CurrentCentenePolicy CP.PHAR.385

Corticosteroids for Ophthalmic Injection (Dextenza, Iluvien, Ozurdex, Retisert, Xipere, Yutiq)

Defines prior authorization medical necessity criteria, dosing limits, approval durations, continued therapy requirements, contraindications, and coding implications for ophthalmic corticosteroid products across Centene lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyCorticosteroids for Ophthalmic Injection (Dextenza, Iluvien, Ozurdex, Retisert, Xipere, Yutiq)

Policy CodePolicy CP.PHAR.385

Change TypeRevised (multiple updates 2021-2025; RT4 additions/clarifications)

Effective Date09.01.18

Next Review Date

Key ActionPrior authorization is required and providers must submit documentation supporting that the member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395 and updated age requirement for allergic conjunctivitis to ≥ 2 years per FDA pediatric expansion; clarified failure of a single intravitreal anti-VEGF agent for RVO and DME; updated Ozurdex maximum dose/interval to every 3 months (then clarified to every 6 months in later note).

For DME, macular edema, and uveitis removed required step through of intravitreal steroid injections due to lack of commercial availability (Triesence shortage).

Updated Ozurdex dosing frequency from every 4 months to every 3 months per literature and specialist feedback (3Q2023-2025 updates), with later clarifications to maximum dosing interval in Section V.

6Named Products Covered

7Initial Approval Indications Listed

2025-08-25Last Review Date

Coverage Summary

Policy CP.PHAR.385 — Corticosteroids for Ophthalmic Injection (Dextenza, Iluvien, Ozurdex, Retisert, Xipere, Yutiq) is CURRENT, effective 09.01.18 with last review date 08.25. Scope covers prior authorization medical necessity criteria, dosing/interval limits, approval durations, contraindications, and coding implications across lines of business: Commercial, HIM, Medicaid. Coverage stance: covered_with_criteria. The policy lists 6 named products as covered.

Policy-level dosing/interval thresholds

Dextenza dosing limit0.4 mg (1 insert) per eye every 30 days

Ozurdex dosing limit1 implant per eye; continued therapy interval at least 3 months

Iluvien dosing limitOne implant per eye every 12 months for DME; one implant per eye every 36 months for uveitis

Retisert dosing limitOne implant per eye every 30 months

Yutiq dosing limitOne implant per eye every 36 months

Xipere dosing limit4 mg (1 vial) per eye every 12 weeks

Approval Criteria

Initial Approval Criteria

It is policy that corticosteroids for ophthalmic injection are medically necessary when the following criteria are met:

ALL of the following

A. Ocular Inflammation and Pain Following Ophthalmic Surgery (must meet all)
- Diagnosis of ocular inflammation and pain following ophthalmic surgery
- Request is for Dextenza
- Prescribed by or in consultation with an ophthalmologist
- Member has received or is scheduled to receive ophthalmic surgery within 30 days of this request

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for the listed ophthalmic corticosteroid products. Submit supporting documentation with the prior authorization request (office chart notes, laboratory results, and other relevant clinical information) to demonstrate that the member meets the approval criteria. Affected HCPCS/J-codes: J1096, J7311, J7312, J7313, J7314, J3299.

Submit office chart notes, lab results, and clinical information with the PA request

Documentation Required

Documentation of prior therapy and contraindications

Providers must document failure of required prior therapies or document contraindications, clinically significant adverse effects, or inability to manage eye drop use. Required prior therapies include topical corticosteroids; topical antihistamines and/or mast cell stabilizers (or a dual-acting product) for allergic conjunctivitis; intravitreal anti-VEGF agents for macular edema/DME/RVO where specified; and systemic corticosteroids or non-biologic systemic immunosuppressive therapy for non-infectious uveitis. Exceptions/bypasses apply when therapies are contraindicated, cause clinically significant adverse effects, or the member is unable to manage regular eye drop use. For Illinois HIM, step therapy requirements are bypassed per IL HB 5395 effective 1/1/2026.

Relevant Codes

HCPCS/J-codes referencedmixed

J1096	Dexamethasone, lacrimal ophthalmic insert, 0.1 mg
J7311	Injection, fluocinolone acetonide intravitreal implant, 0.01 mg (Retisert)
J7312	Injection, dexamethasone intravitreal implant, 0.1 mg
J7313	Injection, fluocinolone acetonide intravitreal implant, 0.01 mg (Iluvien)
J7314	Injection, fluocinolone acetonide intravitreal implant, 0.01 mg (Yutiq)
J3299	Injection, triamcinolone acetonide (Xipere), 1 mg

Background & Safety Considerations

Background: The policy addresses multiple ophthalmic corticosteroid products — dexamethasone intravitreal implant (Ozurdex), dexamethasone ophthalmic insert (Dextenza), fluocinolone acetonide implants (Iluvien, Retisert, Yutiq), and suprachoroidal triamcinolone (Xipere) — requiring prior authorization for use.

