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CurrentAetnaPolicy 0719

Fluocinolone Acetonide Intra-vitreal Implant (Retisert, Yutiq and Iluvien)

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Clinical coverage policy for the use of fluocinolone acetonide intravitreal implants (Retisert, Yutiq, Iluvien) addressing indications, contraindications, investigational uses, and applicable billing codes for Aetna members.

Policy Summary

PayerAetna

PolicyFluocinolone Acetonide Intra-vitreal Implant (Retisert, Yutiq and Iluvien)

Policy CodePolicy 0719

Change TypeNo material change

Effective DateNov 15, 2005

Last ReviewJan 5, 2024

Next Review DateAug 8, 2024

Key ActionSubmit prior authorization documenting diagnosis, prior corticosteroid treatment and tolerability, lens status, and implant type/route.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3devices addressed

1Retisert FDA indication

1Iluvien covered DME

≥1contraindications listed

NumerousICD-10 codes

Coverage Criteria

Retisert / Yutiq (medical necessity)

Covered when ALL of the following are met:

Retisert/Yutiq initial coverage: Chronic non-infectious uveitis affecting the posterior segment of the eye (including birdshot chorioretinopathy).

Retisert is FDA‑approved for chronic non‑infectious posterior uveitis; Yutiq is approved for chronic noninfectious posterior uveitis and is deliverable in an office setting.

Treatment history: Patient does not respond to or is intolerant of conventional treatment (failed corticosteroid or immunosuppressive therapy).

Policy requires failure of or intolerance to conventional therapy prior to implant.

Infection exclusion: No active ocular or periocular infection is present.

Presence of active ocular or periocular infection is a contraindication and will trigger denial.

Glaucoma exclusion: Not diagnosed with glaucoma with a cup‑to‑disc ratio greater than 0.8.> 0.8

Glaucoma with cup‑to‑disc ratio >0.8 is a contraindication to Retisert/Yutiq.

Iluvien (medical necessity)

Covered when ALL of the following are met:

Indication: Diagnosis of diabetic macular edema (DME).

Iluvien is indicated for DME in patients previously treated with corticosteroids who tolerated them.

Prior steroid exposure: Previously treated with a course of corticosteroids.

Documentation of prior corticosteroid treatment is required for Iluvien candidacy.

Steroid tolerability: Did not have a clinically significant rise in intraocular pressure during prior corticosteroid treatment.

Absence of clinically significant IOP rise during prior steroid course is required per product labeling and policy.

Infection exclusion: No active ocular or periocular infection is present.

Active ocular or periocular infection is a contraindication to Iluvien.

Glaucoma exclusion: Not diagnosed with glaucoma with a cup‑to‑disc ratio greater than 0.8.> 0.8

Iluvien therapy is not medically necessary for members with glaucoma with cup‑to‑disc ratio >0.8.

Indication evidence summaries

Clinical indications and evidence summaries present in the document:

Uveitis indication (Retisert/Yutiq): Randomized trials of Retisert and phase 3 trials of Yutiq demonstrate reduced uveitis recurrence rates and reduced need for adjunctive therapy; Yutiq is approved for chronic noninfectious posterior uveitis and can be administered in an office setting.

Evidence supports implant use for chronic posterior noninfectious uveitis.

DME indication (Iluvien): Iluvien is FDA‑approved for DME in patients previously treated with corticosteroids without clinically significant IOP rise; clinical trials (FAME) showed higher proportions achieving ≥15‑letter ETDRS gain at 24–36 months, especially in chronic DME (≥3 years).24–36 months outcomes

Trial evidence demonstrates durable visual benefit for selected DME patients.

Evidence summaries relevant to medical necessity

Clinical findings reported in the document that inform coverage considerations:

Durable visual benefit in chronic DME: FAc implants provided substantial and durable visual benefit in chronic DME with higher proportions gaining ≥15 ETDRS letters at 36 months versus sham; benefit was greatest in patients with DME duration ≥3 years.month 36 outcomes

Supports consideration in chronic/refractory DME after prior therapies.

