry eye de-TECH-tive within your practice.

References

  1. Paulsen AJ, Cruickshanks KJ, Fischer ME, et al. Dry eye in the Beaver Dam Offspring Study: Prevalence, risk factors, and health-related quality of life. Am J Ohthalmol. 2014;157(4):799-806.
  2. US Census Bureau. Current Population Survey, Annual Social and Economic Supplement, 2008. Accessed October 5, 2020. https://www.census.gov/data/tables/2008/demo/age-and-sex/2008-age-sexcomposition.html.
  3. Stapleton F, Alves M, Bunya VY, et al. TFOS DEWS II epidemiology report. Ocul Surf. 2017;15:334.365.
  4. American Optometric Association. Dry eye. Accessed October 5, 2020. https://www.aoa.org/patients-andpublic/eye-and-vision-problems/glossary-of-eye-and-vision-conditions/dry-eye.
  5. Sullivan DA, Rocha EM, Aragona P, et al. TFOS DEWS II sex, gender, and hormones report. Ocul Surf. 2017;15:287-333.
  6. Starr CE, Gupta PK, Farid M, et al. An algorithm for the preoperative diagnosis and treatment of ocular surface disorders. J Cataract Refract Surg. 2019;45:669-684.
  7. Wolffsohn JS, Arita R, Chalmers R, et al. TFOS DEWS II diagnostic methodology report. Ocul Surf. 2017;15(3):539-574.
  8. Jones L, Downie LE, Korb D, et al. TFOS DEWS II management and therapy report. Ocul Surf. 2017;15:575-628.

Chapterized Indication & Important Safety Information

Xiidra is indicated for the treatment of the signs and symptoms of dry eye disease.

Please refer to the Important Safety Information and Full Prescribing Information regarding taking Xiidra that may include that it is contraindicated in patients with known hypersensitivity to lifitegrast or any other ingredients, as well as the common adverse reactions, such as instillation site irritation, dysgeusia, and reduced visual acuity.

Hello, my name is Lisa Jurgens. I am a Certified Ophthalmic Technician and Certified Ophthalmic Scribe at Art Vision in Sioux Falls, South Dakota. Welcome to Tech Talks – Speaking with Patients About Dry Eye Disease.

Today we are going to go over how technicians can talk to patients about dry eye disease. I have found that in our practice, our patients are empowered and invested in their health – they have lots of questions and are interested in learning about their condition. In my opinion, effective communication and education are critical tools that help technicians set patients up for success.

Let’s talk about the conversation between a technician and a patient around dry eye disease. For the purposes of our discussion today, we are going to assume that the patient has gone through the proper screening and diagnostic testing and the Optometrist or Ophthalmologist has diagnosed the patient with dry eye disease.

At this point, what does that conversation with the patient sound like? How can we effectively explain what dry eye is to our patients in a clear, simple, and meaningful way?

Once they are diagnosed with dry eye, patients want to know more about their disease. The first thing I let my patients know is that dry eye is an ocular surface disease.1 It is important that they appreciate that they have a disease and it is something that may need to be managed with treatment.2

In my practice, we often simplify what the disease is for the patients. We tell them that there are several factors that can contribute to the disease and that if the tear film is unstable or unhealthy, the eye can be negatively affected, and dry eye can occur. Keeping things simple is best.

In addition, our patients need to understand that inflammation may be an important driver of dry eye disease.3 In some patients, the vicious cycle of dry eye may continue, which may then perpetuate the signs and symptoms of the disease.3

In addition to the disease process, I also reiterate that dry eye can encompass both symptoms, which are experienced by the patient, and signs, which are observed by the physician. I explain that symptoms and signs do not always correlate.4

Once the patient has a better understanding of their dry eye disease, they typically want more details about what can be done. There are several treatment options for dry eye, which will be based on what the Ophthalmologist or Optometrist believes is appropriate for the patient, based on their symptoms and diagnostic testing.

In many cases in my practice, patients may already be taking artificial tears. In cases where artificial tears may not be enough, the doctor may decide to prescribe other treatments, including prescription treatment with Xiidra (lifitegrast ophthalmic solution) 5%.2,5 Xiidra is a lymphocyte function-associated antagonist, which is one strategy to target inflammation in dry eye.2,5

In my practice, I stress the importance of adherence to the treatment plan the physician has outlined for the patient. I’ve found that many dry eye patients in our practice have never had a dry eye prescription prior to their visit, so it is important to help the patient develop habits or routines to take the medication in the manner that it is prescribed.