FDA indications and labeled limitations include: Dextenza for ocular inflammation and pain following ophthalmic surgery and for ocular itching associated with allergic conjunctivitis (age ≥ 2 years for allergic conjunctivitis; insertion sedation limitation noted for pediatric patients); Iluvien for DME in patients previously treated with corticosteroids without clinically significant IOP rise and for chronic non-infectious posterior uveitis; Ozurdex for macular edema following BRVO/CRVO, non-infectious posterior uveitis, and DME; Retisert and Yutiq for chronic non-infectious posterior uveitis; Xipere for macular edema associated with uveitis.

Therapeutic alternatives are listed (Appendix B) and include topical agents (mast cell stabilizers, dual-acting mast cell stabilizer/antihistamines, topical corticosteroids), intravitreal anti-VEGF agents (bevacizumab, ranibizumab, aflibercept, etc.), systemic corticosteroids (e.g., prednisone) and non-biologic systemic immunosuppressive therapies (azathioprine, cyclosporine, methotrexate, tacrolimus) as appropriate per indication.

Contraindications and safety considerations: product-specific contraindications include active ocular infections (e.g., epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial and fungal eye infections) for Dextenza, Retisert, Iluvien, Ozurdex, Xipere, and Yutiq; additional contraindications include glaucoma with cup-to-disc ratios > 0.8 for Iluvien and Ozurdex and Ozurdex use with torn/ruptured posterior lens capsule (risk of anterior migration).

Safety profile highlights (Appendix D): Retisert is associated with high rates of intraocular pressure (IOP) elevation requiring medical therapy (approximately 77% within 3 years) and surgical filtering procedures (~37%), near-universal cataract formation in phakic eyes within 3 years, and an immediate temporary decrease in visual acuity post-implantation. Real-world and trial data for dexamethasone implants (Ozurdex/DEX) report variable injection frequency (CHROME mean ~1.7 injections; repeat injections in ~44.2% of eyes) and comparative efficacy data (BEVORDEX trial outcomes).

Definitions

BRVO (definition)Branch retinal vein occlusion

CRVO (definition)Central retinal vein occlusion

DME (definition)Diabetic macular edema

VEGF (definition)Vascular endothelial growth factor

Revision History

01.23.23material_revision

Added Dextenza to the policy; revised Ozurdex dosing frequency from every 4 months to every 3 months per literature review, market analysis, and specialist feedback; updated HCPCS code for Xipere.

02.22.21 / 12.16.21material_revision

RT4 update: Added Xipere to policy with corresponding criteria for uveitic macular edema; changed policy name to 'corticosteroids for ophthalmic injection'; added step-through of intravitreal steroid injections back to all indications when Triesence available.

03.17.21administrative_update

3Q2021 annual review: revised approval durations from 4 weeks to 3 months to allow staggered dosing of bilateral implants; references reviewed and updated; P&T approval noted.

Policy Summary

PayerCentene

PolicyCorticosteroids for Ophthalmic Injection (Dextenza, Iluvien, Ozurdex, Retisert, Xipere, Yutiq)

Policy CodePolicy CP.PHAR.385

Change TypeRevised (multiple updates 2021-2025; RT4 additions/clarifications)

Effective Date09.01.18

Next Review Date

Key ActionPrior authorization is required and providers must submit documentation supporting that the member has met all approval criteria.

SourceLink

On This Page

Failure of a topical corticosteroid (see Appendix B), unless contraindicated, clinically significant adverse effects are experienced, or member is unable to manage regular eye drop use (e.g., due to age or comorbidities including visual impairment)

For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395

Dose does not exceed 0.4 mg (1 insert) per eye every 30 days

B. Ocular Itching Associated with Allergic Conjunctivitis (must meet all)

Diagnosis of ocular itching associated with allergic conjunctivitis
Request is for Dextenza
Prescribed by or in consultation with an ophthalmologist
Age ≥ 2 years
Failure requirements (must fail both unless exceptions apply)
- Failure of topical mast cell stabilizer and topical antihistamine (as a single dual-acting product or as two products used in combination)
  See Appendix B; bypass if clinically significant adverse effects or both are contraindicated, or member unable to manage regular eye drop use
- Failure of topical corticosteroid
  See Appendix B; bypass if clinically significant adverse effects or contraindicated, or member unable to manage regular eye drop use
Dose does not exceed 0.4 mg (1 insert) per eye every 30 days