Cataract risk and lens status: Almost all phakic patients developed cataract after FAc implantation; visual benefit after cataract surgery was similar to pseudophakic patients.phakic status

High cataract risk; lens status (phakic vs pseudophakic) is relevant to counseling and may affect payer guidance.

Intraocular pressure and glaucoma risk: Increased intraocular pressure, need for IOP‑lowering medications, and incisional glaucoma surgery were reported (incisional surgery up to 8.1% in high‑dose group at 36 months); VKH subgroup showed 70% post‑operative IOP elevation in implanted eyes.IOP events

Monitoring and management of IOP are required post‑implantation.

Use after prior therapies: Studies and case series commonly used FAc implants after inadequate response to prior therapies (e.g., anti‑VEGF, shorter‑acting steroids); limited data exist for vitrectomized eyes though small series report benefit.prior inadequate response

Consistent stepwise use in practice; prior treatment history should be documented.

Off‑label indications and evidence level: Case reports and small series describe off‑label use in conditions such as JIA‑associated uveitis, birdshot retinochoroiditis, radiation retinopathy, Irvine‑Gass CME, serpiginous choroiditis, and others; evidence is limited and largely from small retrospective series or single‑case reports.limited evidence

Off‑label uses are informational and generally lack robust evidence for coverage.

Evidence summary and described indications

Covered indications discussed or summarized in this portion of the policy (evidence background and product instructions):

Approved/primary indications: Retisert (0.59 mg) and Yutiq (0.18 mg) are described for chronic non‑infectious posterior uveitis; Iluvien (0.19 mg) is described for diabetic macular edema in patients previously treated with corticosteroids who did not have clinically significant IOP rise.

Product summaries and FDA approvals are summarized; see appendices for device delivery and monitoring instructions.

Off‑label uses summarized: The document summarizes off‑label reports for conditions including juvenile idiopathic arthritis‑associated uveitis, birdshot retinochoroiditis, radiation retinopathy‑related CME, Irvine‑Gass CME, serpiginous choroiditis, and others, noting that evidence is primarily from small case series or single reports.

These off‑label indications are discussed as background and not supported by robust prospective data.

Aetna considers fluocinolone acetonide intravitreal implant experimental and investigational for multiple indications where effectiveness has not been established. Examples listed include: anterior uveitis, central retinal vein occlusion, cystoid macular edema, diabetic retinal neurodegeneration, diffuse uveal melanocytic proliferation, inflammatory vitreoretinopathy, intermediate (pars planitis) uveitis, paraneoplastic visual syndromes, radiation-induced maculopathy, retinitis pigmentosa, serpiginous choroiditis, Sjögren’s syndrome–related keratopathy, sympathetic ophthalmia, uveitic glaucoma, and Vogt–Koyanagi–Harada disease/uveitis and combined approaches such as implant plus keratoprosthesis and silicone oil for uveitis-associated hypotony and keratopathy.

Iluvien is contraindicated in patients with ocular or periocular infections, those with glaucoma with a cup-to-disc ratio > 0.8, and individuals with known hypersensitivity to fluocinolone acetonide or product components. The labeling also warns that eyes with an absent or torn posterior lens capsule are at risk of implant migration into the anterior chamber, and patients should be monitored after injection for adverse events including cataract, increased intraocular pressure, endophthalmitis, and retinal detachment.

The National Institute for Health and Care Excellence (NICE) guidance limits use of fluocinolone acetonide intravitreal implant for chronic diabetic macular edema to eyes that are pseudophakic and when the manufacturer provides the implant under the agreed patient access scheme discount, indicating payers may restrict access for phakic eyes or require pricing arrangements.

For off‑label indications, the policy highlights that the available literature is limited—predominantly case reports, small retrospective case series, and single‑center studies—so definitive safety and effectiveness cannot be established and larger prospective trials are needed to inform coverage decisions.

Retisert, Yutiq and Iluvien share important contraindications that may trigger denial of coverage: active ocular or periocular infection and glaucoma with cup-to-disc ratio > 0.8. In addition, Iluvien’s labeling specifies risk of migration when the posterior lens capsule is absent or torn and lists known hypersensitivity to fluocinolone or components as a contraindication.

