Intracameral combination product brings benefits during, after cataract surgery

Take-home message: The addition of phenylephrine 1%/ketorolac 0.3% injection to the irrigation bottle maintains pupil dilation and makes patients more comfortable intra- and postoperatively.

By Cheryl Guttman Krader; Reviewed by James C. Loden, MD

Nashville, TN-As an adjunct to cataract surgery, phenylephrine 1%/ketorolac 0.3% injection (Omidria, Omeros) is an easy-to-use product that makes the procedure easier for patients and surgeons and improves the postoperative recovery, according to James C. Loden, MD.

Dr. Loden was an investigator in one of the phase III studies investigating phenylephrine/ketorolac injection. Based on that first-hand experience, he immediately adopted the product into clinical practice once it became commercially available.

Phenylephrine/ketorolac injection is added to the irrigation solution. It has pass-through reimbursement status, and Dr. Loden is using it routinely in all patients covered under Medicare part B.

“The combination of phenylephrine and ketorolac is very effective in preventing miosis, and that allows the surgery to be completed faster and with greater safety,” said Dr. Loden, president, Loden Vision Centers, Nashville, TN.

“The presence of ketorolac in the anterior chamber throughout the procedure also seems to improve patient comfort, and I believe it results in much better tissue penetration than a topical NSAID so that it dramatically limits prostaglandin release, resulting in enhanced control of postoperative pain and inflammation,” Dr. Loden said.

Anecdotally, the benefits of intracameral phenylephrine/ketorolac also seem to be translating into reduced corneal edema on the first postoperative day along with more rapid visual recovery, he noted.

“We are now collecting data to further investigate those observations,” he said.

Primary efficacy analyses

In the phase III clinical trials, patients were treated with topical mydriatic and anesthetic agents and randomly assigned to receive the phenylephrine/ketorolac injection added to the irrigating solution or placebo. The primary efficacy analyses showed that patients who received the active agent had significantly greater maintenance of pupil diameter and significantly less postoperative pain.

Inflammation was not assessed as a primary efficacy endpoint in the study. Although investigators were blinded to treatment, Dr. Loden said he sensed which patients received the phenylephrine/ketorolac injection based on his assessments of inflammation at postoperative follow-up visits.

“At 5 to 7 days after surgery, some patients had breakthrough inflammation with conjunctival injection and significant photophobia and required rescue medication whereas the eyes of other patients were very quiet,” he explained. “Although I had no way of knowing, I was pretty certain I could guess which patients were in the control group and which received active treatment.”

In clinical practice, Dr. Loden’s standard perioperative medication regimen includes initiation of a topical NSAID and antibiotic a few days before surgery. Intraoperatively he uses intracameral non-preserved lidocaine and epinephrine (“Shugarcaine”) at the beginning of the case and the phenylephrine/ketorolac injection that is diluted in the irrigating solution. At the end of the case he injects intracameral triamcinolone-moxifloxacin (Tri-Moxi, Imprimis Pharmaceuticals). 

Dr. Loden explained the Shugarcaine provides an immediate anesthetic effect and increased dilation before the viscoelastic is placed in the eye and so aids with viscodilation, while the phenylephrine/ketorolac in the irrigating solution provides continuous dosing of the medications throughout the case. He stated that since he started using phenylephrine/ketorolac injection, he has noticed better maintenance of pupil dilation and greater patient comfort overall.

“When adding phenylephrine/ketorolac injection, I have not had a single patient who needed to be started on intravenous sedation during the case, which is sometimes necessary when I am operating without phenylephrine/ketorolac injection,” Dr. Loden said. “Nor have I had a single case where the pupil suddenly constricts midsurgery.

Using the product also seems to be helpful for maintaining pupil dilation in patients with small pupils who need additional measures to achieve adequate dilation, he noted.

Furthermore, use of phenylephrine/ketorolac injection seems to have mitigated the need for postoperative rescue with a topical NSAID or corticosteroid medication in patients who develop signs of inflammation or photophobia despite receiving the intracameral triamcinolone.

“Anecdotally, there is probably a 10% breakthrough rate in patients who do not receive the phenylephrine/ketorolac injection,” Dr. Loden said. “Now we are collecting data to see if we can definitively demonstrate whether it has a benefit for reducing or eliminating that issue.”

Dr. Loden also noted that his co-managing optometrist recently remarked he was seeing an increasing number of patients who had much clearer corneas and whiter eyes on the first day after surgery. So that the optometrist can determine whether that observation corresponds to use of intraoperative phenylephrine/ketorolac injection, the patients’ clinical charts are now being labeled to identify intraoperative use of the product.

Pass-through Reimbursement Facts

Phenylephrine 1%/ketorolac 0.3% injection (Omidria, Omeros Corp.) has transitional pass-through reimbursement status, which became effective January 2015 and will expire on Dec. 31, 2017.

For patients with Medicare Part B coverage, the payment rate for phenylephrine 1%/ketorolac 0.3% injection across all Medicare Administrative Contractors is the wholesale acquisition cost plus 6% or $492.90 per vial through Sept. 30, 2015. Thereafter, the payment rate will be the average selling price plus 6%. Phenylephrine 1%/ketorolac 0.3% injection is also covered by Medicare Advantage and commercial payers.

There is no co-payment for phenylephrine 1%/ketorolac 0.3% injection in the hospital outpatient department setting. In the ambulatory surgery center setting, the patient may be subject to a 20% co-payment. About 90% of Medicare Part B patients have some form of supplemental insurance, which covers co-payments.

Phenylephrine 1%/ketorolac 0.3% injection is also on the Federal Supply Schedule and on 340B formularies. To ensure that patients under all payer types can benefit from use of the product, the company offers billing support services (844/OMEROS1), and is establishing a phenylephrine 1%/ketorolac 0.3% injection-focused:

> reimbursement hotline;

> patient assistance program for those who meet certain financial criteria; and

> co-payment program for commercial beneficiaries.

Surgical facilities should obtain prior authorization or confer with payers before using phenylephrine 1%/ketorolac 0.3% injection in patients with Medicare Advantage or commercial coverage.

Phenylephrine 1%/ketorolac 0.3% injection has no effect on physician fees for cataract surgery under Medicare’s Physician Fee Schedule now or in the future.

When pass-through status expires, phenylephrine 1%/ketorolac 0.3% injection is likely to be included in the bundled facility fee for cataract surgery, after which facility fees will increase by an amount correlated with utilization of phenylephrine 1%/ketorolac 0.3% injection during its pass-through status.

The pass-through regulation is budget-neutral to the health-care system, so pass-through payments for phenylephrine 1%/ketorolac 0.3% injection have no meaningful effect on the health-care system. Funds from pass-through set aside that are not used for products like phenylephrine 1%/ketorolac 0.3% injection are simply lost to the system. 

James C. Loden, MD

E: drloden@lodenvision.com

Dr. Loden was a clinical trial investigator for Omeros, but has no other relevant financial interest to disclose.