As technicians, we play an important role in educating patients about their dry eye disease and I try to keep conversations with patients as simple as possible. In our practice, technicians are often one of the main sources of information for patients after they are diagnosed with dry eye disease. Therefore, in my opinion, it is incumbent upon us to provide them with the relevant education they need.

References

  1. Nelson JD, Craig JP, Akoek EK, et al. TFOS DEWS II introduction. Ocul Surf. 2017;15(3):269-275.
  2. Jones L, Downie LE, Korb D, et al. TFOS DEWS II management and therapy report. Ocul Surf. 2017; 15:575-628.
  3. Bron AJ, DePaiva CS, Chauhan SK, et al. TFOS DEWS II pathophysiology report. Ocul Surf. 2017;15:438-510.
  4. Craig JP, Nichols KK, Akpek E, et al. TFOS DEWS II definition and classification report. Ocul Surf. 2017;15:276-283.
  5. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.

XIIDRA 101

Featuring: Maria Vasilopoulos, COA

Paid consultant for Novartis

Xiidra Access Resources

Featuring: Lisa Jurgens, COT, OSC

Paid consultant for Novartis

Chapterized Indication & Important Safety Information

Xiidra is indicated for the treatment of the signs and symptoms of dry eye disease.

Please refer to the Important Safety Information and Full Prescribing Information regarding taking Xiidra that may include that it is contraindicated in patients with known hypersensitivity to lifitegrast or any other ingredients, as well as the common adverse reactions, such as instillation site irritation, dysgeusia, and reduced visual acuity.

Hello, my name is Maria Vasilopoulos. I am a Certified Ophthalmic Assistant at the Illinois Glaucoma Center in Mokena, Illinois.

Welcome to Tech Talks – Xiidra 101. Today, we will review Xiidra (lifitegrast ophthalmic solution 5%), a first-in-class prescription therapy approved to treat both the signs and symptoms of dry eye disease.1,2 Specifically, we will cover the clinical data and learn about what may be important to relay to a patient once they are prescribed Xiidra by their physician.

First, let's review some basics of Xiidra...

Xiidra is an LFA-1 antagonist1; It was specifically designed to target a source of underlying inflammation that may fuel dry eye disease.1,3-5

Xiidra was studied in five clinical trials with over 2400 patients.1,6 Xiidra versus vehicle was evaluated for efficacy and safety in four, 12-week, randomized, double-masked, vehicle-controlled clinical trials of 2133 patients.1 Xiidra versus vehicle was also evaluated in a 1-year safety trial of 331 patients.6

Next, let's take a look at Xiidra and its effect on symptoms of dry eye.

Symptoms of dry eye were evaluated using a patient-reported Eye Dryness Score on a visual analog scale of 0, which equaled no discomfort, to 100, which represented maximal discomfort.1 The average baseline Eye Dryness Score in the clinical trials was between 40 and 70.1

Xiidra provided symptom relief from eye dryness in as little as 2 weeks, which was shown in 2 out of 4 studies.1 In all 4 studies, Xiidra provided symptom relief from eye dryness at 6 and 12 weeks.1

Now, let's take a look at clinical signs, or what the physician may observe.

In the Xiidra clinical trials, Inferior fluorescein Corneal Staining Score was measured on a scale of 0, which equaled no staining, to 4, indicating coalescent staining.1 The average baseline Inferior fluorescein Corneal Staining Score in studies 1 and 2 was 1.8 and in studies 3 and 4 was 2.4.1

With Xiidra, notable improvement was observed in the clinical signs of dry eye disease based on Inferior fluorescein Corneal Staining Score.1 Xiidra demonstrated an improvement in Inferior fluorescein Corneal Staining Score at 12 weeks in 3 out of the 4 studies.1

Artificial tear use was assessed as an exploratory endpoint in the 1-year SONATA safety study of Xiidra versus vehicle in 331 patients.6 A lower proportion of patients in the Xiidra group used artificial tears at any study timepoint after Day 14 compared with the vehicle group.6 At each study visit, the proportion of participants in the Xiidra group who reported use of artificial tears since the last visit was numerically lower than the vehicle. Nearly 8 out of 10 Xiidra patients did not use artificial tears at Day 90.6

