Subject: Adbry 5125-A SGM P2023

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 adult patients 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
          Authorization of 4 months may be granted for treatment of
          moderate-to-severe atopic dermatitis in members 18 years of
          age or older when all of the following criteria are met:
          A.  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.
          B.  Member meets one of the following:
               1.  Member has had an inadequate treatment response with
                    one of the following in the past year:
                    i.      A medium potency to super-high potency topical
                            corticosteroid (see Appendix)
                    ii.     A topical calcineurin inhibitor
               2.  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 18
          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 Adbry concomitantly with any other biologic
          drug or targeted synthetic drug.

 
  VII.  APPENDIX  

Table. Relative potency of select topical corticosteroid products

Potency	Drug	Dosage form	Strength
I. Super-high potency   (group 1)	Augmented   betamethasone   dipropionate	Ointment, Lotion, Gel	0.05%
	Clobetasol   propionate	Cream, Gel, Ointment,   Solution, Cream   (emollient), Lotion,   Shampoo, Foam, Spray	0.05%
	Fluocinonide	Cream	0.1%
	Flurandrenolide	Tape	4 mcg/cm2
	Halobetasol   propionate	Cream, Lotion, Ointment,   Foam	0.05%
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%
Potency	Drug	Dosage form	Strength
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.; July 2022.
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.

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.

May 26, 2023