CurrentAnthemPolicy CC-0208

Adbry (tralokinumab) — Clinical coverage criteria

Clinical coverage criteria and prior authorization requirements for Adbry (tralokinumab) when used to treat moderate-to-severe atopic dermatitis in patients aged 12 years and older under the medical benefit.

Policy Summary

PayerAnthem

PolicyAdbry (tralokinumab) — Clinical coverage criteria

Policy CodePolicy CC-0208

Change TypeRevision — annual review (08/15/2025) removing 6-month approval duration

Effective Date

Next Review DateAug 15, 2025

Key ActionSubmit prior authorization with documentation of age (≥12), diagnosis of moderate-to-severe atopic dermatitis, and prior trial or contraindication to specified topical/systemic therapies.

SourceLink

POLICY UPDATE CHANGES

Remove 6 month approval duration for consistency; wording and formatting updates.

Add Adbry 300 mg autoinjector and Zoryve 0.15% cream trial to criteria in prior revisions.

Lower age limit for Adbry from 18 to 12 years in prior revision.

12+minimum age for coverage

L20.0-L20.9ICD-10 diagnoses listed

2/28 days150 mg syringe limit

1/28 days300 mg autoinjector limit

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Coverage Criteria for Adbry (tralokinumab)

Initial Therapy

Initial requests for Adbry may be approved when ALL of the following are met:

Initial criteria: I. Individual is 12 years of age or older; AND II. Individual has a diagnosis of moderate to severe atopic dermatitis; AND III. Documentation is provided that individual has tried one of the following and treatment failed to achieve and maintain remission of low or mild disease activity: A. Topical calcineurin inhibitors; OR B. Eucrisa; OR C. Opzelura; OR D. Zoryve 0.15% Cream; OR E. Vtama; OR F. Phototherapy (UVB or PUVA); OR G. Non-corticosteroid systemic immunosuppressants (such as cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil); OR H. Individual has contraindications to topical calcineurin inhibitors AND Eucrisa AND Opzelura AND Vtama AND Zoryve 0.15% Cream AND Non-corticosteroid systemic immunosuppressants AND unable to use phototherapy.

Must document trial failure or contraindication to listed agents.

Continuation Therapy

Continuation requests after 6 months may be approved when the following is met:

Continuation: I. Treatment with Adbry (tralokinumab) has resulted in significant improvement or stabilization in clinical signs and symptoms of disease (including but not limited to decrease in affected body surface area, pruritus, or severity of inflammation, and/or improved quality of life).after 6 months

Documentation of clinical improvement or stabilization required for continuation.

Maintenance Dosing and Quantity Limits

Quantity limits and maintenance authorization rules:

Standard quantity limits: Adbry 150 mg syringe: limit = 2 syringes per 28 days; Adbry 300 mg autoinjector: limit = 1 autoinjector per 28 days. For initiation of therapy: may approve six (6) - 150 mg syringes or three (3) - 300 mg autoinjectors in the first month (initiation dose plus first maintenance dose), then four (4) -150 mg syringes or two (2) -300 mg autoinjectors for the following five months, for a total of twenty-six (26) -150 mg syringes or thirteen (13) -300 mg autoinjectors in the first six months.initiation dosing allowances

See policy for first-month and six-month totals.

Higher maintenance dosing—weight >=100 kg: Continue authorization for one year with four (4) -150 mg syringes or two (2) -300 mg autoinjectors per 28 days if individual weighs 100 kg or more.weight >=100 kg

Higher maintenance dosing—weight <100 kg: If individual weighs less than 100 kg, higher maintenance dosing (four (4) -150 mg syringes or two (2) -300 mg autoinjectors per 28 days) may be authorized only if one of the following is met: a) Individual has not achieved clear to almost clear skin in the last 6 months; OR b) Provider submits documentation providing rationale for the higher dosing (e.g., patient did not achieve or maintain clear or almost clear skin); OR c) Provider submits documentation that the member has tried two (2) -150 mg syringes or one (1) -300 mg autoinjector per 28 days and did not achieve or maintain clear or almost clear skin.

