ModifiedQualChoicePolicy CP.PCH.60

Tralokinumab-ldrm (Adbry) for moderate-to-severe atopic dermatitis

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This policy defines medical necessity criteria, dosing limits, and authorization requirements for Adbry (tralokinumab-ldrm) for members aged 12 years and older with moderate-to-severe atopic dermatitis, and specifies continuation, exclusions, and related formulary guidance for QualChoice lines of business.

Policy Summary

PayerQualChoice

PolicyTralokinumab-ldrm (Adbry) for moderate-to-severe atopic dermatitis

Policy CodePolicy CP.PCH.60

Change TypeMaterial clinical updates and administrative clarifications

Effective DateDec 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, disease extent (BSA or specified areas), prescriber specialty, age ≥12, required prior topical and biologic/JAK therapy failures, and dosing regimen.

SourceLink

POLICY UPDATE CHANGES

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

For atopic dermatitis initial approval criteria, added redirection to preferred agents Dupixent or Rinvoq.

Added ICHRA line of business to policy.

≥12minimum covered age

≥10% BSA / special areasdisease extent required

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ModifiedQualChoicePolicy CP.PCH.60

Tralokinumab-ldrm (Adbry) for moderate-to-severe atopic dermatitis

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Policy Summary

PayerQualChoice

PolicyTralokinumab-ldrm (Adbry) for moderate-to-severe atopic dermatitis

Policy CodePolicy CP.PCH.60

Change TypeMaterial clinical updates and administrative clarifications

Effective DateDec 1, 2025

Next Review Date

SourceLink

POLICY UPDATE CHANGES

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

For atopic dermatitis initial approval criteria, added redirection to preferred agents Dupixent or Rinvoq.

Added ICHRA line of business to policy.

≥12minimum covered age

≥10% BSA / special areasdisease extent required

Fail Dupixent/Rinvoq >4 mo

required prior biologic/JAK step

600→300 q2wstandard adult dosing

6 moinitial approval length (commercial)

J3590, C9399HCPCS codes referenced

Coverage Criteria for Adbry (tralokinumab-ldrm)

Initial Therapy — Covered when ALL of the following are met for Atopic Dermatitis.

Covered when ALL of the following are met for Atopic Dermatitis:

Initial Approval - Atopic Dermatitis: 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.

Prescriber: 2. Prescribed by or in consultation with a dermatologist or allergist.

Age: 3. Age ≥ 12 years.

Topical therapy failure: 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 or pimecrolimus, or crisaborole/Eucrisa).

Prior biologic/JAK step: 5. Failure of Dupixent (dupilumab) or Rinvoq (upadacitinib) used for > consecutive 4 months unless clinically significant adverse effects are experienced or both are contraindicated. (Note: for Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.)

No concurrent biologic/JAK: 6. Adbry is not prescribed concurrently with another biologic medication (examples include Dupixent, Ebglyss, Nemluvio, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or a Janus kinase (JAK) inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura).

Dosing limits and approval duration: 7. Dose does not exceed one of the following: a) Adults: initial one‑time dose 600 mg (prefilled syringe = four injections; autoinjector = two injections) followed by maintenance 300 mg every 2 weeks (prefilled syringe = two injections; autoinjector = one injection); or b) Age 12–17 years (prefilled syringe): initial one‑time dose 300 mg (two injections) then maintenance 150 mg every 2 weeks (one injection). Approval duration per line of business (e.g., Commercial 6 months; HIM/ICHRA 12 months).

Continuation Therapy — Covered when ALL of the following are met for members already receiving Adbry.

Covered when ALL of the following are met for members already receiving Adbry:

Continuation eligibility: 1. Member meets one of the following: a) currently receiving medication via Centene (QualChoice) benefit or has previously met initial approval criteria; or b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations.

Clinical response: 2. Member is responding positively to therapy as evidenced by clinical improvement (e.g., reduction in itching and scratching).

No concurrent biologic/JAK: 3. Adbry is not prescribed concurrently with another biologic medication or a JAK inhibitor.

Dose adjustments for adults <100 kg: 4. For adult members with weight <100 kg: request for 300 mg every 4 weeks is allowed unless documentation supports the member has not achieved clear or almost clear skin after treatment.

Therapy-specific coverage criteria — Coverage aligns with specified dosing regimens and sequencing to preferred agents; concurrent biologic use is excluded.

Coverage aligns with specified dosing regimens and sequencing to preferred agents; concurrent biologic use is excluded.

Adult initial therapy: Adult patients: initial dose of 600 mg subcutaneously followed by 300 mg subcutaneously every other week.

After 16 weeks, adults with body weight <100 kg who achieve clear or almost clear skin may consider 300 mg every 4 weeks.