Use of intravitreal corticosteroid implants for diabetic macular edema may be off‑label for many corticosteroid products, and Iluvien is covered by this policy only for DME in patients who previously received a course of corticosteroids and did not experience a clinically significant rise in intraocular pressure. The document notes intravitreal triamcinolone and other steroids have transient effects and higher rates of cataract and glaucoma, supporting the need to consider prior steroid response when evaluating implant use.

Multiple off‑label uses of fluocinolone implants are reported only in small case series or single‑patient reports (for example, recurrent Irvine‑Gass CME, birdshot retinochoroiditis, and other rare inflammatory conditions), and these publications often emphasize limited sample size, retrospective design, and the need for validation in larger, controlled studies.

Off‑label indications summarized in the background (radiation‑induced maculopathy, paraneoplastic syndromes, Sjögren’s‑related keratopathy, RVO, CME, diabetic retinal neurodegeneration, retinitis pigmentosa, serpiginous choroiditis, JIA‑associated uveitis, etc.) are supported primarily by limited case reports and small retrospective series; the policy states that higher‑quality evidence is needed before these uses can be considered established.

Coding and Billing

Covered CPT Codes (if selection criteria met)CPTCovered

67027	Implantation of intravitreal drug delivery system (e.g., ganciclovir implant), includes concomitant removal of vitreous.
67028	Intravitreal injection of a pharmacologic agent (separate procedure).

HCPCS Codes (covered if selection criteria met / not covered items listed)HCPCS

J7311	Injection, fluocinolone acetonide, intravitreal implant (Retisert), 0.01 mg.
J7314	Injection, fluocinolone acetonide, intravitreal implant (Yutiq), 0.01 mg.
J7313	Injection, fluocinolone acetonide intravitreal implant (Iluvien), 0.01 mg.
C1814	Retinal tamponade device, silicone oil.

ICD-10 Codes (covered if selection criteria met; many listed; some codes not covered)ICD-10

E08.311	Diabetic retinopathy with macular edema (example of many covered diabetes-related ICD-10 codes).
H30.001 - H30.049	Focal chorioretinal inflammation (covered chorioretinal inflammation codes).
H30.90 - H30.93	Unspecified chorioretinal inflammation (birdshot chorioretinopathy listed; note exclusions for birdshot retinochoroiditis).
H40.001 - H40.9	Glaucoma (noted as contraindicated when cup-to-disc ratio > 0.8).

Codes listed as not covered or not applicable for CPB-listed indicationsmixedNot Covered

65770	Keratoprosthesis.
H44.431 - H44.439	Hypotony of eye due to other ocular disorders [uveitis-associated hypotony].
H59.031 - H59.039	Cystoid macular edema following cataract surgery.

Device descriptions (no billing codes listed in this section)mixed

No codes listed

Cup-to-disc ratio — contraindication threshold

Contraindication thresholdCup-to-disc ratio > 0.8

ContextGlaucoma with a C/D ratio greater than 0.8 is listed as a contraindication for fluocinolone intravitreal implants (Iluvien noted explicitly).

Policy actionClaims may be denied when glaucoma with C/D > 0.8 is documented

Provider Actions and Requirements

Prior Authorization

Obtain prior authorization for device CPT/HCPCS codes

Prior authorization is required for implantation or intravitreal injection device codes; coverage of HCPCS J7311 (Retisert), J7314 (Yutiq), and J7313 (Iluvien) is contingent on meeting the policy's selection criteria.

CPT codes 67027 and 67028 are covered only if selection criteria are met.
HCPCS J7311, J7314, and J7313 are listed as covered if selection criteria are met.

Prior Authorization

Show prior corticosteroid exposure and steroid tolerability

Document prior corticosteroid treatment and that the patient did not have a clinically significant rise in intraocular pressure during that steroid course, as Iluvien is covered only for DME in patients previously treated with corticosteroids without a clinically significant IOP rise.

