Omidria Earns Listing on VA Formulary, Regains CMS Pass-Through Status

April 13, 2018: By Joan McKenna

Seattle-based Omeros announced April 12 that its ophthalmic drug Omidria has been added to the national formulary for the US Veterans Affairs system.

The company also announced that Omidria received a two-year extension on pass-through status through the US omnibus bill signed into law March 23. The drug’s pass-through status expired Dec. 31. It restarts Oct. 1, 2018.

Surgeons use Omidria (phenylephrine and ketorolac injection) during cataract surgery for maintaining pupil size by preventing miosis and for reducing postoperative ocular pain.

In 2014, Omidria gained US FDA approval and pass-through status for three years. The latter allowed the Centers for Medicare and Medicaid Services (CMS) to reimburse ASCs $465 per single-use-patient vial above the cataract surgery facility fee of about $1 thousand.

When pass-through status expired, the CMS rolled the cost of Omidria into the cataract facility fee.

Omeros said Omidria is available to ophthalmic surgeons in all VA facilities immediately. The initial recommendation is that Omidria use be limited to high-risk patients at the discretion of VA ophthalmic surgeons, the company said, adding that high-risk patients include those with a history of using an alpha-1-antagonist (such as Flomax), panretinal photocoagulation, eye trauma, pseudoexfoliation, peripheral iridotomy, pilocarpine use, or those who have a dense lens or will be receiving a toric intraocular lens (IOL). The company said many of these risk factors are common in the VA system.

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