ModifiedCentenePolicy CP.PHAR.577

Tralokinumab-ldrm (Adbry) coverage for atopic dermatitis

This policy governs medical necessity criteria, dosing limits, and coverage requirements for Adbry (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis for Centene-affiliated health plans (Medicaid). It applies to prescribers seeking prior authorization and pharmacy/provider reviewers.

Policy Summary

PayerCentene

PolicyTralokinumab-ldrm (Adbry) coverage for atopic dermatitis

Policy CodePolicy CP.PHAR.577

Change TypeCriteria updated: pediatric extension, new autoinjector, extended approval duration, excluded biologics added

Effective DateJun 1, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis, prior topical therapy failures, prescriber specialty, age, and dosing within specified limits.

SourceLink

POLICY UPDATE CHANGES

Added new autoinjector 300 mg/2 mL dosage formulation and added maximum numbers of injections to approval criteria.

Extended initial approval duration from 4 months to 12 months and removed Commercial and HIM line of business.

Updated criteria with pediatric extension to include ages 12 years and older and removed systemic immunosuppressant therapy step criterion for initial criteria.

Added Ebglyss and Nemluvio as examples of biologic medications for which concurrent use is excluded.

12+min approved patient age

BSA ≥10%disease extent required

12 mo

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initial approval duration

600 mginitial adult dose

300 mg q2wmaintenance dose

examples addedexcluded biologics updated

Coverage Criteria

Updated Coverage Criteria (summary) — Policy criteria were updated as follows

Policy criteria were updated as follows

Pediatric Extension: Criteria expanded to include patients aged 12 years and older for initial approval.

Formulation and Dose Limits: New autoinjector 300 mg/2 mL formulation was added and maximum numbers of injections were added to approval criteria.

Approval Duration: Initial approval duration was extended from 4 months to 12 months.

Concurrent Use Exclusions: Concurrent use with certain biologic immunomodulators is not allowed; examples now include Ebglyss and Nemluvio.

Requests for uses that are non‑FDA approved indications and are not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety per the off‑label use policy (see CP.PMN.53) or other applicable evidence of coverage documents.

Adbry must not be prescribed concurrently with specified biologic immunomodulator therapies. The list of examples of biologic medications for which concurrent use is excluded has been expanded to explicitly include Ebglyss and Nemluvio.

Requests for non‑FDA approved indications that do not include sufficient supporting documentation (such as clinical evidence demonstrating efficacy and safety consistent with off‑label use policies) are not authorized.

Inclusion or exclusion of procedure or HCPCS codes in this policy does not by itself guarantee coverage. Providers should reference current professional coding guidance prior to claim submission. Use of unclassified HCPCS codes (for example, J3590 or C9399) may be denied if the claim does not meet medical necessity or applicable coding guidance.

Coding and Billing

Product availability / NDCsNDC

NDCs not listed

Product availability listed (pre-filled syringe 150 mg/mL; autoinjector 300 mg/2 mL) but no NDC codes provided in this document

HCPCS Codes (informational)HCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Body surface area (BSA) — At least 10% BSA or involvement of specified special areas

Required disease extentAt least 10% of the member's body surface area (BSA) OR involvement of hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas.

Prescriber requirementPrescribed by or in consultation with a dermatologist or allergist.

Age requirementPatient is age ≥ 12 years.

Dosing noteDose must not exceed approved initial and maintenance dosing (adult initial 600 mg one-time; maintenance 300 mg every 2 weeks; pediatric 12–17 initial 300 mg then 150 mg every 2 weeks).

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required and must demonstrate that the member meets all approval criteria for Adbry, including diagnosis, prescriber specialty, age, prior topical therapy failures, absence of concurrent biologic or JAK inhibitor therapy, and dosing within specified limits.

Prior authorization must document diagnosis of atopic dermatitis and extent/location criteria (≥10% BSA or involvement of specified areas).
Prescriber requirement: dermatologist or allergist (or consultation).
Age requirement: ≥ 12 years.
Topical therapy step: failure of two different medium-to-very-high potency topical corticosteroids (different molecular identities) each used ≥2 weeks, and failure of one non-steroidal topical therapy used ≥4 weeks (e.g., topical calcineurin inhibitor or crisaborole).
Concurrent use exclusion: not prescribed with another biologic immunomodulator or a JAK inhibitor.
Dosing limits: initial and maintenance dosing and maximum number of injections per formulation as specified in the criteria (see policy for prefilled syringe and autoinjector dosing and limits).

Background

Adbry (tralokinumab‑ldrm) is an interleukin‑13 (IL‑13) antagonist indicated for the treatment of moderate‑to‑severe atopic dermatitis. The policy documentation has been updated to reflect the addition of a new autoinjector formulation (300 mg/2 mL), maximum injection limits in approval criteria, and extensions to initial approval duration and pediatric eligibility over time.

