CurrentBlue Cross Blue Shield - WisconsinPolicy CC-0208

Adbry (tralokinumab) — Coverage Criteria for Atopic Dermatitis

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Medical benefit coverage and prior authorization criteria for Adbry (tralokinumab) for treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older.

Policy Summary

PayerBlue Cross Blue Shield - Wisconsin

PolicyAdbry (tralokinumab) — Coverage Criteria for Atopic Dermatitis

Policy CodePolicy CC-0208

Change TypeRevised

Effective Date

Last ReviewAug 15, 2025

Next Review DateAug 15, 2025

Key ActionObtain prior authorization showing patient is ≥12 years, has moderate-to-severe atopic dermatitis, and documentation of required prior trials or contraindications.

SourceLink

POLICY UPDATE CHANGES

Removed 6 month approval duration for consistency and updated wording/formatting.

Added Vtama as an acceptable topical/systemic prerequisite trial option.

Lowered the minimum age for Adbry from 18 to 12 years.

12+

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CurrentBlue Cross Blue Shield - WisconsinPolicy CC-0208

Adbry (tralokinumab) — Coverage Criteria for Atopic Dermatitis

Customize your policy alerts

Sign up for Blue Cross Blue Shield - Wisconsin Policy CC-0208 alerts

Get alerted when Policy CC-0208 changes without checking for updates manually.

Monitor payer policy activity

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

Medical benefit coverage and prior authorization criteria for Adbry (tralokinumab) for treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older.

Policy Summary

PayerBlue Cross Blue Shield - Wisconsin

PolicyAdbry (tralokinumab) — Coverage Criteria for Atopic Dermatitis

Policy CodePolicy CC-0208

Change TypeRevised

Effective Date

Last ReviewAug 15, 2025

Next Review DateAug 15, 2025

Key ActionObtain prior authorization showing patient is ≥12 years, has moderate-to-severe atopic dermatitis, and documentation of required prior trials or contraindications.

SourceLink

POLICY UPDATE CHANGES

Removed 6 month approval duration for consistency and updated wording/formatting.

Added Vtama as an acceptable topical/systemic prerequisite trial option.

Lowered the minimum age for Adbry from 18 to 12 years.

12+

Minimum age for therapy

L20.0-L20.9Covered diagnosis codes

150mg x26Initiation supply example

300mg = 1/28dAutoinjector monthly limit

Coverage Criteria for Adbry (tralokinumab)

Initial Therapy

Covered when ALL of the following are met:

Initial approval requirements: 1) Individual is 12 years of age or older; AND 2) Individual has a diagnosis of moderate to severe atopic dermatitis; AND 3) Documentation is provided that the individual has tried one of the following and treatment failed to achieve and maintain remission of low or mild disease activity: topical calcineurin inhibitors OR Eucrisa OR Opzelura OR Zoryve 0.15% Cream OR Vtama OR phototherapy (UVB or PUVA) OR non-corticosteroid systemic immunosuppressants (such as cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil); OR documentation that the individual has contraindications to topical calcineurin inhibitors AND Eucrisa AND Opzelura AND Vtama AND Zoryve 0.15% Cream AND non-corticosteroid systemic immunosuppressants AND is unable to use phototherapy.

Maintenance Therapy / Continuation after initial period

Continuation authorization conditions (maintenance dosing and duration):

Maintenance dosing allowance: Continue authorization for one year with four (4) 150 mg syringes or two (2) 300 mg autoinjectors per 28 days if: A) individual weighs >=100 kg; OR B) individual weighs <100 kg AND one of: a) has not achieved clear to almost clear skin in the last 6 months; OR b) provider documents rationale for the four 150 mg syringes or two 300 mg autoinjectors per 28 days dosing; OR c) provider documents trial of the lower dosing (two 150 mg syringes or one 300 mg autoinjector per 28 days) without achieving/maintaining clear or almost clear skin.

Continuation after 6 months

Requirement to continue beyond 6 months:

6-month continuation: Treatment with Adbry (tralokinumab) has resulted in significant improvement or stabilization in clinical signs and symptoms of disease (including but not limited to decreased affected body surface area, reduced pruritus, decreased inflammation, and/or improved quality of life).

Adbry (tralokinumab) is not approved for use in combination with other systemic or topical immunomodulatory therapies. Specifically, concomitant use with oral or topical JAK inhibitors, dupilumab, lebrikizumab, nemolizumab, or other immunosuppressants (for example, cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil) will not be approved.

Any request for Adbry that does not meet the specified initial or continuation criteria is not medically necessary / not covered. This includes uses outside the covered indication of atopic dermatitis and requests that fail to document the required elements for approval (age ≥ 12 years, diagnosis of moderate-to-severe atopic dermatitis, required prior trials of topical therapies/phototherapy/non-corticosteroid systemic immunosuppressants or documented contraindications, and for continuation after 6 months, evidence of significant clinical improvement or stabilization).

Adbry is also not approved for use in combination with the agents listed as contraindicated (see concomitant use restrictions), and any other indications beyond atopic dermatitis are not covered.

