Tracking Omidria since its arrival ...

... finds that some surgeons won’t try this dilation medication; they’re misinformed about its purpose and cost.

By Robert Calandra, Contributing Editor

Here’s a head-scratcher. A product on the market has shown through clinical studies its efficacy and its value, to surgeon and patient. Those ophthalmologists who use it are quite happy with it.

And it’s practically free — for two more years. Medicare picks up most of the tab. There is no co-payment for Omidria in a hospital outpatient setting. In the ASC, the patient might have a 20% copayment.¹

But it hasn’t been universally adopted. The reason? Misconceptions — over its purpose and its cost.

“Doctors shouldn’t be scared of [Omidria],” says James Loden, MD, one of several authors of a 2014 study. “It’s a very good product [for cataract surgery]. We love the product and we’re using it on every single patient who qualifies.”

“I definitely use it,” says Cynthia Matossian, MD. “Omidria [phenylephrine and ketorolac injection, Omeros] helps secure that the pupil stays nice and dilated. When the pupil becomes small it makes surgery much more difficult, and that leads to complications.”

Yet some surgeons have been slow to incorporate this treatment; a study published in Clinical Ophthalmology in June 2015 called it “an exciting new class of medication” and another in the same journal in September 2014 “an innovative addition to the available therapies.”

Triple whammy

In their July study 2015 published in Clinical Ophthalmology, Lola Elizabeth Lawuyi and Avinash Gurbaxani describe FDA-approved Omidria as a combination phenylephrine/ketorolac injection that “maintains intraoperative mydriasis, prevents miosis and reduces postoperative pain. When miosis develops during cataract surgery, it compromises the visualization of the surgical field and working space for surgeons, which may cause posterior capsular tear and associated vitreous loss, longer surgical time and postoperative inflammation.”

“We see eyes every day that start out well dilated where the pupil constricts throughout the case,” says Dr. Loden, who runs three vision centers in Nashville, Tenn. “Omidria keeps the pupil better dilated, which makes the surgery easier for me and makes the surgery go faster.”

While Dr. Loden uses Omidria in its combined, injectable form — a 4-ml vial of Omidria is mixed with a 500 cc-bottle of balanced salt solution — he says some surgeons have had success removing the medication from the bottle to insert into the anterior chamber, where normally they would use a lidocaine epinephrine mixture.

Dr. Loden has also found Omidria to be “very synergistic” with triamcinolone/moxifloxacin (Tri-Moxi, Imprimis) injections used in dropless cataract surgery.

“We’ve shown that Tri-Moxi has an 8.5% breakthrough rate where the patient has to be started on drops,” says Dr. Loden, who plans to submit these findings in a paper. “However, only one out of more than 70 patients that had Tri-Moxi with Omidria needed breakthrough medications. That’s a fairly big difference that is going to improve patient satisfaction.”

Misconceptions

Dr. Loden believes that surgeons have been slow to adopt Omidria for two reasons. First, physicians simply don’t understand what Omidria does. “Some doctors think that you’re supposed to put the Omidria in and it will make a poorly dilating pupil dilate,” he says. “That is not true in any form or fashion.”

Dr. Matossian agrees that “a misunderstanding” has contributed to the drug’s low adoption rate. “It is not for dilating the pupil,” says Dr. Matossian, who has offices in Pennsylvania and New Jersey. “It actually is for maintaining the pupil from getting smaller. It doesn’t take a tiny pupil and make it big. It keeps the pupil from getting small.”

Studies show complications in cataract surgery increase when operating in a pupil smaller than 6 mm, says Dr. Matossian. Surgeons may leave a small nuclear fragment or cortex in the bag, or the implant may not be aligned properly. “So ideally you can use it on any patient where you think the pupil may get small,” she says. “That is one of its two main indications besides pain control during surgery and in the immediate post operative period.”

The other reason for the low adoption rate, both surgeons agree, is price. Omidria costs $465 per 4-ml vial. Many doctors look at the medication’s price, factor in Medicare’s $500 to $600 reimbursement for cataract surgery plus concern about their utilization rate going up and say “no thank you.”

Take advantage of pass-through

Those concerned about the price should consider that Omidria is known as a pass-through drug, Dr. Loden says.

The pass-through system, created by the federal government, allows medical professionals in any specialty to try the pass-through-designated drugs so that Medicare can evaluate the adoption rate and decide if it will add the therapy to its formulary. Money to pay for pass-through drugs is set aside in a separate budget.

Until New Year’s Day 2018, Medicare handles most, if not all, of the cost, as already noted. But for patients with insufficient medical coverage or otherwise financial problems, Omidria has started a program called OMIDRIAssure.*

The thing that physicians need to remember when trying to bill for these patients is don’t contact Medicare: they must enroll these patients in Omidria’s program first.²

“They … have a really good program to pre-certify all the patients to make sure that Omidria is approved with their insurance plan,” Dr. Loden says. “Doctors really shouldn’t be scared of it. It’s a very good product. We’re using it on every single patient that qualifies.”

*Details about the Omidria program can be found at www.omidriassure.com

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