Definitions and References

body surface area — BSA definition / reference

Definition (BSA)BSA = body surface area (abbreviation used in this policy).

Policy thresholdInitial approval requires at least 10% BSA OR involvement of specified special areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous).

Appendix referenceSee Appendix A: Abbreviation/Acronym Key for BSA definition in policy appendices.

Janus kinase — JAK definition

Definition (JAK)JAK = Janus kinase (abbreviation used in this policy).

Clinical exclusionAdbry must not be prescribed concurrently with a Janus kinase (JAK) inhibitor (policy lists examples such as Olumiant®, Rinvoq®, Cibinqo®, Opzelura™).

Policy Summary

PayerCentene

PolicyTralokinumab-ldrm (Adbry) coverage for atopic dermatitis

Policy CodePolicy CP.PHAR.577

Change TypeCriteria updated: pediatric extension, new autoinjector, extended approval duration, excluded biologics added

Effective DateJun 1, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis, prior topical therapy failures, prescriber specialty, age, and dosing within specified limits.

SourceLink

On This Page

Prior Authorization Criteria Updated

Prior authorization criteria were updated to add a new 300 mg/2 mL autoinjector formulation and to specify maximum number of injections for initial and maintenance doses. Operational changes and timeline updates are reflected in the policy history.

New autoinjector formulation: 300 mg/2 mL added to dosing options.
Maximum injections: initial and maintenance maximum injection counts defined separately for prefilled syringes and autoinjectors.
Policy history notes operational updates (dates shown in coding/history section).

Denial Risk

Documentation Missing or Non‑Covered Indication — Denial Risk

If required supporting documentation is missing or does not demonstrate that the member meets all approval criteria, the request may be denied. This includes lack of documentation of prior topical therapy failures, prescriber specialty, age, dosing, or exclusion of concurrent biologic/JAK therapies.

Provider must submit office chart notes, lab results, or other clinical information to support that approval criteria are met.
Requests lacking documentation of the required topical therapy trials (two medium-to-very-high potency corticosteroids of different molecular identities and one non-steroidal topical) may be denied.
Non-FDA indications are not authorized unless sufficient documentation for off-label use is provided per off-label policies.

Documentation Required

Required Clinical Documentation

Providers must submit supporting clinical documentation such as office chart notes, prior medication history, and relevant clinical assessments showing response or treatment failure to meet initial and continued therapy criteria.

Initial requests: documentation of diagnosis, BSA or affected areas, prior topical therapy trials (agents, durations), prescriber specialty, age, and intended dosing formulation and injections.
Continuation requests: evidence of clinical response (e.g., reduction in itching/scratching or other clinician assessment), current dosing, and documentation of prior approval or continuity-of-care where applicable.
Include chart notes, medication administration records, and any pertinent laboratory or imaging results when relevant.

Billing Rule

Coding Documentation Guidance

Coding references in this policy are informational only. Providers must use current professional coding guidance when submitting claims; inclusion or exclusion of codes in this policy does not guarantee coverage.

HCPCS codes referenced for informational use: J3590 (unclassified biologics) and C9399 (unclassified drugs/biologicals).
Use up-to-date professional coding guidance prior to claim submission; appropriate HCPCS code selection does not replace clinical medical necessity documentation.
Claims submitted with J3590 or C9399 may be denied if medical necessity and approval criteria are not met.

Step Therapy

Topical Therapy Step Requirement

Step therapy requirement for topical treatments: prior failure of specified topical therapies is required unless contraindicated or intolerant.

Required: failure of two formulary medium-to-very-high potency topical corticosteroids of different molecular identities, each used for ≥2 weeks.
Required: failure of one non-steroidal topical therapy used for ≥4 weeks (examples include topical calcineurin inhibitors such as tacrolimus 0.03% ointment or pimecrolimus 1% cream, or crisaborole).
Appendix B lists examples of medium-to-very-high potency topical corticosteroids; low potency corticosteroids were removed.
These topical agents may themselves require prior authorization on the formulary.

Appendix referenceSee Appendix A: Abbreviation/Acronym Key for JAK definition in policy appendices.

References — Adbry prescribing information and clinical trial publications

Prescribing informationAdbry Prescribing Information. LEO Pharma, Inc.; December 2025. Available at: https://www.adbry.com/.

Clinical trialsKey clinical trial publications: ECZTRA 1 and ECZTRA 2 (Wollenberg et al., Br J Dermatol. 2021) and ECZTRA 3 (Silverberg et al., Br J Dermatol. 2021).

Clinical pharmacology databaseClinical Pharmacology database (Elsevier) referenced for product information and dosing.