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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAdvanced Health Voquezna Coverage | OpenPayer
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    CurrentAdvanced HealthPolicy N/A

    Voquezna (vonoprazan) Coverage Criteria

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    This policy governs prior authorization for Voquezna in adults with endoscopy-confirmed erosive esophagitis or non-erosive GERD with heartburn symptoms. It requires safety screening and, for GERD indications, an inadequate response or intolerance to an 8-week formulary proton pump inhibitor trial.

    Policy Summary
    PayerAdvanced Health
    PolicyVoquezna (vonoprazan) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Last ReviewFeb 4, 2025
    Next Review DateN/A
    Key ActionRequire prior authorization and document an inadequate response or intolerance to at least 8 weeks of a formulary PPI at the maximum tolerated dose for GERD indications before approving Voquezna.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    18+Minimum member age
    8 weeksFormulary PPI trial
    8 weeksInitial erosive esophagitis approval
    4 weeksInitial non-erosive GERD approval

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    6 months
    Renewal approval
    6Contraindicated drugs or categories

    Coverage Criteria

    Initial Therapy Criteria

    Covered for an initial request when all applicable criteria are met.

    Initial therapy criteria

    • Qualifying diagnosis

      • Member has erosive esophagitis confirmed by endoscopy.
      • Member has non-erosive gastroesophageal reflux disease with heartburn symptoms.

    • Age and safety requirements

      • Member is 18 years of age or older.>= 18 years
      • Member does not have severe hepatic impairment (Child-Pugh Class C).
      • Member is not taking pimozide, ergot alkaloids, lomitapide, lovastatin, simvastatin, or colchicine in the presence of renal or hepatic impairment.

    • GERD step therapy

      • For a GERD indication, the patient has experienced an inadequate response or intolerance to at least an 8-week course of a formulary proton pump inhibitor at the maximum tolerated dose.At least 8 weeks

    Renewal Therapy Criteria

    Covered for renewal when all criteria are met.

    Renewal therapy criteria

    • Member has a diagnosis of erosive esophagitis.
    • Patient has demonstrated clinical benefit from Voquezna therapy without significant adverse effects.

    Off-label use of Voquezna is not a covered benefit on OHP. Coverage is limited to the policy’s qualifying indications and criteria.

    Maintenance therapy for indications other than erosive esophagitis is not covered. Voquezna is not FDA-approved for maintenance therapy for those indications, and off-label use is not a covered benefit on OHP.

    Use in a member younger than 18 years, use in severe hepatic impairment defined as Child-Pugh Class C, or use with listed contraindicated medications does not meet coverage criteria. The listed medications are pimozide, ergot alkaloids, lomitapide, lovastatin, simvastatin, or colchicine in patients with renal or hepatic impairment.

    Coverage Parameters

    Age requirement
    Minimum age18 years or older
    Step-therapy requirement
    Formulary PPI trialAt least 8 weeks at the maximum tolerated dose
    Erosive esophagitis
    Initial approvalUp to 8 weeks
    Non-erosive GERD
    Initial approvalUp to 4 weeks

    Provider Actions and Decision Rules

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for both initial and renewal requests. When approved, initial therapy is limited to up to 8 weeks for erosive esophagitis or up to 4 weeks for non-erosive GERD; renewal approval may be granted for up to 6 months.

    • Initial approval: up to 8 weeks for erosive esophagitis.
    • Initial approval: up to 4 weeks for non-erosive GERD.
    • Renewal approval: up to 6 months when renewal criteria are met.
    Step Therapy

    Formulary PPI First-Line Trial

    For GERD indications, the member must have an inadequate response or intolerance to a formulary proton pump inhibitor before Voquezna is approved.

    • Complete at least an 8-week course of a formulary PPI at the maximum tolerated dose.
    • Document inadequate response or intolerance to the formulary PPI.

    Therapeutic Background

    Voquezna contains vonoprazan, a potassium-competitive acid blocker (PCAB). Vonoprazan suppresses basal and stimulated gastric acid secretion by inhibiting the H+, K+-ATPase enzyme system in gastric parietal cells. The policy evaluates coverage for erosive esophagitis and non-erosive gastroesophageal reflux disease; Helicobacter pylori eradication is listed as an FDA-approved indication but is not included in this policy’s authorization criteria.

    Definitions

    Erosive esophagitis (EE)
    Confirmation requirementErosive esophagitis must be confirmed by endoscopy for the initial coverage criteria.
    PCAB
    DefinitionPotassium-competitive acid blocker
    Vonoprazan mechanismSuppresses basal and stimulated gastric acid secretion through potassium-competitive inhibition of the H+, K+-ATPase enzyme system.
    Site of actionThe secretory surface of the gastric parietal cell

    Initial Therapy Criteria

    Initial Request Criteria

    Initial approval requires all applicable diagnosis, age, safety, and prior-treatment criteria.

    Initial request

    • Qualifying diagnosis

      • Member has erosive esophagitis confirmed by endoscopy.
      • Member has non-erosive gastroesophageal reflux disease with heartburn symptoms.

