CurrentMolina HealthcarePolicy C11728-A

Iluvien (fluocinolone acetonide intravitreal implant) Coverage Criteria

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This policy governs Molina Healthcare coverage and prior authorization requirements for Iluvien in adults with diabetic macular edema or non-infectious posterior segment uveitis.

Policy Summary

PayerMolina Healthcare

PolicyIluvien (fluocinolone acetonide intravitreal implant) Coverage Criteria

Policy CodePolicy C11728-A

Change TypeAdministrative template revisionno material coverage changes

Effective DateDecember 1, 2025

Next Review DateOctober 1, 2025

Key ActionDocument diagnosis-specific medical necessity, prior treatment history, safety evaluation, and qualified specialist prescribing or consultation when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

The Coding/Billing Information template was updated.

The Required Medical Information section was revised.

2Covered diagnosis categories

18+Minimum member age

36 monthsAuthorization duration

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CurrentMolina HealthcarePolicy C11728-A

Iluvien (fluocinolone acetonide intravitreal implant) Coverage Criteria

Customize your policy alerts

Sign up for Molina Healthcare Policy C11728-A alerts

Get alerted when Policy C11728-A changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy governs Molina Healthcare coverage and prior authorization requirements for Iluvien in adults with diabetic macular edema or non-infectious posterior segment uveitis.

Policy Summary

PayerMolina Healthcare

PolicyIluvien (fluocinolone acetonide intravitreal implant) Coverage Criteria

Policy CodePolicy C11728-A

Change TypeAdministrative template revisionno material coverage changes

Effective DateDecember 1, 2025

Next Review DateOctober 1, 2025

Key ActionDocument diagnosis-specific medical necessity, prior treatment history, safety evaluation, and qualified specialist prescribing or consultation when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

The Coding/Billing Information template was updated.

The Required Medical Information section was revised.

2Covered diagnosis categories

18+Minimum member age

36 monthsAuthorization duration

1 implant/eye/36 months

Non-hospital facilityAdministration setting

3Contraindication categories

Coverage Criteria

Initial therapy: diabetic macular edema

Covered for initial therapy when all criteria are met.

Initial therapy for diabetic macular edema

Diagnosis and baseline status: Documented diabetic macular edema and baseline visual status, with the eye being treated identified
ONE of: prior anti-VEGF treatment
- Inadequate response, clinically significant adverse effects, or contraindication to bevacizumabFor bevacizumab, inadequate response is defined as 1–2 injections with minimal to no improvement
- Bevacizumab is unavailable, with inadequate response, serious side effects, or contraindication to ranibizumab
Prior intravitreal steroid treatment: Documented inadequate response to an appropriate trial of intravitreal glucocorticoids, such as triamcinolone
Corticosteroid pressure safety: Previously treated with corticosteroids without a clinically significant rise in intraocular pressure
Administration and contraindication safety: Prescriber attests, or clinical reviewer finds, that Iluvien will not be administered by simultaneous bilateral implantation and that the member has no unaddressed FDA-labeled contraindication
Contraindications include ocular or periocular infections, glaucoma, and hypersensitivity to any component of Iluvien

Initial therapy: non-infectious uveitis

Covered for initial therapy when all criteria are met.

Initial therapy for non-infectious posterior segment uveitis

Diagnosis and baseline status: Documented non-infectious posterior segment uveitis and baseline best-corrected visual acuity, with the eye or eyes being treated identified
ONE of: prior corticosteroid treatment
- Inadequate response after an appropriate trial period, serious side effects, or contraindication to formulary topical glucocorticoids
- Inadequate response, serious side effects, or contraindication to an intravitreal steroid, such as triamcinolone or dexamethasone
- Inadequate response, serious side effects, or contraindication to a systemic corticosteroid

Continuation therapy: diabetic macular edema

Continuation is available only for the same previously treated eye and when all criteria are met.