Iluvien coverage requires prior corticosteroid course and absence of clinically significant IOP increase.
Prior treatment history and response should be included in prior authorization requests.

Note

Document lens status (phakic vs pseudophakic) for consideration

Indicate lens status in the record and prior authorization; guideline and labeling considerations note that use in pseudophakic eyes may be required or preferred (NICE recommendation for pseudophakic lens).

NICE recommends use only in pseudophakic eyes for chronic DME when prior therapy response was inadequate.
Iluvien labeling warns of implant migration when the posterior lens capsule is not intact.

Prior Authorization

Specify device, administration route, and monitoring in PA requests

Specify the implant product, route of administration, and monitoring plan (including IOP and endophthalmitis surveillance) in the prior authorization and procedure documentation; Retisert is surgically inserted while Yutiq and Iluvien are intravitreal injections.

Retisert: surgically inserted implant into the posterior segment; lasts ~30 months.
Yutiq and Iluvien: intravitreal injection; monitor for elevated IOP and endophthalmitis; last ~36 months.

Note

Refer to policy history for review dates; no extra PA code rules in this section

Policy history and review dates are provided in the document; the extracted chunks do not state additional explicit prior authorization coding requirements beyond those listed in the CPT/HCPCS coding section.

Last review: 01/05/2024; Effective date: 11/15/2005; Next review: 08/08/2024.
No additional PA code requirements are specified in the referenced policy history chunk.

Step Therapy

Document failure/intolerance of conventional therapy before implant

For Retisert and Yutiq coverage, document that the member did not respond to or was intolerant of conventional therapy (failed corticosteroid or immunosuppressive therapy).

Coverage requires chronic non-infectious posterior uveitis and failure or intolerance of conventional treatment.
Include prior therapy types (corticosteroids, immunosuppressive agents) and reason for failure or intolerance.

Step Therapy

Step up to implants after inadequate response to prior DME therapies

For DME, prior therapies should be documented; implants have been evaluated after inadequate response to prior treatments (e.g., macular laser, anti‑VEGF), and NICE recommends use only after inadequate response to available therapies in pseudophakic eyes.

FAME trials and guidance evaluate implants in patients with persistent DME despite prior therapies.
NICE restricts use to pseudophakic eyes after inadequate response to available therapies.

Step Therapy

Record prior intravitreal therapies and inadequate response

Document prior intravitreal therapy (anti‑VEGF and shorter‑acting steroid injections) and inadequate response, as many studies used fluocinolone implants after prior intravitreal treatments.

Retrospective series report prior mean anti‑VEGF injections (~3.8) and steroid injections (~1.9) before FAc implant.
Trials and real‑world reports commonly describe implants used after insufficient response to prior intravitreal therapy.

Documentation Required

Include prior topical, intravitreal, and systemic treatments in the record

When requesting authorization, list prior topical steroids, anti‑VEGF agents, dexamethasone implants, or systemic immunosuppression if these were used, since literature commonly reports these therapies before considering fluocinolone implants.

Case series and reports describe prior use of topical steroids, anti‑VEGF, dexamethasone implants, and systemic immunosuppression.
Provide treatment dates, agents, response, and intolerance details.

Step Therapy

No formal step therapy rules described in these sections

No step therapy requirements (formal mandated sequences) are specified in the cited chunks of this policy.

The document provides evidence summaries and references but does not define mandatory step therapy protocols in the extracted sections.

Documentation Required

Document diagnosis and prior steroid response matching ICD‑10 codes

Ensure the medical record supports the ICD‑10 diagnosis that meets selection criteria (e.g., chronic non‑infectious posterior uveitis for Retisert/Yutiq; DME with prior steroid tolerance for Iluvien).

Include diagnostic documentation that matches listed ICD‑10 codes associated with covered indications.
Tie the diagnosis to the documented prior treatments and responses.

Documentation Required

Provide prior steroid course and steroid‑tolerability documentation

Include clinical documentation of the prior corticosteroid course and explicit evidence that the patient did not experience a clinically significant rise in intraocular pressure during that course; also document lens status and posterior capsule integrity given migration risk.

