CurrentBlue Cross Blue Shield - IowaPolicy 05.04.55

Adbry (tralokinumab) for moderate-to-severe atopic dermatitis

Policy governs prior authorization, coverage criteria, dosing limits, and documentation requirements for Adbry (tralokinumab-ldrm) in patients with moderate-to-severe atopic dermatitis age 12 and older for members of Wellmark/Blue Cross Blue Shield Iowa.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyAdbry (tralokinumab) for moderate-to-severe atopic dermatitis

Policy CodePolicy 05.04.55

Change TypeDocumentation-only revision

Effective DateSep 28, 2025

Next Review Date

Key ActionSubmit prior authorization with chart documentation of age, affected body surface area (or involvement of crucial areas), prior topical therapy trials (dose/duration/response), and current medications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age ≥ 12minimum patient age for coverage

4 monthsinitial approval duration

12 monthscontinuation approval duration

BSA ≥ 10%disease severity threshold

05.04.55policy identifier

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Coverage Criteria for Adbry (tralokinumab)

Initial Therapy Criteria

Authorization of 4 months may be granted when ALL of the following are met:

Initial approval: All conditions must be satisfied for initial approval4 months

Age: Patient is 12 years of age or olderage >= 12

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Disease severity: Affected body surface area is greater than or equal to 10% OR crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affectedBSA >= 10% or crucial areas

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Topical therapy trial or contraindication: Patient has had an inadequate treatment response in the past 180 days to both: (1) a medium- to super-high potency topical corticosteroid (or topical corticosteroids are not advisable), AND (2) a topical calcineurin inhibitor (or TCI is not advisable). Documentation of doses, durations, and responses is requiredpast 180 days referenced for prior therapies

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Concomitant therapy restriction: Patient will not use Adbry concomitantly with other biologics or targeted synthetic drugs indicated for atopic dermatitisno concomitant biologic/targeted synthetic

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Continuation Therapy Criteria

Authorization of 12 months may be granted when ALL of the following are met:

Continuation approval: Patient has achieved or maintained a positive clinical response as evidenced by low disease activity (i.e., clear or almost clear skin) or improvement in signs and symptomspositive clinical response

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Concomitant therapy restriction: Patient will not use Adbry concomitantly with other biologics or targeted synthetic drugs indicated for atopic dermatitisno concomitant biologic/targeted synthetic

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General clinical criteria references

Referenced coverage and clinical criteria

Referenced criteria: Policy references utilization management criteria for dermatology biologic agents and multiple guideline and evidence sources (e.g., AAD guidelines, NEA, NICE, UM criteria, and key clinical trials and reviews) to define appropriate clinical use of topical and systemic therapies for atopic dermatitis. Reviewers should consult the cited references and the full policy for detailed stepwise logic and appendix material (topical corticosteroid potencies).

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Members who are currently receiving Adbry as samples or through the manufacturer's patient assistance program must still satisfy the documented coverage criteria to qualify for authorization. This requirement ensures equitable treatment regardless of how the member initially obtained the medication and that prior authorization criteria (including indication, prior topical therapy trials or contraindications, disease severity, and concomitant therapy restrictions) are met before coverage is approved.

The policy excerpt does not list explicit exclusions; however, an appendix is provided that enumerates topical corticosteroids and their potency groupings. The appendix content (topical corticosteroid agents and potencies) is informational and does not itself state exclusion conditions in the excerpted material.

Adbry (tralokinumab) is considered not medically necessary for patients who do not meet the coverage criteria described in this policy. Requests failing to demonstrate the required indication, prior therapy documentation, disease severity, dosing within labeling, or other listed criteria are subject to denial as not medically necessary.

The provided excerpt does not consistently present formalized or repeated 'not medically necessary' statements beyond the single explicit statement in the policy text; reviewers should consult the full policy for any additional explicit determinations or specific language used elsewhere in the document.

Coding, Dosing Presentations, and Quantity Limits

Covered dosing presentations and quantity limitsmixedCovered

Adbry 300 mg/2 mL auto-injector	Quantity limits: Initiation of therapy: Three 300 mg injections per first 28 days; Maintenance: Two 300 mg per 28 days; FDA-recommended dosing: Initial dose of 600 mg (four 150 mg injections OR two 300 mg injections), followed by 300 mg administered every other week; after 16 weeks consider 300 mg every 4 weeks for patients <100 kg who achieve clear or almost clear skin.
Adbry 150 mg/mL prefilled syringe	Quantity limits: Initiation of therapy: Six 150 mg injections per first 28 days; Maintenance: Four 150 mg injections per 28 days; FDA-recommended dosing: Initial dose of 600 mg (four 150 mg injections OR two 300 mg injections), followed by 300 mg administered every other week; after 16 weeks consider 300 mg every 4 weeks for patients <100 kg who achieve clear or almost clear skin.

Procedures and billing codes (general instruction)mixed

CPT / HCPCS / Revenue / ICD diagnostic codes

Provider services should be reported using appropriate CPT codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD diagnostic codes as applicable.

Affected body surface area — key clinical threshold

Affected body surface area (BSA)>= 10%

Threshold contextDefines moderate-to-severe atopic dermatitis when BSA is greater than or equal to 10%

Use in initial approvalOne of the required disease-severity criteria for initial 4-month authorization

Provider Requirements, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for Adbry (tralokinumab-ldrm). Initial approvals may be granted for up to 4 months for patients 12 years of age or older with moderate-to-severe atopic dermatitis when the clinical criteria are met (affected BSA ≥ 10% or involvement of crucial body areas, prior trials of topical therapies or documentation why they are not advisable, inadequate response to at least two preferred products unless exceptions apply).

Initial authorization: up to 4 months when ALL initial-approval criteria are met
Age requirement: ≥ 12 years
Disease severity: affected BSA ≥ 10% or crucial body-area involvement

Step Therapy

Preferred-Product Step Requirement

The plan requires trial of two preferred products (Dupixent, Ebglyss, and Rinvoq) before approval of a non-preferred agent such as Adbry, unless there is documentation of inadequate response, intolerance, or contraindication to at least two preferred products, the member is currently receiving the non-preferred drug with demonstrated positive therapeutic outcome, or only one preferred product exists for the indication.

Background and Context

Adbry (tralokinumab-ldrm) is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older whose disease is inadequately controlled with topical prescription therapies or when such therapies are not advisable. It may be used with or without topical corticosteroids. For coverage consideration, moderate-to-severe disease is defined as involvement of a body surface area of ≥ 10% or involvement of crucial body areas (for example hands, feet, face, neck, scalp, genitals/groin, intertriginous areas). Prior authorization is required and initial approval may be granted for 4 months when the policy's clinical criteria (including documented prior topical therapy trials, disease severity, and no concomitant biologic/targeted synthetic therapy) are met; continuation authorization may be granted for 12 months with documented clinical benefit.

Key Definitions

Adbry — drug identifier (Adbry / tralokinumab-ldrm)

Proprietary nameAdbry

Nonproprietary nametralokinumab-ldrm

Indication summaryTreatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older not adequately controlled with topical prescription therapies or when those therapies are not advisable

Dosing presentations (see coding)300 mg/2 mL auto-injector and 150 mg/mL prefilled syringe

Moderate-to-severe atopic dermatitis — definition

Clinical definitionModerate-to-severe atopic dermatitis: affected body surface area >= 10% OR involvement of crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)

Policy Revision History and References

2025-09-28Policy effective dateLatest

Current policy effective date set to September 28, 2025 (Policy 05.04.55).

2022-07-01Original effective date

Original effective date of the policy established as July 1, 2022.

2023-12Reference update