Continuation therapy for diabetic macular edema

Same eye and interval: Reauthorization is for the same eye as the initial authorization and at least 36 months have passed since the last Iluvien administrationAt least 36 months
Disease and visual status: Documentation shows improvement or stabilization of the disease state and visual status
Expected benefit and safety: Prescriber attests that retreatment is likely to benefit the member without significant risk and that there is no evidence of intolerable adverse effects or drug toxicity
Examples of toxicity include cataracts, increased intraocular pressure, hypotony, and endophthalmitis

Continuation therapy: non-infectious uveitis

Continuation is available only for the same previously treated eye and when all criteria are met.

Continuation therapy for non-infectious uveitis

Same eye and interval: Reauthorization is for the same eye as the initial authorization and at least 36 months have passed since the last Iluvien administrationAt least 36 months
Positive treatment response: Documentation shows positive response to treatment, indicated by lack of recurrence, greater than 15 letters (3 lines) improvement in BCVA from baseline, achieved driving visual acuity, or visual acuity maintained to at least 50% of the best recorded following diagnosis of uveitisGreater than 15 letters (3 lines) in BCVA from baseline, or visual acuity maintained to at least 50% of the best recorded
Expected benefit and safety:

Coverage requires documentation that the member has no unaddressed FDA-labeled contraindication to Iluvien. Contraindications include ocular or periocular infections, glaucoma, and hypersensitivity to any component of the product.

Simultaneous bilateral implantation is not covered. The prescriber must attest, or the clinical reviewer must determine, that Iluvien will not be administered in both eyes at the same time.

Uses of Iluvien other than treatment of diabetic macular edema in appropriately previously corticosteroid-treated patients and chronic non-infectious uveitis affecting the posterior segment are considered experimental or investigational and follow Molina’s Off-Label policy.

Iluvien is contraindicated in the presence of ocular or periocular infections, glaucoma, or hypersensitivity to Iluvien or any of its components.

Iluvien must not be administered with another intravitreal implant, including Ozurdex (dexamethasone intravitreal implant) or Retisert (fluocinolone acetonide intravitreal implant).

Coding and Clinical Coding Notes

HCPCSHCPCS

J7313

Injection, fluocinolone acetonide intravitreal implant (Iluvien), 0.01 mg

HCPCSHCPCS

J7313

Injection, fluocinolone acetonide intravitreal implant (Iluvien), 0.01 mg

DME Bevacizumab Inadequate Response

Number of injections1-2 injections

Response thresholdMinimal to no improvement

Inadequate response definitionAn inadequate response is defined as 1-2 injections with minimal to no improvement.

Uveitis Continuation Visual Response

BCVA improvementGreater than 15 letters (3 lines) from baseline

Driving acuityThe member achieved driving visual acuity

Maintained visual acuity

Authorization and Documentation Requirements

Prior Authorization

Initial Authorization Requirements

Obtain prior authorization before administration. Iluvien is covered initially when the member is 18 years of age or older, the request meets the applicable diagnosis-specific criteria for diabetic macular edema (DME) or non-infectious posterior segment uveitis, and the drug is prescribed by or in consultation with a qualified specialist. Initial authorization is approved for 36 months.

The prescriber must be a board-certified ophthalmologist, ophthalmic surgeon, retinal specialist experienced in intravitreal implants, or another specialist in uveal eye disease.
If prescribed in consultation, submit the consultation notes with the initial request.
The implant must not be administered simultaneously in both eyes.
The member must have no unaddressed FDA-labeled contraindication.

Denial Risk

Policy Background

This policy addresses Iluvien (fluocinolone acetonide intravitreal implant) coverage for adults with diabetic macular edema or non-infectious posterior segment uveitis. Coverage and prior authorization depend on diagnosis-specific medical necessity, prior treatment history, safety evaluation, qualified prescribing, and appropriate administration.

