CurrentNeighborhood Health Plan of Rhode IslandPolicy 6634-A

Lebrikizumab (Ebglyss) for moderate-to-severe atopic dermatitis — Coverage Criteria

Policy governing coverage and prior authorization requirements for Ebglyss (lebrikizumab-lbkz) for adults and pediatric patients ≥12 years and ≥40 kg with moderate-to-severe atopic dermatitis; defines documentation, prescriber specialty, and treatment criteria for initial and continuation coverage.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLebrikizumab (Ebglyss) for moderate-to-severe atopic dermatitis — Coverage Criteria

Policy CodePolicy 6634-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with chart notes documenting affected areas/BSA, prior topical therapy trials or reasons topical therapies are not advisable, and prescriber specialty (dermatologist or allergist/immunologist).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12minimum patient age for coverage

≥40 kgminimum patient weight for coverage

10% BSABSA threshold for initial auth

4 monthsshort auth after prior biologic/systemic

12 months

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continuation authorization length

Coverage Criteria for Ebglyss (lebrikizumab-lbkz)

Initial Therapy Criteria

Covered when ALL of the following are met

FDA indication: Patient is aged >=12 years and weighs >=40 kg with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisableage>=12; weight>=40 kg

Ebglyss can be used with or without topical corticosteroids

Disease severity: Either affected body surface area >=10% OR involvement of crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)BSA>=10% or crucial site involvement

Used to establish moderate-to-severe disease

Prior topical therapy: Member has had an inadequate treatment response within the past year to one of: a medium- to super-high potency topical corticosteroid, a topical calcineurin inhibitor, a topical JAK inhibitor, or a topical PDE-4 inhibitor; OR use of these topical therapies is not advisable (document clinical reason)trial within past year or documented contraindication/intolerance

See topical corticosteroid potency table (appendix) for examples

Prior Biologic/Systemic Use — Short Authorization

Alternative initial authorization path

Prior systemic/biologic: Member received a biologic (e.g., Adbry, Dupixent, Nemlouvio) or a systemic targeted synthetic drug (e.g., Cibinqo, Rinvoq) indicated for moderate-to-severe atopic dermatitis in the past yearprior biologic/systemic within 1 year

Authorization of 4 months may be granted

Continuation of Therapy

Covered when ALL of the following are met

Continuation criteria: Member has achieved or maintained a positive clinical response as evidenced by low disease activity (clear or almost clear skin) or improvement in signs and symptoms (e.g., redness, itching, oozing/crusting)clinical improvement/low disease activity

Authorization of 12 months may be granted

Requests for Ebglyss (lebrikizumab-lbkz) for indications other than the FDA-approved use — treatment of moderate-to-severe atopic dermatitis in patients aged 12 years or weighing less than 40 kg — are considered experimental/investigational and not medically necessary. Such requests may be denied if the submitted indication falls outside the FDA-specified population and labeled use. Ebglyss is indicated for patients aged 12 years and older who weigh at least 40 kg with disease not adequately controlled with topical prescription therapies or when topical therapies are not advisable; it may be used with or without topical corticosteroids.

The policy appendix includes a relative potency table of topical corticosteroid products (groups I–VII) with examples and strengths for groups VI (low potency) and VII (least potent). This table is provided for clinical reference; no explicit coverage exclusions beyond the FDA-approved indication are stated in these potency table chunks.

Coverage of Ebglyss is limited to the FDA-specified population: adults and pediatric patients aged 12 years and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when topical therapies are not advisable. Use outside this age/weight/indication context is not supported by the policy language in these chunks.

The referenced chunks containing the topical corticosteroid potency table and related material do not include any statements labeling specific scenarios as not medically necessary; they present potency groupings and product examples for clinical reference only.

Key Clinical Thresholds and Coding-related Values

inv-08: Body Surface Area (BSA) — threshold for initial authorization

BSA threshold for initial authorizationAffected body surface area >= 10%

Alternative to BSA thresholdInvolvement of crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)

Use window for prior systemic/biologic usersAuthorization of 4 months may be granted for members with prior biologic/systemic use in past year

inv-09: Age / Weight — FDA-approved population minimums

Minimum age for coveragePatients aged >= 12 years

Minimum weight for coveragePatients weighing >= 40 kg

Provider Requirements, Documentation, and Restrictions

Note
Provider Requirements, Documentation, and Restrictions
This section contains provider requirements, documentation expectations, and restrictions for use of Ebglyss.

