CurrentConnectiCarePolicy C29044-A

Ebglyss Coverage for Moderate-to-Severe Atopic Dermatitis

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This policy governs prior authorization and coverage of Ebglyss (lebrikizumab-lbkz) for members 12 years of age and older with moderate-to-severe atopic dermatitis, including clinical eligibility, prescriber, dosing, continuation, administration, and documentation requirements.

Policy Summary

PayerConnectiCare

PolicyEbglyss Coverage for Moderate-to-Severe Atopic Dermatitis

Policy CodePolicy C29044-A

Change TypeNo material change

Effective DateJune 11, 2026

Next Review DateApril 1, 2027

Key ActionBefore initial approval, document inadequate response, serious side effects, or contraindication to two topical corticosteroids or preferred topical calcineurin inhibitors and one additional specified topical therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12+ yearsMinimum member age

6 monthsInitial authorization

12 monthsContinuation authorization

85%Continuation adherence

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CurrentConnectiCarePolicy C29044-A

Ebglyss Coverage for Moderate-to-Severe Atopic Dermatitis

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Policy Summary

PayerConnectiCare

PolicyEbglyss Coverage for Moderate-to-Severe Atopic Dermatitis

Policy CodePolicy C29044-A

Change TypeNo material change

Effective DateJune 11, 2026

Next Review DateApril 1, 2027

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12+ yearsMinimum member age

6 monthsInitial authorization

12 monthsContinuation authorization

85%Continuation adherence

250 mg every 4 weeksMaintenance dose

Coverage Criteria

Initial Therapy

Covered for initial therapy when all of the following are met.

Initial therapy requirements

Diagnosis and eligibility
- The member has a documented diagnosis of moderate-to-severe chronic atopic dermatitis (eczema).
- The member is 12 years of age or older and weighs at least 40 kg.Age ≥ 12 years; weight ≥ 40 kg
No prohibited concurrent therapy
- The member is not receiving, and Ebglyss will not be used in combination with, a TNF inhibitor, biologic response modifier, other biologic DMARD, Janus kinase inhibitor, or phosphodiesterase 4 inhibitor.
  May be verified by prescriber attestation, medication fill history, or submitted documentation.
Disease extent or sensitive-area involvement
- Atopic dermatitis involvement is estimated at 10% or more of body surface area (BSA) according to the prescribing physician.≥ 10% BSA
- Atopic dermatitis involvement is estimated at less than 10% of BSA but affects the face, eyes or eyelids, skin folds, and/or genitalia according to the prescribing physician.< 10% BSA with specified sensitive-area involvement
Two prior topical corticosteroid or calcineurin inhibitor options
- Document inadequate response, serious side effects, or contraindication to a topical corticosteroid or preferred/formulary topical calcineurin inhibitor such as tacrolimus or pimecrolimus.
One additional topical therapy
- Document inadequate response, serious side effects, or contraindication to one of Eucrisa (crisaborole), Opzelura (ruxolitinib), Vtama (tapinarof), or Zoryve (roflumilast).
Baseline disease assessment
- The prescriber documents baseline disease activity, including relevant findings such as erythema, induration/papulation/edema, excoriations, lichenification, pruritus, affected BSA, and topical treatment requirement.
Non-formulary or non-preferred product requirement
- If Ebglyss is non-formulary or non-preferred, document trial and failure or serious side effects involving a majority of preferred formulary or PDL alternatives for the diagnosis.Majority of alternatives; no more than 3 required
  Include the medications tried, trial dates, and reasons for treatment failure or discontinuation.

Continuation Therapy

Covered for continuation therapy when all of the following are met.

Continuation therapy requirements

Adherence
- Adherence to therapy is at least 85% of the time.≥ 85% adherence
- Adherence is below 85% because surgery or treatment of an infection required temporary discontinuation.
  Adherence may be verified by the prescriber or member medication fill history.
Tolerability and safety
- The prescriber attests to, or clinical review finds, no evidence of intolerable adverse effects or drug toxicity.
Clinical response

FDA-approved indication

Ebglyss is covered for the following FDA-approved use when all conditions are met.