Clinical Definitions

Diabetic Macular Edema (DME)

ConditionDiabetic macular edema (DME)

Underlying processLeakage of fluid from retinal blood vessels

EffectCauses the macula to swell

Diabetic Retinopathy (DR)

ConditionDiabetic retinopathy (DR)

Disease courseProgressive damage

Affected structuresThe blood vessels in the back of the eye

Initial Therapy Criteria

DME initial therapy

Initial DME therapy requires all diagnosis, prior-treatment, safety, administration, and contraindication criteria.

Documented diabetic macular edema, with baseline visual status and the treated eye identified
ONE of
- Inadequate response, clinically significant adverse effects, or contraindication to bevacizumab1–2 injections with minimal to no improvement defines inadequate response to bevacizumab
- Bevacizumab is unavailable and there is inadequate response, serious side effects, or contraindication to ranibizumab
Documented inadequate response to an appropriate trial of intravitreal glucocorticoids, such as triamcinolone

Continuation and Reauthorization Criteria

DME continuation

DME continuation requires same-eye retreatment at least 36 months after the prior Iluvien administration, disease and visual stabilization or improvement, expected benefit without significant risk, and no intolerable adverse effects or toxicity.

Same eye and timing: The request is for the same eye as the initial authorization and at least 36 months have passed since the last Iluvien administrationAt least 36 months
Disease and visual status: Disease state and visual status have improved or stabilized
Expected benefit and safety: Retreatment is likely to benefit the member without significant risk, with no evidence of intolerable adverse effects or drug toxicity
Examples of toxicity include cataracts, increased intraocular pressure, hypotony, and endophthalmitis

Required Prior Therapies

Step	Prerequisite treatment	Requirement for coverage
1	Bevacizumab; if bevacizumab is unavailable, ranibizumab	Document an inadequate response, clinically significant or serious adverse effects, or contraindication. For bevacizumab, inadequate response means 1–2 injections with minimal to no improvement.
1	Intravitreal glucocorticoid, such as triamcinolone	Document an inadequate response to an appropriate trial.

Step	Prerequisite treatment	Requirement for coverage
1	Formulary topical glucocorticoid, intravitreal steroid (such as triamcinolone or dexamethasone), or systemic corticosteroid	Document an inadequate response after an appropriate trial period, serious side effects, or contraindication.
1	Antimetabolite (such as methotrexate, azathioprine, or mycophenolate) or calcineurin inhibitor (such as cyclosporine or tacrolimus)	Document a trial and failure, serious side effects, or contraindication.

Quantity and Frequency Limits

Quantity Limit

Quantity limitOne implant

FrequencyPer eye per 36 months

ProductIluvien (fluocinolone acetonide intravitreal implant)

Administration Site and Method

Billing Rule

Use a non-hospital facility-based site

The implant is recommended for pharmacy or medical benefit coverage and administration in a non-hospital facility-based location.

Recommended site of care: office or other non-hospital facility-based location.

Billing Rule

Administer by ophthalmic intravitreal injection

Iluvien is administered by ophthalmic intravitreal injection.

Bill and administer the product consistent with the specified route of administration.

Policy Summary

PayerMolina Healthcare

PolicyIluvien (fluocinolone acetonide intravitreal implant) Coverage Criteria

Policy CodePolicy C11728-A

Change TypeAdministrative template revisionno material coverage changes

Effective DateDecember 1, 2025

Next Review DateOctober 1, 2025

Key ActionDocument diagnosis-specific medical necessity, prior treatment history, safety evaluation, and qualified specialist prescribing or consultation when requesting prior authorization.

