CurrentCignaPolicy N/A

Adbry (tralokinumab) prior authorization for atopic dermatitis

This Cigna coverage policy governs prior authorization requirements, medical necessity criteria, and exclusions for Adbry (tralokinumab-ldrm) for insured members, primarily addressing use for moderate to severe atopic dermatitis in patients aged 12 and older.

Policy Summary

PayerCigna

PolicyAdbry (tralokinumab) prior authorization for atopic dermatitis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 9, 2025

Next Review DateApr 9, 2025

Key ActionObtain prior authorization and document age, estimated BSA (≥10%), prior topical corticosteroid trial (≥28 days), and specialist prescribing/consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12minimum age for coverage

≥10% BSAminimum BSA involvement

4 moinitial approval duration

1 yrcontinuation approval

asthma/othernon-covered indications

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Coverage Criteria for Adbry (tralokinumab-ldrm)

FDA-Approved Indication: Atopic Dermatitis

Covered when ALL of the following are met for initial therapy or continuation therapy as specified

Initial Therapy (Approve 4 months): Patient is ≥ 12 years of age; AND patient has atopic dermatitis involvement estimated to be ≥ 10% of the body surface area according to the prescriber; AND patient meets ALL of the following: (a) patient has tried at least one medium-, medium-high, high-, and/or super-high-potency prescription topical corticosteroid; (b) this topical corticosteroid was applied daily for at least 28 consecutive days; (c) inadequate efficacy was demonstrated with this topical corticosteroid therapy, according to the prescriber; AND the medication is prescribed by or in consultation with an allergist, immunologist, or dermatologist.

Initial approval duration = 4 months

Continuation Therapy (Approve 1 year): Patient has already received at least 4 months of therapy with Adbry; AND patient has responded to therapy as determined by the prescriber (examples of response include marked improvements in erythema, induration/papulation/edema, excoriations, lichenification; reduced pruritus; decreased requirement for other topical or systemic therapies; reduced body surface area affected; or other observed responses).

Continuation approval duration = 1 year

Adbry (tralokinumab-ldrm) is not medically necessary for uses outside its FDA-approved indication of moderate to severe atopic dermatitis. Requests for Adbry for indications other than atopic dermatitis will be considered not medically necessary and may be denied.

Specific indications considered not medically necessary include: asthma; concurrent use with another monoclonal antibody therapy (examples listed in the policy: Dupixent, Cinqair, Ebglyss, Fasenra, Nemluvio, Nucala, Tezspire, Xolair); concurrent use with Janus kinase (JAK) inhibitors (oral or topical; examples include Cibinqo, Leqselvi, Rinvoq/Rinvoq LQ, Opzelura); idiopathic pulmonary fibrosis; and ulcerative colitis. The safety and efficacy of Adbry in combination with other biologic therapies or JAK inhibitors have not been established, and clinical trials did not show benefit for several of these conditions.

Coding, Age & Treatment Duration

Product referenceNDC | mixed

tralokinumab-ldrm

Adbry (trastlokinumab-ldrm) subcutaneous injection - product name as referenced

inv-05: Body surface area (BSA) — ≥ 10%

Body surface area (BSA) threshold≥ 10% of body surface area (as estimated by the prescriber)

Evidence sourcePivotal trials enrolled patients with ≥ 10% BSA involvement

Usage in criteriaRequired for initial therapy approval (part of the FDA-Approved Indication criteria)

inv-06: Age — ≥ 12 years

Minimum age for therapy≥ 12 years

Indication contextAdbry indicated for moderate to severe atopic dermatitis in patients ≥ 12 years of age

Role in approvalRequired for initial therapy approval (criterion i)

inv-07: Initial therapy duration for approval — 4 months

Initial approval duration4 months

Applies toInitial Therapy (when patient meets criteria A i–iv)

Continuation notePatients currently receiving Adbry are evaluated under continuation criteria for 1-year approvals

Prior Authorization, Documentation, and Denials

Prior Authorization

Prior Authorization and Approval Durations

Prior Authorization Required. Initial approvals are limited to 4 months; continuation/maintenance approvals for patients currently receiving Adbry are authorized for 1 year when continuation criteria are met.

