CurrentUnitedHealthcarePolicy N/A

Voquezna (vonoprazan) prior authorization

Defines UnitedHealthcare prior authorization and medical necessity criteria for Voquezna (vonoprazan) for adults, including indications for erosive esophagitis, non-erosive GERD, and H. pylori combination therapy; affects providers prescribing and pharmacists processing PA for members under applicable benefit plans.

Policy Summary

PayerUnitedHealthcare

PolicyVoquezna (vonoprazan) prior authorization

Policy CodePolicy N/A

Change TypeAdded indicationstep therapy updated

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document prior trial, failure, contraindication, or intolerance to one of: omeprazole, pantoprazole, or rabeprazole.

SourceLink

POLICY UPDATE CHANGES

Added coverage for GERD based on updated labeling.

Updated step one options to include omeprazole and pantoprazole.

New prior authorization/medical necessity program created for Voquezna.

9 monthsauth duration (EE/GERD)

1 monthauth duration (H. pylori)

3required PPI trial options

4/1/2025effective date

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Coverage Criteria for Voquezna (vonoprazan)

Erosive Esophagitis / Non-erosive GERD (Initial)

Covered when ALL of the following are met:

Indication: Patient has one of: (a) treatment or maintenance of erosive esophagitis; (b) treatment of non-erosive gastroesophageal reflux disease (GERD)

based on FDA labeling

Prior PPI failure/contraindication/intolerance: History of failure, contraindication, or intolerance to one of: omeprazole, pantoprazole, or rabeprazole

required for approval

Authorization duration/limits: Authorization will be issued for 9 months

H. pylori Combination Therapy (Initial)

Covered when ALL of the following are met:

Indication: Voquezna used in combination with amoxicillin or amoxicillin and clarithromycin for treatment of Helicobacter pylori infection

per labeling

Prior PPI failure/contraindication/intolerance: History of failure, contraindication, or intolerance to one of: omeprazole, pantoprazole, or rabeprazole

required for approval

Authorization duration/limits: Authorization will be issued for 1 month

Coverage may be modified by applicable state mandates, federal regulatory requirements, or the member's specific benefit plan. Other UnitedHealthcare policies and utilization management programs may also affect whether Voquezna is covered for a given member; providers should verify eligibility and benefit specifics prior to prescribing.

Use of Voquezna without documentation of prior failure, contraindication, or intolerance to one of the listed proton pump inhibitors (omeprazole, pantoprazole, or rabeprazole) does not meet the authorization criteria and will not be approved under this program. Prior medication history demonstrating one of these outcomes must be submitted with the request.

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required. Approval is granted only when both the indication-specific criteria (treatment or maintenance of erosive esophagitis or treatment of non-erosive GERD) and a documented history of failure, contraindication, or intolerance to one of the listed PPIs are met.

Step Therapy

Step therapy (PPI trial)

A trial with and inadequate response or intolerance to at least one proton pump inhibitor — omeprazole, pantoprazole, or rabeprazole — is required before Voquezna will be approved.

Documentation Required

Required documentation

Definitions and Drug Indication

Voquezna (vonoprazan) indication

Drug classPotassium-competitive acid blocker (vonoprazan)

Approved adult indicationsHealing and maintenance of all grades of erosive esophagitis; relief of heartburn associated with erosive and non-erosive gastroesophageal reflux disease (GERD)

H. pylori useApproved as part of combination therapy with amoxicillin or amoxicillin plus clarithromycin for eradication of Helicobacter pylori in adults

Authorization notePrior authorization required; approval contingent on meeting indication-specific criteria and documented prior PPI failure/contraindication/intolerance (omeprazole, pantoprazole, or rabeprazole)

Typical authorization durationsErosive esophagitis/GERD: 9 months; H. pylori combination therapy: 1 month

Background

Voquezna (vonoprazan) is a potassium-competitive acid blocker indicated for healing and maintenance of erosive esophagitis and for relief of heartburn related to erosive and non-erosive gastroesophageal reflux disease in adults. It is also approved for use as part of combination therapy with amoxicillin, with or without clarithromycin, for eradication of Helicobacter pylori in adults. Its mechanism differs from proton pump inhibitors and is reflected in the labeling-based indications referenced in this policy.

Revision History and Policy Changes

2025-04-01effective_dateLatest

Program effective date established for the Voquezna prior authorization/medical necessity program.

2025-01label_expansion

Added coverage for non-erosive GERD (label expansion) and reflected this indication in authorization criteria.

2024-06step_therapy_update