WHA
 

Vonoprazan Containing Agents - PA, NF

Indications for Prior Authorization

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 20mg tablet

Prior Authorization

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

  • Diagnosis of Helicobacter pylori infection
    • AND
  • Provider attests to both of the following:
    • Patient is experiencing a new occurrence of Helicobacter pylori (H. pylori) infection
    • Medication will not be used for longer than 14 days for any one occurrence for the treatment of Helicobacter pylori (H. 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 10mg tablet

Prior Authorization, NonFormulary


For diagnosis of Helicobacter pylori (H. pylori) Infection

  • For the 10mg tablet, requests for the diagnosis of Helicobacter pylori infection will not be approved*
Voquezna

Prior Authorization

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

  • Diagnosis of erosive esophagitis
    • AND
  • Provider attests to both of the following:
    • Patient is experiencing a new occurrence of heartburn associated with Erosive Esophagitis
    • Medication will not be used for longer than 8 weeks for any one occurrence for the healing and relief of heartburn associated with 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 [L]

  • Used to maintain healing and relief of heartburn associated with erosive esophagitis
    • AND
  • Provider attests to both of the following:
    • Patient has a new occurrence of erosive esophagitis that requires maintenance treatment for the healing and relief of heartburn
    • Medication will not be used for longer than 6 months for any one occurrence for maintenance treatment for the 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 20mg tablet

Prior Authorization, NonFormulary


For diagnosis of Maintenance of Healing and Relief of Heartburn associated with Erosive Esophagitis

  • For the 20mg tablet, requests for the maintenance of healing and relief of heartburn associated with erosive esophagitis will not be approved*
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 [M]

  • Diagnosis of non-erosive Gastroesophageal Reflux Disease
    • AND
  • Provider attests to both of the following:
    • Patient is experiencing a new occurrence of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease
    • Medication will not be used for longer than 4 weeks for any one occurrence for the Relief of Heartburn associated with 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

Prior Authorization, NonFormulary


For diagnosis of Relief of Heartburn associated with Non-Erosive Gastroesophageal Reflux Disease

  • For the 20mg tablet, requests for the relief of heartburn associated with non-erosive gastroesophageal reflux disease will not be approved*
Voquezna 20mg tablet

Non Formulary

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

  • Submission of medical records (e.g., chart notes) confirming diagnosis of Helicobacter pylori infection
    • AND
  • Submission of medical records (e.g., chart notes) or paid claims confirming both of the following:
    • Patient is experiencing a new occurrence of Helicobacter pylori (H. pylori) infection
    • Medication will not be used for longer than 14 days for any one occurrence for the treatment of Helicobacter pylori (H. 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) or paid claims, 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

Non Formulary

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

  • Submission of medical records (e.g., chart notes) confirming diagnosis of erosive esophagitis
    • AND
  • Submission of medical records (e.g., chart notes) or paid claims confirming both of the following:
    • Patient is experiencing a new occurrence of heartburn associated with Erosive Esophagitis
    • Medication will not be used for longer than 8 weeks for any one occurrence for the healing and relief of heartburn associated with 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) or paid claims, 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) or paid claims confirming both of the following:
    • Patient has a new occurrence of erosive esophagitis that requires maintenance treatment for the healing and relief of heartburn
    • Medication will not be used for longer than 6 months for any one occurrence for maintenance treatment for the healing and relief of heartburn associated with Erosive Esophagitis
    AND
  • Submission of medical records (e.g., chart notes) or paid claims, 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

  • Submission of medical records (e.g., chart notes) confirming diagnosis of non-erosive Gastroesophageal Reflux Disease
    • AND
  • Submission of medical records (e.g., chart notes) or paid claims confirming both of the following:
    • Patient is experiencing a new occurrence of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease
    • Medication will not be used for longer than 4 weeks for any one occurrence for the Relief of Heartburn associated with 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) or paid claims, 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-484361

