Health Net Adbry Coverage Prior Auth

Coverage Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met

Initial Approval - Atopic Dermatitis: 1) Diagnosis of atopic dermatitis affecting either: 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) Patient age ≥ 12 years; 4) Failure of two formulary medium to very high potency topical corticosteroids of different molecular identities, each used for ≥ 2 weeks, unless contraindicated; 5) Failure of one non‑steroidal topical therapy used for ≥ 4 weeks (e.g., topical calcineurin inhibitor or crisaborole), unless contraindicated; 6) Requested dose does not exceed specified initial and maintenance dosing limits (see dosing).see text

Unless contraindicated or significant adverse effects experienced

inv-02: Continuation Therapy

Covered for continuation when ALL of the following are met

Continued Therapy - Atopic Dermatitis: 1) Member is currently receiving medication via the benefit or has previously met initial approval criteria (or is enrolled in applicable continuity of care regulations); 2) Member is responding positively to therapy as evidenced by clinical improvement (e.g., reduction in itching and scratching); 3) Adbry is not prescribed concurrently with another biologic medication for atopic dermatitis or a JAK inhibitor; 4) Requested dose does not exceed maintenance dosing limits (see dosing); 5) For adult members with body weight ≥100 kg who after 16 weeks achieve clear or almost clear skin, 300 mg every 4 weeks may be considered when documented.see text

Continuation aligns with documented clinical response and dosing limits

Requests for treatment of non‑FDA approved indications are not authorized under this policy unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or other applicable evidence‑of‑coverage documents.

Concurrent‑use restrictions reflected in prior policy reviews prohibit prescribing Adbry at the same time as certain other biologic immunomodulators or JAK inhibitors for atopic dermatitis. These updates were applied during previous reviews and are documented in the policy history and appendices; providers should reference the full policy appendices for the specific agents and the effective edits.

Use of Adbry for indications that are not FDA‑approved and that lack adequate supporting evidence will be considered not authorized unless the provider supplies documentation meeting the referenced off‑label use policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53).

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (e.g., office chart notes, lab results, or other clinical information) demonstrating that the member meets all approval criteria.

Prior authorization required with documentation that approval criteria are met
Provider must submit supporting documentation (office chart notes, lab results, other clinical information)

Denial Risk

Non‑FDA Indications

Requests for indications that are not FDA‑approved may be denied unless sufficient documentation is provided per applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid).

Non‑FDA indications require supporting evidence per off‑label use policies

Coding

HCPCS Codes referencedHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

inv-07: Body Surface Area (BSA) — At least 10% BSA or involvement of specified sensitive areas

BSA thresholdAt 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 age ≥12 years

Initial Therapy Criteria & Dosing

inv-20: Initial Therapy Dosing

Initial dosing and prerequisites

Initial Dosing/Criteria: Adbry dosing: Adults — initial (one‑time) dose 600 mg SC (delivered as 1 x 600 mg or 2 x 300 mg injections depending on device) followed by maintenance 300 mg every 2 weeks (prefilled syringe: two injections for initial, two injections for maintenance; autoinjector: two injections initial, one injection maintenance as device-specific); Adolescents 12–17 years — initial one‑time dose 300 mg SC (two 150 mg injections) followed by maintenance 150 mg every 2 weeks (one injection); For adults ≥100 kg who achieve clear or almost clear skin after 16 weeks, consideration may be given to 300 mg every 4 weeks with documentation.dose limits specified

Device-specific injection counts described in policy

inv-21: Initial therapy (policy history)

Policy edits impacting initial criteria noted in history

initial criteria history: Initial criteria were modified to remove the systemic immunosuppressant therapy step requirement and to add a pediatric extension to include ages 12 years and older.

