Market Applicability Market GA KY MD NJ NY Applicable X NA X X X

Trelegy Ellipta ( furoate/umeclidinium/vilanterol)

Override(s) Approval Duration Prior Authorization 1 year Quantity Limit

Medications Quantity Limit Trelegy Ellipta May be subject to quantity limit (/umeclidinium/vilanterol)

APPROVAL CRITERIA

Requests for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) may be approved if the following criteria are met:

I. Individual is using for the treatment of chronic obstructive pulmonary disease (COPD); AND II. Individual is currently utilizing an inhaled (ICS)/long-acting beta-2 agonist (LABA) agent but requires additional treatment for COPD symptoms or exacerbations (GOLD 2020); OR III. Individual is currently utilizing a long-acting (LAMA)/long-acting beta-2 agonist (LABA) agent but requires additional treatment for COPD symptoms or exacerbations (GOLD 2020);

OR IV. Individual is using for the treatment of ; AND V. Individual is currently utilizing a medium-to-high dose inhaled corticosteroid (ICS)/long-acting beta-2 agonist (LABA) agent but requires additional treatment for asthma symptoms or exacerbations (GINA 2020).

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) may not be approved for the following:

I. Treatment of acute episodes of asthma or COPD; OR II. Concurrent therapy with another agent containing a long-acting beta-2 agonist (LABA) (including but not limited to tartrate, fumarate, , or ); OR III. Individual with a hypersensitivity to milk proteins.

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Key References:

1. DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health website. http://dailymed.nlm.nih.gov/dailymed/about.cfm. Accessed: October 7, 2020. 2. DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Updated periodically. 3. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2020. Available from: http://ginasthma.org/gina-reports/. Accessed on: October 8, 2020. 4. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2020. Available from: Available from: http://goldcopd.org. Accessed on: October 8, 2020. 5. Lexi-Comp ONLINE™ with AHFS™, Hudson, Ohio: Lexi-Comp, Inc.; 2020; Updated periodically. 6. Wenzel S. Treatment of severe asthma in adolescents and adults. Last updated: July 6, 2020. UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Accessed: October 8, 2020.

Federal and state laws or requirements, contract language, and Plan utilization management programs or polices may take precedence over the application of this clinical criteria.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

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