At each study visit the proportion of participants in the Xiidra group who reported use of artificial tears since the last visit was numerically lower than the vehicle. Nearly 8 out of 10 Xiidra patients did not use artificial tears at day 90.6

Xiidra was generally well tolerated in clinical trials.1,6

The most common adverse events reported in 5% to 25% of patients were instillation-site irritation, dysgeusia, which is an unusual taste sensation, and reduced visual acuity.1

In the 1-year safety study, most adverse events were mild-to-moderate in severity.6

Additionally, less than 2% of Xiidra patients discontinued treatment due to the most frequent adverse events.6

In our practice, we tell our patients that when starting Xiidra, they may not notice immediate symptom relief and we instruct them to continue their preservative-free artificial tears as well. We also let them know that they may experience burning or irritation, or they may have unusual taste sensation, after instilling Xiidra.

Once I explain the Xiidra efficacy and safety profile to patients, I review all the necessary information they will need to start and stay on treatment.

First and foremost, I always instruct my patients to use Xiidra twice a day, about 12 hours apart.1 They should use one drop in each eye in the morning and one drop in each eye in the evening.1 I tell my patients to use the medication as directed by their eye care professional. One thing that I find helpful when I advise patients on dosing is to tell them to incorporate Xiidra into their daily routine, like brushing their teeth.

I also tell them that they should use Xiidra right away after opening the single-use container. After they have applied it to both eyes, I tell them to immediately throw it away and do not save it for later.1 If they are a contact lens patient, they need to wait 15-minutes after installation before putting their contact lenses back in.1

As technicians, we need to be knowledgeable about treatment, including when it may start working, the safety profile, and how to instill it, to name a few. Once the doctor leaves the room, it is inevitable that the patients will always have more questions and they rely on me to provide them with the information they need.

References

  1. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
  2. U.S. Food and Drug Administration. Accessed October 5, 2020. https://www.fda.gov/news-events/pressannouncements/fda-approves-new-medication-dry-eye-disease.
  3. Perez VL, Pflugfelder SC, Zhang S, Shojaei A, Haque R. Lifitegrast, a novel integrin antagonist for treatment of dry eye disease. Ocul Surf. 2016;14:207-215.
  4. Pflugfelder SC, Stern M, Zhang S, Shojaei A. LFA-1/ICAM-1 interaction as a therapeutic target in dry eye disease. J Ocul Pharmacol Ther. 2017;33:5-12.
  5. Bron AJ, DePaiva CS, Chauhan SK, et al. TFOS DEWS II pathophysiology report. Ocul Surf. 2017;15:438-510.
  6. Donnenfeld ED, Karpecki PM, Majmudar PA, et al. Safety of lifitegrast ophthalmic solution 5.0% in patients with dry eye disease: a 1-year, multicenter, randomized, placebo-controlled study. Cornea. 2016;35(6):741-748.

Chapterized Indication & Important Safety Information

Xiidra is indicated for the treatment of the signs and symptoms of dry eye disease.

Please refer to the Important Safety Information and Full Prescribing Information regarding taking Xiidra that may include that it is contraindicated in patients with known hypersensitivity to lifitegrast or any other ingredients, as well as the common adverse reactions, such as instillation site irritation, dysgeusia, and reduced visual acuity.

Hello, my name is Lisa Jurgens. I'm a Certified Ophthalmic Technician and Certified Ophthalmic Scribe at Art Vision in Sioux Falls, South Dakota.

Welcome to Tech Talks, Xiidra Access Resources. Today we will review Xiidra access resources available to your patients.

In my practice, not only are technicians typically the first point of contact for the patient, but we are often also the last. From my perspective, once the patient receives a prescription for Xiidra from the physician, I try to do everything I can to remove any potential barriers that may get in the way of a patient getting Xiidra.

In my practice, the first question patients typically ask is, “Is Xiidra covered by my insurance?” Here are a few helpful things to know. A prescription for Xiidra is available as a 30-day supply or a 90-day supply.

In my practice, once the physician prescribes Xiidra, I proactively discuss coverage and out-of-pocket costs with the patient. I let them know that this will be determined by their insurance – and that every insurance is different.

If the patient has commercial insurance, I explain that Xiidra is covered on 88% of commercial insurance plans. I also add that 66% of those commercial plans cover Xiidra without any restrictions.1 So, if they fall under one of those plans, this means they can go right to the pharmacy and get their prescription filled without any additional information needed

Typically, in my practice, if the patient is under 65 years of age and has insurance, most likely it is a commercial plan.

