WHA

Vonoprazan Containing Agents - PA, NF

Indications for Prior Authorization

Voquezna Dual Pak (vonoprazan, amoxicillin)
  • For diagnosis of Helicobacter pylori (H. pylori)
    Indicated for the treatment of Helicobacter pylori (H. pylori) in adults.

Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin)
  • For diagnosis of Helicobacter pylori (H. pylori)
    Indicated for the treatment of Helicobacter pylori (H. pylori) in adults.

Voquezna (vonoprazan)
  • For diagnosis of Healing and Relief of Heartburn associated with Erosive Esophagitis
    Indicated for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults.

  • For diagnosis of Maintenance of Healing and Relief of Heartburn associated with Erosive Esophagitis
    Indicated to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults.

  • For diagnosis of Helicobacter pylori (H. pylori)
    Indicated in combination with amoxicillin and clarithromycin or in combination with amoxicillin for the treatment of H. pylori infection in adults.

  • For diagnosis of Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease (NERD)
    Indicated for the relief of heartburn associated with non-erosive gastroesophageal reflux disease in adults.

Criteria

Voquezna Dual Pak, Voquezna Triple Pak

Prior Authorization

Length of Approval: 1 month [A]
For diagnosis of Helicobacter pylori (H. pylori) Infection

  • Diagnosis of Helicobacter pylori infection
    • AND
  • Trial and failure, contraindication, or intolerance to bismuth quadruple therapy (e.g., bismuth and metronidazole and tetracycline and proton pump inhibitor [PPI] ) [15]
Voquezna 20mg tablet

Prior Authorization

Length of Approval: 1 month [A]
For diagnosis of Helicobacter pylori (H. pylori) Infection

  • Diagnosis of Helicobacter pylori infection
    • AND
  • One of the following:
    • Used in combination with amoxicillin and clarithromycin for the treatment of H. pylori infection
    • Used in combination with amoxicillin for the treatment of H. pylori infection
    AND
  • Trial and failure, contraindication, or intolerance to bismuth quadruple therapy (e.g., bismuth and metronidazole and tetracycline and proton pump inhibitor [PPI] ) [15]
Voquezna 20mg tablet

Prior Authorization

Length of Approval: 2 Month(s)
For diagnosis of Healing and Relief of Heartburn associated with Erosive Esophagitis

  • Diagnosis of erosive esophagitis
    • AND
  • Used for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis [E, 2, 6]
    • AND
  • Trial (of a minimum 8-week supply) and inadequate response (within the last 365 days), contraindication, or intolerance to TWO of the following generic proton pump inhibitors (PPI’s) [F, 9]
    • omeprazole
    • esomeprazole
    • pantoprazole
    • lansoprazole
    • rabeprazole
    • dexlansoprazole
Voquezna 10mg tablet

Prior Authorization

Length of Approval: 6 Month(s)
For diagnosis of Maintenance of Healing and Relief of Heartburn associated with Erosive Esophagitis

  • Used to maintain healing and relief of heartburn associated with erosive esophagitis
    • AND
  • Trial (of a minimum 8-week supply) and inadequate response (within the last 365 days), contraindication, or intolerance to TWO of the following generic proton pump inhibitors (PPI’s) [F, 9]
    • omeprazole
    • esomeprazole
    • pantoprazole
    • lansoprazole
    • rabeprazole
    • dexlansoprazole
Voquezna 10mg tablet

Prior Authorization

Length of Approval: 1 Month [G, 2]
For diagnosis of Relief of Heartburn associated with Non-Erosive Gastroesophageal Reflux Disease

  • Diagnosis of non-erosive Gastroesophageal Reflux Disease
    • AND
  • Both of the following: [M, 2, 14]
    • Patient has history of heartburn for at least 6 months
    • Heartburn symptoms are present for at least 4 days during any consecutive 7-day period
    AND
  • Trial (of a minimum 8-week supply) and inadequate response (within the last 365 days), contraindication, or intolerance to TWO of the following generic proton pump inhibitors (PPI’s) [H-L,15-18]
    • omeprazole
    • esomeprazole
    • pantoprazole
    • lansoprazole
    • rabeprazole
    • dexlansoprazole
Voquezna 20mg tablet

Non Formulary

Length of Approval: 1 month [A]
For diagnosis of Helicobacter pylori (H. pylori) Infection

  • Diagnosis of Helicobacter pylori infection
    • AND
  • One of the following:
    • Used in combination with amoxicillin and clarithromycin for the treatment of H. pylori infection
    • Used in combination with amoxicillin for the treatment of H. pylori infection
    AND
  • Submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to ALL of the following:
    • bismuth quadruple therapy (e.g., bismuth and metronidazole and tetracycline and proton pump inhibitor [PPI] )
    • rifabutin triple - based therapy (e.g., Talicia)
    • Voquezna Dual Pak OR Voquezna Triple Pak
Voquezna 20mg tablet