Patient eligibility
- The patient is an adult or pediatric patient 12 years of age or older and weighs at least 40 kg.Age ≥ 12 years; weight ≥ 40 kg
Disease and prior treatment status
- The patient has moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Coverage excludes concurrent or planned combination use of Ebglyss with a TNF inhibitor, biologic response modifier, other biologic DMARD, Janus kinase inhibitor, or phosphodiesterase 4 inhibitor. Medication use may be verified through prescriber attestation, medication fill history, or submitted clinical documentation.

Uses of Ebglyss other than the approved indication for moderate-to-severe atopic dermatitis are considered experimental or investigational and are handled under the applicable Off-Label policy.

Ebglyss is excluded for patients with a history of serious hypersensitivity to lebrikizumab-lbkz or any excipient in Ebglyss.

Live vaccines should be avoided during treatment with Ebglyss.

Coding and Eligibility Parameters

HCPCS CodeHCPCS

NA	HCPCS code not available/listed as NA

Qualifying Disease Extent

Standard extent thresholdAt least 10% of total body surface area (BSA) affected by atopic dermatitis.

Sensitive-area exceptionLess than 10% BSA qualifies when the face, eyes or eyelids, skin folds, and/or genitalia are affected.

Assessment sourceThe affected BSA and anatomic involvement must be estimated by the prescribing physician.

Age Requirement

Minimum age12 years of age or older.

Eligible populationAdults and pediatric patients may qualify when they are at least 12 years old.

Authorization and Documentation Requirements

Prior Authorization

Initial Prior Authorization Required

Prior authorization is required for initial Ebglyss requests. Submit the requested clinical information, prescriber qualifications, applicable consultation notes, member-specific dosing data, and supporting documentation for review.

Initial authorization is approved for 6 months.
The drug must be prescribed by or in consultation with a board-certified allergist, immunologist, or dermatologist.
Age restriction: 12 years of age and older.

Prior Authorization

Continuation Prior Authorization

Continuation requests require documentation that the member remains adherent, is tolerating therapy without drug toxicity, and has demonstrated a positive clinical response. Continuation authorization is approved for 12 months when criteria are met.

Adherence must be at least 85%, unless lower adherence is due to surgery or treatment of an infection that caused temporary discontinuation.
The prescriber must attest, or the clinical reviewer must find, no intolerable adverse effects or drug toxicity.

Background

Ebglyss (lebrikizumab) is a subcutaneous monoclonal antibody that targets interleukin-13 (IL-13), a cytokine associated with inflammation and skin-barrier dysfunction in atopic dermatitis. It is used for moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg, when the condition is not adequately controlled with topical prescription therapies or those therapies are not advisable. Ebglyss may be used with or without topical corticosteroids.

Definitions

Qualifying Atopic Dermatitis Extent

Primary thresholdAtopic dermatitis involvement is estimated at least 10% of total body surface area.

Sensitive anatomic involvementInvolvement of less than 10% BSA qualifies when it affects the face, eyes or eyelids, skin folds, and/or genitalia.

Who estimates extentThe prescribing physician estimates the affected body surface area and relevant anatomic involvement.

Atopic Dermatitis

ConditionAtopic dermatitis is a chronic inflammatory skin condition.

Common featuresIt is characterized by itching and recurring eczematous lesions.

Initial Therapy Criteria

Initial Therapy

Initial therapy requires all policy criteria to be met.

Initial Ebglyss therapy

Diagnosis and eligibility
- The member has a documented diagnosis of moderate-to-severe chronic atopic dermatitis (eczema).
- The member is 12 years of age or older and weighs at least 40 kg.Age ≥ 12 years; weight ≥ 40 kg
No prohibited concurrent therapy
- The member is not receiving, and Ebglyss will not be used in combination with, a TNF inhibitor, biologic response modifier, other biologic DMARD, Janus kinase inhibitor, or phosphodiesterase 4 inhibitor.

Continuation Criteria

Continuation Therapy

Continuation authorization requires all of the following.