SourceLink

On This Page

ONE of: prior immunomodulator treatment

Documented trial and failure, serious side effects, or contraindication to an antimetabolite, such as methotrexate, azathioprine, or mycophenolate
Documented trial and failure, serious side effects, or contraindication to a calcineurin inhibitor, such as cyclosporine or tacrolimus

Corticosteroid pressure safety: Previously treated with corticosteroids without a clinically significant rise in intraocular pressure

Contraindication safety: Prescriber attests, or clinical reviewer finds, that the member has no unaddressed FDA-labeled contraindication

Contraindications include ocular or periocular infections, glaucoma, and hypersensitivity to any component of Iluvien

Prescriber attests that retreatment is likely to benefit the member without significant risk and that there is no evidence of intolerable adverse effects or drug toxicity

Examples of toxicity include cataracts, increased intraocular pressure, hypotony, and endophthalmitis

Visual acuity maintained to at least 50% of the best recorded following diagnosis of uveitis

Unaddressed Contraindication

Address all applicable FDA-labeled contraindications in the submitted clinical documentation. Coverage or administration may be denied when the member has an ocular or periocular infection, glaucoma, or hypersensitivity to any component of Iluvien, unless the issue has been appropriately addressed by the prescriber.

Document the relevant safety assessment and any prescriber explanation addressing a potential contraindication.
Do not proceed when an applicable contraindication remains unaddressed.

Denial Risk

Unsafe Administration or Retreatment

Retreatment requires safe administration and must meet the continuation criteria. Do not administer Iluvien simultaneously in both eyes, and do not retreat the same eye until at least 36 months have passed since the last Iluvien administration.

Retreatment is limited to the same previously treated eye under the continuation criteria.
The prescriber must attest that the member is likely to benefit without significant risk.
There must be no evidence of intolerable adverse effects or drug toxicity, including cataracts, increased intraocular pressure, hypotony, or endophthalmitis.

Denial Risk

Other Uses Are Experimental/Investigational

All uses of Iluvien other than the covered DME and non-infectious posterior segment uveitis indications are considered experimental or investigational and are handled under Molina's Off-Label policy.

Submit documentation supporting the applicable covered indication.
Noncovered or investigational uses may be denied under the Off-Label policy.

Documentation Required

Initial DME Documentation

For an initial DME request, document the diagnosis and baseline clinical status, including the eye to be treated. Include evidence of required prior treatment, corticosteroid response and safety history, the administration plan, and the contraindication assessment.

Documented diagnosis of diabetic macular edema.
Baseline visual status with notation of the eye being treated.
Inadequate response, clinically significant adverse effects, or contraindication to bevacizumab; if bevacizumab is unavailable, document the applicable inadequate response, serious side effects, or contraindication to ranibizumab.
Inadequate response to an appropriate trial of intravitreal glucocorticoids, such as triamcinolone.
Prior corticosteroid treatment without a clinically significant rise in intraocular pressure.
Attestation or clinical review confirming no unaddressed FDA-labeled contraindication and no simultaneous bilateral implantation.

Documentation Required

Initial Uveitis Documentation

For an initial non-infectious uveitis request, document the diagnosis, baseline best-corrected visual acuity (BCVA), and treated eye or eyes. Include the required formulary treatment history, corticosteroid safety history, administration plan, and contraindication assessment.

Documented diagnosis of non-infectious posterior segment uveitis.
Baseline BCVA to measure efficacy, with notation of the eye or eyes being treated.
Inadequate response after an appropriate trial period, serious side effects, or contraindication to formulary topical glucocorticoids, an intravitreal steroid, or a systemic corticosteroid.
Trial and failure, serious side effects, or contraindication to an antimetabolite such as methotrexate, azathioprine, or mycophenolate, or to a calcineurin inhibitor such as cyclosporine or tacrolimus.
Prior corticosteroid treatment without a clinically significant rise in intraocular pressure.
Attestation or clinical review confirming no unaddressed FDA-labeled contraindication.

Step Therapy

DME Anti-VEGF and Steroid Prerequisites

For DME, document the required anti-VEGF and steroid prerequisites before requesting Iluvien. The record must establish the applicable inadequate response, safety issue, or contraindication and include the relevant treatment history.

