Tralokinumab-ldrm (Adbry) Form

Tralokinumab-ldrm (Adbry®) is an interleukin-13 antagonist. FDA Approved Indication(s) Adbry is 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. Adbry can be used with or without topical corticosteroids. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Adbry is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Atopic Dermatitis (must meet all):

1. Diagnosis of atopic dermatitis affecting one of the following (a or b): a. At least 10% of the member’s body surface area (BSA); b. 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 (a and b), 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; b. One non-steroidal topical therapy used for ≥ 4 weeks: topical calcineurin inhibitor (e.g., tacrolimus 0.03% ointment, pimecrolimus 1% cream) or Eucrisa®; These agents may require prior authorization
3. Adbry is not prescribed concurrently with another biologic medication (e.g., Dupixent®, Cinqair®, Fasenra®, Nucala®, Tezspire™, Xolair®) or a Janus kinase (JAK) inhibitor (e.g., Olumiant®, Rinvoq®, Cibinqo®, Opzelura™);

4. Dose does not exceed one of the following (a or b):
   a. Adults (both i and ii): Initial (one-time) dose of 600 mg (four injections);
   i. ii. Maintenance dose of 300 mg (two injections) every 2 weeks; Page 1 of 8

   CLINICAL POLICY Tralokinumab-ldrm b. Age 12 to 17 years (both i and ii): Initial (one-time) dose of 300 mg (two injections); i. ii. Maintenance dose of 150 mg (one injection) every 2 weeks. Approval duration: 4 months B. Other diagnoses/indications (must meet 1 or 2):

5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Atopic Dermatitis (must meet all):
7. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
8. Member is responding positively to therapy as evidenced by, including but not limited to, reduction in itching and scratching;
9. Adbry is not prescribed concurrently with another biologic medication (e.g., Dupixent, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or a JAK inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura);

10. 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;

    5. If request is for a dose increase, new dose does not exceed one of the following (a or b): a. Adults: 300 mg (2 injections) every 2 weeks; b. Age 12 to 17 years: 150 mg (1 injection) every 2 weeks.
       Approval duration:
       Medicaid/HIM – 12 months Commercial – 6 months or to the member’s renewal date, whichever is longer Page 2 of 8

    CLINICAL POLICY Tralokinumab-ldrm B. Other diagnoses/indications (must meet 1 or 2):

11. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

12. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key BSA: body surface area FDA: Food and Drug Administration JAK: Janus kinase Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen
    Dose Limit/ Maximum Dose Apply topically to the affected area(s) BID Varies
    Very High Potency Topical Corticosteroids augmented betamethasone 0.05% (Diprolene AF) cream, ointment, gel, lotion clobetasol propionate 0.05% (Temovate ) cream, ointment, gel, solution diflorasone diacetate 0.05% (Maxiflor, Psorcon E) cream, ointment halobetasol propionate 0.05% (Ultravate) cream, ointment Page 3 of 8

    CLINICAL POLICY Tralokinumab-ldrm Drug Name Dosing Regimen
    Dose Limit/ Maximum Dose High Potency Topical Corticosteroids amcinonide 0.1% ointment, lotion augmented betamethasone 0.05% (Diprolene AF) cream, ointment, gel, lotion betamethasone valerate 0.1%, 0.12% (Luxiq®) ointment, foam clobetasol propionate 0.025% (Impoyz ) cream diflorasone 0.05% (Florone, Florone E, Maxiflor,Psorcon E) cream fluocinonide acetonide 0.05% (Lidex, Lidex E) cream, ointment, gel, solution fluticasone propionate 0.005% cream, ointment halcinonide 0.1% cream, ointment, solution (Halog®) halobetasol propionate 0.01% lotion (Bryhali®) mometasone furoate 0.1% ointment triamcinolone acetonide 0.5% (Aristocort, Kenalog) cream, ointment Medium Potency Topical Corticosteroids clocortolone pivalate 0.1% cream desoximetasone 0.05%, 0.025% (Topicort) cream, ointment, gel fluocinolone acetonide 0.025% (Synalar) cream, ointment flurandrenolide 0.05% lotion, ointment (Cordran®) hydrocortisone valerate 0.2% cream mometasone 0.1% (Elocon) cream, ointment, lotion triamcinolone acetonide 0.025%, 0.1% (Aristocort, Kenalog) cream, ointment Other Classes of Agents tacrolimus (Protopic), Elidel (pimecrolimus) Apply topically to the affected area(s) BID Varies Apply topically to the affected area(s) BID Varies Varies Children ≥ 2 years and adults: Apply a thin layer topically to affected skin BID.
    Treatment should be discontinued if Page 4 of 8 CLINICAL POLICY Tralokinumab-ldrm Drug Name Eucrisa® (crisaborole) Dosing Regimen
    resolution of disease occurs. Apply to the affected areas BID Dose Limit/ Maximum Dose Varies Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to tralokinumab-ldrm or any excipients in Adbry • Boxed warning(s): none V. Dosage and Administration
    Indication Moderate-to- severe atopic dermatitis Dosing Regimen Adult: Initial dose of 600 mg SC followed by 300 mg SC every other week After 16 weeks of treatment, for adult patients with body weight < 100 kg who achieve clear or almost clear skin, a dosage of 300 mg every 4 weeks may be considered Pediatric 12-17 years of age: Initial dose of 300 mg SC followed by 150 mg SC every other week Maximum Dose Adult: 300 mg every other week (maintenance dose) Pediatric 12-17 years of age: 150 mg every other week (maintenance dose) VI. Product Availability
    Pre-filled syringe: 150 mg/mL VII.