Continuation therapy

Adherence
- Adherence to therapy is at least 85% of the time.≥ 85% adherence
- Adherence is below 85% because surgery or treatment of an infection caused temporary discontinuation.
  Adherence may be verified by the prescriber or member medication fill history.
Safety and tolerability
- There is no evidence of intolerable adverse effects or drug toxicity, as attested by the prescriber or determined by clinical review.

Step Therapy Requirements

Step	Required therapy trials	Documentation required
1	Document inadequate response, serious side effects, or contraindication to TWO topical corticosteroids or preferred/formulary topical calcineurin inhibitors (tacrolimus or pimecrolimus), AND ONE of Eucrisa (crisaborole), Opzelura (ruxolitinib), Vtama (tapinarof), or Zoryve (roflumilast).	For each trial, document the inadequate response, serious side effects, or contraindication.

Step	Requirement	Documentation required
2	For non-formulary or non-preferred Ebglyss, document trial and failure or serious side effects to a majority of the preferred formulary or PDL alternatives for the diagnosis; no more than three alternatives are required.	Submit the medication(s) tried, dates of trial(s), and reason(s) for treatment failure(s).

Quantity and Dosing Limits

Ebglyss Dosing Schedule

Loading dose500 mg at Week 0 and Week 2.

Induction dosingThen 250 mg every two weeks until Week 16 or later, when adequate clinical response is achieved.

Maintenance dose250 mg every four weeks.

Site of Care and Administration

Billing Rule

Use home administration

Injectable medication is recommended for pharmacy benefit coverage and patient self-administration.

Policy Summary

PayerConnectiCare

PolicyEbglyss Coverage for Moderate-to-Severe Atopic Dermatitis

Policy CodePolicy C29044-A

Change TypeNo material change

Effective DateJune 11, 2026

Next Review DateApril 1, 2027

SourceLink

On This Page

The member demonstrates a positive clinical response, shown by low disease activity and/or improvement in signs and symptoms of atopic dermatitis.
Examples include marked improvement in erythema, induration/papulation/edema, excoriations, or lichenification; reduced pruritus; decreased need for other topical or systemic therapies; or reduced affected BSA.

Use with other therapy

Ebglyss may be used with or without topical corticosteroids when coverage criteria are met.

Weight Requirement

Minimum weightAt least 40 kg.

Applies toThe weight requirement applies to adult and pediatric patients 12 years of age and older in the FDA-approved population.

Indication contextThe patient must have moderate-to-severe atopic dermatitis that is not adequately controlled with topical prescription therapies or for whom those therapies are not advisable.

Continuation Adherence

Required adherenceAdherence must be at least 85% of the time.

Temporary-discontinuation exceptionAdherence below 85% may qualify when surgery or treatment of an infection caused a temporary discontinuation.

VerificationAdherence may be verified by the prescriber or through the member’s medication fill history.

Document low disease activity and/or improvement in signs and symptoms, including reduced pruritus, affected BSA, topical or systemic therapy requirements, or other observed response.

Billing Rule

Illinois Authorization Duration

For Illinois Marketplace members, prior authorization for a recurring health care service or maintenance medication for a chronic or long-term condition remains valid for the lesser of 12 months from approval or the length of treatment determined by the treating health care professional.

Illinois medical exception approvals must be honored for 12 months after approval or until plan renewal, as applicable.
The state duration rule does not require coverage of care or services otherwise excluded from the benefit.

Step Therapy

Required Topical Treatment Trials

Document inadequate response, serious side effects, or contraindication to the required prior topical therapies before requesting Ebglyss.

Two options must be documented from topical corticosteroids or preferred/formulary topical calcineurin inhibitors: tacrolimus or pimecrolimus.
One additional nonsteroidal option must also be documented: Eucrisa (crisaborole), Opzelura (ruxolitinib), Vtama (tapinarof), or Zoryve (roflumilast).

Step Therapy

Preferred Formulary Alternatives

For a non-formulary or non-preferred request, document trial and failure of, or serious side effects to, a majority of the preferred formulary or PDL alternatives for the diagnosis.

