Clinical Policy: (Symlin) Reference Number: ERX.ST.20 Effective Date: 06.01.15 Last Review Date: 08.17 Line of Business: Commercial [ Plan] Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description Pramlintide (Symlin®) is an analog.

FDA approved indication Symlin is indicated for patients with type 1 or type 2 diabetes who use mealtime and have failed to achieve desired glycemic control despite optimal insulin therapy.

Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria

It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Symlin is medically necessary when the following criteria are met:

I. Initial Approval Criteria A. Step Therapy for Symlin (must meet all): 1. Age ≥ 18 years; 2. Previous use of mealtime insulin therapy (e.g., Apidra, Humalog, Humulin, Novolin, Novolog) or an insulin pump in the last 30 days; 3. Dose does not exceed 120 mcg/injection (1 pen/injection). Approval duration: 6 months

II. Continued Therapy A. Step Therapy for Symlin (must meet all): 1. Currently receiving via a health plan affiliated with Envolve Pharmacy Solutions or member has previously met all initial approval criteria; 2. Current use of mealtime insulin therapy or an insulin pump; 3. If request is for a dose increase, new dose does not exceed 120 mcg/injection (1 pen/injection). Approval duration: 12 months

III. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration

Appendix B: Therapeutic Alternatives Drug Dosing Regimen Dose Limit/ Maximum Dose Novolog® () Diabetes See regimen Varies (dosage is individualized) Apidra® (insulin glulisine) Diabetes See regimen Varies (dosage is individualized) Humalog® () Diabetes See regimen Varies (dosage is individualized)

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Drug Dosing Regimen Dose Limit/ Maximum Dose Novolin® N, Humulin® N Diabetes See regimen (isophane insulin) Varies (dosage is individualized) Novolin® R, Humulin® R Diabetes See regimen () Varies (dosage is individualized)

IV. Dosage and Administration Indication Dosing Regimen Maximum Dose Diabetes 1 injection subcutaneously prior to each major 120 mcg/injection meal (≥ 250 kcal or containing ≥ 30 g of carbohydrate)

V. Product Availability  1.5 mL SymlinPen disposable multidose pen-injector: 15 mcg, 30 mcg, 45 mcg, 60 mcg  2.7 mL SymlinPen disposable multidose pen-injector: 60 mcg, 120 mcg

VI. References 1. Symlin Prescribing Information. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2015. Available at: www.symlin.com. Accessed January 11, 2017. 2. American Diabetes Association. Standards of medical care in diabetes—2017. Diabetes Care. 2017; 40(suppl 1): S1-S133.

Reviews, Revisions, and Approvals Date P&T Approval Date Policy created 06/15 06/15 Updated to new template (converted algorithm to bulleted 07/16 09/16 criteria). Clarified trial/failure requirement from basal insulin and either or to combination metformin + insulin (removed option for trial/failure of sulfonylurea as sulfonylurea + insulin combination therapy is not recommended due to limited efficacy and increased weight gain). Converted to new template. Initial: Modified mealtime 06/17 08/17 insulin/insulin pump requirement to indicate that this therapy must have been used in the last 30 days. Removed requirement for trial/failure of combination metformin + insulin per FDA labeling which requires only insulin therapy. Modified max dose requirement from generic statement to actual dose.

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.

This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. 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 policy is the property of Envolve Pharmacy Solutions. Unauthorized copying, use, and distribution of this Policy or any information contained herein is strictly prohibited. By accessing this policy, you agree to

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©2015 Envolve Pharmacy Solutions. All rights reserved. All materials are exclusively owned by Envolve Pharmacy Solutions 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 Envolve Pharmacy Solutions. You may not alter or remove any trademark, copyright or other notice contained herein.

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