CurrentUnitedHealthcarePolicy 2025 P 2269-5

Adbry (tralokinumab-ldrm) prior authorization — Pharmacy Clinical Policy

Criteria and prior authorization requirements for coverage of Adbry (tralokinumab-ldrm) for treatment of moderate to severe atopic dermatitis in patients (aged criteria noted) under UnitedHealthcare Pharmacy clinical programs.

Policy Summary

PayerUnitedHealthcare

PolicyAdbry (tralokinumab-ldrm) prior authorization — Pharmacy Clinical Policy

Policy CodePolicy 2025 P 2269-5

Change TypeUpdated combination therapy criteriawording clarifications

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization with documented diagnosis, trials of two topical therapy classes (or contraindications), and ensure Adbry is not prescribed with listed biologics or JAK inhibitors.

SourceLink

POLICY UPDATE CHANGES

Updated not used in combination criteria and reference.

Clarified topical steroid potency in atopic dermatitis with no change to clinical intent or coverage criteria.

Removed age requirement from initial authorization (previous change history).

12 monthsauthorization duration

2topical therapy classes tried

12+approved age

2025 P 2269-5

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Coverage Criteria for Adbry (tralokinumab-ldrm)

inv-01: Initial Therapy

Covered when ALL of the following are met:

Diagnosis of moderate to severe chronic atopic dermatitis

Topical therapy trials: History of failure, contraindication, or intolerance to two of the following topical therapy classes with documented trial dates or contraindications: medium, high, or very‑high potency topical corticosteroid (e.g., mometasone furoate, fluocinolone acetonide, fluocinonide); Eucrisa (crisaborole); topical calcineurin inhibitor (pimecrolimus or tacrolimus)2 classes

Document date of trial and/or contraindication

Concomitant therapy restriction: Patient is not receiving Adbry in combination with a biologic immunomodulator (e.g., dupilumab, lebrikizumab, nemolizumab) or a Janus kinase inhibitor (e.g., abrocitinib, topical ruxolitinib, upadacitinib, tofacitinib)

Prescriber specialty: Prescribed by a dermatologist, immunologist, or allergist

inv-02: Continuation / Reauthorization

Reauthorization covered when ALL of the following are met:

Clinical response: Documentation of positive clinical response to Adbry therapy

Prescriber specialty: Prescribed by a dermatologist, immunologist, or allergist

Use of Adbry in combination with specified biologic immunomodulators or Janus kinase inhibitors is not allowed. Specifically, Adbry must not be prescribed concurrently with a biologic immunomodulator (for example, dupilumab, lebrikizumab, or nemolizumab) or a Janus kinase (JAK) inhibitor (for example, abrocitinib, topical ruxolitinib, upadacitinib, or tofacitinib).

Adbry is intended for treatment of moderate to severe chronic atopic dermatitis; use for diagnoses other than this or without required documentation of topical therapy trials may be considered not medically necessary. Approval for initial therapy requires documentation of a diagnosis of moderate to severe chronic atopic dermatitis and a history of failure, contraindication, or intolerance to two of the specified topical therapy classes with trial dates or documented contraindications (medium/high/very-high potency topical corticosteroid; Eucrisa/crisaborole; topical calcineurin inhibitor).

Initial Therapy Requirements

inv-13: Initial therapy

Initial authorization criteria

Diagnosis: Moderate to severe chronic atopic dermatitis

Topical therapy trials: Failure, contraindication, or intolerance to two topical therapy classes: medium, high, or very‑high potency topical corticosteroid; Eucrisa (crisaborole); topical calcineurin inhibitor (pimecrolimus or tacrolimus)2 classes

Document dates of trials and/or contraindications

No concurrent biologic/JAK: Patient is not receiving Adbry in combination with a biologic immunomodulator (e.g., dupilumab, lebrikizumab, nemolizumab) or a Janus kinase inhibitor (e.g., abrocitinib, topical ruxolitinib, upadacitinib, tofacitinib)

Continuation / Reauthorization Requirements

inv-14: Reauthorization

Reauthorization requirements and documentation of effectiveness

Positive response: Documentation of positive clinical response to Adbry therapy

Provide clinical measures or notes demonstrating improvement

Concomitant therapy restriction: Patient is not receiving Adbry in combination with a biologic immunomodulator or a Janus kinase inhibitor

Examples include dupilumab, lebrikizumab, nemolizumab, abrocitinib, topical ruxolitinib, upadacitinib, tofacitinib

Prescriber specialty: Continued prescription by a dermatologist, immunologist, or allergist

Authorization duration:

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required — Initial Authorization

Initial prior authorization is required. Adbry (tralokinumab-ldrm) will be approved only when all initial authorization criteria are met; document dates of trials and/or contraindications for alternative topical therapies.