Iluvien coverage requires prior steroid treatment without clinically significant IOP rise.
Labeling cautions regarding posterior capsule defects and implant migration should be documented.

Documentation Required

Document visual acuity and central macular thickness outcomes

When reporting outcomes or supporting continued use, include visual acuity measures (ETDRS letters or logMAR) and central/foveal macular thickness measurements as reported in clinical trials and series.

FAME trials used ≥15‑letter ETDRS gains as primary outcomes; real‑world studies report BCVA changes and central foveal thickness.
Include baseline and follow‑up measures and timepoints used.

Documentation Required

Document device type, administration route, and follow‑up monitoring plan

Record the implant type placed (Retisert, Yutiq, or Iluvien), the route (surgical insertion for Retisert; intravitreal injection for Yutiq/Iluvien), and the monitoring plan for IOP and signs of endophthalmitis in the procedure and follow‑up notes.

Retisert: surgically inserted; release profile and ~30‑month duration noted.
Yutiq/Iluvien: injected intravitreally; monitor for elevated IOP and endophthalmitis; ~36‑month duration.

Note

Denial Risk

Do not bill/submit claims when active ocular infection or C/D >0.8 is present

Claims for Retisert or Yutiq will be denied for members with active ocular or periocular infections or glaucoma with a cup‑to‑disc ratio greater than 0.8; Iluvien is likewise contraindicated in these conditions.

Active ocular or periocular infection is a contraindication to Retisert/Yutiq/Iluvien.
Glaucoma with cup‑to‑disc ratio > 0.8 is a contraindication and may trigger denial.

Denial Risk

Recognize Iluvien contraindications and migration risk to avoid denial

Iluvien is contraindicated in patients with ocular or periocular infections, glaucoma with cup‑to‑disc ratio >0.8, and known hypersensitivity; document these exclusions to avoid denial and note risk of implant migration if posterior capsule is absent or torn.

Labeling states contraindications: ocular/periocular infection, glaucoma C/D >0.8, hypersensitivity to fluocinolone or components.
Posterior capsule defects increase risk of anterior chamber migration and should be documented.

Denial Risk

Expect payer restrictions (e.g., NICE recommends pseudophakic eyes only)

Be aware that external payers or guidance documents (e.g., NICE) may restrict use to pseudophakic eyes and to pricing/access arrangements; use outside those conditions may result in restricted coverage by some payers.

NICE recommends use only in pseudophakic eyes and with manufacturer patient access scheme discount.
Document rationale if treating a phakic eye or when access schemes do not apply.

Documentation Required

Monitor and document IOP and endophthalmitis surveillance after insertion

Monitor and document follow‑up for elevated intraocular pressure and signs of endophthalmitis after implant insertion; failure to document monitoring or complications may trigger utilization review or denial of continued coverage.

Labeling advises patients be monitored following Iluvien injection for elevated IOP and endophthalmitis.
Appendix instructs monitoring after Yutiq implantation for elevated IOP and endophthalmitis.

Note

No additional provider actions in the referenced policy history chunk

No provider actions are specified in the cited policy history chunk beyond the items already listed; review the full policy for any additional administrative steps.

Policy history lists review dates but no extra provider action requirements in these chunks.

Background and Evidence Context

Uveitis is intraocular inflammation that can affect anterior, intermediate, posterior, or panuveitis compartments and is a significant cause of visual impairment. Corticosteroids are the mainstay of short‑term therapy and immunosuppressive agents are used for long‑term control. Retisert is a surgically inserted fluocinolone implant and Yutiq/Iluvien are injectable intravitreal implants; these sustained‑release devices were developed to provide prolonged corticosteroid delivery (months to years) to reduce recurrences and the need for adjunctive therapy in chronic posterior non‑infectious uveitis and certain cases of diabetic macular edema.

Posterior non-infectious uveitis

Definition and clinical relevance for coverage of Retisert/Yutiq:

Definition: Posterior non‑infectious uveitis: inflammation affecting the posterior segment of the eye not caused by infection.

This anatomic definition identifies the target population for Retisert and Yutiq.