  • Formulary
    premium

  • Effective date
    Apr 1, 2026

  • P&T approval date
    Jan 17, 2024

P & T Revisions

1970-01-01, 2025-12-18, 2025-12-18, 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. Antunes, C., Sharma, A. Esophagitis. Available at: Esophagitis - StatPearls - NCBI Bookshelf (nih.gov). Accessed December 5, 2023.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. Gillson, S. Treatments for Nonerosive Reflux Disease (NERD). Available at: https://www.verywellhealth.com/nonerosive-reflux-disease-nerd-1742334. Accessed August 5, 2024.
  13. 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.
  14. 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.
  15. 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.
  16. Shirley, M. Vonoprazan: A Review in Helicobacter pylori Infection. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC11090951/#CR1. Accessed January 22, 2026.
  17. Malfertheiner P, Megraud F, Rokkas T, et al. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022;71(9):1724–1762. doi: 10.1136/gutjnl-2022-327745.
  18. Shah S, Hubscher E, Pelletier C, et al. Helicobacter pylori infection treatment in the United States: clinical consequences and costs of eradication treatment failure. Expert Rev Gastroenterol Hepatol. 2022;16(4):341–357. doi: 10.1080/17474124.2022.2056015.
  19. Shah SC, Iyer PG, Moss SF. AGA clinical practice update on the management of refractory Helicobacter pylori infection: expert review. Gastroenterology. 2021;160(5):1831–1841. doi: 10.1053/j.gastro.2020.11.059.
  20. Chey WD, Mégraud F, Laine L, et al. Vonoprazan triple and dual therapy for Helicobacter pylori infection in the United States and Europe: randomized clinical trial. Gastroenterology. 2022;163(3):608–619. doi: 10.1053/j.gastro.2022.05.055
  21. Sugano K, Tack J, Kuipers EJ, et al. Kyoto global consensus report on Helicobacter pylori gastritis. Gut. 2015;64(9):1353–1367. doi: 10.1136/gutjnl-2015-309252.
  22. Fernandez, A., Rux C., and Clark, N. Successful treatment of refractory Helicobacter pylori infection with a potassium-competitive acid blocker-based regimen: A case report. Available at: https://www.sciencedirect.com/science/article/pii/S1201971225004291. Accessed January 22, 2026.
  23. Graham, D. Regarding the AGA Clinical Practice Update on Integrating Vonoprazan Into Clinical Practice. Available at: https://www.gastrojournal.org/article/S0016-5085(25)00010-1/fulltext. Accessed January 22, 2026.
  24. Cumber, J., Rushing, N., Castillo, S., et al. Advancements and Challenges in H pylori Management. Available at: https://www.uspharmacist.com/article/advancements-and-challenges-in-h-pylori-management. Accessed January 22, 2026.
  25. Moss, S., Shah, S., Tan, M., et al. Evolving Concepts in Helicobacter pylori Management. Available at: https://www.gastrojournal.org/article/S0016-5085(23)05083-7/fulltext. Accessed January 22, 2026.
  26. UptoDate: Helicobacter pylori: Epidemiology, pathophysiology, and overview of disease associations. Available at: https://www.uptodate.com/contents/helicobacter-pylori-epidemiology-pathophysiology-and-overview-of-disease-associations. Accessed January 22, 2026.
  27. Elste, J. Voquezna for Treating Gastroesophageal Reflux Disease and Esophagitis. Available at: https://www.webmd.com/heartburn-gerd/voquezna-gerd-esophagitis. Accessed January 22, 2026.
  28. Zhang, M., Xiao, Y., Chen, M., et al. The role of vonoprazan in patients with erosive esophagitis. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC9478709/. Accessed January 22, 2026.
  29. Tanabe T, Hoshino S, Kawami N, et al. Efficacy of long-term maintenance therapy with 10-mg vonoprazan for proton pump inhibitor-resistant reflux esophagitis. Esophagus 2019; 16: 377–381.
  30. Zhang M, Tan N, Li Y, et al. Esophageal physiologic profiles within erosive esophagitis in China: predominantly low-grade esophagitis with low reflux burden. Neurogastroenterol Motil 2019; 31: e13702.
  31. Lee HH, Ho RH. Interindividual and interethnic variability in drug disposition: polymorphisms in organic anion transporting polypeptide 1B1 (OATP1B1; SLCO1B1). Br J Clin Pharmacol 2017; 83: 1176–1184.
  32. Kushima R, Kinoshita Y, Haruma K, et al. 4-year interim analysis results of VISION trial: a randomized, open-label study to evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive esophagitis. DDW, San Diego, 2022, p. EP1118.
  33. Yadlapati, R., Hubscher, E., Pellet, C., et al. Induction and maintenance of healing in erosive esophagitis in the United States. Available at: https://www.tandfonline.com/doi/full/10.1080/17474124.2022.2134115. Accessed January 22, 2026.
  34. Lewine, H. Esophagitis. Available at: https://www.health.harvard.edu/a_to_z/esophagitis-a-to-z. Accessed January 22, 2026.
  35. Howden, C. Insights on the Potential Use of Potassium-Competitive Acid Blockers in Erosive Esophagitis. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC8132630/. Accessed January 22, 2026.
  36. Ha, N., Lee, H., Lee, O., et al.Differences in Clinical Characteristics between Patients with Non-Erosive Reflux Disease and Erosive Esophagitis in Korea. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC2923803/#:~:text=Abstract,closely%20related%20to%20abdominal%20obesity. Accessed January 22, 2026.
