When the going gets weird
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Man, this sure is not turning into one of those “nothing to see here” columns.
No sir, the 12 months that have passed since we last sat down together to review the state of anti-inflammation treatment in dry eye disease (DED) have been tumultuous, to say the least. Yes ma’am, I am planning to review the whole mess for you all out there in Eyeland. After doing that, I may have a thought or two about what is on the way and how we may collectively be able to turn this wild and woolly world into one in which both our patients and our practices thrive.
Oh, and if I were a betting man, I would make a wager that somehow AzaSite (azithromycin ophthalmic solution, Théa) will be a factor, too.
Why not start with the biggest DED story since the approval of Xiidra (lifitegrast ophthalmic solution 5%, Novartis) in 2016, the generification of Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan). More than anything else, the day that Mylan's “Fauxstasis” was approved by the FDA is the day this all started to get weird. Calling this the elephant in the room is a monumental understatement. This is Colonel Hathi leading the whole Dawn Patrol through the Dry Eye Jungle, stamping and crushing through the underbrush in military style. For the moment, we still live in a world where the core strategy to treat DED is to identify and treat the underlying inflammation. For almost 20 years, even with the approval of Xiidra and Cequa (cyclosporine ophthalmic solution 0.09%, Sun Pharmaceutical), this part of the conversation has been filtered through Allergan and the Restasis prism.
Now? Where once every newcomer of any type was forced to confront the Allergan managed markets juggernaut in both the commercial market and Medicare Part D, we now have a landscape that is divided in two as completely as a pre-rail age Continental Divide. We have found that every prescription we write in the under-65 commercial market is being put through a step edit, requiring that the patient be put on “generic” Restasis first. Like a petulant toddler, I have reacted to this by writing for cyclosporine A 0.09%, just to make the insurance carriers squirm a bit under the “you are practicing medicine without a license” accusation thing. How is that working? Stomped and squashed by Colonel Hathi’s patrol.
Other than the frustration of being thwarted by United Aetna Bluemana, does it really matter if our patients get a “generic” Restasis? Meh, probably not. As I recently wrote, three of the four generic options are actually manufactured by Allergan; they are real, live Restasis with a different label. Only Fauxstasis is different. Who knows if it will be any good? I still have yet to have a patient who is using it. If it turns out to be pretty good, there is no reason why we should give a hoot. On the other hand, if most of our patients fail, we will be able to document that they have failed generics and that they require brand. Not a terrible outcome.
Medicare Part D for the 65 and older crowd has likewise been trampled beyond recognition. With a few notable outliers notwithstanding, through 2021, your Medicare patients could get any immunomodulator you wanted for them as long as it was Restasis. Is this also a generic desert like the commercial market? Far from it. As of this writing, Part D is a “brand over generic” market with very little generic penetration. Weirder still, almost any brand you write has equal coverage. You read that right: If you write for Xiidra and in many cases Cequa, your Medicare patient is covered as if you wrote Restasis.
I know. Crazy talk. Enjoy it while we can.
Want some more immunomodulator weird? Of course you do. There is another cyclosporine on the market right now, and yet another company has filed with the FDA to bring a new and unique cyclosporine drop to your sample drawer. Santen introduced Verkazia, a 0.1% cyclosporine approved for the treatment of vernal keratoconjunctivitis. Why not use Verkazia for DED, you might ask? I mean, if 0.09% is good, 0.1% must be better, right? Like garlic. Sorry, Bucky. Verkazia is going for the whole orphan drug, rare disease thing, and it is priced accordingly. Think Oxervate’s (cenegermin-bkbj, Dompé) little brother. Nobody is going to pay that price to treat DED.
Novaliq rounds out the immunomodulator news with its recent announcement that it is applying for FDA approval for CyclASol. This is a water-free formulation that passed the traditional FDA bar of increased Schirmer score compared with vehicle. In later studies, CyclASol also reduced staining and had a positive effect on some symptoms. Not gonna lie, this seems like a very cool product that would have taken the market by storm if it came out 3 or 4 years ago. Novaliq, or whoever may own it when it launches, faces a heavy lift; as a cyclosporine A product, I just cannot see it avoiding the dreaded step edit in favor of a generic. We will see.
Things have been plenty of weird in the topical steroid world, too. Alcon has reentered the world of eye care pharmaceuticals, purchasing Eysuvis (loteprednol etabonate ophthalmic suspension 0.25%) and Inveltys (loteprednol etabonate ophthalmic suspension 1%) from Kala Pharmaceuticals. Poor Kala. I cannot think of another company in our space that was so completely bludgeoned by the pandemic and resulting lockdowns. Colonel Hathi and the Dawn Patrol on the other steroids. The Alcon acquisition set off the third sales force bloodbath in the DED space; pretty much the entire Kala sales crew headed out the door in the sad footsteps of their Shire/Takeda and Allergan colleagues lost in prior upheavals. Bausch + Lomb, the traditional leader in the loteprednol space, has been quiet of late. Boy, it would be great if it grabbed the reins and took a shot at sales dominance here. What a weird time to be doing a management change.
Santen also entered the market by taking out Eyevance. Without an existing presence in U.S. eye care, Santen kept the sales force intact. In addition to the above mentioned Verkazia, Flarex (fluorometholone acetate 0.1%) and Zerviate (cetirizine ophthalmic solution 0.24%) are its products in this space. Reviving Flarex was weird to begin with. What made these products viable in such a crowded landscape was brilliant positioning and marketing by Jerry St. Peter and Jason Werner, neither of whom is around at the moment. Can the new (big) kid on the block keep the oldest promoted steroid brand, Flarex, relevant?
Finally, the latest on my personal white whale, Moby AzaSite. Talk about weird. Théa swooped in from France and picked off the branded portfolio previously treading water at Akorn. The seas were calm, and the winds were following. Everything looked awfully promising for a smooth, seamless handover of AzaSite. Yah. About that. Did you know that the FDA not only reviews clinical trials in order to approve or disapprove a new drug, but that it also inspects and certifies every manufacturing line responsible for producing the finished products? Weird. The winds howl through empty warehouses as we await the FDA’s blessing, hopeful that AzaSite will once again be swimming in the wild.
An awful lot has transpired since my 2021 anti-inflammatory review, most of it weird. I said above that I may have some thoughts on what is to come, but alas, I am afraid I have nothing to offer right now. Frankly, it is all too weird. But fear not, me droogies. We are DED doctors. We are all, each of us in our own way, weird. We are what has become of the original red-haired stepchildren who once upon a time insisted that DED was, indeed, a real disease and should be treated as such. On behalf of our patients, we will figure this all out, even the AzaSite part.
Remember, when the going gets weird, the weird turn pro.
- 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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