Submit the preferred alternative medication names, trial dates, and reasons for treatment failure.
The required majority may not exceed three preferred alternatives.

Documentation Required

Medical Necessity Documentation

Provide records and other information sufficient to establish medical necessity, that the requested use is not investigational or experimental, and that the service is within the member’s benefits. The plan may request additional documentation and may deny reimbursement when submitted information does not support coverage or indicates inappropriate or excessive billing.

Patient records and test results.
Credentials of the provider ordering or performing the drug or service.
Additional information required for case-by-case review or updated FDA-label review.

Documentation Required

Diagnosis and Medication-Use Verification

Verify and document a diagnosis of moderate-to-severe chronic atopic dermatitis and confirm that Ebglyss will not be used with prohibited concurrent therapies.

The member must not be receiving, and Ebglyss must not be combined with, a TNF inhibitor, biologic response modifier, other biologic DMARD, Janus kinase inhibitor, or phosphodiesterase 4 inhibitor.
Examples include apremilast, tofacitinib, and baricitinib.
Verification may be provided through prescriber attestation, member medication fill history, or submitted documentation.

Documentation Required

Initial Clinical Assessment

Before initial authorization, document the extent and severity of disease, prior topical treatment history, contraindications or serious side effects, and the baseline clinical findings supporting treatment.

Document atopic dermatitis affecting at least 10% BSA, or less than 10% BSA involving the face, eyes or eyelids, skin folds, and/or genitalia.
Document inadequate response, serious side effects, or contraindication to the required topical corticosteroid/calcineurin inhibitor options and one additional nonsteroidal option.
Record baseline disease activity, such as erythema, induration/papulation/edema, excoriations, lichenification, pruritus, BSA affected, and topical treatment requirement.

Documentation Required

Preferred Alternative History

For non-formulary or non-preferred requests, submit the member’s preferred formulary or PDL treatment history with the request.

List each preferred medication tried.
Include the dates of each trial.
Explain the outcome, including treatment failure or serious side effects.

Documentation Required

Continuation Response Documentation

Continuation requests must document medication adherence, tolerability, absence of toxicity, and a positive clinical response.

Verify adherence through the prescriber or member medication fill history.
Explain any adherence below 85% when caused by surgery or infection-related temporary discontinuation.
Document improvement in disease signs and symptoms or reduced treatment burden.

Documentation Required

Consultation Notes Required

When Ebglyss is prescribed by or in consultation with a board-certified allergist, immunologist, or dermatologist, include the consultation notes with both the initial request and each reauthorization request.

Consultation documentation must accompany the initial authorization submission.
Consultation documentation must also accompany continuation or reauthorization submissions.

Documentation Required

Member-Specific Dosing Information

When dosing or medical-necessity review depends on a member-specific measurement, include the applicable measurement with the request.

Submit weight when applicable.
Submit body surface area or another applicable member-specific dosing measurement when required.

Documentation Required

FDA-Approved Indication Support

Support the request with documentation that the member meets an FDA-approved Ebglyss indication.

Diagnosis: moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Age: adult or pediatric patient 12 years of age and older.
Weight: at least 40 kg.
Ebglyss may be used with or without topical corticosteroids.

Denial Risk

Prohibited Concurrent Therapy

Concurrent or planned combination use with specified biologic or immunomodulator therapies does not meet the coverage criteria and may result in denial.

Do not use concurrently with TNF inhibitors, biologic response modifiers, other biologic DMARDs, Janus kinase inhibitors, or phosphodiesterase 4 inhibitors.
Confirm medication use through prescriber attestation, medication fill history, or submitted records.

Denial Risk

Insufficient Prior Topical Therapy

A request may be denied when the required prior topical therapy history is absent or incomplete.

Document two topical corticosteroid or preferred/formulary topical calcineurin inhibitor trials, or a qualifying serious side effect or contraindication.
Document one additional nonsteroidal option, or a qualifying serious side effect or contraindication.

Denial Risk

Non-Preferred Requirements Not Met

A non-formulary or non-preferred request may be denied when the required preferred formulary or PDL alternative history is not submitted or does not meet the policy requirement.

