CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step Therapy for Voquezna Dual Pak and Triple Pak (vonoprazan-based H. pylori regimens)

Defines step therapy requirements for coverage of Voquezna Dual Pak and Triple Pak (vonoprazan with amoxicillin ± clarithromycin) for treatment of H. pylori infection; affects pharmacy prior authorization decisions for members under the payer's pharmacy clinical programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep Therapy for Voquezna Dual and Triple Pak

Policy CodePolicy N/A

Change TypeNew step therapy program

Effective DateOct 1, 2024

Next Review DateJul 1, 2024

Key ActionPrior authorization requires documented trial and failure, contraindication, or intolerance to clarithromycin-based therapy OR bismuth quadruple therapy; approvals are issued for 1 month.

SourceLink

POLICY UPDATE CHANGES

New Step Therapy program established for Voquezna (Dual and Triple Pak) requiring trial of clarithromycin-based therapy or bismuth quadruple therapy prior to coverage.

References updated and annual review noted in change control.

2Product variants covered

1 moAuth duration (when approved)

2Required prior regimen options

10/01/2024

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Coverage Criteria

Initial Therapy

Covered when ONE of the following is met:

Prior regimen failure/contraindication/intolerance: Member has history of failure, contraindication, or intolerance to a clarithromycin-based therapy (either clarithromycin-based triple therapy or clarithromycin-based concomitant therapy).

clarithromycin-based therapies defined in document

Bismuth quadruple failure/contraindication/intolerance: Member has history of failure, contraindication, or intolerance to bismuth quadruple therapy (bismuth + metronidazole + tetracycline + proton pump inhibitor).

Alternative to clarithromycin-based requirement

Coverage may be impacted by state mandates, federal regulatory requirements, the member's specific benefit plan coverage, and other policies or utilization management programs. These external requirements may alter applicability of the criteria in this policy or require alternative authorization pathways.

Provider Actions 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 a documented history of failure, contraindication, or intolerance to specified lower-cost alternatives.

Affected products: Voquezna Dual Pak (vonoprazan + amoxicillin), Voquezna Triple Pak (vonoprazan + amoxicillin + clarithromycin)

Step Therapy

Step Therapy Requirement

Member must trial a lower-cost alternative before Voquezna is approved: either a clarithromycin-based regimen (triple or concomitant) OR bismuth quadruple therapy.

Clarithromycin-based triple therapy: clarithromycin + (amoxicillin or metronidazole) + a proton pump inhibitor
Clarithromycin-based concomitant therapy: clarithromycin + amoxicillin + (tinidazole or metronidazole) + a proton pump inhibitor
Bismuth quadruple therapy: bismuth + metronidazole + tetracycline + a proton pump inhibitor

Initial Therapy Criteria

Initial Therapy — Initial authorization criteria

Initial authorization criteria

Failure/intolerance/contraindication to clarithromycin-based therapy: Documented history of failure, contraindication, or intolerance to clarithromycin-based triple therapy (clarithromycin + either amoxicillin or metronidazole + PPI) OR clarithromycin-based concomitant therapy (clarithromycin + amoxicillin + tinidazole or metronidazole + PPI).

See definitions for regimen components

Failure/intolerance/contraindication to bismuth quadruple therapy: Documented history of failure, contraindication, or intolerance to bismuth quadruple therapy (bismuth + metronidazole + tetracycline + PPI).

Alternative pathway

Re-Authorization / Continuation Criteria

Re-authorization

Re-authorization rules

Re-authorization may be automated: UnitedHealthcare may approve initial and re-authorization based on previous claim/medication history, diagnosis codes, and/or claim logic; supply limits may apply.

Automated processes vary by program

Definitions

Clarify: Clarithromycin-based triple therapy

DefinitionClarithromycin-based triple therapy = clarithromycin + either amoxicillin or metronidazole + a proton pump inhibitor

ContextListed as a required prior regimen option that must be failed, contraindicated, or not tolerated before Voquezna coverage is granted

Source noteExact phrase from policy: 'clarithromycin-based triple therapy (i.e. clarithromycin, either amoxicillin or metronidazole, and a proton pump inhibitor)'

Clarify: Clarithromycin-based concomitant therapy

DefinitionClarithromycin-based concomitant therapy = clarithromycin + amoxicillin + either tinidazole or metronidazole + a proton pump inhibitor

ContextListed as an alternative clarithromycin-based prior regimen (trial required prior to Voquezna)

Step Therapy Requirements

Step	Required prior regimen (trial of ONE of the following)	Documentation required	Coverage status
{"text":"1","status":""},{"text":"Clarithromycin-based regimen: either clarithromycin-based triple therapy (clarithromycin + either amoxicillin or metronidazole + PPI) OR clarithromycin-based concomitant therapy (clarithromycin + amoxicillin + tinidazole or metronidazole + PPI)","status":""},{"text":"Provider must document history of failure, contraindication, or intolerance to the specified clarithromycin-based therapy","status":""},{"text":"Covered with criteria","status":"covered_with_criteria"}
{"text":"2","status":""},{"text":"Bismuth quadruple therapy: bismuth + metronidazole + tetracycline + PPI","status":""},{"text":"Provider must document history of failure, contraindication, or intolerance to bismuth quadruple therapy","status":""},{"text":"Covered with criteria","status":"covered_with_criteria"}

Quantity Limits

Voquezna Dual Pak / Triple Pak — Quantity and supply limits

Quantity limit noteSupply limits may be in place for Voquezna Dual Pak and Triple Pak

Authorization durationWhen approved, authorization will be issued for 1 month (per policy)

Automated re-authorizationUnitedHealthcare may approve initial and re-authorization based on previous claim/medication history, diagnosis codes, and/or claim logic; supply limits may apply

Background

Voquezna Dual Pak (vonoprazan + amoxicillin) and Voquezna Triple Pak (vonoprazan + amoxicillin + clarithromycin) are co-packaged treatments indicated for Helicobacter pylori infection. This policy establishes a step therapy approach that encourages use of lower-cost, guideline-supported alternatives by requiring documented failure, contraindication, or intolerance to a clarithromycin-based regimen (triple or concomitant) or to bismuth quadruple therapy before coverage of Voquezna is approved.

When prior authorization is approved under the policy, authorization will be issued for 1 month; note that state mandates, federal requirements, the member's benefit plan, and other policies or utilization management programs may still affect coverage.