Non Formulary

Length of Approval: 2 Month(s)
For diagnosis of Healing and Relief of Heartburn associated with Erosive Esophagitis

  • Diagnosis of erosive esophagitis
    • AND
  • Used for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis [E, 2, 6]
    • AND
  • Submission of medical records (e.g., chart notes) confirming one of the following:
    • Trial (of a minimum 8-week supply) and inadequate response (within the last 365 days), to TWO of the following generic proton pump inhibitors (PPI’s)
      • omeprazole
      • esomeprazole
      • pantoprazole
      • lansoprazole
      • rabeprazole
      • dexlansoprazole
      OR
    • Contraindication, or intolerance to ALL of the following generic proton pump inhibitors (PPI’s)
      • omeprazole
      • esomeprazole
      • pantoprazole
      • lansoprazole
      • rabeprazole
      • dexlansoprazole
Voquezna 10mg tablet

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Maintenance of Healing and Relief of Heartburn associated with Erosive Esophagitis

  • Used to maintain healing and relief of heartburn associated with erosive esophagitis
    • AND
  • Submission of medical records (e.g., chart notes) confirming one of the following:
    • Trial (of a minimum 8-week supply) and inadequate response (within the last 365 days), to TWO of the following generic proton pump inhibitors (PPI’s)
      • omeprazole
      • esomeprazole
      • pantoprazole
      • lansoprazole
      • rabeprazole
      • dexlansoprazole
      OR
    • Contraindication, or intolerance to ALL of the following generic proton pump inhibitors (PPI’s)
      • omeprazole
      • esomeprazole
      • pantoprazole
      • lansoprazole
      • rabeprazole
      • dexlansoprazole
Voquezna 10mg tablet

Non Formulary

Length of Approval: 1 Month [G, 2]
For diagnosis of Relief of Heartburn associated with Non-Erosive Gastroesophageal Reflux Disease

  • Diagnosis of non-erosive Gastroesophageal Reflux Disease
    • AND
  • Both of the following: [M, 2, 14]
    • Patient has history of heartburn for at least 6 months
    • Heartburn symptoms are present for at least 4 days during any consecutive 7-day period
    AND
  • Submission of medical records (e.g., chart notes) confirming one of the following:
    • Trial (of a minimum 8-week supply) and inadequate response (within the last 365 days), to TWO of the following generic proton pump inhibitors (PPI’s)
      • omeprazole
      • esomeprazole
      • pantoprazole
      • lansoprazole
      • rabeprazole
      • dexlansoprazole
      OR
    • Contraindication, or intolerance to ALL of the following generic proton pump inhibitors (PPI’s)
      • omeprazole
      • esomeprazole
      • pantoprazole
      • lansoprazole
      • rabeprazole
      • dexlansoprazole

  • Guideline ID
    GL-241196

  • Formulary
    premium

  • Effective date
    Apr 12, 2025

  • P&T approval date

P & T Revisions

1970-01-01, 2025-01-06, 2024-08-16, 2024-06-13, 2024-03-25, 2024-01-17, 2023-07-05, 2022-06-21