Adult maintenance therapy: Maintenance dose: 300 mg every other week.

Dose reduction option after 16 weeks for responders <100 kg.

Pediatric therapy (12–17 years): Initial dose 300 mg subcutaneously followed by 150 mg subcutaneously; maintenance 150 mg every 2 weeks for ages 12–17.

Pediatric dosing is specified for ages 12–17.

Concurrent biologics exclusion:

Non–FDA approved indications are not authorized under this policy unless the provider supplies sufficient clinical documentation supporting efficacy and safety in accordance with QualChoice off‑label use policies. For commercial lines reference CP.CPA.09, and for HIM/ICHRA lines reference HIM.PA.154, or other applicable evidence of coverage documents when submitting requests for consideration of an off‑label use.

Requests for Adbry that indicate concurrent use with another biologic are not eligible for coverage. The policy explicitly excludes concurrent administration with other biologic medications (examples added during the 2Q 2026 review include Ebglyss and Nemluvio), and such concurrent prescribing may result in denial of the request.

Inclusion of procedure or HCPCS codes in this clinical policy is for informational purposes only and does not guarantee payment or coverage. Providers must consult the member’s benefit documents and the most current professional coding guidance prior to claim submission. Examples of HCPCS codes referenced in this policy are J3590 and C9399, but listing or omitting a code here is not a determination of coverage.

Coding and Dosing Notes

HCPCS Codes referencedHCPCS

J3590	Unclassified biologics.
C9399	Unclassified drugs or biologicals.

Body weight for dosing adjustment — < 100 kg

Body weight thresholdAdults with body weight < 100 kg may be eligible to switch to 300 mg every 4 weeks after 16 weeks if they achieve clear or almost clear skin.

Timing for adjustmentDose reduction option is considered after 16 weeks of treatment for eligible adult responders.

ApplicabilityApplies to adult patients with moderate-to-severe atopic dermatitis receiving tralokinumab-ldrm (Adbry).

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required — submit full criteria evidence

Prior authorization is required for Adbry. Initial approval requests must document the diagnosis of atopic dermatitis, extent of disease (≥10% BSA or involvement of specified special areas), prescriber specialty (dermatologist or allergist), member age ≥12 years, required prior topical therapies and prior biologic/JAK therapy failures, and adherence to the dosing limits specified in the policy.

Diagnosis: atopic dermatitis with ≥10% BSA or involvement of hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas.
Prescriber: must be prescribed by or in consultation with a dermatologist or allergist.
Age: member must be ≥ 12 years.
Prior therapies: required topical therapy failures and prior Dupixent or Rinvoq use as specified.
Dosing limits: initial and maintenance doses must not exceed policy-specified amounts.

Prior Authorization

Include complete dosing regimens with PA requests

Background

Tralokinumab‑ldrm (Adbry) is an interleukin‑13 antagonist indicated for the treatment of moderate‑to‑severe atopic dermatitis in patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The product may be used with or without topical corticosteroids and has specific dosing and administration guidance described elsewhere in this policy.

Definitions and Dosing Terms

BSA (Body surface area)

AbbreviationBSA = body surface area

PurposeUsed in criteria to quantify extent of atopic dermatitis (e.g., ≥10% BSA for coverage).

Location in policyDefined in Appendix A: Abbreviation/Acronym Key.

Contraindication

ContraindicationKnown hypersensitivity to tralokinumab-ldrm or any excipients in Adbry.

Boxed warningsNone listed for Adbry.

Appendix referenceListed in Appendix C: Contraindications/Boxed Warnings.

Policy Revision History

2025-08-20policy_creation

Policy adapted from CP.PHAR.577 and created with revision to initial approval criteria to redirect to preferred agents Dupixent or Rinvoq; P&T approval recorded on 2025-11-25.

2026-04-03annual_review

2Q 2026 annual review updated references and added Ebglyss and Nemluvio as examples of biologic medications for which concurrent use is excluded.

2026-05-26operational_updateLatest

Policy Summary

PayerQualChoice

PolicyTralokinumab-ldrm (Adbry) for moderate-to-severe atopic dermatitis

Policy CodePolicy CP.PCH.60

Change TypeMaterial clinical updates and administrative clarifications

Effective DateDec 1, 2025

Next Review Date

SourceLink

On This Page

Dose ceiling for increases: 5. If the request is for a dose increase, the new dose must not exceed: a) Adults — 300 mg every 2 weeks (prefilled syringe = two injections; autoinjector = one injection); or b) Age 12–17 years — 150 mg every 2 weeks (one prefilled‑syringe injection).

