Is Adbry (tralokinumab) medically necessary for a patient with atopic neurodermatitis, who has a history of inadequate response to other treatments, is experiencing a flare, and has affected body surface areas including the neck, with moderate symptoms disrupting sleep?

Medical Necessity Determination for Adbry (Tralokinumab)

DETERMINATION: MEDICALLY NECESSARY

Based on the clinical documentation and insurance criteria, Adbry is medically necessary for this patient with atopic neurodermatitis who has previously failed Dupixent (dupilumab) and multiple other systemic therapies, meets the insurance plan's specific approval criteria for prior biologic use, and demonstrates ongoing moderate disease requiring systemic treatment. 1, 2

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RATIONALE

Patient Meets Insurance Criteria for Initial Approval

The patient satisfies Criterion IV.A from the insurance policy, which authorizes 4 months of treatment for members 12 years or older who have previously received a biologic indicated for moderate-to-severe atopic dermatitis in the past year. 1

Documented prior biologic use:

• Dupixent 300 mg Q14D was used from 2023 through early 2024, with the patient ultimately discontinuing due to adverse effects (rosacea potentially related to Dupixent) 1
• The patient was then initiated on Adbry 150 mg Q14D in 2024 and has been maintained on this therapy for 17 months with documented clinical improvement 1

Clinical Evidence of Treatment Response

Current disease status demonstrates controlled atopic dermatitis on Adbry:

• BSA reduced to <1-2% (from historical highs of 10-35%) 2
• IGA scores of 0-2 (from historical scores of 3-4) 2
• SPS scores of 0-2 (from historical scores of 3) 2

This represents achievement of "low disease activity (clear or almost clear skin)" as required for continuation criteria per the insurance policy. 2

Extensive Prior Treatment Failures

The patient has an exceptionally robust history of inadequate response to multiple treatment modalities, demonstrating medical necessity for advanced biologic therapy:

Failed systemic therapies:

• Cyclosporine (2021-2022): BSA remained at 10-35% with IGA 2-4 2
• Methotrexate (2023): BSA 2-4% with IGA 3-4 2
• Cibinqo/JAK inhibitor (2022): BSA 1-10% with IGA 1-4 2
• Rinvoq/JAK inhibitor (2022): Inadequate control 2
• Dupixent (2023-2024): Developed adverse effects (rosacea) requiring discontinuation 2, 3
• Systemic corticosteroids (prednisone 2021): Only temporary control 2

Failed topical therapies:

• Multiple high-potency topical corticosteroids (halobetasol, mometasone, triamcinolone) 2
• Topical calcineurin inhibitors (tacrolimus) 2
• Topical JAK inhibitor (Opzelura) - currently used as adjunctive therapy 2

Adbry as Appropriate Alternative to Dupixent

The American Academy of Dermatology guidelines support tralokinumab (Adbry) as a first-line biologic option with strong recommendation for moderate-to-severe atopic dermatitis. 2 While dupilumab is often preferred as initial biologic therapy, tralokinumab represents an appropriate alternative when dupilumab causes adverse effects. 2

Key evidence supporting Adbry switch:

• Real-world data demonstrates that 50% of patients who fail dupilumab due to inadequate response or adverse events achieve good clinical response with tralokinumab 4
• Tralokinumab has a potentially lower incidence of ocular adverse events compared to dupilumab, though both IL-13 pathway inhibitors carry this risk 2
• The patient's documented rosacea flare potentially related to Dupixent provides clear rationale for biologic switch 2, 3

Current Clinical Presentation Supports Continuation

The patient is experiencing a flare (BSA 2%, IGA 2-3, SPS 2) with moderate symptoms disrupting sleep, occurring in the context of missed doses due to insurance coverage issues. 2 This demonstrates:

• Disease remains active without consistent biologic therapy 2
• Topical therapies alone (Opzelura, urea cream) are insufficient for disease control 2
• The patient requires ongoing systemic immunomodulation to maintain remission 2

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CRITERIA FULFILLMENT SUMMARY

Initial Approval Criteria (IV.A) - MET

✓ Age ≥12 years (adult patient) 1
✓ Previously received biologic (Dupixent) for moderate-to-severe AD in past year 1
✓ Authorization period: 4 months 1

Alternative Initial Approval Criteria (IV.B) - ALSO MET

✓ Age ≥12 years 1
✓ Moderate-to-severe atopic dermatitis 2
✓ Crucial body areas affected (neck, axillas, heels) 1
✓ Inadequate response to high-potency topical corticosteroids (halobetasol, mometasone) 2
✓ Inadequate response to topical calcineurin inhibitor (tacrolimus) 2

Continuation Criteria (V) - MET

✓ Age ≥12 years 1
✓ Using medication for moderate-to-severe AD 2
✓ Achieved positive clinical response: BSA <1-2%, IGA 0-2, improvement from baseline BSA 10-35% and IGA 3-4 2
✓ Authorization period: 12 months 1

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CLINICAL CONSIDERATIONS AND MONITORING

Dosing Verification

The requested dose of Adbry 150 mg/mL syringe 2 mL/28 days is INCORRECT per FDA labeling. 1

• Correct dosing: 300 mg Q2W (every 14 days), not every 28 days 1
• This requires either: Two 150 mg/1 mL syringes Q2W OR one 300 mg/2 mL autoinjector Q2W 1
• The prescription should be corrected to reflect Q14D (every 2 weeks) administration 1

Ongoing Management Recommendations

Continue adjunctive topical therapy:

• Opzelura (topical JAK inhibitor) BID for localized flares 2
• Urea 20% cream for hyperkeratosis on heels 2
• Liberal emollient use for barrier repair 2

Monitor for ocular adverse events:

• Conjunctivitis occurs in approximately 25% of patients on IL-13 inhibitors, typically within first 4 months 2, 3
• Patient has been on therapy 17 months without documented ocular complaints, suggesting lower risk 2, 3
• Initiate preservative-free artificial tears if any ocular symptoms develop 2, 3
• Refer to ophthalmology for persistent or severe ocular symptoms 2, 3

Assess treatment response:

• Evaluate at 16 weeks using IGA and EASI scores 2
• Patient has already demonstrated sustained response over 17 months 2
• Current flare is temporally related to missed doses due to insurance issues 2

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COMMON PITFALLS TO AVOID

Do not discontinue Adbry prematurely during insurance authorization delays - the current flare demonstrates disease reactivation with treatment interruption. 2

Do not substitute with systemic corticosteroids - guidelines conditionally recommend against long-term systemic corticosteroids for AD due to rebound flares and adverse effects. 2

Do not require "step back" to Dupixent - documented adverse effects (rosacea) and successful control on Adbry for 17 months justify continued tralokinumab therapy. 2, 4

Do not delay approval based on current low BSA - the patient's extensive treatment history, crucial body area involvement (neck, hands, feet), and documented flare with treatment interruption demonstrate ongoing need for systemic therapy. 2, 1