Prevpac Pylera Omeclamox-Pak

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: -Pak Page: 1 of 5 Last Review Date: September 20, Pak Description (lansoprazole, clarithromycin, and amoxicillin) (bismuth subcitrate, metronidazole, tetracycline) -Pak (omeprazole, clarithromycin, and amoxicillin) Background and -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. is a copackaged product containing two antimicrobials; metronidazole, tetracycline and bismuth subcitrate potassium. is also used to eradicate Helicobacter pylori (H. pylori) in patients with H. pylori infection and duodenal ulcer disease; is FDA-approved for use only in combination with omeprazole. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence (1-3). 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 mucosalassociated lymphoid tissue (MALT) lymphoma, as well as, a possible risk factor for the development idiopathic thrombocytopenic purpura and anemia (1-3). Regulatory Status

2 Subject: -Pak Page: 2 of 5 The components in, and -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). 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., and -Pak may be considered medically necessary in patients 18 years of age and older with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) and if the conditions below are met., and -Pak are considered investigational for patients less than 18 years of age and for all other indications. Prior-Approval Requirements Age 18 years of age or older Diagnoses Patient must have ALL of the following: 1. H. Pylori Infection 2. Duodenal ulcer disease (active or up to one-year history) AND ALL of the following: a. NOT clarithromycin resistant when using and -Pak b. Will be co-administered with omeprazole when using c. NO previous use of the requested therapy regimen in the last 365 days Prior Approval Renewal Requirements Same as above

3 Subject: -Pak Page: 3 of 5 Policy Guidelines Pre - PA Allowance 12 months per 365 days Prior Approval Limits per 14 days **Must be a different therapy regimen than Pre-PA** 2 weeks Prior Approval Renewal Limits per 14 days **Must be a different therapy regimen than Pre-PA and previous PA** 2 weeks Rationale

4 Subject: -Pak Page: 4 of 5 Summary, and -Pak are indicated for the treatment of patients with Heliobacter pylori infection and duodenal ulcer disease (active one-year history) to eradicate H. pylori. They should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. and -Pak should only be used in patients with no clarithromycin resistance. Patients taking will need to be coadministered with omeprazole (1-3). Prior approval is required to ensure the safe, clinically appropriate and cost effective use of, and -Pak while maintaining optimal therapeutic outcomes. References 1. -Pak [package insert]. Nashville, TN: Cumberland Pharmaceuticals Inc; October PrevPac [package insert]. Deerfield, IL: Takeda Pharmaceuticals America Inc.; October [package insert]. Irvine, CA: Allergan USA, Inc.; May Policy History Date January 2013 June 2014 September 2015 March 2016 September 2016 March 2017 March 2018 July 2018 Action Addition of Annual editorial review Annual review and addition of Annual editorial review, Subsection changed from anti-infective agents to gastrointestinal agents, Policy code changed from to ,. Update in Pre-PA, Prior Approval, and Prior Approval Renewal Limits Addition of no previous use of the requested therapy regimen in the last 365 days to criteria.

5 Subject: -Pak Page: 5 of 5 September 2018 Keywords Annual review This policy was approved by the FEP Pharmacy and Medical Policy Committee on September 20, 2018 and is effective on October 1, 2018.

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