Initial approval duration = 4 months (1 month = 30 days).
Continuation approval duration = 1 year for patients who have received ≥ 4 months of therapy and have responded to therapy as determined by the prescriber.

Documentation Required

Topical Corticosteroid Trial Requirement

Topical corticosteroid trial required prior to initial approval. The prescriber must document that the patient tried at least one prescription topical corticosteroid of at least medium potency (medium-, medium-high, high-, and/or super-high-potency), applied daily for at least 28 consecutive days (or for the maximum duration recommended in the topical corticosteroid prescribing information), and that the corticosteroid produced inadequate efficacy per the prescriber. Patients who received systemic AD treatment in the prior year may be considered non-responders to topical therapy.

Required trial: ≥1 prescription topical corticosteroid of medium potency or higher.
Duration: applied daily for ≥28 consecutive days (or maximum recommended duration).
Outcome: inadequate efficacy as determined by the prescriber.
Clinical trial eligibility note: prior systemic treatment within 1 year may qualify patient as non-responder to topical therapy.

Documentation Required

Required Documentation for Approval and Denial Triggers

Required documentation for approval. Prescriber must document patient age, estimated body surface area (BSA) affected, prior topical corticosteroid therapy details (agent, potency, dates/duration, adherence, and clinical response/inadequate efficacy), specialty of prescribing or consulting clinician, and for continuation requests, documentation that the patient has received ≥4 months of Adbry and has responded to therapy (examples: improvements in erythema, induration/papulation/edema, excoriations, lichenification, reduced pruritus, decreased need for other therapies, or reduced BSA). Requests lacking these elements may be denied.

Document patient age (must be ≥ 12 for initial therapy).
Document estimated affected BSA (≥ 10% required for initial therapy).
Document prior topical corticosteroid: agent name, potency, dates/duration (≥28 days), and prescriber-assessed efficacy.
For initial therapy, document specialty: allergist, immunologist, or dermatologist involvement (prescribed by or in consultation with).
For continuation, document ≥4 months of prior Adbry therapy and clinical response to therapy (examples provided).
Include any relevant prior systemic therapy within 1 year (may indicate topical nonresponse).

Denial Risk

Denial Triggers

Denial triggers. Requests will be denied if documentation does not demonstrate that the patient meets medical necessity criteria (e.g., age ≥12 for initial therapy, ≥10% BSA, adequate topical corticosteroid trial with inadequate efficacy, specialty prescriber/consultation, or for continuation requests, ≥4 months of Adbry and prescriber-assessed response).

Missing or incomplete documentation of age, BSA, topical corticosteroid trial details, specialty prescriber/consultation, or prior Adbry duration/response.
Requests for uses considered not medically necessary (e.g., asthma or concurrent use with another monoclonal antibody) will be denied.

Definitions and Response Criteria

inv-13: Inadequate response — Inadequate response to topical corticosteroid therapy

DefinitionInadequate response to topical corticosteroid therapy

Clinical trial basisPatients had a recent history of an inadequate response to a sufficient course of topical therapy (e.g., topical corticosteroids and/or topical calcineurin inhibitors)

Implication for eligibilityDocumented inadequate response to topical corticosteroids is required for initial approval

inv-14: Inadequate response (detailed) — Failure to achieve or maintain remission or low disease activity after at least 28 days of adequate potency topical corticosteroid

Detailed definitionFailure to achieve or maintain remission or low disease activity after at least 28 days of topical corticosteroid treatment (medium potency or higher) or for the maximum duration recommended by the topical corticosteroid prescribing information

Alternate evidencePrior systemic treatment for atopic dermatitis within the previous year may be considered evidence of non-response to topical therapies

Required trial specificsTopical corticosteroid must have been applied daily for at least 28 consecutive days (part of initial therapy criteria)

OpenPayer

Adbry (tralokinumab) prior authorization for atopic dermatitis

Coverage Criteria for Adbry (tralokinumab-ldrm)

Coding, Age & Treatment Duration

Prior Authorization, Documentation, and Denials

Background on Adbry

Definitions and Response Criteria