Adbry (tralokinumab-ldrm) (PG110) Form

Atopic dermatitis (AD) is a chronic inflammatory skin disorder that affects approximately 10% of adults and 20% of children worldwide. It is characterized by intense itching, redness, and eczematous lesions, which can be accompanied by skin dryness, scaling, and thickening. The severity of AD can be classified as mild, moderate, or severe, depending on the extent and intensity of skin inflammation, as well as the impact on the patient's quality of life. Moderate-to-severe AD is defined by the presence of extensive or widespread lesions, intense pruritus, and a significant impairment of daily activities, sleep, and mood. Treatment options for moderate-to-severe AD involve a combination of topical and systemic therapies, tailored to the individual patient's needs and preferences. The goal of treatment is to control inflammation, relieve itching, restore the skin barrier, prevent flares, and improve quality of life. ● Topical treatments for moderate-to-severe AD include corticosteroids, calcineurin inhibitors, and phosphodiesterase-4 (PDE4) inhibitors. These drugs act by reducing inflammation and pruritus and promoting skin healing. However, their long-term use may be limited by adverse effects, such as skin atrophy, telangiectasias, or the potential risk of skin infections or malignancies. 1

● Systemic treatments for moderate-to-severe AD are reserved for patients with inadequate response or contraindications to topical therapies, or those with severe or rapidly worsening disease. The most commonly used systemic agents include oral immunosuppressants, such as cyclosporine, methotrexate, or mycophenolate mofetil, and biologic agents, such as dupilumab, which targets the interleukin-4 (IL-4)/interleukin-13 (IL-13) pathway. Adbry (tralokinumab) is FDA-approved for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry (tralokinumab) can be used with or without topical corticosteroids. Adbry (tralokinumab) works by directly inhibiting interleukin (IL)-13 cytokine, which is a major driver of atopic dermatitis signs and symptoms. Adbry (tralokinumab) is administered subcutaneously (SC) every 2 weeks after an initial loading dose of 600 mg at the start of treatment. After 16 weeks of treatment, patients with a body weight <100 kg who achieve clear or almost clear skin may be eligible for dosing every 4 weeks. Definitions “Atopic Dermatitis” also known as eczema is a chronic skin condition that makes a person’s skin red, itchy and scaly. Atopic dermatitis (AD) often begins during childhood and persists into adulthood. Some people experience occasional flares followed by periods of improvement or a “waxing and waning” course of the disease. “Interleukin (IL)-13 cytokine” is a protein secreted by certain cells of the immune system that affects many aspects of chronic airway inflammation. Medical Necessity Criteria for Initial Authorization The Plan considers Adbry (tralokinumab) medically necessary when ALL of the following criteria are met:

1. Prescribed by or in consultation with a dermatologist, allergist, or immunologist; AND
2. The member is 18 years of age or older; AND

3. The member has a documented diagnosis of moderate to severe atopic dermatitis AND ONE of the following: a. b. Involvement of (≥) 10% or more of body surface area; or Involvement of sensitive body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas); AND 2

4. The member is unable to use, or has adequately tried and failed ONE of the following topical therapies for at least 8 weeks each in the past 365 days: a. A topical corticosteroid (TCS) from medium potency (group III to IV) classes to higher potencies (groups I to II) classes (see Table 1); and/or b. Tacrolimus ointment; and/or c. Eucrisa (crisaborole) [PA may be required, please check the member’s Plan-specific Formulary]; AND
5. Adbry (tralokinumab) will not be used concomitantly with other biologics (e.g., Dupixent, Cibinqo, or Rinvoq) in the treatment of atopic dermatitis; AND
6. Dosage does NOT exceed an initial (one-time) dose of 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) administered every other week; AND
7. Clinical chart documentation is provided for review to substantiate the above listed requirements. If the above prior authorization criteria are met, Adbry (tralokinumab) will be approved for 4 months. Medical Necessity Criteria for Reauthorization Authorization of 12 months may be provided for members 18 years of age or older when recent chart documentation (within the past 4 months) is provided showing ALL of the following criteria are met:
8. The member is responding positively to Adbry (tralokinumab) treatment based upon the prescriber’s assessment as demonstrated by ONE of the following: a. decreased disease activity (e.g., a reduction in BSA%); or b. symptomatic improvement (e.g., redness, itching, oozing/crusting); AND
9. Adbry (tralokinumab) will not be used concomitantly with other biologics (e.g., Dupixent, Cibinqo, or Rinvoq) in the treatment of atopic dermatitis; AND