  1. Voquezna prescribing information. Phathom Pharmaceuticals, Inc. Buffalo Grove, IL. July 2024.
  2. Clinical Trials.gov. Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants with Erosive Esophagitis. Available at: https://www.clinicaltrials.gov/study/NCT04124926?cond=NCT04124926&rank=1#study-plan. Accessed December 1, 2023.
  3. Clinical Study Protocol Erosive Esophagitis. Available at: https://storage.googleapis.com/ctgov2-large-docs/26/NCT04124926/Prot_000.pdf. Accessed December 1, 2023.
  4. UptoDate. Medical management of gastroesophageal reflux disease in adults. Available at: https://www.uptodate.com/contents/medical-management-of-gastroesophageal-reflux-disease-in-adults?search=erosive%20esophagitis&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1. Accessed December 1, 2023.
  5. UptoDate. Clinical manifestations and diagnosis of gastroesophageal reflux in adults. Available at: https://www.uptodate.com/contents/clinical-manifestations-and-diagnosis-of-gastroesophageal-reflux-in-adults?sectionName=Endoscopic%20findings&search=erosive%20esophagitis&topicRef=2258&anchor=H82189930&source=see_link#H82189930. Accessed December 1, 2023.
  6. Katz, P., Dunbar, K., Schnoll-Sussman, F., et al. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Available at: https://journals.lww.com/ajg/Fulltext/2022/01000/ACG_Clinical_Guideline_for_the_Diagnosis_and.14.aspx. Accessed December 1, 2023.
  7. Antunes, C., Sharma, A. Esophagitis. Available at: Esophagitis - StatPearls - NCBI Bookshelf (nih.gov). Accessed December 5, 2023.
  8. Scott, M., Gelhot, A. Gastroesophageal Reflux Disease: Diagnosis and Management. Available at: https://www.aafp.org/pubs/afp/issues/1999/0301/p1161.html. Accessed December 5, 2023.
  9. Clinical Trials.gov. Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection, Available at: Study Details | Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection | ClinicalTrials.gov. Accessed December 5, 2023.
  10. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Clinical Trials.gov. Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD). Available at: https://www.clinicaltrials.gov/study/NCT05195528?cond=NCT05195528&rank=1#participation-criteria. Accessed August 5, 2024.
  11. Park, C., Seo, S., Kim, J., et al. Treatment of non-erosive reflux disease and dynamics of the esophageal microbiome: a prospective multicenter study. Available at: https://www.nature.com/articles/s41598-020-72082-8. Accessed August 5, 2024.
  12. Patel, D., Fass, R., Vaezi, M. Untangling Nonerosive Reflux Disease From Functional Heartburn. Available at: https://www.cghjournal.org/article/S1542-3565(20)30434-1/fulltext. Accessed August 5, 2024.
  13. Gillson, S. Treatments for Nonerosive Reflux Disease (NERD). Available at: https://www.verywellhealth.com/nonerosive-reflux-disease-nerd-1742334. Accessed August 5, 2024.
  14. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8754510/. Accessed August 5, 2024.
  15. Chey WD, Howden CW, Moss SF, et al. ACG Clinical Guideline: Treatment of Helicobacter pylori infection. Am J Gastroenterol. September 2024; 119(9):1730-1753.
  16. UptoDate. Treatment regimens for Helicobacter pylori in adults. November 18, 2024. Available at https://www.uptodate.com/contents/treatment-regimens-for-helicobacter-pylori-in-adults?search=treatment%20regmens%20for%20helicobacter%20pylori%20in%20adults&source=search_result&selectedTitle=1%7E150&usage_type=default&display_rank=1. Accessed December 17, 2024.
  1. H. pylori is an infectious disease that is typically treated with combinations of 2–3 antibiotics along with a PPI, taken concomitantly or sequentially. Current guidelines recommend extended (10 to 14 days) treatment with all antibiotic regimens for H. pylori. [1]
  2. Esophagitis will be graded according to the LA Classification of Esophagitis, Grades A to D [2,6]
  3. PPI's are recommended for the healing and maintenance of healing from erosive esophagitis. Meta-analyses suggest that overall GERD symptom relief and healing rates differ little among the available PPIs. There is conceptual rationale for a trial of switching PPIs for patients who have not responded to one PPI. For patients who have not responded to one PPI, more than one switch to another PPI cannot be supported. [9]
  4. The effectiveness and safety of Voquezna was evaluated in a randomized, placebo-controlled, double-blind, four-week efficacy trial with a 20-week safety extension. [2]
  5. Acid-suppressive therapy with proton-pump inhibitors (PPIs) is a mainstay in the treatment of non-erosive Gastroesophageal Reflux Disease. [15]
  6. Proton pump inhibitors (PPIs) have been shown to be superior to histamine-2–receptor antagonists in patients with NERD. [16]
  7. Treatment for NERD is similar to that for erosive GERD. [17]
  8. For patients with classic GERD symptoms of heartburn and regurgitation who have no alarm symptoms, we recommend an 8-week trial of empiric proton pump inhibitor (PPI) once daily before a meal. We recommend attempting to discontinue the PPIs in patients whose classic GERD symptoms respond to an 8-week empiric trial of PPIs. For GERD patients who do not have erosive esophagitis or Barrett’s esophagus, and whose symptoms have resolved with PPI therapy, an attempt should be made to discontinue PPIs or to switch to on-demand therapy in which PPIs are taken only when symptoms occur and discontinued when they are relieved. [18]
  9. PPIs are the most commonly prescribed medication based on ample data demonstrating consistently superior heartburn and regurgitation relief, as well as improved healing compared to H2RAs. Studies on GERD treatment typically last only 8-12 weeks, in part because symptom relief and healing appear to peak in that time frame. In some cases, patients with NERD and otherwise non-complicated GERD can be managed successfully with on-demand or intermittent PPI therapy. Switching PPIs can be considered for patients who experience minor side PPI effects including headache, abdominal pain, nausea, vomiting, diarrhea, constipation and flatulence. [18]
  10. Per clinical trials, patient had to have history of heartburn for at least 6 months and heartburn was present on at least 4 or more days during any consecutive 7-day period. [14]
  • 2025-01-06: update guideline
  • 2024-08-16: update guideline
  • 2024-06-13: 2024 Annual Review
  • 2024-03-25: Updated GPI's
  • 2024-01-17: update guideline
  • 2023-07-05: 2023 Annual Review
  • 2022-06-21: New UM ST Guideline