Subject: Elidel PA Policy 759-A, 491-A 04-2022

Drug

ELIDEL  (pimecrolimus)

Policy:

FDA-APPROVED INDICATIONS
Elidel 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 is not indicated for use in children less than 2 years of age. 

Compendial Uses
Psoriasis³ - on the face, genitals, or skin folds⁶
Atopic Dermatitis for patients under 2 years of age^4,5
Vitiligo on the head or neck^7,8

COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
    •   The requested drug is being prescribed for psoriasis on the face, genitals, or skin folds OR vitiligo on the
         head or neck
    OR
    •   The requested drug is being prescribed for mild to moderate atopic dermatitis (eczema) AND
         o   The patient is less than 2 years of age
         OR
         o   The requested drug will be used on sensitive skin areas (e.g., face, genitals, or skin folds)
              OR
         o   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)

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, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed February 14, 2022.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed February 14, 2022.
4. Eichenfield L, Tom W, Berger T, et al. Guidelines of Care for the Management of Atopic Dermatitis. J Am Acad Dermatol. 2014 Jul;71:116-32.
5. Sigurgeirsson B, Boznanski A, et al. Safety and Efficacy of Pimecrolimus in Atopic Dermatitis: A 5-Year Randomized 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. 2021;186(1):18-29.

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 14, 2022