Zurampic (Lesinurad)

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Market Applicability Market DC GA KY MD NJ NY WA Applicable X X X X X X NA Zurampic (lesinurad) Override(s) Approval Duration Prior Authorization 1 year Quantity Limit Medications Quantity Limit Zurampic (lesinurad) May be subject to quantity limit APPROVAL CRITERIA Requests for Zurampic (lesinurad) may be approved if the following criteria are met: I. Individual has had a previous trial (medication samples/coupons/discount cards are excluded from consideration as a trial) and inadequate response (unable to achieve target serum uric acid levels) to one preferred xanthine oxidase inhibitor (allopurinol, febuxostat*); AND II. Individual has hyperuricemia associated with gout; AND III. Individual is unable to achieve target serum uric acid levels while on a xanthine oxidase inhibitor (such as allopurinol or febuxostat*); AND IV. Individual remains symptomatic (such as, but not limited to joint pain, swelling, limited range of motion, erythema) despite use of xanthine oxidase inhibitor; AND V. Individual will continue use of a xanthine oxidase inhibitor in conjunction with Zurampic. *requires prior authorization Zurampic (lesinurad) may not be approved for the following: I. Individual has severe renal impairment (creatinine clearance less than 30 mL/min), end stage renal disease, is on dialysis or is a kidney transplant recipient; OR II. Individual has Lesch-Nyhan syndrome or tumor lysis syndrome. PAGE 1 of 2 08/14/2019 This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. CRX-ALL-0429-19 Market Applicability Market DC GA KY MD NJ NY WA Applicable X X X X X X NA Note: Zurampic (lesinurad) has a black box warning indicating risk of acute renal failure is more common when Zurampic is used without a xanthine oxidase inhibitor. Zurampic should be used in combination with a xanthine oxidase inhibitor. State Specific Mandates State name Date effective Mandate details (including specific bill if applicable) N/A N/A N/A 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: March 28, 2019. PAGE 2 of 2 08/14/2019 This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. CRX-ALL-0429-19 .

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New Therapeutic Agents Marketed in 2015: Part 4 Amy M
CPE New therapeutic agents marketed in 2015: Part 4 Amy M. Lugo and Brian Park Amy M. Lugo, PharmD, BCPS, BC-ADM, Abstract FAPhA, Clinical Pharmacy Specialist, Pharmacy Operations Division, Formu- lary Management Branch, Defense Health Objective: To provide information about the most important properties of new Agency, San Antonio therapeutic agents approved by FDA and first marketed in 2015. Brian Park, PharmD candidate, University of Data sources: Product labeling supplemented selectively with published stud- New England College of Pharmacy, Portland, ies and drug information reference sources. ME Data synthesis: This review covers 11 new therapeutic agents approved by FDA Correspondence: Amy M. Lugo, 7800 and first marketed in the United States in 2015: selexipag, cobimetinib, osimertinib, IH-10 W, Ste. 335, San Antonio, TX 78230; necitumumab, alectinib, insulin degludec, lesinurad, mepolizumab, brexpiprazole, [email protected] cariprazine, and flibanserin. Indications and information on dosage and adminis- Disclosure: The authors declare no conflicts tration for these agents are reviewed, as well as efficacy, safety, the most important of interest or financial interests in any product or service mentioned in this article. pharmacokinetic properties, drug interactions, and other precautions. Practical considerations for use of these new agents also are discussed. Whenever possible, Department of Defense (DoD) disclaimer: The information discussed here represents properties of the new drugs are compared with those of older agents marketed for the views of the author and does not neces- the same indications. sarily reflect the views of DoD or the Depart- Summary: Selexipag is the second oral prostacyclin agonist for the treatment ments of the Army, Navy, or Air Force.
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