Coverage Policy Manual
Policy #: 2020025
Category: Pharmacy
Initiated: February 2021
Last Review: November 2023
  Dexamethasone intraocular suspension (e.g., DEXYCU®)
Description:
Dexamethasone intraocular suspension (e.g., DEXYCU®) 9% is a corticosteroid that is indicated for the treatment of postoperative inflammation.  It is administered into the posterior chamber inferiorly behind the iris at the end of ocular surgery.    
 
Regulatory Status
 
The FDA approved dexamethasone intraocular suspension (e.g., DEXYCU®) for use February 09,2018
Policy/
Coverage:
Effective February 15, 2021
 
Does not meet Primary Coverage Criteria Or Is Investigational for Contracts Without Primary Coverage Criteria
 
The use of dexamethasone intraocular suspension (e.g., DEXYCU®), for treatment of postoperative inflammation does not meet member benefit certificate primary coverage criteria because there is a lack of data indicating this intervention is more effective than other interventions that are less costly.
 
For members with contracts without primary coverage criteria, dexamethasone intraocular suspension (e.g., DEXYCU®), for any indication is considered not medically necessary. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Rationale:
In a study by Dr Eric Donnenfeld, et al. (10/2018), the safety and efficacy of dexamethasone intraocular suspension, was compared with prednisolone acetate 1.0% ophthalmic drops in treating inflammation after cataract surgery.  126 IBI-10090 patients and 55 prednisolone patients were included in the safety analysis.  Patients were randomized to 2:1 to receive a 5µL injection of 517 µg IBI-10090 in the anterior eye chamber or topical prednisolone 1.0% (1 drop 4 times daily for 3 weeks).    Two serious adverse events unrelated to treatment were reported.  The decrease in endothelial cell density was not significantly different between the two groups.  The most common adverse events were increased intraocular pressure (11.1%), iritis (6.3%) and systemic (7.9% IBI-10090 group; 10.9% prednisolone group) At 8 days 51.6% of the IBI-10090 eyes and 50.9% of prednisolone eyes had anterior chamber cell clearing. The safety and efficacy of IBI-10090 and prednisolone 1.0% were similar, though patients did prefer the use of IBI-10090 over drops.    
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2023. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
J1095Injection, dexamethasone 9 percent, intraocular, 1 microgram
References: DEXYCU [package insert] Watertown, MA; Eye Point Pharmaceuticals US 2020

Donnenfeld E, Solomon KD, Matossian C.(2018) Safety of IBI-10090 associated with cataract surgery: Phase 3 multicenter study. Journal of Cataract & Refractive Surgery: October 2018 - Volume 44 - Issue 10 - p 1236-1246 doi: 10.1016/j.jcrs.2018.07.015
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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