Disclosures: White reports he is a consultant to Allergan, Shire, Sun, Kala, Ocular Science, Rendia, TearLab, Eyevance and Omeros; is a speaker for Shire, Allergan, Omeros and Sun; and has an ownership interest in Ocular Science and Eyevance.
September 22, 2020
5 min read

Annual anti-inflammatory review

As expected, the past year was quiet in the anti-inflammatory arena.

Disclosures: White reports he is a consultant to Allergan, Shire, Sun, Kala, Ocular Science, Rendia, TearLab, Eyevance and Omeros; is a speaker for Shire, Allergan, Omeros and Sun; and has an ownership interest in Ocular Science and Eyevance.
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“There ain’t no cure for the summertime blues.”

Man, what a weird summer, eh?

Darrell E. White, MD
Darrell E. White

You were at work, sure, but work was not even a little bit normal. If you are in private practice like I am, you quickly got buried in the work you would have done during the pandemic lockdown. Of course, you also had to plow through all of the extra work the lockdown caused because so many of your patients, especially those with dry eye disease, got so much worse because they had to miss appointments. Those of you in academic practices reportedly had the additional challenges posed by countless layers of nonclinical administrators playing CYA, enforcing arbitrary interpretations of the ever-shifting federal, state and local lockdown laws. None of us, of course, enjoyed any of our usual vacation time.

It was enough to give anyone those ol’ summertime blues.

Last September, I predicted that nothing would happen this year. At least nothing good. Was I right? Pretty much. Thus far, no groundbreaking programs to help practices manage the insurance wars. No truly inspiring marketing from anyone, unless you want to count Allergan’s reentry into DED as inspiring. What say we go through the roster of players and review what happened in our offices and out in the business world.

After the “year of steroids” in 2019, this year turned out to involve little of note when it comes to steroids. Like me, you probably noticed that increased IOP is still an issue with long-term steroid use regardless of which one you use. Poor Kala has yet to get its version of loteprednol for intermittent dry eye symptomatic flare-ups approved by the FDA. Its PDUFA date is sometime in October; soon after you read this, we will learn if there will be a topical steroid drop with the words “dry eye” in its labeling. We should be cheering for Eysuvis to be approved if just to hear Mitch Jackson rail at an insurance company for changing his prescription to a non-FDA-approved alternative. Prediction: We use steroids more frequently for shorter periods of time in 2021. Corollary: We attempt a return to the cyclosporine/lifitegrast combo for chronic dual treatment at the expense of chronic steroid use.

Speaking of approvals, after the publication of last year’s review, Sun Pharma did indeed manage to get Cequa (cyclosporine ophthalmic solution 0.09%) onto the market. Not only that, but the Sun managed markets people have somehow gotten Cequa onto the formularies of a few Medicare Advantage programs. Man bites dog! For more years than I care to count, I have been ranting like a madman that giving patients in the Medicare age group access to more than Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan) was basically winning the Triple Crown: ease of use for patients, ease of prescribing for doctors and better business for the pharmaceutical companies. Rising tides and all that. Here is hoping that this is a trend.

The Restasis juggernaut keeps chugging along. Now some 3 years off patent, Restasis continues to enjoy a nearly 70% market share. Some of this can be explained by its dominant position on Medicare Part D formularies, but standing on this fact alone underplays two significant things about Restasis: It works well, and it is better understood than the other immunomodulators on the market due to its long tenure. Yes, it often stings in the early going; we all know that we will be more successful initiating Restasis treatment if we use an adjuvant steroid prescription for a brief period. Everyone who prescribes Restasis knows to caution their patients that it may take weeks to months to fully kick in. Those who are most successful will schedule their patients appropriately to encourage them to keep the faith until it does.

Regarding my prediction that the “big three” would not engage in any significant promotion, it looks like I batted 1.000, at least for 2020. Cequa and Restasis can be expected to engage in the most interesting battle of the upcoming year, at least in part due to the tiny little foothold in Part D noted above. What will make this one a barn burner is Allergan’s reentry into the arena. Reluctant to give much support to Restasis with the threat of generic competition, Allergan has been emboldened by the failure of the large generic manufacturers to bring a product to market. Back into the field have come the reps, armed with new marketing and educational collateral as well as traditional promotions such as staff lunches. Ads have appeared everywhere ophthalmologists cast their eyes. Who knows, when dining restrictions are lifted around the country, we may even see Allergan-sponsored — wait for it — chicken dinners. Prediction: Allergan, Sun and Novartis spend a lot of money on marketing in 2021 (as of this writing, Novartis has introduced us to the Dry Eye Troll). Corollary: Only one company shows any significant resulting sales increase.

Cyclosporine siblings Restasis and Cequa and cousin Xiidra (lifitegrast ophthalmic solution 5%, Novartis) are quirky medications that require a special, detailed knowledge on the part of prescribing doctors and their staff members in order to successfully treat DED. Add to this the fact that all three are quite expensive, and it is easy to see why many anterior segment doctors simply throw up their hands and decline to treat using any of them. Another reason we can look forward to a spirited battle between Allergan and Sun this coming year is a renewed commitment by both to offer assistance to patients (in the form of “buy-downs” and discounts) and your staff (easy to use coupons and prior authorization assistance). It takes a ton of work to get these medications into our patients’ hands, and new programs supporting Restasis and Cequa are going to help.

So, what about Xiidra? Nine hundred-plus words in, and almost nothing about the star of last year’s review? As I have mentioned in the past, Xiidra had perhaps the most auspicious launch of any medication in my career. It spawned a culture that was embraced by the sales staff and early-adopting prescribers. Coupled with its relatively rapid onset of symptom relief (and a side effect profile on a par with Restasis and Cequa), Xiidra quickly became a go-to prescription. Shire added to the allure by creating a dedicated prescriber support system that dramatically reduced the workload shouldered by office staff. Sold twice in the last 18 months, Xiidra has languished without effective corporate support (note: Novartis has pledged to change this; ads have started to appear in journals and on network TV).

Xiidra treatment is just as challenging to institute as Restasis and Cequa, but the particulars are different. It took Allergan 10+ years of constantly working to teach the prescribing community how to use Restasis. Without peer-to-peer education (no chicken dinners), how will Novartis do the same for Xiidra? Of greater concern: What will transpire with the demise of the holdover practice support program “Ask IIRIS”? At first glance, responsibility for much of the digging necessary to determine if a patient is eligible for insurance coverage, once done behind the scenes, has now been passed back to the office. Rather than simply suffer through the prior authorization process, we will now also do the grunt work to determine that we must suffer. How will doctors and staff out in the trenches respond when this becomes evident? Prediction: Not well. Corollary: Not very well at all.

The DED anti-inflammatory scene has entered a steady-state phase. Newcomers such as Kala will add a bit of growth to the market, but it remains for the makers of the immunomodulators Restasis, Cequa, and Xiidra to lead. While fighting among themselves for market share, it is important not to lose sight of the real combatants, the DED doctors and staff fighting alongside their patients in the sacred 8 inches that sit between them at the slit lamp. The company that demonstrates the greatest understanding of this essential, unaltered reality will be the most successful. Prediction: Without in-person professional meetings, big pharma drifts away from the slit lamp.

Corollary: The DED market gets the blues as front-line doctors and staff quietly rebel; DED prescriptions are flat.