Concurrent use of other biologic medications (examples: Ebglyss, Nemluvio, and other listed biologics) is excluded.

Concurrent use may lead to coverage denial.

Step therapy / preferred agents: Initial approval criteria redirect to preferred agents Dupixent or Rinvoq as part of therapy sequencing.

Policy adapted to include redirection to preferred agents.

Include dosing details in the prior authorization request for Adbry: adults require an initial 600 mg SC (one-time) followed by 300 mg SC every 2 weeks maintenance; pediatric patients (ages 12–17) require an initial 300 mg SC then 150 mg SC every 2 weeks. Also note the adult option after 16 weeks for patients <100 kg to consider 300 mg every 4 weeks.

Adult initial: 600 mg SC (one-time) then 300 mg SC every 2 weeks maintenance.
Pediatric (12–17): initial 300 mg SC then 150 mg SC every 2 weeks maintenance.
Dose reduction option after 16 weeks for adults <100 kg: 300 mg every 4 weeks if clear or almost clear.

Step Therapy

Document required step‑therapy failures before Adbry

Step therapy must be documented: the member must have failed two different formulary medium‑to‑very‑high potency topical corticosteroids (different molecular identities), each used for ≥2 weeks, and one non‑steroidal topical therapy used for ≥4 weeks (e.g., topical calcineurin inhibitor or crisaborole). Failure of Dupixent or Rinvoq used for >4 consecutive months is also required unless contraindicated.

Two different medium to very high potency topical corticosteroids, different molecular identities, each ≥2 weeks.
One non‑steroidal topical therapy (e.g., tacrolimus, pimecrolimus, Eucrisa) ≥4 weeks.
Failure of Dupixent or Rinvoq >4 consecutive months unless contraindicated.

Note

Policy redirects to preferred agents (Dupixent, Rinvoq) in sequencing

Initial approval criteria now redirect prescribers to preferred agents as part of sequencing; Dupixent or Rinvoq are listed as preferred agents to try prior to Adbry per the policy adaptation.

Policy revision added redirection to preferred agents Dupixent or Rinvoq for initial therapy sequencing.

Documentation Required

Required supporting documentation — include chart notes and treatment history

Submit supporting clinical documentation with the PA request: office chart notes, relevant lab results, and other clinical information that demonstrate the member meets all approval criteria (diagnosis, extent of disease, prior therapy failures, prescriber specialty, age).

Office chart notes documenting BSA or affected areas and treatment history.
Records showing dates/duration of prior topical therapies and biologic/JAK use.
Specialist consultation notes when applicable.

Billing Rule

Coding reminder — check current guidance; J3590 and C9399 noted

Before claim submission, verify coding guidance and use the policy‑referenced HCPCS codes for informational purposes: J3590 (Unclassified biologics) and C9399 (Unclassified drugs or biologicals). Inclusion/exclusion of codes in the policy does not guarantee coverage.

Reference the most up‑to‑date professional coding guidance prior to claim submission.
HCPCS codes noted in this policy: J3590 and C9399 (informational only).

Denial Risk

Denial risk if required criteria or documentation are missing

Requests that do not include documentation showing the member meets all approval criteria — including diagnosis, BSA or involvement of specified areas, required prior treatment failures, prescriber specialty, age, and dosing limits — may be denied.

Missing documentation of prior topical therapy failures or prior Dupixent/Rinvoq use may trigger denial.
Absence of evidence for required BSA or special‑area involvement may lead to denial.

Denial Risk

Concurrent biologic/JAK therapy excluded — do not co‑prescribe

Adbry must not be prescribed concurrently with other biologic medications or a JAK inhibitor; the policy explicitly lists examples (e.g., Ebglyss and Nemluvio) and concurrent use may result in denial.

Concurrent biologics listed as examples: Ebglyss, Nemluvio, Dupixent, Cinqair, Fasenra, Nucala, Tezspire, Xolair.
Concurrent JAK inhibitors include examples such as Olumiant, Rinvoq, Cibinqo, Opzelura.

Initial dosing

Adult initial dosingInitial dose: 600 mg subcutaneously (one-time).

Pediatric initial dosing (12–17 yrs)Initial dose: 300 mg subcutaneously.

Indication contextDosing regimens specified for moderate-to-severe atopic dermatitis.

Maintenance dosing

Adult maintenance dosing300 mg subcutaneously every other week (every 2 weeks).

Pediatric maintenance dosing (12–17 yrs)150 mg subcutaneously every other week (every 2 weeks).

Dose reduction optionAfter 16 weeks, adults <100 kg who achieve clear or almost clear skin may consider 300 mg every 4 weeks.

2Q 2026 annual review finalized and ICHRA line of business was added to the policy.