Annual anti-inflammatory review
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Sigh. Summertime in the northern latitudes is a fleeting joy.
As you read this, Labor Day has come and gone. We celebrated my Mom, and the memory of my Dad, with a 30th consecutive White Family week on Cape Cod. It always seems like summer is over when I drive back over the Sagamore Bridge and head home. The days are getting shorter and shorter. Even here in Cleveland, on the western border of the Eastern time zone, my beloved Lake Erie sunsets are starting to occur during dinner. It will not be long before my daily commute takes place in the gloaming. You know what that means: It is time, once again, for my annual review of the anti-inflammatory landscape in the treatment of dry eye disease (DED).
We are actually going to have a couple of new things to talk about this year. Well, newish at least. But first, a word from the estimable Maria Scott, MD, of Baltimore. Actually, two words: Ster Roids! While we were playing hooky from a summer conference, I asked Dr. Scott how she was handling dry eye in her cataract surgery patients. She does a ton of cataract surgery and uses multifocal IOLs on a large percentage of her patients. She reminded me of my “go-to” solution for DED that is worrisome when you are doing preop testing. “Ster Roids” is still the “easy button” when you need short-term DED treatment.
This is a good time to reinforce the fact that DED is by and large an inflammatory disease of the ocular surface. Literally any topical steroid is going to reduce that inflammation and consequently reduce your patient’s symptoms. This is not only true for acute perioperative indications but pretty much the majority of DED. Indeed, Kala Pharmaceuticals has done a terrific job pointing out the fact that intermittent symptoms — “flares” as it calls them — are typical of the DED patient’s experience. There is a move afoot to simply treat DED as a chronic, relapsing condition with intermittent topical steroids. Eysuvis (loteprednol etabonate ophthalmic suspension 0.25%, Kala) has this exact indication on its label. While Flarex (fluorometholone acetate ophthalmic suspension 0.1%, Eyevance Pharmaceuticals) does not have “dry eye” on its label, pretty much all of the ocular signs that we see are on the Flarex label.
I would be less than forthright if I did not say “out loud” that any topical steroid containing either loteprednol or fluorometholone is an appropriate DED option. As much as I would like to choose an on-label option, especially one from a company that went through the trouble and expense of obtaining that elusive status, the bottom line remains: Ster Roids. Period. Even here, though, there are risks. In the phase 3 trials of Eysuvis, there were almost no medically significant episodes of elevated IOP. However, anyone who has been in practice for more than 6 months has seen increased IOP with literally every steroid ever produced. You need to monitor these patients for IOP elevation whether they are on chronic daily treatment or chronic intermittent therapy. “Treat ’em and street ’em” is never appropriate when you are prescribing steroids.
In a world in which we have not had a true newcomer since the introduction of Xiidra (lifitegrast ophthalmic solution 5%, Novartis) 5+ years ago, what could possibly be new? Let me be among the first to introduce something that is truly new in the DED world: real competition in the immunomodulator space. You heard that correctly. For the first time in, like, ever, we now have true competition in the entire marketplace for immunomodulators. Yes, I know, in the commercial space for patients younger than 65 years that represents roughly 50% of the DED market, there is already competition. That is to say, there is insurance “coverage” for all three of the players for non-Medicare patients. When I last looked, market share here was roughly 40% Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan), 40% Xiidra and 20% Cequa (cyclosporine ophthalmic solution 0.09%, Sun Pharma) (poor Cequa had the misfortune to be launched just in time for the pandemic lockdowns). True to its roots, Sun also has an aggressive discount program for cash-pay patients in this space through CoverMyMeds.
What is really earth-shaking is what is happening right now for Medicare-eligible patients. Restasis is about to find itself in competition for the Medicare market. It remains astonishing that we still do not have a true “generic” version of Restasis from any of the big pharma players. What we do have is a compounded formulation of cyclosporine 0.1% in the Dick Lindstrom-created chondroitin sulfate emulsion Klarity-C. Klarity-C from ImprimisRx was evaluated by a group led by Cynthia Matossian, MD, in a study published in Clinical Ophthalmology. Dr. Matossian and her colleagues demonstrated a clear clinical effect from Klarity-C on Ocular Surface Disease Index and corneal staining. While there were no adverse reactions noted in the study, the authors did point out that tolerability was not specifically investigated. In a brief trial at SkyVision, we found that both Restasis and Cequa were better tolerated in our patients. Your mileage may vary.
On July 19, Sun rolled out the first program to address covering Medicare Part D patients. Like all of these programs, the first hurdle that must be overcome is that of compliance with the myriad regulations involved with all things government. There are two issues that apply. First, patients who require chronic ongoing care can opt out of Medicare coverage for that single care item. That sounds weird, but it is true. Step one is your patient attesting by email that they will not be asking Medicare to pay for their immunomodulator. The second compliance hurdle has to do with pricing. Any producer or provider is prohibited from inducing a Medicare-covered patient to seek care. A pharmaceutical company cannot price its product so low that the price could be considered such an inducement. Sun is charging $89 to $95 per box, a 1-month supply of 60 vials, beginning at day 1. This compares with the typical $40 post-deductible co-pay for Restasis. Because your patient has opted out of Medicare coverage for Cequa, this means that deductibles do not come into play, and there is no “donut hole” nonsense to deal with.
In short, we now have competition.
How might this play out in our clinics? Quite frankly, I do not know. Some of you may just write for Klarity-C and hope for the best. Others may become facile with the process of using the Sun/Cequa end around and make that your go-to. I envision those practices that have worked hard to perfect their treatment regimens around the tried and true of Restasis to continue to do everything we have always done to get La Grande Dame of immunomodulators in the eyes of their patients. Might we see some mixing and matching of cyclosporine formulations, with patients moving in and out of specific brands as they move through the “seasons” of an insurance coverage year? Your guess is as good as mine.
What I do know is that this is a big old wakeup call to our friends at Novartis. Xiidra deserves a place at the Part D table. What will it take to get them in the game? Stay tuned, sports fans.
- Reference:
- Matossian C, et al. Clin Ophthalmol. 2021;doi:10.2147/OPTH.S308088.
- For more information:
- Darrell E. White, MD, can be reached at SkyVision Centers, 2237 Crocker Road, Suite 100, Westlake, OH 44145; email: dwhite@healio.com.
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