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How to best incorporate Restasis in treating dry eye syndrome
Restasis usage has several unique challenges involving patient selection, chance of success and long-term medication adherence.
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When I travel to speak on dry eye syndrome, whether I am speaking on behalf of a pharmaceutical or device company or a non-supported CME event, I always use the same introduction to my presentation. There are three core components to caring for dry eye patients in the United States. They deserve the same “care and feeding” and the same level of commitment as your other “important” patients, including premium IOL and refractive patients. If you make this commitment, you deserve to be compensated for your efforts in such a way that you can make a living. Finally, in order to be successful in caring for dry eye patients, you must become an expert in the use of Restasis. Here is a primer on how we use Restasis at SkyVision.
Treating dry eye syndrome
For the moment, Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan) is the only medication that is approved by the U.S. Food and Drug Administration for the treatment of dry eye syndrome. This includes all over-the-counter artificial tears from every manufacturer (more on this in a bit). If only for this reason, it is important to know how, why and when to use it. The pivotal FDA Restasis trials demonstrated an increase in tear production in patients with severe dry eye. We have all seen the slides of goblet cell inflammation before and after treatment with Restasis. In the face of inflammatory dry eye, Restasis works on both a cellular level and “on the hoof.” Safety studies were remarkable in that they uncovered only one side effect of any note: burning upon instillation. Systemic absorption is, for all intents and purposes, zero. While the original indication was for use in “severe” dry eye, groups such as SkyVision and Ophthalmic Consultants of Long Island have shown that Restasis is effective in reducing symptoms and potentially reducing long-term damage to the ocular surface when prescribed in “moderate” dry eye cases.
Physicians are presented with three challenges when using Restasis: choosing appropriate patient candidates for therapy, enhancing the likelihood of clinical success and promoting long-term medication adherence. Each poses a unique challenge when we are talking about Restasis, in part because of the characteristics of the product and in part due to our present health insurance atmosphere. Restasis is not a typical American drug. If you take acetaminophen for a headache, you will likely have some relief from your symptoms within 30 minutes, a pattern that patients have come to expect when treating discomfort. As you know, this is not how Restasis works. It can take weeks after the initiation of treatment to see any effect on signs or symptoms. The medication is expensive and often creates an uncomfortable, adversarial situation within the “health triangle” of patient, doctor and insurer. This can further complicate the task of keeping a patient on her drops in the early going.
Choosing patients
Deciding who should be on Restasis varies with the experience of a particular practice using the medication. The “easy” call comes straight out of the early days of treatment and the FDA trial: low Schirmer results, low tear meniscus and lots of corneal and conjunctival staining. At SkyVision, we would add to this patients with a tear osmolarity (TearLab) higher than 320 mOsm/L and patients who require dosing more than four times a day with over-the-counter artificial tears in order to remain comfortable. These are patients who should be candidates for prescription on the initial visit to your clinic. Anyone who fails conservative treatment (eg, artificial tears, fish oil) who has low tear production and/or staining and/or an abnormal tear osmolarity despite conservative care would qualify for Restasis treatment, especially if he is symptomatic. Philosophically, we are more comfortable with Restasis as a long-term anti-inflammatory treatment than we are with topical steroids, so we tend to attempt a transition from topical steroids to Restasis whenever possible. We will often increase our dosing recommendations to off label three times a day or even four times a day before resorting to adjuvant steroid use.
Increasing chance of success
I am on record that the most important metric in dry eye care is patient symptoms. The greater the severity of your patient’s symptoms, the more important it is to quell them immediately. You also need to do everything you can to prepare your patient for the possibility of discomfort from Restasis itself. In general, the more severe the clinical signs of dryness on your exam, the greater the likelihood that your patient will experience burning and discomfort from your prescription. We assume that every patient will experience this, so we warn everyone; it is hard to get and keep your patient on board when it seems like you made the condition worse. The use of artificial tears before and after Restasis instillation is a good start. Be prepared and become comfortable with prescribing a topical steroid on a tapering schedule for patients who have severe symptoms, signs or both. We like Lotemax gel (loteprednol etabonate ophthalmic gel 0.5%, Bausch + Lomb) four times a day for 2 weeks, two times a day for 2 weeks and then discontinue. Remember to mention to the patient that this is an off-label use.
Continuing treatment
How do we keep patients on Restasis? We continue to see them in the office on a set schedule, just like any other patient with a chronic disease that requires ongoing treatment. A typical schedule is follow-up appointments at 6 weeks after beginning treatment, 3 months after that and then every 6 months for as long as they are on treatment. Remember, people have an “acetaminophen mindset,” and when they feel better, they feel cured. It is your job to keep them on the medication; years of experience have shown us that adherence is dramatically better with 6-month visits than with yearly visits.
A final word on expense and insurance: You, the doctor, will have to be actively involved in discussing both. Because the retail price of Restasis is kept so high, we are forced to respond to incredulous patients suffering sticker shock. Go ahead and give your patient permission to use every last molecule she can squeeze out; her effective monthly price is what she paid divided by how many doses she extracts per applicator. Have your staff learn about every coupon and rebate plan and proactively use them all. Lastly, when you are forced to respond to yet another insurance company demanding justification for your prescription, remember what I mentioned up top and take a page from Mitch Jackson’s playbook for your reply: “I’ve made an accurate diagnosis of dry eye. Restasis is the only medicine that is FDA approved for this diagnosis. Are you asking me to prescribe a treatment for my patient and your insured that is not approved for dry eye?”
For more information:
Darrell E. White, MD, can be reached at SkyVision Centers, 2237 Crocker Road, Suite 100, Westlake, OH 44145; 440-892-3931; email: dwhite2@skyvisioncenters.com.Disclosure: White is a consultant for Bausch + Lomb, Allergan, Nicox and Eyemaginations. He is on the speakers board for Bausch + Lomb and Allergan.