ModifiedmhnPolicy CP.PHAR.577

Tralokinumab (Adbry) for atopic dermatitis

Covers medical necessity and authorization criteria for Adbry (tralokinumab-ldrm) for treatment of moderate-to-severe atopic dermatitis in patients ≥12 years within Centene-affiliated Medicaid line of business.

Policy Summary

Payermhn

PolicyTralokinumab (Adbry) for atopic dermatitis

Policy CodePolicy CP.PHAR.577

Change TypeMultiple material updates (dosage formulation, age extension, exclusions, approval duration)

Effective Date06.01.22

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating diagnosis, age ≥12, required prior topical therapy trials, prescriber specialty, and dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

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

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 lines of business.

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

≥12minimum age for indication

≥10% BSAdisease extent required

600 mginitial dosing (adult)

300 mg q2w

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maintenance dosing (adult)

12 monthsapproval duration

300 mg/2 mLautoinjector dosage introduced

Coverage Criteria for Adbry (tralokinumab-ldrm)

Initial Therapy

Covered when ALL of the following are met

Initial atopic dermatitis criteria

1. Diagnosis of atopic dermatitis affecting one of the following: - a. At least 10% of the member's body surface area (BSA); OR - b. Involvement of hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas.
2. Prescribed by or in consultation with a dermatologist or allergist.
3. Age ≥ 12 years.
4. Failure of BOTH of the following, unless contraindicated or clinically significant adverse effects are experienced: - a. Two formulary medium to very high potency topical corticosteroids of different molecular identities, each used for ≥ 2 weeks; AND - b. One non-steroidal topical therapy used for ≥ 4 weeks (e.g., topical calcineurin inhibitor such as tacrolimus 0.03% ointment or pimecrolimus 1% cream, or Eucrisa®).
5. Adbry is not prescribed concurrently with another biologic medication (e.g., Dupixent®, Ebglyss™, Nemluvio®, Cinqair®, Fasenra®, Nucala®, Tezspire™, Xolair®) or a Janus kinase (JAK) inhibitor (e.g., Olumiant®, Rinvoq®, Cibinqo®, Opzelura™).
6. Dose does not exceed one of the following: - a. Adults (both i and ii): - i. Initial (one-time) dose of 600 mg: for prefilled syringe = four injections; for autoinjector = two injections. - ii. Maintenance dose of 300 mg every 2 weeks: for prefilled syringe = two injections; for autoinjector = one injection. - b. Age 12 to 17 years for prefilled syringe: - i. Initial (one-time) dose of 300 mg (two injections); - ii. Maintenance dose of 150 mg (one injection) every 2 weeks.

Continued Therapy

Covered when ALL of the following are met

Continued therapy criteria

1. Member meets one of the following: - a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; OR - b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state-specific addendums).
2. Member is responding positively to therapy as evidenced by, including but not limited to, reduction in itching and scratching.
3. Adbry is not prescribed concurrently with another biologic medication (e.g., Dupixent, Ebglyss, Nemluvio, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or a JAK inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura).
4. For adult members with weight < 100 kg: Request is for 300 mg every 4 weeks, unless documentation supports member has not achieved clear or almost clear skin.

Requests for use of this medication for non-FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation supporting safety and efficacy in accordance with the plan’s off‑label use requirements (see policy CP.PMN.53 for Medicaid or other applicable evidence‑of‑coverage guidance).

Concurrent prescribing of this agent with certain other biologic therapies is excluded. As examples, Ebglyss and Nemluvio have been added to the list of biologics for which co‑administration is not permitted under this policy; providers should verify concurrent biologic use prior to authorization submission.

What Providers Must Do / Documentation & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Adbry requires prior authorization. Approval is contingent on meeting initial or continued therapy criteria including documented diagnostic and treatment history.

Prior authorization required for Adbry (CP.PHAR.577).
Approval depends on meeting Initial or Continued Therapy criteria in this policy.

Documentation Required

Documentation Submission Requirement

Documentation Submission Requirement — Provider must submit supporting clinical documentation with the prior authorization request.

Include office chart notes, relevant lab results, and other clinical information demonstrating the member meets all approval criteria.
If requested for continuation, provide objective evidence of response (e.g., reduction in itching/scratching, clinician assessment).