Coding

HCPCSHCPCS

J3590	Unclassified biologics (when specified as [Adbry] (tralokinumab)
C9399	Unclassified drugs or biologicals (when specified as Adbry] (tralokinumab)

ICD-10 DiagnosisICD-10

L20.0-L20.9

Atopic dermatitis

Provider Actions and Requirements

Prior Authorization

Prior authorization required for Adbry (tralokinumab)

Prior authorization is required for Adbry (tralokinumab). Initial approval will be granted only when the patient is 12 years of age or older, has a diagnosis of moderate-to-severe atopic dermatitis, and documentation shows trial and failure of one of the specified topical therapies, phototherapy, or non-corticosteroid systemic immunosuppressants (or documentation of contraindications to all listed options).

Initial requests: age ≥12; diagnosis of moderate-to-severe atopic dermatitis; trial and failure of one listed therapy or documented contraindications to all listed topical agents and systemic non-corticosteroid immunosuppressants and inability to use phototherapy.
Continuation after 6 months requires evidence of significant improvement or stabilization in clinical signs/symptoms for ongoing authorization.

Step Therapy

Step‑therapy requirement: documented trial and failure of listed topical/phototherapy/systemic options

Step therapy must be documented: the patient must have tried and failed one of the listed topical agents, phototherapy, or a non‑corticosteroid systemic immunosuppressant prior to Adbry, unless all listed options are contraindicated.

Background

Adbry (tralokinumab) is an injectable, selective interleukin-13 (IL-13) antagonist indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

As a biologic therapy targeting IL-13, Adbry is considered a systemic treatment option for patients with chronic, relapsing inflammatory skin disease who have failed or are unable to use specified topical agents, phototherapy, or non-corticosteroid systemic immunosuppressants.

Definitions

Atopic dermatitis (AD) — definition and characteristic features

DefinitionAtopic dermatitis (AD) is a chronic, relapsing inflammatory skin condition commonly associated with personal or family history of allergies, allergic rhinitis, and asthma.

Characteristic featuresClinical manifestations include erythema, edema, xerosis, excoriations, pruritus, oozing/crusting, and lichenification.

CourseTypically follows a relapsing/chronic course and often resolves by adulthood.

Relevance to Adbry (tralokinumab)Adbry is indicated for moderate-to-severe AD in patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Guideline contextAAD and AAAAI/ACAAI guidelines include systemic biologics (including tralokinumab) as options for patients refractory, intolerant, or unable to use topical treatments; other recommended therapies include dupilumab, JAK inhibitors, and select immunosuppressants or phototherapy.

Policy Summary

PayerBlue Cross Blue Shield - Wisconsin

PolicyAdbry (tralokinumab) — Coverage Criteria for Atopic Dermatitis

Policy CodePolicy CC-0208

Change TypeRevised

Effective Date

Last ReviewAug 15, 2025

Next Review DateAug 15, 2025

Key ActionObtain prior authorization showing patient is ≥12 years, has moderate-to-severe atopic dermatitis, and documentation of required prior trials or contraindications.

SourceLink

On This Page

Acceptable prior therapies include: topical calcineurin inhibitors; Eucrisa; Opzelura; Zoryve 0.15% cream; Vtama; phototherapy (UVB or PUVA); or non‑corticosteroid systemic immunosuppressants (e.g., cyclosporine, azathioprine, methotrexate, mycophenolate mofetil).
Provider must document treatment failure to achieve and maintain remission of low or mild disease activity with one of these agents (or document contraindications to all).

Documentation Required

Documentation required to support initial and continuation requests

Providers must submit documentation showing the patient is ≥12 years old, has moderate‑to‑severe atopic dermatitis, and has trialed and failed one of the specified topical agents, phototherapy, or a non‑corticosteroid systemic immunosuppressant, or has documented contraindications to all listed options. For continuation beyond 6 months, documentation must show significant improvement or stabilization in clinical signs and symptoms.

Include age and diagnosis, specifics of prior therapies tried and treatment response, or documented contraindications to each listed agent and inability to use phototherapy.
For continuation after 6 months, provide clinical evidence of improvement/stabilization (e.g., decreased affected BSA, reduced pruritus, decreased inflammation, or improved quality of life) or provider rationale for continued/higher dosing.

Denial Risk

Combination therapy with other immunomodulators is not approved

Requests for Adbry in combination with other listed immunomodulatory agents will not be approved. Do not submit combined‑therapy requests with oral or topical JAK inhibitors, dupilumab, lebrikizumab, nemolizumab, or other immunosuppressants.

Explicitly excluded combinations: oral or topical JAK inhibitors; dupilumab; lebrikizumab; nemolizumab; or other immunosuppressants (e.g., cyclosporine, azathioprine, methotrexate, mycophenolate mofetil).
Combination therapy requests are non‑approved and should not be authorized.

Denial Risk

Deny requests that fail to meet initial or continuation criteria

Requests that do not meet the initial or continuation criteria must be denied. If the patient does not meet the age requirement, lacks a diagnosis of moderate‑to‑severe atopic dermatitis, has no documented trial/failure of required prior therapies (or contraindications), or lacks evidence of improvement for continuation, the request is not covered.

Non‑covered scenarios include use in combination with excluded agents or any use that does not meet the initial or continuation criteria.
Denial is appropriate when required age, diagnosis, prior trial history, or continuation improvement documentation is missing or insufficient.