Documentation Required
Required documentation for prior authorization
Submission of the following information is necessary to initiate the prior authorization review: initial requests must include chart notes or medical record documentation showing affected area(s) and body surface area (where applicable); documentation or claims history supporting previous medications tried and response to therapy; or clinical rationale if topical therapies are not advisable. Continuation requests must include chart notes or medical record documentation supporting positive clinical response.
Initial requests: chart notes/medical records showing affected areas and BSA where applicable; prior medication history and response; documentation of why topical therapies are not advisable if applicable.
Continuation requests: documentation of positive clinical response.

Clinical Background

Atopic dermatitis is an inflammatory skin disease that can be moderate-to-severe and, when not controlled with topical therapies or when topical treatments are not advisable, may require systemic therapy including biologic agents. Lebrikizumab (Ebglyss) is FDA-approved for patients aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis and may be used with or without topical corticosteroids when documented clinical criteria are met.

Definitions and Key Terms

inv-22: FDA-approved population — Adults and pediatric patients 63years and 6340 kg

FDA-approved populationAdults and pediatric patients aged 12 years and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis

Indication noteFor disease not adequately controlled with topical prescription therapies or when those therapies are not advisable

Concomitant topical useEbglyss can be used with or without topical corticosteroids

inv-23: Crucial body areas — examples

Examples of crucial body areasHands, feet, face, neck, scalp, genitals/groin, intertriginous areas

Role in severity assessmentInvolvement of these areas qualifies as an alternative to BSA >=10% for initial authorization

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLebrikizumab (Ebglyss) for moderate-to-severe atopic dermatitis — Coverage Criteria

Policy CodePolicy 6634-A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

Authorization length for continuation when criteria met

Authorization of 12 months may be granted for members meeting continuation criteria

Prior Authorization
Topical therapy requirement and exceptions
Topical therapy requirement: For members 12 years of age or older and weighing at least 40 kg seeking treatment for moderate-to-severe atopic dermatitis, authorization may be granted when affected BSA is ≥10% OR crucial body areas are involved, AND the member has had an inadequate response to one of the following within the past year: a medium- to super-high potency topical corticosteroid (see potency table), a topical calcineurin inhibitor, a topical JAK inhibitor, or a topical PDE-4 inhibitor. Alternatively, authorization may be granted if use of those topical therapies is not advisable with clinical justification (e.g., contraindication, intolerance).
Affected BSA ≥10% OR crucial body areas involved (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas).
Inadequate response to one of: medium- to super-high potency topical corticosteroid; topical calcineurin inhibitor; topical JAK inhibitor; topical PDE-4 inhibitor — within the past year.
Or documentation why those topical therapies are not advisable.

Note
Topical corticosteroid potency (informational)
Providers should note that the potency table for topical corticosteroids is provided for informational purposes only and is not a prior authorization rule. It lists relative potency groups and example agents/forms to guide clinical decision-making.
Potency table is informational only — it does not itself trigger authorization rules.

Documentation Required
Prescriber specialty and concomitant therapy restriction
Prescriber specialty and concomitant therapy restrictions: Ebglyss must be prescribed by or in consultation with a dermatologist or allergist/immunologist. The member may not use Ebglyss concomitantly with any other biologic or targeted synthetic drug for the same indication.
Prescriber: dermatologist or allergist/immunologist (or documented consultation).
Concomitant use with other biologic or targeted synthetic drugs for the same indication is not permitted.

Note
Step therapy / sequencing
No step therapy or specific sequencing rules beyond the topical therapy requirement and prior biologic/systemic use guidance are specified in this section.
There are no additional step therapy or sequencing rules included here.

Documentation requirementChart notes or medical record documentation should show affected area(s) when applicable

inv-24: Relative potency groups — topical corticosteroid examples (groups VI–VII)

Potency group definitionRelative potency groups I–VII rank topical corticosteroids from most to least potent

Group VI (low potency) examplesAlclometasone dipropionate (0.05%), Betamethasone valerate (0.1%), Desonide (0.05%), Fluocinolone acetonide (0.01%), Triamcinolone acetonide (0.025%)

Group VII (least potent) examplesHydrocortisone (various bases and strengths: >=2%, 2.5%, 2%, 1%, 0.5%), Hydrocortisone acetate (up to 2.5%)