Xiidra is also covered on select Medicare plans, but if you find this is not the case, there is support available for Medicare patients to help them gain access to Xiidra.

Novartis has several resources available to help you and your patients with Xiidra access and coverage.

These include the new Xiidra Access Program with CoverMyMeds, which offers dedicated support services for the prescription process, including benefits verification and prior authorization assistance, if required.

Once the physician writes a prescription for Xiidra, you can proactively request a benefits check of prescription insurance coverage and cost for your patient through CoverMyMeds. This typically takes 1 to 2 business days and no patient signature is required.

While this service is optional, it is helpful to know what your patients will pay and what the coverage is for Xiidra up front.

Many commercially insured patients do not require a prior authorization, however if one is required, enhanced PA support services are available through CoverMyMeds.

In my practice, we have a person dedicated to assisting patients with prior authorizations, but not all practices have that. Therefore, it is important to document as much as possible in the patient’s chart. This will assist everyone in the office, as well as your patient, with the prior authorization process.

A Xiidra specialist monitors the progress of each patient case and contacts you if additional information is needed. They track and assist with office- and pharmacy-initiated PA requests to obtain a decision for your patient. They communicate with you and the pharmacy after the PA decision is obtained.

Then, if the prior authorization is approved, CoverMyMeds will follow up with the pharmacy to fill the prescription and notify the patient. If it is denied, they can help request additional forms and provide appeals process support, if needed.

There are great patient support and savings programs in place for Xiidra. Novartis has provided our office with a lot of education so that we have the knowledge and tools to be successful. In our practice, we use CoverMyMeds for a lot of prior authorizations. In particular, the prior authorization support for Xiidra is very helpful.

The biggest hurdle with prior authorizations is adequate clinical information. Documenting a thorough history, including any past dry eye therapies, both over-the-counter and prescription, is especially important. Knowing how a medication works and how it differs from other prescription therapies is imperative in this process as well. We have great success with Xiidra in our practice. We believe in the science behind it and see that it works. We do what we can to help our patients benefit from the right therapy the first time.

If your patients need additional financial assistance or support, there are different ways that you and Novartis may be able to reduce their out-of-pocket costs for Xiidra. These avenues are available to you through CoverMyMeds as well.

These include a Xiidra co-pay assistance program for commercially insured patients and the Novartis Patient Assistance Foundation for those with limited or no prescription coverage.

If your patient is experiencing financial hardship or has limited or no prescription coverage, they may be eligible to receive their Novartis medications for free. Information for the Novartis Patient Assistance Foundation can be found by visiting pap.novartis.com.

Once a physician prescribes Xiidra, the conversation with the patient is very important. As technicians, we want to be aware of all of the patient services and programs that support patient affordability, and be prepared to relay that information to all patients who are prescribed Xiidra.

Ask your Novartis representative to walk you and your colleagues through the details of these programs. They can be helpful and can alleviate some of the burden for your patients.

References

  1. Data on file. Fingertip Formulary Datafeed, March 10, 2020. Novartis Pharmaceuticals Corp; March 2020.

Technician Resource Center

Tech Total Leave Behind

Learn how to recognize the risk factors and symptoms of DED to help identify appropriate patients for diagnosis.

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Key Facts Tech Flashcard

Help set patients up for success with key facts about Xiidra, patient savings opportunities, and more.

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Xiidra Prior Authorization Checklist

Ensure seamless access assistance for appropriate patients with this easy-to-use Prior Authorization Checklist.

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Indication

Xiidra® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of signs and symptoms of dry eye disease (DED).

Important Safety Information

Click here for Full Prescribing Information.

Indication

Xiidra® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of signs and symptoms of dry eye disease (DED).

Important Safety Information

  • Xiidra is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients.
  • In clinical trials, the most common adverse reactions reported in 5-25% of patients were instillation site irritation, dysgeusia and reduced visual acuity. Other adverse reactions reported in 1% to 5% of the patients were blurred vision, conjunctival hyperemia, eye irritation, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus and sinusitis.
  • To avoid the potential for eye injury or contamination of the solution, patients should not touch the tip of the single-use container to their eye or to any surface.
  • Contact lenses should be removed prior to the administration of Xiidra and may be reinserted 15 minutes following administration.
  • Safety and efficacy in pediatric patients below the age of 17 years have not been established.

Click here for Full Prescribing Information.