Subject: Adbry 5125-A SGM P2024

Drug

ADBRY  (tralokinumab-ldrm)

Policy:

      I.  INDICATIONS
          The indications below including FDA-approved indications and compendial uses are
          considered a covered benefit provided that all the approval criteria are met and the member
          has no exclusions to the prescribed therapy.

          FDA-Approved Indication
          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.

          All other indications are considered experimental/investigational and not medically necessary.


     II.  DOCUMENTATION

          Submission of the following information is necessary to initiate the prior authorization review:
          A.  For initial requests:
               1.  Member’s chart notes or medical records showing affected area(s) and body surface
                    area (where applicable).
               2.  Member’s chart notes, medical record documentation, or claims history of prerequisite
                    therapies including response to therapy. If prerequisite therapies are not advisable,
                    documentation of why therapy is not advisable for the member.
          B.  For continuation requests: Documentation (e.g., chart notes) that the member has
               experienced a positive clinical response to therapy as evidenced by low disease activity or
               improvement in signs or symptoms of atopic dermatitis.


    III.  PRESCRIBER SPECIALTIES

          This medication must be prescribed by or in consultation with a dermatologist or
          allergist/immunologist.


    IV.  CRITERIA FOR INITIAL APPROVAL
          Atopic dermatitis
          A.  Authorization of 4 months may be granted for members 12 years of age or older who have
               previously received a biologic (e.g., Dupixent) or targeted synthetic drug (e.g., Cibinqo,
               Rinvoq) indicated for moderate-to-severe atopic dermatitis in the past year.

          B.  Authorization of 4 months may be granted for members 12 years of age or older for
               treatment of moderate-to-severe atopic dermatitis when both of the following criteria are
               met:
               1.  Affected body surface is greater than or equal to 10% body surface area OR crucial
                    body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are
                    affected.
               2.  Member meets one of the following:
                    i.     Member has had an inadequate treatment response with one of the following in the
                           past year:
                           a.  A medium potency to super-high potency topical corticosteroid (see Appendix)
                           b.  A topical calcineurin inhibitor
                    ii.    The use of medium potency to super-high potency topical corticosteroid and topical
                           calcineurin inhibitor are not advisable for the member (e.g., due to
                           contraindications, prior intolerances).


    V.  CONTINUATION OF THERAPY

          Atopic dermatitis
          Authorization of 12 months may be granted for members 12 years of age or older (including
          new members) who are using the requested medication for moderate-to-severe atopic
          dermatitis when the member has achieved or maintained a positive clinical response as
          evidenced by low disease activity (i.e., clear or almost clear skin), or improvement in signs
          and symptoms of atopic dermatitis (e.g., redness, itching, oozing/crusting).


   VI.  OTHER

          Member cannot use the requested medication concomitantly with any other biologic drug or
          targeted synthetic drug for the same indication.


VII.  APPENDIX

Table. Relative potency of select topical corticosteroid products

Potency	Drug	Dosage form	Strength
II. High potency (group 2)	Amcinonide	Ointment	0.1%
	Augmented betamethasone dipropionate	Cream	0.05%
	Betamethasone dipropionate	Ointment	0.05%
	Clobetasol propionate	Cream	0.025%
	Desoximetasone	Cream, Ointment, Spray	0.25%
		Gel	0.05%
	Diflorasone diacetate	Ointment, Cream (emollient)	0.05%
	Fluocinonide	Cream, Ointment, Gel, Solution	0.05%
	Halcinonide	Cream, Ointment	0.1%
	Halobetasol propionate	Lotion	0.01%
III. High potency (group 3)	Amcinonide	Cream, Lotion	0.1%
	Betamethasone dipropionate	Cream, hydrophilic emollient	0.05%
	Betamethasone valerate	Ointment	0.1%
		Foam	0.12%
	Desoximetasone	Cream, Ointment	0.05%
	Diflorasone diacetate	Cream	0.05%
	Fluocinonide	Cream, aqueous emollient	0.05%
	Fluticasone propionate	Ointment	0.005%
	Mometasone furoate	Ointment	0.1%
	Triamcinolone acetonide	Cream, Ointment	0.5%
IV. Medium potency    (group 4)	Betamethasone dipropionate	Spray	0.05%
	Clocortolone pivalate	Cream	0.1%
	Fluocinolone acetonide	Ointment	0.025%
	Flurandrenolide	Ointment	0.05%
	Hydrocortisone valerate	Ointment	0.2%
	Mometasone furoate	Cream, Lotion, Solution	0.1%
	Triamcinolone acetonide	Cream	0.1%
		Ointment	0.05% and 0.1%
		Aerosol Spray	0.2 mg per 2-second spray
V. Lower-mid potency    (group 5)	Betamethasone dipropionate	Lotion	0.05%
	Betamethasone valerate	Cream	0.1%
	Desonide	Ointment, Gel	0.05%
	Fluocinolone acetonide	Cream	0.025%
	Flurandrenolide	Cream, Lotion	0.05%
	Fluticasone propionate	Cream, Lotion	0.05%
	Hydrocortisone butyrate	Cream, Lotion, Ointment, Solution	0.1%
	Hydrocortisone probutate	Cream	0.1%
	Hydrocortisone valerate	Cream	0.2%
	Prednicarbate	Cream (emollient), Ointment	0.1%
	Triamcinolone acetonide	Lotion	0.1%
		Ointment	0.025%
VI. Low potency (group 6)	Alclometasone dipropionate	Cream, Ointment	0.05%
	Betamethasone valerate	Lotion	0.1%
	Desonide	Cream, Lotion, Foam	0.05%
	Fluocinolone acetonide	Cream, Solution, Shampoo, Oil	0.01%
	Triamcinolone acetonide	Cream, lotion	0.025%
VII. Least potent (group 7)	Hydrocortisone (base, greater than or equal to 2%)	Cream, Ointment, Solution	2.5%
		Lotion	2%
	Hydrocortisone (base, less than 2%)	Cream, Ointment, Gel, Lotion, Spray, Solution	1%
		Cream, Ointment	0.5%
	Hydrocortisone acetate	Cream	2.5%
		Lotion	2%
		Cream	1%

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Adbry [package insert]. Madison, NJ: LEO Pharma Inc.; December 2023.
2. Eichenfield LF, Tom WL, Chamlin SL, et. al. Guidelines of care for the management of atopic dermatitis: Section 1. Diagnosis and Assessment of Atopic Dermatitis. J Am Acad Dermatol. 2014;70:338-351.
3. Topical Corticosteroids. Drug Facts and Comparisons.  Facts & Comparisons [database online]. St. Louis, MO:  Wolters Kluwer Health Inc; September 1, 2023.  Accessed November 2, 2023.

 

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

April 11, 2024