Proton Pump Inhibitors. Description. Section: Prescription Drugs Effective Date: July 1, 2014

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Proton Pump Inhibitors Page: 1 of 7 Last Review Date: June 12, 2014 Proton Pump Inhibitors Description Aciphex (rabeprazole), Dexilant (dexlansoprazole), Esomeprazole Strontium, Nexium (esomeprazole), Prevacid (lansoprazole), Prilosec (omeprazole), Protonix (pantoprazole), First- Lansoprazole suspension, Zegerid (omeprazole / sodium bicarbonate) Background Omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, and pantoprazole belong to a class of antisecretory compounds, the substituted benzimidazoles, that do not exhibit anticholinergic or histamine H 2 antagonistic properties, but that suppress gastric acid secretion by specific inhibition of the H + /K + ATPase enzyme system, the proton pump. These drugs are the most potent suppressors of gastric acid secretion. In typical doses, they diminish the daily production of acid (basal and stimulated) by 80-95%. As a class, PPIs are safe, although some evidence indicates that the drugs in this class affect cytochrome P450 activity. Additionally, caution should be used in patients being treated concurrently with anticoagulants. PPIs have been shown to be more effective than H2RAs and antacids at relieving the symptoms of GERD and preventing its recurrence.

2 Subject: Proton Pump Inhibitors Page: 2 of 7 Regulatory Status The individual agent proton pump inhibitor products addressed by this policy are FDA-approved for use in one or more of the following conditions: Duodenal ulcer Gastric ulcer Gastroesophageal reflux disease (GERD) Erosive esophagitis (EE) Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome Relief of hearburn Zegerid (omeprazole / sodium bicarbonate); FDA-approved indications: Short-term treatment of active duodenal ulcer Short-term treatment of active benign gastric ulcer Treatment of gastroesophageal reflux disease (GERD) Maintenance of healing of erosive esophagitis Reduction of risk of upper GI bleeding in critically ill patients (9) The safety and effectiveness of Zegerid Powder for Oral Suspension and Capsules in pediatric patients (<18 years of age) have not been established (9). Proton Pump therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated (5). Proton pump inhibitor therapy may be associated with an increased risk of Clostrium difficile associated diarrhea (CDAD) and hypomagnesemia. Low magnesium levels may occur in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. Discontinuation of the PPI may be required. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that cause hypomagnesemia, healthcare professionals

3 Subject: Proton Pump Inhibitors Page: 3 of 7 may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically (5). Related policies Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Proton Pump Inhibitors are medically necessary for the indications listed below. Proton Pump Inhibitors may be considered investigational in all other patients. Prior-Approval Requirements Diagnoses Patient must have ONE of the following: Achalasia associated with GERD Cancer Cancer, gastric related ** Dyspepsia associated with GERD Dysphagia Epiphrenic Diverticula Esophageal Shortening ** Esophageal Stricture ** Esophageal Varicies Esophagitis Esophagitis, Barrett s ** Esophagitis, Erosive * Esophagitis, Sclerodermal ** (this is part of CREST syndrome) Gastritis associated with GERD Gastroparesis Gastroparesis caused by diabetes or vagotomy **

4 Subject: Proton Pump Inhibitors Page: 4 of 7 Gastropathy, medication related (other than traditional NSAID) Gastropathy, NSAID Related* GERD (includes laryngeal and pharyngeal) GI Bleed H.Pylori Patients currently undergoing treatment Hiatal Hernia HIV / AIDS ** Ulcer Ulcer, Peptic Ulcer Disease (PUD) Ulcer, Gastric Ulcer, Duodenal* Short bowel syndrome* Crohn s Disease ** Zollinger-Ellison Syndrome ** Any hypersecretory condition ** Pancreatitis ** Multiple Endocrine Adenomas ** Systemic Mastocytosis ** Cystic Fibrosis ** OR ONE of the following: 1. Failure of therapy with one H2 blocker 2. Failure of therapy with another PPI 3. Prescriber is ONE of the following a. Gastroenterologist b. Ear, Nose and Throat Specialist i. Other Throat Specialist c. Pulmonologist 4. Patient has a medical history of transplant surgery ** Prior Approval Renewal Requirements Same as above

5 Subject: Proton Pump Inhibitors Page: 5 of 7 Policy Guidelines Pre - PA Allowance Quantity Duration 90 dosage units 900 ml of First-lansoprazole suspension 365 days Prior - Approval Limits Quantity Duration up to 3 dosage units per day 10,800 ml of First-lansoprazole suspension every 365 days 1 year * These diagnoses may be approved for 2 years ** These diagnoses may be approved for lifetime therapy Prior Approval Renewal Limits Same as above Rationale Summary Proton pump inhibitors are the most potent suppressors of gastric acid secretion. In typical doses, they diminish the daily production of acid (basal and stimulated) by 80-95%. PPIs are generally safe, although caution should be used in patients being treated concurrently with anticoagulants, tacrolimus, theophylline, and methotrexate. Proton Pump therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Proton pump inhibitor therapy may be associated with an increased risk of Clostrium difficile associated diarrhea (CDAD) and hypomagnesemia (5). Prior approval is required to ensure the safe, clinically appropriate and cost effective use of the proton pump inhibitors while maintaining optimal therapeutic outcomes.

6 Subject: Proton Pump Inhibitors Page: 6 of 7 References 1. Aciphex. Prescribing Information. Woodcliff Lake, NJ. Eisai Inc. November Dexilant. Prescribing Information. Deerfield, IL. Takeda Pharmaceuticals America, Inc. October Nexium. Prescribing Information. Wilmington DE. AstraZeneca LP. February Nexium IV. Prescribing Information. Wilmington DE. AstraZeneca LP. March Prevacid. Prescribing Information. Deerfield, IL. Takeda Pharmaceuticals America, Inc. September Prilosec. Prescribing Information. Wilmington DE. AstraZeneca LP. February Protonix. Prescribing Information. Philadelphia, PA. Pfizer Inc. December Protonix IV. Philadelphia, PA. Pfizer Inc. December Zegerid. Prescribing Information. San Diego, CA. Santarus, Inc. November Esomeprazole Strontium [package insert]. Glasgow, KY. Amneal Pharmaceuticals. August Policy History Date September 2004 January 2009 February 2009 March 2009 March 2010 June 2010 Action In order to be consistent with current benefit design, Zegerid was included in the overall current upfront PPI 90 quantity allowance per year. Removal of Prilosec/omeprazole from the FEP PA Program (all strengths). Prescription Prilosec/omeprazole 20mg will be covered by the plan. Addition of Kapidex to PA process. Removal of Prevacid Naprapac due to discontinuation by the manufacturer in December of Kapidex name change to Dexilant due to dispensing errors. Line extension, addition of Vimovo, a FDA approved fixed-dose combination of delayed-release enteric-coated naproxen, a non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a stomach acid-reducing proton pump inhibitor (PPI), approved for the relief

7 Subject: Proton Pump Inhibitors Page: 7 of 7 of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. November 2011 December 2012 March 2013 April 2013 September 2013 June 2014 Addition of short bowel syndrome as an approvable diagnosis with 2-year approval. Annual editorial review and reference update Annual editorial review and reference update Removal of Vimovo into separate criteria. Line-extension First-Lansoprazole Line-extension addition of Esomeprazole Strontium Annual editorial review and reference update Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on June 12, 2014 and is effective July 1, Signature on File Deborah M. Smith, MD, MPH

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