Relevance to Retisert/Yutiq: Chronic posterior non‑infectious uveitis can be sight‑threatening; Retisert (surgically inserted 0.59 mg implant) and Yutiq (0.18 mg intravitreal implant) deliver fluocinolone acetonide for up to ~30–36 months and have shown reduced uveitis recurrence and reduced adjunctive therapy use in clinical trials.30–36 months device duration

Device delivery method differs (surgical insertion for Retisert; intravitreal injection for Yutiq) and monitoring for elevated IOP and endophthalmitis is required after placement.

Diabetic macular edema (DME) — definition and clinical importance

DefinitionDiabetic macular edema (DME): swelling/thickening of the macula from leaking retinal blood vessels in patients with diabetes, causing distortion of central vision.

PathophysiologyCaused by vascular leakage from diabetic retinopathy with upregulation of VEGF and inflammatory cytokines; classified as focal or diffuse.

Clinical importancePrimary cause of vision loss in diabetic retinopathy; treatment options include laser photocoagulation, intravitreal anti-VEGF, intravitreal corticosteroids, and corticosteroid implants.

Significant visual gain — trial definition

Definition used in trialsSignificant visual gain = gain of ≥15 letters on the ETDRS acuity chart at specified follow-up.

Example outcomeFAME trials: at month 36, 28.7% (low-dose) and 27.8% (high-dose) of FAc-treated patients achieved ≥15-letter gains vs 18.9% in sham (LOCF).

Subgroup notePatients with DME duration ≥3 years had higher proportions gaining ≥15 letters (e.g., 34.0% low-dose at month 36).

IOP elevation — definition and reported rates

DefinitionIOP elevation: post-operative increase in intraocular pressure reported as the proportion of eyes experiencing a clinically significant rise following implantation.

Example reported rateIn a VKH subgroup, post-operative IOP elevation occurred in 70% of implanted eyes versus 20% of fellow eyes (Heo et al.).

Incisional surgery ratesIncisional glaucoma surgery incidence at month 36 was 4.8% (low-dose) and 8.1% (high-dose) in FAc insert groups (FAME data).

Retisert — device description, dose, and duration

Device descriptionRetisert: surgically inserted intravitreal implant containing 0.59 mg fluocinolone acetonide for treatment of chronic non-infectious posterior uveitis.

Dose/strength0.59 mg fluocinolone acetonide per implant

Release profile and durationInitial release ≈0.6 mcg/day, decreases to ~0.3–0.4 mcg/day at steady state, lasting approximately 30 months; may be replaced if uveitis recurs after depletion.

Yutiq / Iluvien — device descriptions, doses, and release profiles

Yutiq descriptionYutiq: intravitreal injectable implant containing 0.18 mg fluocinolone acetonide, designed for intravitreal injection and office-based delivery.

Iluvien descriptionIluvien: intravitreal injectable implant containing 0.19 mg fluocinolone acetonide for treatment of diabetic macular edema.

Release profile and durationBoth Yutiq (0.18 mg) and Iluvien (0.19 mg) are designed to release fluocinolone acetonide at an initial rate of ~0.25 mcg/day and provide drug delivery for approximately 36 months; monitor for elevated IOP and endophthalmitis.

Policy Revision History

2005-11-15effective_date

Policy became effective on 2005-11-15.

2024-01-05last_review

Policy last reviewed on 2024-01-05.

2024-08-08next_reviewLatest

Next scheduled policy review on 2024-08-08.

Policy effective date: 11/15/2005. Last review date: 01/05/2024. Next scheduled review: 08/08/2024.

Policy Summary

PayerAetna

PolicyFluocinolone Acetonide Intra-vitreal Implant (Retisert, Yutiq and Iluvien)

Policy CodePolicy 0719

Change TypeNo material change

Effective DateNov 15, 2005

Last ReviewJan 5, 2024

Next Review DateAug 8, 2024

Key ActionSubmit prior authorization documenting diagnosis, prior corticosteroid treatment and tolerability, lens status, and implant type/route.

SourceLink

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