10. The requested dosage does NOT exceed the following: a. 300 mg every 4 weeks for a member with body weight below 100 kg who achieve clear or almost clear skin after 16 weeks of treatment; or b. 300 mg every 2 weeks for a member weighing at least 100 kg OR documentation supports member has not achieved clear or almost clear skin after 16 weeks of treatment. 3

    Table 1: Topical Corticosteroid Potency NOTE: The following chart is only for approximate comparative purposes. Please check product-specific information to best assess product potency, which can also be affected by a multitude of factors (e.g., formulation, site of application, member and disease-specific factors) Group Potency Steroid Strength Dosage Form I Very High Betamethasone dipropionate (augmented) 0.05% Gel, Lotion, and Ointment Clobetasol propionate 0.05% Cream, Emollient Cream, Foam, Gel, Lotion, Ointment, Spray, and Solution Desoximetasone 0.25% Spray Diflorasone diacetate 0.05% Ointment Fluocinonide Flurandrenolide 0.1% 0.05% Cream Tape Halobetasol propionate 0.05% and 0.01% Cream, Foam, Lotion and Ointment II High Amcinonide Betamethasone dipropionate (augmented) Betamethasone dipropionate Desoximetasone Desoximetasone 0.1% 0.05% Ointment Cream 0.05% Ointment 0.25% 0.05% Cream and Ointment Gel Diflorasone diacetate 0.05% Cream, and Emollient Cream Fluocinonide Halcinonide 0.05% 0.1% Cream, Gel, Ointment, and Solution Cream, Ointment, and Solution Triamcinolone acetonide 0.5% Ointment III Upper Medium Amcinonide Betamethasone dipropionate 0.1% 0.05% Cream and Lotion Cream Betamethasone valerate 0.12% Foam 4

    Betamethasone valerate 0.1% Ointment Fluocinonide 0.05% Emollient Cream Fluticasone propionate 0.005% Ointment Mometasone furoate 0.1% Ointment Triamcinolone acetonide 0.5% Cream Triamcinolone acetonide 0.1% Ointment IV Medium Betamethasone 0.05% Spray dipropionate Clocortolone pivalate 0.1% Cream Desoximetasone 0.05% Cream and Ointment Fluocinolone acetonide 0.025% Ointment Flurandrenolide 0.05% Ointment Hydrocortisone valerate 0.2% Ointment Mometasone furoate 0.1% Cream, Lotion, and Solution Triamcinolone acetonide 0.1% Cream and Spray V Lower Medium Betamethasone dipropionate 0.05% Lotion Betamethasone valerate 0.1% Cream and Lotion Desonide 0.05% Gel and Ointment Fluocinolone acetonide 0.025% Cream Fluocinolone acetonide 0.01% Shampoo Flurandrenolide 0.05% Cream and Lotion Fluticasone propionate 0.05% Cream and Lotion Hydrocortisone butyrate 0.1% Cream, Lotion, Ointment, and Solution Hydrocortisone probutate 0.1% Hydrocortisone valerate 0.2% Cream Cream 5

    Prenicarbate 0.1% Emollient Cream and Ointment Triamcinolone acetonide 0.1% Lotion Triamcinolone acetonide 0.025% Ointment VI Low Alclometasone dipropionate 0.05% Cream and Ointment Desonide 0.05% Cream, Lotion, and Foam Fluocinolone acetonide 0.01% Cream, Oil, and Solution Triamcinolone acetonide 0.025% Cream and Lotion VII Lowest Hydrocortisone acetate 0.5% and 1% Cream and Ointment Hydrocortisone base 0.5% to 2.5% Cream, Lotion, Ointment, Solution, and Spray Experimental or Investigational / Not Medically Necessary
    Adbry (tralokinumab) for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.
    References