Document trial and failure of, or serious side effects to, a majority of preferred alternatives, limited to no more than three.
Include medication names, trial dates, and treatment-failure reasons.

Denial Risk

Continuation Criteria Not Met

Continuation authorization may be denied when adherence, tolerability, toxicity, or positive clinical response criteria are not adequately documented.

Document adherence of at least 85%, or an allowed temporary interruption due to surgery or infection.
Document no intolerable adverse effects or drug toxicity.
Document low disease activity and/or meaningful improvement in signs and symptoms.

Denial Risk

Insufficient Supporting Documentation

The plan may deny a request when supporting information does not establish medical necessity, non-investigational status, eligibility, or appropriate use within the member’s benefits.

Submit patient records, test results, provider credentials, and other requested documentation.
Additional case-by-case information may be required, including when the FDA label has recently changed.
Documentation may also be reviewed for inappropriate or excessive billing patterns.

Denial Risk

Non-Covered or Investigational Use

Uses of Ebglyss other than the covered criteria and FDA-approved indication are considered experimental or investigational and follow the plan’s Off-Label policy.

Coverage is limited to eligible, documented uses within the member’s benefit.

Denial Risk

Hypersensitivity or Unresolved Helminth Infection

Do not initiate or continue Ebglyss in the presence of an applicable serious hypersensitivity reaction or unresolved helminth infection.

Contraindication: prior serious hypersensitivity to lebrikizumab-lbkz or any Ebglyss excipient.
Discontinue Ebglyss after a serious hypersensitivity reaction, including angioedema or urticaria.
Treat pre-existing helminth infections before initiation.
If helminth infection develops and does not respond to standard antihelminth therapy, discontinue Ebglyss until the infection resolves.
Avoid live vaccines during treatment.

Ebglyss is used for moderate-to-severe atopic dermatitis in adults and children aged 12 years and older who weigh at least 40 kg.

Interleukin-13 (IL-13)

Biologic targetInterleukin-13 (IL-13) is targeted by lebrikizumab.

Role in atopic dermatitisIL-13 contributes to inflammation and skin-barrier dysfunction associated with atopic dermatitis.

Associated effectsIL-13 contributes to skin inflammation, increased epidermal thickness, itching, and elevated infection risk.

Verification may be by prescriber attestation, medication fill history, or submitted documentation.

Qualifying disease extent

Atopic dermatitis involvement is estimated at 10% or more of BSA according to the prescribing physician.≥ 10% BSA
Atopic dermatitis involvement is estimated at less than 10% of BSA but affects the face, eyes or eyelids, skin folds, and/or genitalia according to the prescribing physician.< 10% BSA with specified sensitive-area involvement

Prior topical corticosteroid or calcineurin inhibitor therapy

Document inadequate response, serious side effects, or contraindication to a topical corticosteroid or preferred/formulary topical calcineurin inhibitor, including tacrolimus or pimecrolimus.

Additional topical therapy

Document inadequate response, serious side effects, or contraindication to one of Eucrisa (crisaborole), Opzelura (ruxolitinib), Vtama (tapinarof), or Zoryve (roflumilast).

Baseline disease activity

The prescriber documents baseline disease activity, including signs and symptoms, pruritus, affected BSA, and topical treatment requirement.

Non-formulary or non-preferred Ebglyss

If applicable, document trial and failure or serious side effects involving a majority of preferred formulary or PDL alternatives for the diagnosis.Majority of alternatives; no more than 3 required
Include medications tried, trial dates, and reasons for treatment failure.

FDA-approved indication

Ebglyss is indicated when all of the following conditions apply.

Initial therapy eligibility

The patient is an adult or pediatric patient 12 years of age or older and weighs at least 40 kg.Age ≥ 12 years; weight ≥ 40 kg
The patient has moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Positive clinical response

The member demonstrates positive clinical response with low disease activity and/or improvement in signs and symptoms of atopic dermatitis.
Supporting improvement may include reduced erythema, induration/papulation/edema, excoriations, lichenification, pruritus, affected BSA, or need for topical or systemic therapies.