Drug Class Monograph

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Drug Class Monograph Class: Proton Pump Inhibitors Drugs: Aciphex Sprinkle (rabeprazole), Dexilant (dexlansoprazole), Lansoprazole, Nexium (esomeprazole capsule, esomeprazole granules), Omeprazole,

1 Drug Class Monograph Class: Proton Pump Inhibitors Drugs: Aciphex Sprinkle (rabeprazole), Dexilant (dexlansoprazole), Lansoprazole, Nexium (esomeprazole capsule, esomeprazole granules), Omeprazole, Pantoprazole, Prevacid (lansoprazole capsule, lansoprazole disintegrating tab), Prilosec (omeprazole granule), Protonix (pantoprazole granule), Rabeprazole, Zegerid (omeprazole-sodium bicarbonate capsule, omeprazole-sodium bicarbonate packet powder for suspension) Formulary medications: Lansoprazole, Nexium 24 Hour (esomeprazole capsule), Omeprazole, Pantoprazole, Prevacid 24 Hour (lansoprazole capsule), Prilosec OTC (omeprazole), Rabeprazole Line of Business: Non-Medicare Effective Date: November 16, 2016 Revision Date: November 16, 2016 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics Subcommittee. Policy/Criteria: 1. Non-formulary Proton Pump Inhibitor (e.g. Dexilant, Zegerid, Prevacid SoluTab etc.) a. Confirmed diagnosis of symptomatic GERD, erosive esophagitis, pathological hypersecretory condition (e.g. Zollinger Ellison syndrome), gastroduodenal ulcer, NSAID associated gastric ulcer, H. pylori infection, or Barrett s esophagus; b. And one of the following: i. Failure or clinically significant adverse effects of each formulary PPI alternative (lansoprazole, omeprazole, pantoprazole, rabeprazole and esomeprazole OTC); ii. For patients with documented difficulty swallowing: Trial and failure of formulary omeprazole and lansoprazole capsules sprinkled on apple sauce or juice as directed. iii. For patients with tube feeding: Nexium granule packet and Protonix granule packet are the preferred PPI products. c. Requested dose and duration must be consistent with FDA package labeled recommendation or DrugDex compendia.

2 Clinical Justification: Comparison of Clinical Indications and Dosages Clinical Indications & Dosages Erosive Esophagitis associated with GERD Dexlansoprazole Treatment: 60mg once daily for 8 weeks Maintenance: 30mg once daily Esomeprazole Treatment: 20-40mg once daily for 4-8 weeks Lansoprazole Treatment: 30mg once daily for 8 weeks Omeprazole Treatment: 20mg once daily for 4-8 weeks Pantoprazole Treatment: 40mg once daily for 8 weeks Maintenance: 40mg once daily Rabeprazole Treatment: 20mg once daily for 4-8 weeks Omeprazole-sodium bicarbonate Treatment: 20mg daily for 4-8 weeks Symptomatic GERD Dexlansoprazole 30mg once daily for 4 weeks Esomeprazole 20mg once daily for 4 weeks Lansoprazole 15mg once daily for 8 weeks Omeprazole 20mg once daily for 4 weeks Pantoprazole 40mg once daily for 4 weeks ± Rabeprazole 20mg once daily for 4 weeks Omeprazole-sodium 20mg once daily for 4 weeks bicarbonate NSAID Associated Gastric Ulcer Esomeprazole Treatment: 20mg once daily for 4-8 weeks ± Prevention: 20mg-40mg once daily for 6 months Lansoprazole Treatment: 30mg once daily for 8 weeks Prevention: 15mg once daily for 12 weeks Omeprazole Treatment: 20mg once daily for 4-8 weeks ± Prevention: 20mg once daily for 6 months ± Pantoprazole Prevention: 20mg once daily ± Pathological Hypersecretory Condition (e.g. Zollinger-Ellison Syndrome) Esomeprazole 40mg twice daily Lansoprazole 60mg once daily Omeprazole 60mg once daily (up to 120mg tid) Pantoprazole 40mg twice daily (up to 240mg daily)