11. Adbry (tralokinumab) [prescribing information]. Madison, NJ: LEO Pharma Inc; July 2022.
    2. Blauvelt A, Gooderham M, Bhatia N, Langley RG, Schneider S, Zoidis J, Kurbasic A, Armstrong A, Silverberg JI. Tralokinumab Efficacy and Safety, with or without Topical Corticosteroids, in North American Adults with Moderate-to-Severe Atopic Dermatitis: A Subanalysis of Phase 3 Trials ECZTRA 1, 2, and 3. Dermatol Ther (Heidelb). 2022 Nov;12(11):2499-2516. doi: 10.1007/s13555-022-00805-y.
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13. Draelos, Z. D., Feldman, S. R., Berman, B., Olivadoti, M., Sierka, D., Tallman, A. M., ... & Baldwin, S. (2019). Tolerability of topical treatments for atopic dermatitis. Dermatology and Therapy, 9(1), 71-102.
14. Drucker AM, Ellis AG, Bohdanowicz M, et al. Systemic Immunomodulatory Treatments for Patients with Atopic Dermatitis: A Systematic Review and Network Meta-analysis. JAMA Dermatol. 2020;156(6):659-667.

15. Eichenfield LF et al: Current guidelines for the evaluation and management of atopic dermatitis: a comparison of the Joint Task Force Practice Parameter and American Academy of Dermatology guidelines. J Allergy Clin Immunol. 139(4S):S49-S57, 2017 6

16. Eichenfield LF et al: Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 70(2):338-51, 2014
    8. Eichenfield LF et al: Translating atopic dermatitis management guidelines into practice for primary care providers. Pediatrics. 136(3):554-65, 2015
17. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: Section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71:116-32. (Including potencies of topical corticosteroids). 10. Mayo Clinic.org - Atopic Dermatitis. Available at: https://www.mayoclinic.org/diseases- conditions/atopic-dermatitis-eczema. Last Update June 2020. Accessed Feb 28, 2022.
18. Silverberg JI, Toth D, Bieber T, et al; ECZTRA 3 study investigators. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021;184(3):450-463. doi:10.1111/bjd.19573
19. Simpson EL, Merola JF, Silverberg JI, Reich K, Warren RB, Staumont-Sallé D, Girolomoni G, Papp K, de Bruin-Weller M, Thyssen JP, Zachariae R, Olsen CK, Wollenberg A. Safety of tralokinumab in adult patients with moderate-to-severe atopic dermatitis: pooled analysis of five randomized, double-blind, placebo-controlled phase II and phase III trials. Br J Dermatol. 2022 Sep 9. doi: 10.1111/bjd.21867.
20. Wollenberg A, Blauvelt A, Guttman-Yassky E, Worm M, Lynde C, Lacour JP, Spelman L, Katoh N, Saeki H, Poulin Y, Lesiak A, Kircik L, Cho SH, Herranz P, Cork MJ, Peris K, Steffensen LA, Bang B, Kuznetsova A, Jensen TN, Østerdal ML, Simpson EL; ECZTRA 1 and ECZTRA 2 study investigators. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021 Mar;184(3):437-449. doi: 10.1111/bjd.19574.
21. Wollenberg A, Christen-Zӓch S, Taieb A, et al. ETFAD/EADV Eczema task force 2020 position paper on diagnosis and treatment of atopic dermatitis in adults and children. J Eur Acad Dermatol Venereol. 2020 Dec;34(12):2717-2744.
22. Wollenberg A, Oranje A, Deleuran M, et al. ETFAD/EADV Eczema task force 2015 position paper on diagnosis and treatment of atopic dermatitis in adult and paediatric patients. J Eur Acad Dermatol Venereol 2016; 30:729.
23. Wong, I. T., Tsuyuki, R. T., Cresswell-Melville, A., Doiron, P., & Drucker, A. M. (2017). Guidelines for the management of atopic dermatitis (eczema) for pharmacists. Canadian Pharmacists Journal/Revue des Pharmaciens du Canada, 150(5), 285-297.
24. Yew, Y. W., Thyssen, J. P., & Silverberg, J. I. (2019). A systematic review and meta-analysis of the regional and age-related differences in atopic dermatitis clinical characteristics. Journal of the American Academy of Dermatology, 80(2), 390-401. Clinical Guideline Revision / History Information Original Date: 03/17/2022 Reviewed/Revised: 12/08/2022, 3/23/2023, 9/21/2023, 10/27/2023 7