C. Macular Edema following BRVO or CRVO (must meet all)

Diagnosis of macular edema following BRVO or CRVO
Request is for Ozurdex
Prescribed by or in consultation with an ophthalmologist
Age ≥ 18 years
Failure of an intravitreal anti-vascular endothelial growth factor (VEGF) agent, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B)
For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395
Dose does not exceed 1 implant per eye

D. Non-Infectious Uveitis (must meet all)

Diagnosis of non-infectious uveitis affecting the posterior segment of the eye
Request is for Iluvien, Ozurdex, Retisert, or Yutiq
Prescribed by or in consultation with an ophthalmologist
Age requirement (one of)
- For Iluvien, Ozurdex, Yutiq: Age ≥ 18 years
- For Retisert: Age ≥ 12 years
Failure of one of the following (a or b)
- Systemic corticosteroid (e.g., prednisone)
  See Appendix B; for IL HIM step therapy bypass applies per IL HB 5395
- Non-biologic systemic immunosuppressive therapy (e.g., azathioprine, cyclosporine, methotrexate, tacrolimus)
  See Appendix B; for IL HIM step therapy bypass applies per IL HB 5395
Dose does not exceed 1 implant per eye

E. Diabetic Macular Edema (must meet all)

Diagnosis of DME
Request is for Ozurdex or Iluvien
Prescribed by or in consultation with an ophthalmologist
Age ≥ 18 years
Failure of an intravitreal anti-VEGF agent, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B)
For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395
Dose does not exceed 1 implant per eye

F. Macular Edema with Uveitis (must meet all)

Diagnosis of macular edema associated with non-infectious uveitis
Request is for Xipere
Prescribed by or in consultation with an ophthalmologist
Age ≥ 18 years
Dose does not exceed 4 mg (1 vial) per eye every 12 weeks

G. Other diagnoses/indications

If drug has recently (within last 6 months) undergone a label change not yet reflected in this policy, refer to formulary/no-coverage/non-formulary policies depending on formulary status
References to CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable
If requested use is not specifically listed under section III and no label change applies, refer to off-label use policy for relevant line of business
References CP.CPA.09, HIM.PA.154, CP.PMN.53

Continued Therapy

Criteria that must be met for renewal/continuation for all indications in Section I:

ALL of the following

A. All Indications in Section I (must meet all)
- Member meets one of the following: a) currently receiving medication via Centene benefit or previously met initial approval criteria; b) currently receiving medication and enrolled in state/product with continuity of care regulations
  Refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B
- Member is responding positively to therapy
- If request is for Dextenza, one of
  - Request is for an ophthalmic surgery unrelated to the previous request and Member has received or is scheduled to receive the new surgery within 30 days of this request
  - Member continues to experience ocular inflammation and pain/itching related to their ophthalmic surgery/allergic conjunctivitis as evidenced by findings on magnified examination
- Minimum interval since last treatment (one of)
  - For Dextenza: At least 1 month has passed since last treatment
  - For Ozurdex: At least 3 months have passed since last treatment
  - For Iluvien (one of)
    For DME: At least 12 months have passed since last treatment
    For non-infectious uveitis: At least 36 months have passed since last treatment
  - For Retisert: At least 30 months have passed since last treatment
  - For Yutiq: At least 36 months have passed since last treatment
- Dose limit for continued therapy (one of)
  - Dextenza: 0.4 mg (1 insert) per eye
  - Ozurdex, Iluvien, Retisert, Yutiq: 1 implant per eye
  - Xipere: 4 mg (1 vial) per eye

Topical corticosteroids (e.g., loteprednol, dexamethasone)
Topical antihistamine and/or mast cell stabilizer or dual-acting product (e.g., olopatadine, ketotifen, azelastine)
Intravitreal anti-VEGF agents when required (e.g., bevacizumab, ranibizumab, aflibercept, brolucizumab, Vabysmo) — failure required where specified
Systemic corticosteroids (e.g., prednisone) or non-biologic systemic immunosuppressives (e.g., azathioprine, cyclosporine, methotrexate, tacrolimus) for uveitis

Billing Rule

Dose and interval limits

Claims that exceed the policy-specified dose or interval thresholds for each product may not meet medical necessity. Refer to the policy thresholds when billing: Dextenza — 0.4 mg (1 insert) per eye every 30 days; Ozurdex — 1 implant per eye (continued therapy interval at least 3 months); Iluvien — one implant per eye every 12 months for DME and every 36 months for uveitis; Retisert — one implant per eye every 30 months; Yutiq — one implant per eye every 36 months; Xipere — 4 mg (1 vial) per eye every 12 weeks. Affected HCPCS/J-codes: J1096, J7312, J7313, J7311, J7314, J3299.