Continuation Therapy Criteria

inv-22: Continuation Therapy

Continuation criteria for members already receiving Adbry

Continuation: 1) Member currently receiving medication via the benefit or previously met initial approval criteria (or enrolled in continuity of care where applicable); 2) Member demonstrates clinical response (e.g., reduced itching/scratching or other documented improvement); 3) Adbry is not used concurrently with another biologic for atopic dermatitis or a JAK inhibitor; 4) Requested dose is within specified maintenance limits (adults: 300 mg every 2 weeks; adolescents 12–17: 150 mg every 2 weeks); 5) Adults ≥100 kg who achieve clear or almost clear after 16 weeks may switch to 300 mg every 4 weeks with documentation.see text

See approval duration per line of business

inv-23: Continuation therapy (policy history)

Continuation therapy (policy history) — template and editorial changes

continuation history note: Template changes to the continued therapy section were applied in 2022 and subsequent reviews (see full policy for archived edits and dates).

Step Therapy Requirements

Required topical therapy trials (prior to initial approval)	Minimum duration / notes
Two formulary medium to very high potency topical corticosteroids of different molecular identities (each from Appendix B)
Each corticosteroid used for ≥2 weeks
One non‑steroidal topical therapy (e.g., topical calcineurin inhibitor such as tacrolimus 0.03% ointment or pimecrolimus 1% cream, or crisaborole)
Used for ≥4 weeks; these agents may require prior authorization

Step therapy history note	Effect on initial criteria
Systemic immunosuppressant therapy step criterion removed per updated guideline and competitor analysis
Systemic immunosuppressant therapy is no longer required as a prior step for initial approval

Quantity Limits & Formulations

inv-26: Tralokinumab‑Idrm (Adbry) — per prescribing dosing (initial loading then maintenance as specified)

Adult dosing (initial and maintenance)Initial one-time dose 600 mg SC followed by maintenance 300 mg SC every 2 weeks

Adolescent (12–17) dosingInitial one-time dose 300 mg SC followed by maintenance 150 mg SC every 2 weeks

Adult weight-based adjustment after 16 weeksFor adults ≥100 kg who achieve clear or almost clear skin after 16 weeks, 300 mg every 4 weeks may be considered

inv-27: Tralokinumab (Adbry) autoinjector — maximum numbers of injections added to approval criteria

Autoinjector injection counts (adults)Initial (one-time) adult dose with autoinjector: two injections; maintenance with autoinjector: one injection every 2 weeks

Prefilled syringe injection counts (adults)

Site of Care

Note

Approval duration varies by line of business; site of care not restricted

Approval duration depends on line of business: Medicaid/HIM approvals are for 12 months; commercial approvals are for 6 months (or to the member’s renewal date). Site of care is not explicitly restricted in this portion of the policy.

Medicaid/HIM: 12 months
Commercial: 6 months or to member renewal date, whichever is longer

Note

Home administration possible — available as pre-filled syringe and autoinjector

Product formulations include a pre‑filled syringe (150 mg/mL) and an autoinjector (300 mg/2 mL); the policy does not restrict administration setting in these sections.

Pre‑filled syringe: 150 mg/mL
Autoinjector: 300 mg/2 mL

Background

Tralokinumab‑Idrm (Adbry) is an interleukin‑13 antagonist indicated for treatment of moderate‑to‑severe atopic dermatitis in patients aged ≥12 years whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dosing includes an adult initial dose of 600 mg followed by 300 mg every 2 weeks; adolescents (12–17 years) receive an initial 300 mg dose (two 150 mg injections) followed by 150 mg every 2 weeks. The product is available as a 150 mg/mL pre‑filled syringe and a 300 mg/2 mL autoinjector.

Definitions

inv-18: body surface area — BSA

DefinitionBSA = body surface area

Use in criteriaBSA used as a threshold (see initial approval: ≥10% BSA) to define disease extent for coverage

Appendix referenceBSA abbreviation listed in Appendix A (Appendices/General Information)

inv-19: Atopic dermatitis — definition and trial evidence summary

Clinical definitionAtopic dermatitis: an inflammatory skin condition evaluated in randomized, placebo-controlled phase III trials and addressed in guideline recommendations

Indication for AdbryIndicated for moderate-to-severe atopic dermatitis in patients ≥12 years whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable

OpenPayer

Clinical Policy: Tralokinumab‑Idrm (Adbry)