Policy: Atopic Dermatitis and Topical Antipsoriatics Reference Number: TCHP.PHAR.18004 Effective Date: 01.01.18 Last Review Date: 10.12.18 Line of Business: Oregon Health Plan Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Coverage guidelines for agents to treat atopic dermatitis and psoriasis. These coverage guidelines do not apply to biologics for psoriasis, which is subject to separate clinical PA criteria. Goals Restrict dermatological drugs only for funded Oregon Health Plan (OHP) diagnoses. Moderate/severe psoriasis and moderate/severe atopic dermatitis treatments are funded on the OHP. Treatments for mild psoriasis, seborrheic dermatitis, keroderma and other hypertrophic and atrophic conditions of skin are not funded. Requires PA: Non-preferred antipsoriatics All atopic dermatitis drugs Covered Alternatives: Current Trillium Preferred Drug List listed at: 1. https://www.trilliumohp.com/providers/helpful-links.html 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 Trillium Oregon Health Plan that the requested medication is medically necessary when the following criteria are met: Approval Criteria 1. What is diagnosis is being treated? 2. Is the diagnosis for seborrheic dermatitis, keroderma or other hypertrophic and atrophic conditions of the skin? 3. Is the diagnosis psoriasis? 4. Is the psoriasis moderate/severe? Moderate/severe psoriasis is defined as: Having functional impairment (e.g. inability to use hands or feet for activities of daily living, or significant facial involvement preventing normal Record ICD-10 code. Yes: Deny; not funded by the OHP. Yes: Go to #4 Yes: Go to #5 Page 1 of 5 No: Go to #3 No: Go to #7 No: Deny; not funded by the OHP
social interaction) and one of the following: 1. At least 10% body surface area involved or with functional impairment and/or: 2. Hand, foot or mucous membrane involvement. 5. Is the product requested preferred? 6. Will the provider consider a change to a preferred product? Message: Preferred products are evidencebased reviewed for comparative effectiveness and safety by the Pharmacy and Therapeutics (P&T) Committee. 7. Is the diagnosis atopic dermatitis? 8. Is the diagnosis moderate/severe atopic dermatitis (AD)? Moderate/severe atopic dermatitis is defined as: Having functional impairment (e.g. inability to use hands or feet for activities of daily living, or significant facial involvement preventing normal social interaction) and one of the following: 1. At least 10% body surface area involved or with functional impairment and/or: 2. Hand, foot or mucous membrane involvement. 9. Is the drug topical tacrolimus, pimecrolimus or crisaborole? 10. What is the age of the patient? 11. Does the patient meet the age requirements per the FDA label? Tacrolimus 0.1% ointment is FDA approved for patients 16 years of age and older Tacrolimus 0.03% ointment, pimecrolimus 1% cream, and crisaborole ointment are FDA approved for patients 2 years of age and older. Yes: Approve for up to 1 year Yes: Inform provider of preferred alternatives. Approve preferred alternative for up to 1 year Yes: Go to #8 Yes: Go to #9 No: Go to #6 No: Deny as non preferred agent (non formulary). No: Go to #17 No: Deny; Not funded by the OHP Yes: Go to #10 No: Go to #13 Age less than 2 years: Deny; medical. Yes: Go to #12 Age 2 years and older: Go to #11 Page 2 of 5 No: Deny, medical
12. Does the patient have a documented contraindication, intolerance or failed trials of at least 2 first line agents indicated for the treatment of moderate to severe AD (topical corticosteroids)?* *Note pimecrolimus and crisaborole are FDA approved to manage mild to moderate AD, while tacrolimus is FDA approved to manage moderate to severe AD. 13. Is the drug dupilumab? 14. What is the age of the patient? Dupilumab injection is FDA approved for patients 18 years of age and older 15. Is the medication being prescribed by or in consultation with a dermatologist or allergist? 16. Does the patient have a documented contraindication or failed trial of the following treatments: Moderate to high potency topical corticosteroid (e.g., clobetasol, desoximetasone, desonide, mometasone, betamethasone, halobetasol, fluticasone, or fluocinonide) AND Topical calcineurin inhibitor (tacrolimus, pimecrolimus) or topical phosphodiesterase (PDE)-4 inhibitior (crisaborole) AND Oral immunomodular therapy (cyclosporine, methotrexate, azathioprine, mycophenolate, mofetil, or oral corticosteroids)? 17. All other indications need to be evaluated as whether they are funded by the OHP.* Yes: Document drug and dates trialed and intolerances if applicable. Approve for up to 6 months Yes: Go to #14 Age 17 years or younger: Deny; medical. Yes: Go to #16 No: Go to #17 Age 18 years and older: Go to #15 Yes: Document drug and dates trialed and intolerance if applicable. Approve for up to 6 months If funded, or clinic provides supporting literature: Approve for up to 6 months If not funded: Deny; not funded by the OHP * The Health Evidence Review Commission has stipulated via Guideline Note 21 that mild, uncomplicated inflammatory skin conditions including psoriasis, atopic dermatitis, lichen planus, Darier disease, pityriasis rubra pilaris, and discoid lupus are not funded. Uncomplicated is defined as no functional impairment; and/or involving less than 10% of body surface area and no involvement of the hand, foot, or mucous membranes. I. References 1. Atopic Dermatitis and Topical Antipsoriatics. Oregon Health Plan Current Drug Use Criteria. Available at: http://orpdl.org/drugs/index.php. Accessed September 27, 2018. Page 3 of 5
2. Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed September 27, 2018. Reviews, Revisions, and Approvals Date New policy created. Approved by P&T P&T Approval Date 9.27.18 10.12.18 Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. Health Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan s affiliates, as applicable. The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures. This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time. This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan. This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members and their Page 4 of 5
representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services. Note: For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy. 2017 Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene and Centene Corporation are registered trademarks exclusively owned by Centene Corporation. Page 5 of 5