Subject: Elidel PA 759-A, 491-A P04-2026

Drug

ELIDEL  (pimecrolimus)

Policy:

Indications

FDA-approved Indications

Elidel (pimecrolimus) Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.

Elidel Cream, 1% is not indicated for use in children less than 2 years of age.

Compendial Uses

Psoriasis³ - on the face, genitals, or skin folds.⁶

Atopic Dermatitis for patients under 2 years of age.^4,5

Vitiligo on the head or neck.^7,8

Coverage Criteria

Atopic Dermatitis

Authorization may be granted when the requested drug is being prescribed for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (eczema) when ONE of the following criteria is met:

·        The patient is less than 2 years of age.

·        The requested drug will be used on sensitive skin areas (e.g., face, genitals, or skin folds).

·        The patient has experienced an inadequate treatment response, intolerance, or contraindication to at least ONE first line therapy agent (e.g., medium or higher potency topical corticosteroid).

Psoriasis

Authorization may be granted when the requested drug is being prescribed for the treatment of psoriasis on the face, genitals, or skin folds.

Vitiligo

Authorization may be granted when the requested drug is being prescribed for the treatment of vitiligo on the head or neck.

Continuation of Therapy

Atopic Dermatitis

Authorization may be granted when the requested drug is being prescribed for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (eczema) when the following criteria is met:

·        The patient has achieved or maintained a positive clinical response as evidenced by improvement [e.g., improvement in or resolution of any of the following signs and symptoms: erythema (redness), edema (swelling), xerosis (dry skin), erosions, excoriations (evidence of scratching), oozing and crusting, lichenification (epidermal thickening), OR pruritus (itching)].

Psoriasis

Authorization may be granted when the requested drug is being prescribed for the treatment of psoriasis on the face, genitals, or skin folds when the following criteria is met:

·        The patient has achieved or maintained a positive clinical response as evidenced by improvement (e.g., clear, or almost clear outcome, patient satisfaction, etc.).

Vitiligo

Authorization may be granted when the requested drug is being prescribed for the treatment of vitiligo on the head or neck when the following criteria is met:

·        The patient has achieved or maintained a positive clinical response as evidenced by improvement (e.g., meaningful repigmentation).

Duration of Approval (DOA)

·        491-A:

§  2 years of age and older: Initial therapy DOA: 3 months; Continuation of therapy DOA: 12 months.

§  Less than 2 years of age: DOA: 3 months.

·        759-A:

§  2 years of age and older: Initial therapy DOA: 3 months; Continuation of therapy DOA: 36 months.

§  Less than 2 years of age: DOA: 3 months.

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Elidel [package insert]. Bridgewater, NJ: Bausch Health US, LLC; September 2020.

2.     Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2026. https://online.lexi.com. Accessed January 20, 2026.

3.     Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 01/20/2026).

4.     Eichenfield LF, Tom WL, 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.

5.     Sigurgeirsson B, Boznanski A, et al. Safety and Efficacy of Pimecrolimus in Atopic Dermatitis: A 5-Year Randomized Trial. Pediatrics. 2015:135(4): 594-606.

6.     Elmets CA, Korman NJ, Prater EF, et al. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021 Feb;84(2):432-470.

7.     Kubelis-López DE, Zapata-Salazar NA, et al. Updates and new medical treatments for vitiligo (Review). Exp Ther Med. 2021;22(2):797.

8.     Eleftheriadou V, Atkar R, et al. British Association of Dermatologists guidelines for the management of people with vitiligo 2021. The British Journal of Dermatology. 2022;186(1):18-29.

9.     Eichenfield LF, Tom WL, et. al. Guidelines of Care for the Management of Atopic Dermatitis: Section 1. Diagnosis and Assessment of Atopic Dermatitis. J Am Acad Dermatol 2014; 70:338-51.

10.  Sidbury RS, Alikhan A, Berovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023: 89(1): e1-e20.

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.

August 20, 2026