Generic: Sumatriptan Oral Tablets/Injection

PRIOR AUTHORIZATION CRITERIA BRAND NAME* (generic) ZURAMPIC (lesinurad)

Status: CVS Caremark Criteria MDC-1 Type: Initial Prior Authorization Ref # 1324-A * Drugs that are listed in the target drug box include both brand and generic and all dosage forms and strengths unless otherwise stated. OTC products are not included unless otherwise stated.

FDA-APPROVED INDICATIONS Zurampic (lesinurad) is indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone.

Limitations of Use: Zurampic is not recommended for the treatment of asymptomatic hyperuricemia. Zurampic should not be used as monotherapy.

COVERAGE CRITERIA The requested drug will be covered with prior authorization when the following criteria are met:  The requested drug is being prescribed in combination with a xanthine oxidase inhibitor (e.g., allopurinol or febuxostat) for hyperuricemia associated with gout in a patient who has not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone

RATIONALE These criteria meet the Medicare Part D definition of a medically accepted indication. This definition includes uses which are approved by the FDA or supported by a citation included, or approved for inclusion, in one of the Medicare approved compendia.

The intent of the criteria is to provide coverage consistent with product labeling, FDA guidance, standards of medical practice, evidence-based drug information, and/or published guidelines. Zurampic (lesinurad) is indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone. Zurampic is not recommended for the treatment of asymptomatic hyperuricemia. Zurampic should not be used as monotherapy.

REFERENCES 1. Zurampic [package insert]. Cambridge, MA: Ironwood Pharmaceuticals; January 2018. 2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, OH: Wolters Kluwer Clinical Drug Information, Inc. http://online.lexi.com/. October 2018. 3. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. http://www.micromedexsolutions.com/. October 2018.

Written by: UM Development (JH) Date Written: 01/2016 Revised: (MS) 12/2016 (removed contraindication question due to lack of denials), (KC) 12/2017 (combined questions); (RP) 11/2018 (extended DOA; updated dx question) Reviewed: Medical Affairs (GAD) 01/2016; (AN) 12/2016, (LSM) 12/2017; (ME) 11/2018 External Review: 02/2016, 02/2017, 02/2018, 02/2019

This document contains confidential and proprietary information of CVS Caremark and cannot be reproduced, distributed or printed without written permission from CVS Caremark. This document contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with CVS Caremark. 1

CRITERIA FOR APPROVAL

1 Is the requested drug being prescribed with a xanthine oxidase inhibitor (e.g., allopurinol Yes No or febuxostat) for hyperuricemia associated with gout in a patient who has not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone?

Guidelines for Approval Duration of Approval 36 Months Set 1 Yes to question(s) No to question(s) 1 None

Mapping Instructions Yes No DENIAL REASONS – DO NOT USE FOR MEDICARE PART D 1. Approve, 36 Deny You do not meet the requirements of your plan. Your plan covers this Months drug when you need to take another drug with your current treatment to help treat gout. Your request has been denied based on the information we have. [Short Description: No approvable diagnosis]