Not Medically Necessary / Do Not Approve

Adbry may not be approved for the following:

Disallowed combinations and other indications: I. Use in combination with oral or topical JAK inhibitors; OR II. Use in combination with dupilumab, lebrikizumab, or nemolizumab; OR III. Use in combination with other immunosuppressants (such as cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil); OR IV. Requests that do not meet the specified initial or continuation criteria or for all other non-indicated uses.

Requests for disallowed combinations will not be approved.

Requests for Adbry (tralokinumab) in combination with other specified immunomodulatory or biologic agents are excluded and will not be approved. Disallowed concomitant therapies include oral or topical JAK inhibitors, and concurrent use with other biologics such as dupilumab, lebrikizumab, or nemolizumab. Also excluded is combination use with other systemic immunosuppressants (for example, cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil).

Requests that do not meet the policy's specified initial or continuation criteria, or that are for disallowed combinations or other non‑indicated uses, are not medically necessary and will be denied. Initial approval requires documented age (≥12 years), a diagnosis of moderate‑to‑severe atopic dermatitis, and evidence of prior trial and failure (or contraindication) to the required topical/alternative therapies; continuation after the initial period requires documentation of significant clinical improvement or stabilization. Requests proposing excluded combinations (see exclusions) will also be denied.

Coding and Diagnosis Codes

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

Weight-based maintenance dosing allowance — higher quantity allowance for patients 60 kg

Policy allowanceIf individual weighs ≥100 kg, continue authorization for one year with 4 x 150 mg syringes or 2 x 300 mg autoinjectors per 28 days.

Standard maintenance alternativeFor individuals <100 kg, higher maintenance dosing may be authorized only with: (a) not achieving clear to almost clear skin in last 6 months; (b) provider rationale supporting higher dosing; or (c) documentation that standard lower dosing (2 x150 mg or 1 x300 mg per 28 days) was tried and failed.

Initiation vs maintenanceInitiation dosing and first-month/6-month totals differ from maintenance limits; see policy for exact initiation allowances and total supplies for first 6 months.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Initial and continuation therapy for Adbry (tralokinumab) require prior authorization.

PA required for all requests for Adbry (tralokinumab) for atopic dermatitis

Billing Rule

Initial and Quantity Rules

Initial therapy will be approved only when all clinical entry criteria are met, including age, diagnosis, and prior treatment trials. Quantity limits and initiation dosing rules apply.

Initial approval requires: individual ≥ 12 years; diagnosis of moderate to severe atopic dermatitis; and documentation of trial and failure of at least one listed topical/systemic/phototherapy option (see required prior therapies).

Definitions

Adbry (tralokinumab) — brief description

Drug class and mechanismAdbry (tralokinumab) is an injectable, selective interleukin (IL)-13 antagonist.

IndicationIndicated for treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older whose disease is not adequately controlled with topical therapies or when topical therapies are not advisable.

Formulations noted in policyAvailable as 150 mg syringes and 300 mg autoinjectors (policy references device formulation and dosing rules).

Atopic dermatitis (AD) — brief definition/description

DefinitionAtopic dermatitis (AD) is a common eczema characterized by relapsing/chronic skin inflammation frequently associated with allergies, allergic rhinitis, and asthma.

Typical symptoms

Background

Adbry (tralokinumab) is an injectable, selective IL‑13 antagonist indicated for treatment of moderate‑to‑severe atopic dermatitis in patients aged 12 years and older who are not adequately controlled with topical therapies or when topical therapies are not advisable. Initial coverage requires documented moderate‑to‑severe disease and prior trial and failure (or documented contraindication) of at least one specified topical agent, phototherapy, or non‑corticosteroid systemic immunosuppressant. The policy also specifies that Adbry should never be used concomitantly with certain other systemic or biologic immunomodulators (see exclusions).

Revision History and Document Changes

2025-08-15annual review - material changeLatest

Removed 6-month approval duration for consistency; wording and formatting updates.

2025-02-21annual review - criteria update

Added Vtama option to criteria and updated do not approve criteria; coding updated to remove HCPCS J3490 and set diagnoses to ICD-10-CM L20.0-L20.9.

2024-08-16annual review - formulation & criteria addition