3 Rabeprazole 60mg once daily (up to 60mg bid) Active and Maintenance Therapy of Gastroduodenal Ulcers Lansoprazole Duodenal ulcer: 15mg once daily for 4 weeks Gastric ulcer: 30mg once daily for 8 weeks Omeprazole Duodenal ulcer: 20mg once daily for 4 weeks Gastric ulcer: 40mg once daily for 4-8 weeks Pantoprazole Duodenal ulcer: 40mg once daily for 2 weeks (may extend for additional 2-4 weeks) ± Gastric ulcer: 40mg once daily for 4 weeks (may extend for additional 2-4 weeks) ± Rabeprazole Duodenal ulcer: 20mg once daily for 4 weeks Gastric ulcer: 20mg once daily for 6 weeks ± Omeprazole-sodium Duodenal ulcer: 20mg once daily for 4-8 weeks bicarbonate Gastric ulcer: 40mg once daily for 4-8 weeks H. Pylori Eradication Esomeprazole 40mg once daily as part of triple therapy Lansoprazole 30mg bid-tid for 10 or 14 days as part of triple/dual therapy Omeprazole 40mg once daily as part of dual therapy or 20mg twice daily as part of triple therapy Pantoprazole 40mg twice daily as part of triple therapy ± Rabeprazole 20mg twice daily as part of triple therapy ± Off labeled use American College of Gastroenterology: Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease 2013 Management of GERD: An 8-week course of PPIs is the therapy of choice for symptom relief and healing of erosive esophagitis. There is no major difference in efficacy between the different PPIs. Traditional delayed release PPIs should be administered minutes before meal for maximal ph control. Newer PPIs may offer dosing flexibility relative to meal timing. PPI therapy should be initiated at once a day dosing, before the first meal of the day. For patients with partial response to once daily therapy, tailored therapy with adjustment of dose timing and/or twice daily dosing should be considered in patients with night-time symptoms, variable schedules, and/or sleep disturbance. Non-responders to PPI should be referred for evaluation. In patients with partial response to PPI therapy, increasing the dose to twice daily therapy or switching to a different PPI may provide additional symptom relief.

4 Maintenance PPI therapy should be administered for GERD patients who continue to have symptoms after PPI is discontinued and in patients with complications including erosive esophagitis and Barrett s esophagus. For patients who require long-term PPI therapy, it should be administered in the lowest effective dose, including on demand or intermittent therapy. Potential Risks Associated with PPIs: Switching PPIs can be considered in the setting of side effects. Patients with known osteoporosis can remain on PPI therapy. Concern for hip fractures and osteoporosis should not affect the decision to use PPI long-term except in patients with other risk factors for hip fracture. PPI therapy can be a risk factor for Clostridium difficile infection and should be used with care in patients at risk. Short-term PPI usage may increase the risk of community acquired pneumonia. The risk does not appear elevated in long-term users. PPI therapy does not need to be altered in concomitant clopidogrel users as clinical data does not support an increased risk for adverse cardiovascular events. American College of Gastroenterology: Diagnosis and Management of Barrett s Esophagus 2015 Therapy: Chemoprevention: Patients with BE should receive once-daily PPI therapy. Routine use of twice-daily dosing is not recommended, unless necessitated because of poor control of reflux symptoms or esophagitis. o PPI therapy is common in patients with BE, in part because of the high proportion of those patients who also have symptomatic GERD. In these cases, the use of PPIs is substantiated by the need for symptom control, making consideration of chemoprevention secondary. o With respect to optimizing medical therapy, dosages of PPI beyond twice daily have not been demonstrated to have beneficial effect in patients with BE. We recommend once-daily PPI therapy for patients with BE unless GERD symptoms require twice daily for adequate symptom control. Aspirin or nonsteroidal anti-inflammatory drugs should not be routinely prescribed to patients with BE as an antineoplastic strategy. Similarly, other putative chemopreventive agents currently lack sufficient evidence and should not be administered routinely. American College of Gastroenterology: Guideline on the Management of Helicobacter Pylori Infection 2007 Treatment of H. Pylori Infection: In the United States, the recommended primary therapies for H. pylori infection include: a PPI, clarithromycin, and amoxicillin or metronidazole (clarithromycin-based triple

5 therapy) for 14 days or a PPI or H2RA, bismuth, metronidazole, and tetracycline (bismuth quadruple therapy) for days. Eradication rates with a PPI, clarithromycin and amoxicillin are decreasing worldwide. Fourteen-day courses of therapy are more effective than seven-day treatment regimens. A PPI, levofloxacin and amoxicillin for 10 days appear to be more effective and better tolerated than a PPI, bismuth, tetracycline and metronidazole in patients with persistent H. pylori infection but require validation in North America. References: 1. Katz, PO, Gerson, LB, et al. Am J Gastroenterol 2013; 108: Chey WD, Wong BCY, et al. Am J Gastroenterol 2007; 102: Shaheen NJ, Walk, GW, et al. Am J Gastroenteroladvance online publication, 3 November 2015; doi: /ajg.2015: Micromedex. Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Accessed September 21, Prevacid [Prescribing Information] Deerfield, IL: Takeda Pharmaceuticals; December Prilosec [Prescribing Information] Wilmington, DE: AstraZeneca; July Aciphex/Aciphex Sprinkle [Prescribing Information] Woodcliff Lake, NJ: Eisai, Inc; April Dexilant [Prescribing Information] Deerfield, IL: Takeda Pharmaceuticals; August Nexium [Prescribing Information] Wilmington, DE: AstraZeneca; July Zegerid [Prescribing Information] San Diego, CA: Santarus; June 2016.

Proton Pump Inhibitors Drug Class Prior Authorization Protocol

Proton Pump Inhibitors Drug Class Prior Authorization Protocol Line of Business: Medi-Cal P&T Approval Date: November 15, 2017 Effective Date: January 1, 2018 This policy has been developed through review