Blue Cross Blue Shield of Minnesota Medical Policy

 
 

Medical Policy:
II-100-005
Topic:
Intravitreal Corticosteroid Implants
Section:
Medicine
Effective Date:
May 31, 2021
Issued Date:
May 31, 2021
Last Revision Date:
March 2021
Annual Review:
March 2021
 
 

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.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

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

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Table 1. FDA Labeled Contraindications

Agent

FDA Labeled Contraindications

Dexamethasone intravitreal implant 0.7 mg (Ozurdex®)

Active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritis keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

Glaucoma, with cup to disc ratios of greater than 0.8.

Posterior lens capsule is torn or ruptured because of the risk of migration into the anterior chamber.

Known hypersensitivity to any components of this product.

Fluocinolone acetonide intravitreal implant 0.59 mg (Retisert®)

Active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in active bacterial, mycobacterial or fungal infections of the eye.

Fluocinolone acetonide intravitreal implant 0.19 mg (Iluvien®)

Active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.

Glaucoma, with cup to disc ratios of greater than 0.8.

Known hypersensitivity to any components of this product.

Fluocinolone acetonide intravitreal implant 0.18 mg (Yutiq™)

Active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.

Known hypersensitivity to any components of this product.

 



Denial Statements

No additional statements.



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Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.

Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.

Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites. 

Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. 

These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Acknowledgements:

CPT® codes copyright American Medical Association® 2022. All rights reserved.

CDT codes copyright American Dental Association® 2022. All rights reserved.