BLOG: N = 1: The dry eye doc as guinea pig
Click Here to Manage Email Alerts
Here it is, at last, the official report of the (not very) momentous (non)randomized (un)controlled clinical trial of “Fauxstasis.”
As I promised in my Dec. 7 post, I engaged in a clinical trial of Fauxstasis (cyclosporine A 0.05% in a castor oil emulsion, Mylan/Viatris) as a substitute for Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan), N = 1. With the exception of (successful!) trials of Cequa (cyclosporine ophthalmic solution 0.09%, Sun) and Xiidra (lifitegrast ophthalmic solution 5%, Novartis), I have been on Restasis continually since it was originally approved. One of my long-term dry eye disease patients was changed to Fauxstasis after roughly 5 years of continuous treatment with Restasis. But before she made the switch, her insurance changed and — huzzah — original branded Restasis was once again a covered med. She handed over several boxes of Fauxstasis, and I switched over for a 10-week trial.
And the verdict is: Meh, a great big nothingburger nonevent.
In my (not at all) massive trial, switching from one oil emulsion to another, I did not find any meaningful difference between the two versions of 0.05% cyclosporine A. No stinging or burning. No drop-off in overall comfort weeks after starting. There are several things that should be noted. First, I have been treated for many, many years. My trial doesn’t tell us anything about starting treatment-naive patients on Fauxstasis vs. the real deal. Second, I have demonstrated a tolerance for other immunomodulators; I was successful taking both Cequa and Xiidra, too. Still, using Fauxstasis rather than Restasis was clinically a nonevent.
What does this mean for you as the prescriber, your staff as the facilitators and your patients? I am telling patients not to worry if their insurance pushes a switch to a generic Restasis. It’s not worth fighting over, at least the first time it happens. You still have a 75+% chance that they will get real Restasis (three of the four generics on the market are made by Allergan), they are likely to have the same experience as I did, and like my patient above, they will likely be bounced between immunomodulators multiple times by their insurance company anyway. We tell them to send us a picture of what they get, and if they fail on Fauxstasis, we can reasonably demand brand only from then on.
What if they are just starting on an immunomodulator? I am still sticking to brand only for at least three rounds of doing battle with insurance. We try to make an end-around by prescribing Cequa or Xiidra. Note that Sun is still offering a very aggressive specialty pharmacy option at a very reasonable cost to the patient, and Novartis (still here!) has continued to increase coverage, especially in Part D. Get stuck prescribing a generic after all of the battles? Our EMR drop-down gave us the option of choosing our generic manufacturer! Yahtzee!
At the end of the day, the barrier to obtaining an immunomodulator, brand or generic, is going to be out-of-pocket cost for your patient. If you are stymied, you can always reach out to my new BFF Mark Cuban at Mark Cuban Cost Plus Drugs! Sixty vials (90 days for our patients) is currently $128 and change. That’s less than $43 per month. You can sell that price point all day.
N = 1. Your mileage may vary.
Collapse