Bevacizumab is required unless the provider indicates it is unavailable.
Document 1–2 bevacizumab injections with minimal to no improvement, or clinically significant adverse effects or contraindication.
When bevacizumab is unavailable, document inadequate response, serious side effects, or contraindication to ranibizumab.
Document inadequate response to an appropriate trial of intravitreal glucocorticoids, such as triamcinolone.
Document prior corticosteroid treatment without a clinically significant rise in intraocular pressure.

Step Therapy

Uveitis Corticosteroid and Immunosuppressant Prerequisites

For non-infectious posterior segment uveitis, document the required formulary treatment prerequisites before requesting Iluvien. The record must include an appropriate trial period where applicable and the reason a prior therapy cannot be continued.

Document inadequate response, serious side effects, or contraindication to formulary topical glucocorticoids, an intravitreal steroid such as triamcinolone or dexamethasone, or a systemic corticosteroid.
Document trial and failure, serious side effects, or contraindication to an antimetabolite such as methotrexate, azathioprine, or mycophenolate, or to a calcineurin inhibitor such as cyclosporine or tacrolimus.
Document prior corticosteroid treatment without a clinically significant rise in intraocular pressure.

Documentation Required

General Medical Necessity Documentation

Be prepared to provide additional information needed for medical-necessity review. Molina may request patient records, test results, provider credentials, and other case-specific documentation; when dosing or review depends on a member-specific measurement, that measurement is required.

Provide clinical rationale supporting medical necessity and that the service is not investigational or experimental.
Submit relevant patient records and test results.
Provide credentials of the provider ordering or performing the drug or service.
Include member-specific dosing data when applicable.
Molina may review updated FDA-label information, state and federal requirements, benefit provisions, and formulary preferencing on a case-by-case basis.

Documentation Required

Initial DME Documentation Checklist

The initial DME submission must contain sufficient evidence to evaluate the diagnosis, baseline visual status, treated eye, prior treatment response or safety issues, and planned administration.

DME diagnosis.
Baseline visual status and treated eye.
Bevacizumab prerequisite or documented unavailability with the required ranibizumab evidence.
Prior intravitreal glucocorticoid trial and response.
Prior corticosteroid exposure without clinically significant intraocular-pressure rise.
Bilateral implantation prohibition and contraindication assessment.

Documentation Required

Initial Uveitis Documentation Checklist

The initial uveitis submission must contain sufficient evidence to evaluate the diagnosis, baseline BCVA, treated eye or eyes, prior treatment response or safety issues, and planned administration.

Non-infectious posterior segment uveitis diagnosis.
Baseline BCVA and treated eye or eyes.
Prior corticosteroid treatment history and response, side effects, or contraindication.
Prior antimetabolite or calcineurin-inhibitor treatment history and response, side effects, or contraindication.
Prior corticosteroid exposure without clinically significant intraocular-pressure rise.
Contraindication assessment and applicable specialist documentation.

Documentation Required

Continuation DME Documentation

For DME reauthorization, document that the request is for the same previously treated eye and that at least 36 months have passed since the last Iluvien administration. Also document stabilization or improvement of the disease and visual status and the clinical basis for safe retreatment.

A request for a newly affected untreated eye must be submitted as a new request and meet all initial criteria.
Document stabilization or improvement of the disease state, such as macular edema, and visual status.
The prescriber must attest that retreatment is likely to benefit the member without significant risk.
Document no intolerable adverse effects or drug toxicity, including cataracts, increased intraocular pressure, hypotony, or endophthalmitis.
Continuation authorization is for 36 months.

Documentation Required

Continuation Uveitis Documentation

For non-infectious uveitis reauthorization, document that the request is for the same previously treated eye and that at least 36 months have passed since the last Iluvien administration. Submit evidence of a positive response and safe, clinically appropriate retreatment.