Diagnosis: moderate to severe chronic atopic dermatitis.
Topical therapy trial requirement: history of failure, contraindication, or intolerance to two of the specified topical therapy classes (document dates of trials and/or reasons for contraindication/intolerance). Required classes include: medium/high/very-high potency topical corticosteroid (e.g., Elocon/mometasone furoate, Synalar/fluocinolone acetonide, Lidex/fluocinonide), Eucrisa (crisaborole), and topical calcineurin inhibitors (e.g., Elidel/pimecrolimus, Protopic/tacrolimus).
Concomitant therapy exclusion: patient must NOT be receiving Adbry in combination with a biologic immunomodulator (e.g., Dupixent/dupilumab, Ebglyss/lebrikizumab, Nemluvó/nemolizumab) or a Janus kinase (JAK) inhibitor (e.g., Cibinqo/abrocitinib, Opzelura/topical ruxolitinib, Rinvoq/upadacitinib, Xeljanz/tofacitinib).
Prescriber requirement: prescribed by a dermatologist, immunologist, or allergist.

Key Coding and Demographics

Age threshold

Approved ageAdults and adolescents 12 years of age and older

Authorization durationAuthorizations issued for 12 months

Age grouping wordingAdults and adolescents (12 years of age and older)

Definitions and Drug Description

Adbry (tralokinumab-ldrm)

DrugAdbry (tralokinumab-ldrm)

Mechanism of actionInterleukin-13 antagonist

Indicated populationTreatment of moderate to severe atopic dermatitis in patients 12 years and older

Usage notesMay be used with or without topical corticosteroids; indicated when disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable

Step Therapy Requirements

Required prior trials or documented contraindications (must trial 2 classes)	Notes / examples
Medium, high, or very‑high potency topical corticosteroid	Examples: Elocon (mometasone furoate), Synalar (fluocinolone acetonide), Lidex (fluocinonide). Document date of trial or reason for contraindication/intolerance.
Eucrisa (crisaborole)	Topical nonsteroidal PDE‑4 inhibitor. Document date of trial or reason for contraindication/intolerance.
Topical calcineurin inhibitor	Examples: Elidel (pimecrolimus), Protopic (tacrolimus). Document date of trial or reason for contraindication/intolerance.

Background and Clinical Context

Adbry (tralokinumab-ldrm) is an interleukin-13 antagonist indicated for the treatment of moderate to severe atopic dermatitis in patients 12 years of age and older. The policy requires that initial authorization be based on a diagnosis of moderate to severe chronic atopic dermatitis and other coverage criteria described in this document.

Policy Revision History

2025-04annual reviewLatest

Annual review: clarified topical steroid potency in atopic dermatitis; updated background and references (no change to coverage criteria).

2024-03annual review

Annual review: updated 'not used in combination' criteria and reference.

2023-03policy revision

Removed age requirement from initial authorization and updated reference.

Policy Summary

PayerUnitedHealthcare

PolicyAdbry (tralokinumab-ldrm) prior authorization — Pharmacy Clinical Policy

Policy CodePolicy 2025 P 2269-5

Change TypeUpdated combination therapy criteriawording clarifications

Effective DateJul 1, 2025

Next Review Date

SourceLink

On This Page

Prescriber specialty: Prescribed by a dermatologist, immunologist, or allergist

Authorizations will be issued for 12 months

State mandates and member‑specific benefits may affect coverage

Documentation Required

Reauthorization Criteria

For continuation of therapy, submit documentation demonstrating a positive clinical response and attest that Adbry is not being used with prohibited therapies; authorization periods and required documentation are noted below.

Documented positive clinical response to Adbry therapy is required for reauthorization.
For reauthorization, confirm the member is not receiving Adbry in combination with a biologic immunomodulator (e.g., Dupixent/dupilumab, Ebglyss/lebrikizumab, Nemluvó/nemolizumab) or a JAK inhibitor (e.g., Cibinqo/abrocitinib, Opzelura/topical ruxolitinib, Rinvoq/upadacitinib, Xeljanz/tofacitinib).
Prescriber requirement for reauthorization: dermatologist, immunologist, or allergist.
Authorization duration: up to 12 months; state mandates, federal requirements, and member benefit plan terms may affect approval.

Documentation Required

Documentation Requirements

Document the dates and outcomes of topical therapy trials or the reason(s) for contraindication/intolerance. For reauthorization, provide clinical measures of improvement or other evidence of positive response.

Required documentation for initial authorization: dates of trials of at least two topical therapy classes and specific reasons for failure, intolerance, or contraindication.
Required documentation for reauthorization: clinical documentation of positive response to Adbry (e.g., symptom improvement, clinician assessment) and confirmation of absence of prohibited concomitant therapies.
Note: Trials/failed alternatives should be consistent with FDA labeling when applicable; Elidel, Protopic (tacrolimus), and Eucrisa require prior authorization per plan rules.

Denial Risk

Denial Risks / Triggers

Denial may result if required criteria or documentation are missing or if the drug is used with excluded therapies.

Denial triggers: incorrect diagnosis (not moderate to severe chronic atopic dermatitis), missing documentation of trials or contraindications to two topical therapy classes, missing documentation of positive clinical response for reauthorization, or concurrent use with a prohibited biologic or JAK inhibitor.
Operational note: ensure prescriber specialty and trial dates are clearly documented; state and benefit plan limits may also affect coverage.

2022-07new program

Program established as a prior authorization/medical necessity policy for Adbry (tralokinumab-ldrm).

2022-02change control entry

Initial change control record created for Adbry (tralokinumab-ldrm).