OMECLAMOX-PAK (omeprazole, clarithromycin, and amoxicillin) PREVPAC (lansoprazole, clarithromycin, and amoxicillin) PYLERA (bismuth subcitrate, metronidazole, tetracycline) TALICIA (omeprazole, amoxicillin, and rifabutin) RATIONALE FOR INCLUSION IN PA PROGRAM Background Prevpac and Omeclamox-Pak are a copackaged product containing a proton pump inhibitor, a macrolide antimicrobial, and a penicillin class antibacterial that, when taken together, is indicated for the eradication of Heliobacter pylori infection in patients with duodenal ulcer disease that is active or up to a one year history. Pylera is a copackaged product containing two antimicrobials; metronidazole, tetracycline and bismuth subcitrate potassium. Pylera is also used to eradicate Helicobacter pylori (H. pylori) in patients with H. pylori infection and duodenal ulcer disease; Pylera is FDA-approved for use only in combination with omeprazole. Talicia is a three-drug combination of a proton pump inhibitor, a penicillin-class antibacterial, and a rifamycin antibacterial. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence (1-4). It is important to treat H. pylori infection because it has been identified as a risk factor in the development of peptic ulcer, duodenal ulcer, atrophic gastritis, gastric cancer, and mucosal- associated lymphoid tissue (MALT) lymphoma, as well as, a possible risk factor for the development idiopathic thrombocytopenic purpura and anemia (1-4). Regulatory Status The components in Prevpac, Pylera and Omeclamox-Pak are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori (1-3). The components in Talicia are indicated for the treatment of H. pylori infection in adults (4). Summary Prevpac, Pylera and Omeclamox-Pak are indicated for the treatment of patients with Heliobacter pylori infection and duodenal ulcer disease (active one-year history) to eradicate H. pylori. Talicia is indicated for the treatment of H. pylori. They should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Prevpac and Omeclamox-Pak should only be used in patients with no clarithromycin resistance. Patients taking Pylera will need to be co- Prevpac Pylera Omeclamox Talicia FEP Clinical Rationale OMECLAMOX-PAK (omeprazole, clarithromycin, and amoxicillin) PREVPAC (lansoprazole, clarithromycin, and amoxicillin) PYLERA (bismuth subcitrate, metronidazole, tetracycline) TALICIA (omeprazole, amoxicillin, and rifabutin) administered with omeprazole (1-4). Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Prevpac, Pylera, Omeclamox-Pak, and Talicia while maintaining optimal therapeutic outcomes. References 1. Omeclamox-Pak [package insert]. Nashville, TN: Cumberland Pharmaceuticals Inc; October 2016. 2. PrevPac [package insert]. Deerfield, IL: Takeda Pharmaceuticals America Inc.; October 2016. 3. Pylera [package insert]. Irvine, CA: Allergan USA, Inc.; May 2017. 4. Talicia [package insert]. Raleigh, NC: Redhill Biopharma Inc.; November 2019. Prevpac Pylera Omeclamox Talicia FEP Clinical Rationale .