This policy version was replaced on February 28, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Intravitreal corticosteroid implants are being investigated for a variety of inflammatory eye conditions. These drug delivery systems are surgically implanted into the posterior segment of the eye to deliver a constant concentration of drug over a prolonged period. The goal of therapy is to reduce the inflammatory process in the eye while minimizing the adverse effects of the therapeutic regimen.

Four intraocular corticosteroid implants have been approved by the U.S. Food and Drug Administration (FDA): 

• Dexamethasone intravitreal implant (Ozurdex®) is FDA approved for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO), non-infectious uveitis affecting the posterior segment of the eye, and diabetic macular edema.
• Fluocinolone acetonide intravitreal implant (Retisert®) if FDA approved for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. 
• Fluocinolone acetonide intravitreal implant (Iluvien®) is FDA approved for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
• Fluocinolone acetonide intravitreal implant (Yutiq®) is FDA approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

I.    A dexamethasone intravitreal implant 0.7 mg (Ozurdex®) may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:

• Diagnosis of ONE of the following:
  • Noninfectious ocular inflammation, or uveitis, affecting the intermediate or posterior segment of the eye; OR
  • Macular edema following branch or central retinal vein occlusion; OR
  • Diabetic macular edema; 
• AND
• Prescribed by or in consultation with an ophthalmologist; AND
• Not used in combination with an intravitreal angiogenesis inhibitor or verteporfin photodynamic therapy; AND
  
• No FDA labeled contraindications to Ozurdex® (see table 1 below).

II.   A fluocinolone acetonide intravitreal implant 0.59 mg (Retisert®) may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:

• Diagnosis of chronic noninfectious intermediate, posterior, or panuveitis; AND
• Prescribed by or in consultation with an ophthalmologist; AND
• Not used in combination with an intravitreal angiogenesis inhibitor or verteporfin photodynamic therapy; AND
  
• No FDA labeled contraindications to Retisert® (see table 1 below).

III.  A fluocinolone acetonide intravitreal implant 0.19 mg (Iluvien®) may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:

• Diagnosis of diabetic macular edema; AND
• Previously treated with a course of standard corticosteroid injection and did not have a clinically significant rise in intraocular pressure; AND
• Prescribed by or in consultation with an ophthalmologist; AND
• Not used in combination with an intravitreal angiogenesis inhibitor or verteporfin photodynamic therapy; AND
  
• No FDA labeled contraindications to Iluvien® (see table 1 below); AND
• For commercial health plan members only, step therapy supplement criteria may apply for select conditions (see policy II-242: Step Therapy Supplement).
  

IV.   A fluocinolone acetonide intravitreal implant 0.18 mg (Yutiq™) may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:

• Diagnosis of chronic non-infectious uveitis affecting the posterior segment of the eye; AND
• Prescribed by or in consultation with an ophthalmologist; AND
• Not used in combination with an intravitreal angiogenesis inhibitor or verteporfin photodynamic therapy; AND
  
• No FDA labeled contraindications to Yutiq™(see table 1 below).

V.    A fluocinolone acetonide intravitreal implant 0.59 mg (Retisert®) or 0.19 mg (Iluvien®) or 0.18 mg (Yutiq™) or dexamethasone intravitreal implant 0.7 mg (Ozurdex®) is considered EXPERIMENTAL/INVESTIGATIVE for all other indications including but not limited to the following due to the lack of clinical evidence demonstrating an impact on improved health outcomes:

• Birdshot retinochoroidopathy
• Cystoid macular edema related to retinitis pigmentosa
• Idiopathic macular telangiectasia type 1
• Postoperative macular edema
• Circumscribed choroidal hemangiomas
• Proliferative vitreoretinopathy
• Radiation retinopathy

Table 1. FDA Labeled Contraindications