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5.50.21

Section: Prescription Drugs Effective Date: July 1, 2020 Subsection: Gastrointestinal Agents Original Policy Date: September 8, 2011 Subject: Prevpac Pylera Omeclamox-Pak Page: 1 of 6 Talicia

Last Review Date: June 18, 2020

Prevpac Pylera Omeclamox-Pak Talicia

Description Omeclamox-Pak (omeprazole, clarithromycin, and amoxicillin) Prevpac (lansoprazole, clarithromycin, and amoxicillin) Pylera (bismuth subcitrate, metronidazole, tetracycline) Talicia (omeprazole, amoxicillin, and rifabutin)

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).

5.50.21

Section: Prescription Drugs Effective Date: July 1, 2020 Subsection: Gastrointestinal Agents Original Policy Date: September 8, 2011 Subject: Prevpac Pylera Omeclamox-Pak Page: 2 of 6 Talicia

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).

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.

Prevpac, Pylera and Omeclamox-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 indicated below are met.

Talicia may be considered medically necessary in patients 18 years of age and older with H. pylori infection and if the conditions indicated below are met.

Prevpac, Pylera, Omeclamox-Pak, and Talicia are considered investigational for patients less than 18 years of age and for all other indications.

Prior-Approval Requirements

Omeclamox-Pak, Prevpac, Pylera only

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)

5.50.21

Section: Prescription Drugs Effective Date: July 1, 2020 Subsection: Gastrointestinal Agents Original Policy Date: September 8, 2011 Subject: Prevpac Pylera Omeclamox-Pak Page: 3 of 6 Talicia

AND ALL of the following: a. Prevpac and Omeclamox-Pak only: NOT clarithromycin-resistant b. Pylera only: will be co-administered with omeprazole c. NO previous use of the requested therapy regimen in the last 365 days

Talicia only

Age 18 years of age or older

Diagnosis

Patient must have the following:

1. H. Pylori Infection

AND ALL of the following: a. Suspected to be clarithromycin-resistant b. NO concurrent use with certain HIV medications, such as rilpivirine and delavirdine c. NO previous use of the requested therapy regimen in the last 365 days

Prior – Approval Renewal Requirements Same as above

Policy Guidelines Pre - PA Allowance

Quantity Drug Quantity per 365 days Pylera 120 capsules OR Prevpac 112 capsules OR Omeclamox 80 capsules OR Talicia 168 capsules *Regimens needing more than the quantities listed above are not covered*

5.50.21

Section: Prescription Drugs Effective Date: July 1, 2020 Subsection: Gastrointestinal Agents Original Policy Date: September 8, 2011 Subject: Prevpac Pylera Omeclamox-Pak Page: 4 of 6 Talicia

Duration 12 months

Prior – Approval Limits

Quantity Drug Quantity per 14 days Pylera 120 capsules OR Prevpac 112 capsules OR Omeclamox 80 capsules OR Talicia 168 capsules *Regimens needing more than the quantities listed above are not covered* **Must be a different therapy regimen than Pre-PA**

Duration 2 weeks

Prior – Approval Renewal Limits

Quantity Drug Quantity per 14 days Pylera 120 capsules OR Prevpac 112 capsules OR Omeclamox 80 capsules OR Talicia 168 capsules *Regimens needing more than the quantities listed above are not covered* **Must be a different therapy regimen than Pre-PA and previous PA**

Duration 2 weeks

Rationale

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

5.50.21

Section: Prescription Drugs Effective Date: July 1, 2020 Subsection: Gastrointestinal Agents Original Policy Date: September 8, 2011 Subject: Prevpac Pylera Omeclamox-Pak Page: 5 of 6 Talicia

Omeclamox-Pak should only be used in patients with no clarithromycin resistance. Patients taking Pylera will need to be co-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.

Policy History

Date Action January 2013 Addition of Omeclamox Annual editorial review June 2014 Annual review and addition of Pylera September 2015 Annual editorial review and reference update March 2016 Annual editorial review, Subsection changed from anti-infective agents to gastrointestinal agents, Policy code changed from 5.03.21 to 5.50.21, September 2016 Annual editorial review and reference update. March 2017 Annual editorial review and reference update March 2018 Annual editorial review and reference update July 2018 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 September 2018 Annual review March 2019 Annual review November 2019 Addition of Talicia and renamed policy Prevpac Pylera Omeclamox Talicia March 2020 Annual review. Added Talicia requirements that infection is suspected to be clarithromycin-resistant and no concurrent use with certain HIV medications, such as rilpivirine and delavirdine per SME

5.50.21

Section: Prescription Drugs Effective Date: July 1, 2020 Subsection: Gastrointestinal Agents Original Policy Date: September 8, 2011 Subject: Prevpac Pylera Omeclamox-Pak Page: 6 of 6 Talicia

June 2020 Annual review Keywords

This policy was approved by the FEP® Pharmacy and Medical Policy Committee on June 18, 2020 and is effective on July 1, 2020.