    • Adult age

      • Member is 18 years of age or older.>= 18 years

    • Safety exclusions

    Continuation Criteria

    Erosive Esophagitis Maintenance Criteria

    Renewal is covered when all continuation criteria are met.

    Erosive esophagitis maintenance

    • Member has a diagnosis of erosive esophagitis.
    • Patient has demonstrated clinical benefit from Voquezna therapy without significant adverse effects.

    Step Therapy

    StepRequired therapyRequirementApplies before
    1Formulary proton pump inhibitor (PPI)At least 8 weeks at the maximum tolerated dose, with inadequate response or intoleranceVoquezna for GERD indications

    Quantity and Duration Limits

    Voquezna for erosive esophagitis
    Initial quantity limitUp to 8 weeks per course
    Voquezna for non-erosive GERD
    Initial quantity limitUp to 4 weeks per course
    Voquezna renewal for erosive esophagitis
    Renewal quantity limitUp to 6 months
    Policy Summary
    PayerAdvanced Health
    PolicyVoquezna (vonoprazan) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Last ReviewFeb 4, 2025
    Next Review DateN/A
    Key ActionRequire prior authorization and document an inadequate response or intolerance to at least 8 weeks of a formulary PPI at the maximum tolerated dose for GERD indications before approving Voquezna.
    SourceLink
    On This Page
    Coverage CriteriaCoverage ParametersProvider Actions and Decision RulesTherapeutic BackgroundDefinitionsInitial Therapy CriteriaContinuation CriteriaStep TherapyQuantity and Duration Limits
    Renewal
    Renewal approvalUp to 6 months
    Documentation Required

    Initial Request Documentation

    Document a qualifying diagnosis and the information needed for initial review. Erosive esophagitis must be confirmed by endoscopy; non-erosive GERD requires heartburn symptoms.

    • Erosive esophagitis: endoscopy confirmation.
    • Non-erosive GERD: documentation of heartburn symptoms.
    • For GERD indications: inadequate response or intolerance to at least 8 weeks of a formulary PPI at the maximum tolerated dose.
    Documentation Required

    Renewal Documentation

    Renewal requests require documentation that the member continues to have erosive esophagitis and has benefited clinically from Voquezna without significant adverse effects.

    • Diagnosis of erosive esophagitis.
    • Demonstrated clinical benefit from Voquezna therapy.
    • No significant adverse effects.
    Denial Risk

    Uncovered Diagnosis

    Deny the request when the diagnosis does not meet the covered criteria. Off-label use is not a covered benefit on OHP.

    • Initial coverage is limited to erosive esophagitis confirmed by endoscopy or non-erosive GERD with heartburn symptoms.
    • Renewal coverage is limited to erosive esophagitis; Voquezna is not FDA-approved for maintenance therapy for other indications.
    • Deny when the diagnosis does not meet the applicable coverage criteria.
    Denial Risk

    Pediatric Use

    Deny the request when the member is younger than 18 years. Voquezna is not FDA-approved for pediatric use.

    • Member must be 18 years of age or older.
    Denial Risk

    Severe Hepatic Impairment

    Deny the request when the member has severe hepatic impairment, defined as Child-Pugh Class C, because Voquezna is contraindicated.

    • Severe hepatic impairment: Child-Pugh Class C.
    • Voquezna is contraindicated in this condition.
    Denial Risk

    Contraindicated Concomitant Therapy

    Deny the request when the member is taking a contraindicated interacting medication or combination identified in the criteria.

    • Pimozide.
    • Ergot alkaloids.
    • Lomitapide.
    • Lovastatin.
    • Simvastatin.
    • Colchicine in patients with renal or hepatic impairment.
    Denial Risk

    Required Formulary PPI Trial

    Deny the request when the required formulary PPI step therapy has not been completed or does not demonstrate inadequate response or intolerance.

    • At least 8 weeks of a formulary PPI at the maximum tolerated dose is required for GERD indications.
    • The trial must demonstrate inadequate response or intolerance.
    • A formulary PPI trial is required as first-line therapy.
    Denial Risk

    Renewal Criteria Not Met

    Deny renewal when the member does not have erosive esophagitis or has not demonstrated clinical benefit from Voquezna without significant adverse effects.

    • Renewal diagnosis must be erosive esophagitis.
    • Clinical benefit must be demonstrated.
    • Therapy must be without significant adverse effects.
    • Maintenance therapy for indications other than erosive esophagitis is not covered.
    • Member does not have severe hepatic impairment (Child-Pugh Class C).
    • Member is not taking pimozide, ergot alkaloids, lomitapide, lovastatin, simvastatin, or colchicine in the presence of renal or hepatic impairment.

  1. GERD step therapy

    • For a GERD indication, the patient has experienced an inadequate response or intolerance to at least an 8-week course of a formulary proton pump inhibitor at the maximum tolerated dose.At least 8 weeks

      If met, approval may be granted for up to 8 weeks for erosive esophagitis or up to 4 weeks for non-erosive GERD.