  37. Eluri, S. Non-Erosive GERD Does Not Lead to an Increased Risk of Esophageal Adenocarcinoma: A Nordic Population Based Cohort Study. Available at: https://gi.org/journals-publications/ebgi/eluri_feb2024/#:~:text=COMMENTARY,%2Dconfirmed%20non%2Derosive%20GERD. Accessed January 22, 2026.
  38. Drummond, C. This New Drug for GERD Works Better Than Proton Pump Inhibitors. Available at: https://www.verywellhealth.com/voquenza-gerd-treatment-8690022#:~:text=If%20you%20have%20erosions%20in,2. Accessed January 22, 2026.
  39. Ernst, D. Voquezna Approved to Relieve Heartburn With Nonerosive GERD. Available at: https://www.renalandurologynews.com/news/voquezna-approved-to-relieve-heartburn-with-nonerosive-gerd/#:~:text=%E2%80%9CThis%20approval%20provides%20patients%20and,once%20daily%20for%204%20weeks. Accessed January 22, 2026.
  40. Vélez, C. On-Demand Vonoprazan for Non-Erosive Reflux Disease Symptoms: A New Option. Available at: https://gi.org/journals-publications/ebgi/velez_nov2024/. Accessed January 22, 2026.
  41. Fass, R. On-Demand Therapy for Gastroesophageal Reflux Disease. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC12397781/. Accessed January 22, 2026.
  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]
  11. Helicobacter Pylori (H. Pylori) is a bacterial infection which can cause dyspepsia (discomfort or pain after eating), peptic ulcer disease, and gastric cancer. Treatment is indicated whenever the infection is identified. Vonoprazan is approved for use in combination with amoxicillin, or amoxicillin and clarithromycin, for the treatment of H. pylori infection in adults. Voquezna comes in the following forms: Voquezna (vonoprazan) 10mg tabs; Voquezna 20mg tabs; Voquezna Dual Pack (amoxicillin 500mg caps + vonoprazan 20mg tabs); Voquezna Triple Pack (amoxicillin 500mg caps+ clarithromycin 500mg tabs + vonoprazan 20mg tabs). The recommended dosage for the dual therapy regimen is vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily for 14 days. The recommended dosage for the triple therapy regimen is vonoprazan 20 mg, amoxicillin 1000 mg, and clarithromycin 500 mg, each given twice daily for 14 days. Both the dual and triple therapy regimens are also available as co-packaged products (Voquezna® Dual Pak® and Voquezna® Triple Pak®, respectively. Per the prescribing label, the recommended duration of treatment for H. pylori Infection is 14 days. H. pylori infection is thought to be transmitted via fecal-oral, gastro-oral, and oral-oral routes, with socioeconomic status and hygiene being significant contributors to the risk of infection. The mode of transmission and factors such as increasing antibiotic resistance (e.g., clarithromycin), unknown or variances in regional susceptibility patterns, inadequate acid suppression, patient allergies, or nonadherence (e.g., duration of treatment), may all play a role in treatment failure and require a repeat course. [1, 16-26]
  12. Erosive esophagitis is due to damage of the esophageal lining, from stomach acid. Per the prescribing label, the recommended dose for the healing and relief of heartburn associated with Erosive Esophagitis is Voquezna 20 mg once daily for 8 weeks. Depending on the severity of renal or heptiic impairment the 10mg strength may also be used. The duration of treatment may vary (e.g., longer than 8 weeks) from patient to patient, inadequate acid inhibition, and the severity of the condition (Los Angeles Grade C or D), lifestyle factors (e.g, smoking), gastric surgery, immunocompromised, among other factors. The maintenance phase in erosive esophagitis is to prevent relapse. Per the prescribing label, the recommended dose for the maintenance of healing and relief of heartburn associated with Erosive Esophagitis is Voquezna 10 mg once daily for up to 6 months. The recommended dosage in with hepatic or renal impairment is the same as for patients with normal hepatic or renal function. Several studies in Japan have shown that a longer duration of treatment (e.g., 52 weeks) maintained remission. [1, 27-35]
  13. Non-Erosive Gastroesophageal Reflux disease. is associated with the symptoms of GERD (e.g., heartburn, problems swallowing), but without damage to the esophagus. Per the prescribing label, the recommended dose for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease, is Voquezna 10 mg once daily for 4 weeks. The recommended dosage with hepatic or renal impairment is the same as for patients with normal hepatic or renal function. The clinical trials showed a mean percentage of 45% patients with heartburn-fee days over 4 weeks. vs 28% with placebo. Certain factors, such as diet (e.g., spicy food, coffee), stress, anxiety, medications like ibuprofen may necessitate that certain patients require longer therapy (e.g., greater than 4 weeks). In addition, recent data published in the American Journal of Gastroenterology in October 2025 showed that Voquezna, provided rapid and sustained relief of nighttime GERD symptoms in patients with Non-Erosive Reflux Disease (NERD) in an additional 20-week extension trial. The data was an exploratory analysis from the Phase 3 pHalcon-NERD-301 trial. Another train of thought from some providers, suggest that Voquezna could be a good alternative as an on-demand treatment. Voquezna provides potent acid suppression, works fast, and has a durable effect . [1, 36-41]
  • 2025-12-18: No criteria changes
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 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