A request for a newly affected untreated eye must be submitted as a new request and meet all initial criteria.
Document lack of recurrence, a gain of more than 15 letters (3 lines) in BCVA from baseline, achievement of driving visual acuity, or visual acuity maintained at least 50% of the best recorded following diagnosis.
The prescriber must attest that retreatment is likely to benefit the member without significant risk.
Document no intolerable adverse effects or drug toxicity, including cataracts, increased intraocular pressure, hypotony, or endophthalmitis.
Continuation authorization is for 36 months.

Documentation Required

Specialist Consultation Documentation

If Iluvien is prescribed in consultation, submit the consultation note with both the initial authorization request and each reauthorization request. The consultation must involve an appropriately qualified specialist experienced in intravitreal implants or uveal eye disease.

Board-certified ophthalmologist.
Ophthalmic surgeon.
Retinal specialist experienced in administration of intravitreal implants.
Other specialist in uveal eye disease.

Denial Risk

Insufficient Supporting Documentation

Molina may deny reimbursement or take other appropriate action when submitted documentation does not support medical necessity, does not establish that the service is not investigational or experimental and within the member's benefits, or indicates inappropriate or excessive billing or practice.

Provide requested records, test results, rationale, and provider credentials.
Additional documentation may be required during coverage determination, quality improvement, or fraud, waste, and abuse review.

Denial Risk

Contraindication Not Addressed

Coverage or administration may be denied when an applicable contraindication is present and has not been addressed in the submitted documentation. This includes ocular or periocular infection, glaucoma, hypersensitivity to any component of Iluvien, or another applicable FDA-labeled contraindication.

Document the prescriber's assessment of infection, glaucoma, and hypersensitivity risk.
Do not proceed with administration when a contraindication remains unresolved.

Denial Risk

Incomplete Clinical Criteria

A request may be denied when required clinical criteria or supporting evidence are incomplete. The submission must establish the covered diagnosis, baseline assessment, prior treatment response or safety history, qualified prescriber or consultation, and all applicable administration requirements.

Missing DME or non-infectious posterior segment uveitis diagnosis.
Missing baseline visual status or BCVA and treated eye documentation.
Missing required anti-VEGF, corticosteroid, or immunosuppressant treatment history.
Missing contraindication, intraocular-pressure, or bilateral-implantation assessment.
Missing qualified specialist documentation or consultation note when applicable.

Denial Risk

Quantity or Retreatment Limit Exceeded

Do not exceed the quantity and retreatment limit of one implant per eye per 36 months. Continuation requests are limited to the same previously treated eye; a request for an untreated eye must be submitted as a new initial request.

Initial authorization duration: 36 months.
Continuation authorization duration: 36 months.
Same-eye continuation requires at least 36 months since the last Iluvien administration.
A newly affected untreated eye must meet all initial coverage criteria.

Denial Risk

Unsafe Administration or Retreatment

Use safe administration practices for every implant. Iluvien must not be administered simultaneously in both eyes, and same-eye retreatment requires the applicable 36-month interval, documented likely benefit, and no significant safety risk or intolerable toxicity.

The prescriber must attest to or the clinical reviewer must confirm that bilateral implantation will not occur.
Assess for cataracts, increased intraocular pressure, hypotony, endophthalmitis, and other intolerable adverse effects or drug toxicity before retreatment.
Do not retreat when the safety requirements are not met.

Denial Risk

Experimental/Investigational Uses

All other uses of Iluvien are experimental or investigational and are subject to Molina's Off-Label policy. Do not represent an unlisted use as covered under the DME or non-infectious uveitis criteria.

Submit the request under Molina's Off-Label policy when applicable.
Coverage is not established by this policy for uses outside the specified indications.

Denial Risk

Contraindications

Iluvien is contraindicated for ocular or periocular infections, glaucoma, and hypersensitivity to any component of the product. Do not administer when one of these contraindications is present and unresolved.

Ocular infection: administration prohibited.
Periocular infection: administration prohibited.
Glaucoma: administration prohibited unless appropriately addressed under the applicable FDA labeling and documentation requirements.
Hypersensitivity to any component: administration prohibited.