Dextenza: 0.4 mg (1 insert) per eye per 30 days
Ozurdex: 1 implant per eye (continued therapy interval ≥ 3 months)
Iluvien: one implant per eye every 12 months (DME) or every 36 months (uveitis)
Retisert: one implant per eye every 30 months
Yutiq: one implant per eye every 36 months
Xipere: 4 mg (1 vial) per eye every 12 weeks

Step Therapy

Step therapy requirements

Step therapy (failure of specified alternatives) is required for many indications in this policy; the policy specifies the required trials per indication (for example, topical therapies for Dextenza indications; intravitreal anti-VEGF for macular edema/DME/RVO where listed; systemic steroids or non-biologic immunosuppressives for uveitis). Per 3Q2025 updates, Illinois HIM requests bypass step therapy requirements under IL HB 5395 effective 1/1/2026. The policy details indication-specific required trials and allowed exceptions for contraindications, adverse effects, or inability to use eye drops.

Policy lists indication-specific required trials (see initial approval sections for each diagnosis)
IL HIM step therapy bypass per IL HB 5395 effective 1/1/2026
Exceptions when therapies are contraindicated, cause clinically significant adverse effects, or member cannot manage eye drop regimens

Dosing and administration limits are specified per product (examples): Dextenza 0.4 mg (1 insert) per eye every 30 days; Ozurdex intravitreal implant (0.7 mg) with product-specific maximum dosing/interval guidance; Iluvien: one implant per eye every 12 months for DME and every 36 months for uveitis; Retisert: one implant per eye every 30 months; Yutiq: one implant per eye every 36 months; Xipere: 4 mg (1 vial) per eye every 12 weeks.

Applicable lines of business: Commercial, HIM, and Medicaid (policy-specific step therapy/authorization rules and state-specific exceptions, e.g., Illinois HIM bypass per IL HB 5395, are noted).

Evidence highlights (selected trials/studies)

Retisert — IOP medication need (3 years)~77% require IOP-lowering medications; 37% require filtering procedures

BEVORDEX trial — visual acuity (12 months)40% bevacizumab vs 41% DEX implant achieved ≥10-letter gain (P=0.99)

BEVORDEX — mean injections (12 months)Mean injections: bevacizumab 8.6 vs DEX implant 2.7 over 1 year

CHROME study — real-world DEX useMean number of DEX implant injections 1.7; 44.2% had repeat injections (reinjection interval 2.3–4.9 months)

05.24.24 / 08.24 (P&T)material_revision

3Q2024 annual review: revised Ozurdex maximum dose/interval per PI (noted changes to Ozurdex dosing and HCPCS descriptions); references reviewed and updated; P&T approval documented.

08.20.24material_revision

Removed required step-through of intravitreal steroid injections for DME, macular edema, and uveitis due to lack of commercial availability (Triesence shortage).

03.20.25material_revision

RT4: For Iluvien, added newly approved indication for non-infectious posterior uveitis; updated contraindications for Iluvien, Ozurdex, and Yutiq to align with prescribing information; updated HCPCS code descriptions for Retisert, Iluvien, and Yutiq.

05.01.25material_revision

3Q2025 annual review: updated Ozurdex and Iluvien indications per PI and updated Ozurdex maximum dose from every 6 months to every 3 months (later clarified in Section V).

08.25.25material_revisionLatest

3Q2025 annual review: added Dextenza pediatric expansions (removed age requirement for ocular inflammation; allergic conjunctivitis age updated to ≥2 years), added step therapy bypass for Illinois HIM per IL HB 5395 (effective 1/1/2026), clarified failure of a single intravitreal anti-VEGF agent for RVO and DME, clarified non-biologic systemic immunosuppressive examples; P&T approval documented.

12.09.25clarificationLatest

In Section V clarified Ozurdex maximum dose/interval is every 6 months (documented clarification after earlier edits).

For Xipere: At least 12 weeks have passed since last treatment