Coding and Billing References

HCPCS referenced (informational)HCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Background on Adbry (tralokinumab-ldrm)

Adbry (tralokinumab‑ldrm) is an interleukin‑13 antagonist indicated for the treatment of moderate‑to‑severe atopic dermatitis in patients aged 12 years and older who are not adequately controlled with, or for whom topical therapies are not advisable. The policy has been updated to reflect the addition of a new autoinjector 300 mg/2 mL formulation and corresponding maximum injection limits, and to document recent review and approval history updates.

Key Definitions and Terms

BSA — Body surface area definition

DefinitionBSA = body surface area (abbreviation listed in Appendix A: Abbreviation/Acronym Key).

Use in criteriaPolicy requires extent of atopic dermatitis measured as percentage of BSA (e.g., ≥10% BSA) or involvement of specific anatomic areas for initial approval.

ContextBSA is used as a threshold measure within the coverage criteria to quantify disease extent for Adbry (tralokinumab-ldrm).

JAK — Janus kinase definition

DefinitionJAK = Janus kinase (abbreviation listed in Appendix A: Abbreviation/Acronym Key).

RelevancePolicy excludes concurrent use of Adbry with JAK inhibitors; JAK refers to the class of Janus kinase enzymes targeted by those drugs.

Policy Summary

Payermhn

PolicyTralokinumab (Adbry) for atopic dermatitis

Policy CodePolicy CP.PHAR.577

Change TypeMultiple material updates (dosage formulation, age extension, exclusions, approval duration)

Effective Date06.01.22

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating diagnosis, age ≥12, required prior topical therapy trials, prescriber specialty, and dosing within policy limits.

SourceLink

On This Page

5. If request is for a dose increase, the new dose does not exceed one of the following: - a. Adults: 300 mg every 2 weeks (i. prefilled syringe = two injections; ii. autoinjector = one injection); OR - b. Age 12 to 17 years: 150 mg (one injection of prefilled syringe) every 2 weeks.

Approval duration: 12 months.

Step Therapy

Required Topical Therapy Trials

Required Topical Therapy Failures and Non‑steroidal Requirement — For initial approvals the provider must document prior adequate trials as specified.

Failure of two formulary medium to very high potency topical corticosteroids of different molecular identities, each used ≥ 2 weeks.
Failure of one non‑steroidal topical therapy used ≥ 4 weeks (e.g., topical calcineurin inhibitor such as tacrolimus 0.03% ointment or pimecrolimus 1% cream, or crisaborole/Eucrisa).
These agents may require prior authorization; document durations and agents tried.

Denial Risk

Non‑FDA Indications

Non‑FDA Indications Handling — Requests for indications not addressed in this policy (off‑label) require sufficient documentation of efficacy and safety per off‑label use policies; otherwise they may be denied.

Non‑FDA approved indications not addressed in this policy will be reviewed against CP.PMN.53 (Medicaid) or applicable evidence of coverage documents.
Provide peer‑reviewed literature, clinical rationale, and supporting data when requesting off‑label use.

Billing Rule

Coding Documentation & Billing Reminder

Coding Documentation & Billing Reminder — Codes listed are informational only. Providers should verify current coding guidance prior to claim submission to avoid claim denials.

HCPCS codes referenced for informational purposes include: J3590 (Unclassified biologics) and C9399 (Unclassified drugs or biologicals).
Inclusion or exclusion of codes in this policy does not guarantee coverage; improper coding may lead to claim denial. Reference the most up‑to‑date professional coding resources before submission.

ContextJAK is provided in the abbreviations appendix to support interpretation of exclusion language in the criteria.

Tralokinumab-ldrm — definition / drug identifier

Proprietary name and descriptorTralokinumab-ldrm — nonproprietary name for Adbry as referenced in the prescribing information and policy references.

SourceReferenced in the policy's supporting references: Adbry Prescribing Information (LEO Pharma, December 2025).

Clinical roleTralokinumab-ldrm (Adbry) is an interleukin-13 antagonist indicated for moderate-to-severe atopic dermatitis in patients aged ≥12 years (per prescribing information cited).