Denial Risk

Do Not Combine With Other Intravitreal Implants

Do not administer Iluvien concurrently with another intravitreal implant. This prohibition includes Ozurdex (dexamethasone intravitreal implant), Retisert (fluocinolone acetonide intravitreal implant), or another intravitreal implant.

Verify that no other intravitreal implant will be administered concurrently.
Requests that do not address this prohibition may be denied or administration must be deferred.

Intravitreal

RouteInjected into the eye's vitreous humor

Anatomic locationThe vitreous humor is between the lens and the retina

Implant deliveryIntravitreal implants deliver a continuous concentration of drug over a prolonged period of time

Phakic

Eye statusAn eye containing the natural lens

Lens typeNatural lens

DefinitionPhakic refers to an eye containing the natural lens

Pseudophakic

Eye statusAn eye in which a natural lens is replaced

ReplacementThe natural lens is replaced with an artificial lens implant

Lens typeArtificial lens implant

Retinopathy

ConditionRetinopathy

DefinitionDamage to the retina

Affected structureThe retina

Vascular Endothelial Growth Factor (VEGF)

TermVascular endothelial growth factor (VEGF)

SourceA chemical signal produced by the body's cells

EffectStimulates growth of new blood vessels

Uveitis

ConditionUveitis

DefinitionInflammation of part or all of the uvea

Anatomic contextThe uvea is the middle (vascular) tunic of the eye; uveitis commonly involves the sclera, cornea, and retina

Previously treated with corticosteroids without a clinically significant rise in intraocular pressure

Iluvien will not be administered by simultaneous bilateral implantation

No unaddressed FDA-labeled contraindication

Contraindications include ocular or periocular infections, glaucoma, and hypersensitivity to any component of Iluvien

Non-infectious uveitis initial therapy

Initial non-infectious uveitis therapy requires all diagnosis, prior-treatment, safety, and contraindication criteria.

Documented non-infectious posterior segment uveitis, with baseline best-corrected visual acuity and the treated eye or eyes identified
ONE of: corticosteroid treatment history
- Inadequate response after an appropriate trial period, serious side effects, or contraindication to formulary topical glucocorticoids
- Inadequate response, serious side effects, or contraindication to an intravitreal steroid, such as triamcinolone or dexamethasone
- Inadequate response, serious side effects, or contraindication to a systemic corticosteroid
ONE of: immunomodulator treatment history
- Documented trial and failure, serious side effects, or contraindication to an antimetabolite, such as methotrexate, azathioprine, or mycophenolate
- Documented trial and failure, serious side effects, or contraindication to a calcineurin inhibitor, such as cyclosporine or tacrolimus
Previously treated with corticosteroids without a clinically significant rise in intraocular pressure
No unaddressed FDA-labeled contraindication
Contraindications include ocular or periocular infections, glaucoma, and hypersensitivity to any component of Iluvien

Non-infectious uveitis continuation

Non-infectious uveitis continuation requires same-eye retreatment at least 36 months after the prior Iluvien administration, positive response, expected benefit without significant risk, and no intolerable adverse effects or toxicity.

Same eye and timing: The request is for the same eye as the initial authorization and at least 36 months have passed since the last Iluvien administrationAt least 36 months
Positive response: There is a positive treatment response shown by lack of recurrence, greater than 15 letters (3 lines) improvement in BCVA from baseline, achieved driving visual acuity, or visual acuity maintained to at least 50% of the best recorded following diagnosis of uveitisGreater than 15 letters (3 lines) in BCVA from baseline, or visual acuity maintained to at least 50% of the best recorded
Expected benefit and safety: Retreatment is likely to benefit the member without significant risk, with no evidence of intolerable adverse effects or drug toxicity
Examples of toxicity include cataracts, increased intraocular pressure, hypotony, and endophthalmitis