Pharmacy Prior Authorization Criteria

Vonoprazan Containing Agents

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 ONE of the following first line treatment regimens [B, C, 1, 3]
• Clarithromycin based therapy (e.g., clarithromycin based triple therapy, clarithromycin based concomitant therapy) [D]
• Bismuth quadruple therapy (e.g., bismuth and metronidazole and tetracycline and proton pump inhibitor [PPI] )

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 ONE of the following first line treatment regimens [B, C, 1, 3]
• Clarithromycin based therapy (e.g., clarithromycin based triple therapy, clarithromycin based concomitant therapy) [D]
• Bismuth quadruple therapy (e.g., bismuth and metronidazole and tetracycline and proton pump inhibitor [PPI])

Voquezna 20mg tablet

Prior Authorization

Length of Approval: 8 Week(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

P & T Revisions

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

References

1. Chey WD, Leontiadis GI, Howden CW, et al. ACG Clinical Guideline: Treatment of Helicobacter pylori infection. Am J Gastroenterol. 2017; 112:212-238
2. Voquezna prescribing information. Phathom Pharmaceuticals, Inc. Buffalo Grove, IL. July 2024.
3. Myran, L., Zarbock, S. Management of Helicobacter pylori Infection. Available at https://www.uspharmacist.com/article/management-of-helicobacter-pylori-infection. Accessed June 14, 2022.
4. UptoDate. Treatment regimens for Helicobacter pylori in adults. April 7, 2022. Available at https://www.uptodate.com/contents/treatment-regimens-for-helicobacter-pylori-in-adults?search=h%20pylori%20infection&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1. Accessed June 16, 2022.
5. 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.
6. Clinical Study Protocol Erosive Esophagitis. Available at: https://storage.googleapis.com/ctgov2-large-docs/26/NCT04124926/Prot_000.pdf. Accessed December 1, 2023.
7. 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.
8. 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.
9. 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.
10. Antunes, C., Sharma, A. Esophagitis. Available at: Esophagitis - StatPearls - NCBI Bookshelf (nih.gov). Accessed December 5, 2023.
11. 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.
12. Wang, Yao-Kuang, Kuo, Fu-Chen, Liu, Chung-Jung, et al. Diagnosis of Helicobacter pylori infection: Current options and developments. Available at: Diagnosis of Helicobacter pylori infection: Current options and developments - PMC (nih.gov). Accessed December 5, 2023.
13. 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.
14. 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.
15. 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.
16. 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.
17. Gillson, S. Treatments for Nonerosive Reflux Disease (NERD). Available at: https://www.verywellhealth.com/nonerosive-reflux-disease-nerd-1742334. Accessed August 5, 2024.
18. 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.

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End Notes

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. The American College of Gastroenterology, (ACG) treatment guideline for first-line and salvage therapies was last updated in 2017. The 2017 ACG guideline outlines evidence-based, frontline treatment strategies for providers in North America. These include clarithromycin triple therapy, bismuth quadruple therapy, concomitant therapy, sequential therapy, hybrid therapy, levofloxacin triple therapy. Due to the complexity of treatment, hybrid therapy as first line treatment is limited. Sequential therapy is also complex, and it is not uniformly endorsed as first line treatment. Due to the rising rates of levofloxacin resistance, levofloxacin should not be used for treatment, unless the H. pylori strain is known to be sensitive to it or if levofloxacin resistance rates are known to be less than 15 %. Studies evaluating the efficacy of levofloxacin containing regimens in North America are lacking. In clinical practice, the initial course of eradication therapy, heretofore referred to as “first-line” therapy, generally offers the greatest likelihood of treatment success. Thus, careful attention to the selection of the most appropriate first-line eradication therapy for an individual patient is essential. The ACG guidelines for the treatment of H pylori recommend several regimens for 1st line eradication therapy with no preference of 1 regimen over another. Therapy is individualized based on patient's previous antibiotic history and local resistance patterns. [1, 4]
3. In the selection of the most appropriate empiric treatment regimen for H pylori, previous antibiotic exposure, regional antibiotic-resistance patterns, and eradication rates should be taken into consideration because these factors can impact successful treatment. Successful treatment also relies on host factors such as allergies and adherence. [3]
4. Clarithromycin triple therapy consists of a PPI, clarithromycin, and amoxicillin or metronidazole. Clarithromycin based concomitant therapy consists of a PPI, amoxicillin, clarithromycin, and a nitroimidazole (e.g., tinidazole or metronidazole) [1, 4]
5. Esophagitis will be graded according to the LA Classification of Esophagitis, Grades A to D [2,6]
6. 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]
7. 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]
8. Acid-suppressive therapy with proton-pump inhibitors (PPIs) is a mainstay in the treatment of non-erosive Gastroesophageal Reflux Disease. [15]
9. Proton pump inhibitors (PPIs) have been shown to be superior to histamine-2–receptor antagonists in patients with NERD. [16]
10. Treatment for NERD is similar to that for erosive GERD. [17]
11. 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]
12. 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]
13. 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]

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Revision History

• 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

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