CurrentUnitedHealthcarePolicy 2024 P 3168-2

Step Therapy - Voquezna Paks

UnitedHealthcare step therapy program that governs prior authorization and coverage requirements for Voquezna Dual Pak (vonoprazan + amoxicillin) and Voquezna Triple Pak (vonoprazan + amoxicillin + clarithromycin) for treatment of H. pylori infection.

Policy Summary

PayerUnitedHealthcare

PolicyStep Therapy - Voquezna Paks

Policy CodePolicy 2024 P 3168-2

Change TypeNew step therapy programreferences updated

Effective DateOct 1, 2024

Next Review Date

Key ActionObtain prior authorization and document history of failure, contraindication, or intolerance to clarithromycin-based or bismuth quadruple therapy.

SourceLink

POLICY UPDATE CHANGES

New step therapy program for Voquezna was created.

Annual review updated references.

2products covered

1 monthauthorization duration

Step therapy requiredprior treatment

11/2022, 7/2024P&T approvals

Coverage Criteria for Voquezna

Policy Summary

PayerUnitedHealthcare

PolicyStep Therapy - Voquezna Paks

Policy CodePolicy 2024 P 3168-2

Change TypeNew step therapy programreferences updated

Effective DateOct 1, 2024

Next Review Date

Key ActionObtain prior authorization and document history of failure, contraindication, or intolerance to clarithromycin-based or bismuth quadruple therapy.

SourceLink

On This Page

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Initial Authorization

Covered when ONE of the following is met:

Clarithromycin-based therapy failure/CI/intolerance: History of failure, contraindication, or intolerance to clarithromycin-based therapies, defined as either clarithromycin-based triple therapy (clarithromycin + (amoxicillin or metronidazole) + a proton pump inhibitor) OR clarithromycin-based concomitant therapy (clarithromycin + amoxicillin + (tinidazole or metronidazole) + a proton pump inhibitor)

Supports approval of Voquezna Dual Pak or Voquezna Triple Pak

Bismuth quadruple therapy failure/CI/intolerance: History of failure, contraindication, or intolerance to bismuth quadruple therapy (bismuth + metronidazole + tetracycline + a proton pump inhibitor)

Supports approval of Voquezna Dual Pak or Voquezna Triple Pak

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Voquezna Dual Pak and Voquezna Triple Pak. Requests will be approved when the member has documentation of history of failure, contraindication, or intolerance to required prior regimens (see step therapy required prior regimens). Authorization will be issued for 1 month. State mandates, federal requirements, and the member's benefit plan may affect coverage; other policies and utilization management programs may also apply.

Authorization duration: 1 month
Approval may be based on previous claim/medication history, ICD-10 diagnosis codes, and/or claim logic

Step Therapy

Step Therapy Prerequisites

Coverage requires that the member has tried and failed (or has a documented contraindication or intolerance to) one of the following prior regimens before Voquezna will be approved: either a clarithromycin-based therapy OR bismuth quadruple therapy.

Step required: one prior regimen (clarithromycin-based OR bismuth quadruple) must be documented
Acceptable evidence: treatment failure, contraindication, or intolerance

Step Therapy

Step Therapy — Required Prior Regimens

Member must have history of failure, contraindication, or intolerance to either: (1) a clarithromycin-based therapy — clarithromycin-based triple therapy (clarithromycin + either amoxicillin or metronidazole + proton pump inhibitor) or clarithromycin-based concomitant therapy (clarithromycin + amoxicillin + tinidazole or metronidazole + proton pump inhibitor); OR (2) bismuth quadruple therapy (bismuth + metronidazole + tetracycline + proton pump inhibitor).

Clarithromycin-based triple therapy: clarithromycin + (amoxicillin or metronidazole) + PPI
Clarithromycin-based concomitant therapy: clarithromycin + amoxicillin + (tinidazole or metronidazole) + PPI
Bismuth quadruple therapy: bismuth + metronidazole + tetracycline + PPI

Documentation Required

Supporting Documentation

Providers should supply supporting documentation with the prior authorization request to demonstrate trial and failure, contraindication, or intolerance to the required prior regimens. UnitedHealthcare may also approve based solely on prior claim/medication history, ICD-10 diagnosis codes, and/or claim logic when available.

Provide prior medication/claim history documenting the prior regimen and outcome
Include relevant diagnosis codes (ICD-10) indicating H. pylori infection
Attach clinical documentation describing treatment failure, specific adverse reaction, or contraindication to the prior regimen

Initial Therapy Requirements

Initial approval requires ONE of the following prior regimen conditions:

Prior clarithromycin-based regimen failure/CI/intolerance: Failure, contraindication, or intolerance to clarithromycin-based triple or concomitant therapy (see definitions for regimen components)

Document prior trial/failure, contraindication, or intolerance to qualify for Voquezna

Prior bismuth quadruple regimen failure/CI/intolerance: Failure, contraindication, or intolerance to bismuth quadruple therapy (bismuth + metronidazole + tetracycline + a proton pump inhibitor)

Document prior trial/failure, contraindication, or intolerance to qualify for Voquezna

Step Therapy Details

Step	Required prior regimen (trial and failure, or contraindication/intolerance)	Notes
1	Clarithromycin-based therapy: either clarithromycin-based triple therapy (clarithromycin + (amoxicillin or metronidazole) + proton pump inhibitor) OR clarithromycin-based concomitant therapy (clarithromycin + amoxicillin + (tinidazole or metronidazole) + proton pump inhibitor)	History of failure, contraindication, or intolerance to one of the clarithromycin-based regimens supports approval of Voquezna Dual Pak or Triple Pak.
2	Bismuth quadruple therapy: bismuth + metronidazole + tetracycline + proton pump inhibitor	History of failure, contraindication, or intolerance to bismuth quadruple therapy supports approval of Voquezna Dual Pak or Triple Pak.

OpenPayer

Step Therapy - Voquezna Paks

Coverage Criteria for Voquezna

Provider Requirements and Prior Authorization

Initial Therapy Requirements

Step Therapy Details

Defined Prior Regimens

Quantity and Supply Limits

Site-of-Care Requirements

Background