Proton Pump Inhibitors

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Market DC Proton Pump Inhibitors Override(s) Prior Authorization Quantity Limit** Approval Duration Preferred PPI: No Prior Authorization required Preferred PPI quantity override: Lifetime Non-Preferred PPI: 1 year h. pylori diagnosis 14 days Non-Preferred PPI quantity override: Not to exceed termination of approval of PA h. pylori diagnosis 14 days If PAB criteria is met AND The individual has any one of the following diagnosis: [Structural GERD (erosive esophagitis, Barrett s Esophagus, esophageal strictures, acid-induced asthma, scleroderma or limited scleroderma (CREST syndrome)), Hypersecretory Syndromes (Zollinger- Ellison, multiple endocrine adenomas, or systemic mastocytosis.) or laryngeal, esophageal, or gastric cancer]: 1 year **Quantity Supply Overrides (listed in the above below) If Prior Authorization of Benefits criteria for nonpreferred agent are met, the following criteria will apply for quantity supply: If the individual was on a preferred agent, at a dose of 2 per day, then the quantity limit may be overridden on the non-preferred agent to 2 per day If the individual was on a preferred agent at a dose of 1 per day, then they must first try once daily dosing of the non-preferred agent prior to going to BID dosing PAGE 1 of 6 11/01/2018

Market DC Medications Strength Quantity Limit Preferred PPIs Omeprazole Rx (for individuals less than 6 years old only) Omeprazole magnesium OTC Prevacid 24HR OTC (lansoprazole) brand and generic Prilosec OTC (omeprazole, omeprazole magnesium) brand and generic 20mg capsule (for individuals less than 6 years old only) 20.6mg capsules 15mg capsules 20mg, 20.6mg tablets Nexium 24HR OTC 20mg tablets Nexium 24HR OTC (esomeprazole DR OTC) brand and generic Zegerid OTC Non-Preferred PPIs 20mg capsules 20mg-1.1g capsules AcipHex (rabeprazole) 20mg tablets AcipHex Sprinkle 5mg, 10mg capsules (rabeprazole) Dexilant (dexlansoprazole) 30mg, 60mg capsules PAGE 2 of 6 11/01/2018

Market DC Dexilant SoluTab 30mg tablets (dexlansoprazole ODT) esomeprazole strontium 49.3mg capsules lansoprazole (Rx) 15mg, 30mg capsules Nexium (esomeprazole) 20mg, 40mg capsules (Rx) Nexium DR packet 10 mg packet Nexium Suspension (esomeprazole) Omeppi Omeprazole (Rx) 2.5mg, 5mg, 10mg 20mg, 40mg packets 20mg-1.1g, 40mg-1.1g capsules 10mg, 40mg capsules 20mg capsules (for individuals 6 years and older) Pantoprazole (Rx) 20mg, 40mg tablets Prilosec Oral Suspension 2.5mg, 10mg packets (omeprazole magnesium) Prilosec Rx 20mg capsules Prilosec Rx (omeprazole) 40mg capsules Prevacid (lansoprazole) 15mg, 30mg capsules Prevacid Solutab (lansoprazole ODT) 15mg, 30mg oral disintegrating tablets Protonix (pantoprazole) 20mg, 40mg tablets Protonix Oral Suspension 40mg packets (pantoprazole) Rabeprazole 20mg tablets Zegerid Rx 20mg-1.1g, 40mg-1.1g capsules Zegerid Oral Suspension Rx Quantity Limit Override Criteria Increased Dosing up to 4 doses/day 20-1680mg, 40-1680mg packets PAGE 3 of 6 11/01/2018

Market DC for esomeprazole DR 20mg OTC capsules, Nexium 24HR 20mg OTC capsules/tablets, omeprazole OTC, Prilosec OTC, lansoprazole OTC, Prevacid 24 HR OTC Increased Dosing up to 2 doses/day for all other PPIs Approvable if the individual does not respond after a 30-day trial of stated dosing limit with the requested PPI or the individual has been diagnosed with eosinophilic esophagitis. Increased Dosing of 4 per day for 14 days for esomeprazole DR 20mg OTC capsules, Nexium 24HR 20mg OTC capsules/tablets, omeprazole OTC, Prilosec OTC, lansoprazole OTC, Prevacid 24HR OTC Increased Dosing of 2 per day for 14 days for all other PPIs Approvable for a diagnosis of: h. pylori, for eradication Increased Dosing beyond 4 doses/day for esomeprazole DR 20mg OTC capsules, Nexium 24HR 20mg OTC capsules/tablets, omeprazole OTC, Prilosec OTC, lansoprazole OTC, Prevacid 24HR OTC Increased Dosing beyond 2 doses/day for all other PPIs Approvable for: Hypersecretory syndromes (Zollinger-Ellison syndrome, multiple endocrine adenomas, or systemic mastocytosis Barrett s Esophagus Laryngeal, esophageal or gastric cancer Scleroderma or limited scleroderma (CREST syndrome) APPROVAL CRITERIA Requests for a non-preferred Proton Pump Inhibitor (PPI) may be approved for individuals who meet the following criteria: A. Individual has had trials (medication samples/coupons/discount cards are excluded from consideration as a trial) and inadequate response or intolerance to two (2) preferred proton pump inhibitors (PPIs): 1. Esomeprazole DR 20mg OTC (esomeprazole DR OTC or Nexium 24HR OTC 20mg)* PAGE 4 of 6 11/01/2018

Market DC 2. Lansoprazole OTC (lansoprazole OTC or Prevacid 24HR OTC); 3. Omeprazole OTC (omeprazole OTC, omeprazole magnesium OTC or Prilosec OTC tablets)*; 4. Omeprazole 20mg capsules Rx (for individuals less than 6 years old only)*; 5. Omeprazole/sodium bicarbonate OTC bicarbonate OTC, Zegerid OTC)*; B. The preferred PPIs are not acceptable due to the following concomitant clinical situations: 1. Individual has the inability to swallow tablets/capsules and the non-preferred agent is available in suspension or oral disintegrating tablet (ODT) formulation; 2. *Individual is utilizing clopidogrel [trials of esomeprazole DR OTC (Nexium 24HR OTC), omeprazole OTC (Prilosec OTC, omeprazole magnesium OTC), omeprazole 20mg capsule Rx (for individuals less than 6 years old only), and omeprazole/sodium bicarbonate OTC bicarbonate OTC, Zegerid OTC) products will not be required]. C. Individuals less than one (1) year of age are NOT subject to step therapy. Key References: Clinical Pharmacology [database online]. Tampa, : Gold Standard, Inc.: 2017. URL: http://www.clinicalpharmacology.com. Updated periodically. PAGE 5 of 6 11/01/2018

Market DC DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health website. http://dailymed.nlm.nih.gov/dailymed/about.cfm. Accessed: June 7, 2018 DrugPoints System (electronic version). Truven Health Analytics, Greenwood Village, CO. Updated periodically. Lexi-Comp ONLINE with AHFS, Hudson, Ohio: Lexi-Comp, Inc.; 2018; Updated periodically. PAGE 6 of 6 11/01/2018