Subject: Voquezna PA with Limit 6249-C P04-2026

Drug

VOQUEZNA  (vonoprazan)

Policy:

Indications

FDA-approved Indications

Voquezna is indicated

·        for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults.

·        to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults.

·        for the relief of heartburn associated with non-erosive gastroesophageal reflux disease in adults.

·        in combination with amoxicillin and clarithromycin for the treatment of Helicobacter pylori (H. pylori) infection in adults.

·        in combination with amoxicillin for the treatment of H. pylori infection in adults.

Coverage Criteria

Maintenance of Healing of Erosive Esophagitis (EE)

Authorization may be granted when the requested drug is being prescribed for maintenance of healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in an adult when ALL of the following criteria are met:

·        The patient meets ONE of the following:

§  The patient has experienced an inadequate treatment response to a one-month trial of a proton pump inhibitor (PPI).

§  The patient has experienced an intolerance to a PPI.

§  The patient has a contraindication that would prohibit a trial of a PPI.

·        The request is for Voquezna 10 mg tablets.

Relief of Heartburn Associated with Non-erosive Gastroesophageal Reflux Disease (NERD)

Authorization may be granted when the requested drug is being prescribed for the relief of heartburn associated with non-erosive gastroesophageal reflux disease in an adult when ALL of the following criteria are met:

·        The patient meets ONE of the following:

§  The patient has experienced an inadequate treatment response to on-demand or intermittent proton pump inhibitor (PPI) therapy.

§  The patient has experienced an intolerance to a PPI.

§  The patient has a contraindication that would prohibit a trial of a PPI.

·        The request is for Voquezna 10 mg tablets.

Treatment of Healing of Erosive Esophagitis (EE)

Authorization may be granted when the requested drug is being prescribed for the treatment of healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in an adult when ALL of the following criteria are met:

·        The patient meets ONE of the following:

§  The patient has experienced an inadequate treatment response to a one-month trial of a proton pump inhibitor (PPI).

§  The patient has experienced an intolerance to a PPI.

§  The patient has a contraindication that would prohibit a trial of a PPI.

Treatment of Helicobacter Pylori (H. pylori)

Authorization may be granted when the requested drug is being prescribed for the treatment of Helicobacter pylori (H. pylori) infection in an adult in combination with amoxicillin as dual therapy OR amoxicillin and clarithromycin as triple therapy when the following criteria is met:

·        The request is for Voquezna 20 mg tablets.

Quantity Limits Apply

Quantity Limit

The duration of 25 days is used for a 30-day fill period and 75 days is used for a 90-day fill period to allow time for refill processing.

Use of this drug for H. pylori  and treatment of healing of EE is for short term acute use; therefore, the intent is for prescriptions of the requested drug to be filled one month at a time. There should be no 3-month supplies filled.

Drug	1 Month Limit	3 Month Limit
Maintenance of healing of EE	30 tablets / 25 days	90 tablets / 75 days
Relief of heartburn associated with NERD	30 tablets / 25 days	90 tablets / 75 days
Treatment of healing of EE	30 tablets / 25 days	Does Not Apply
Treatment of H. Pylori	28 tablets / 14 days	Does Not Apply

Duration of Approval (DOA)

·        6249-C:

§  Treatment of H. pylori: DOA: 14 days

§  Relief of heartburn associated with non-erosive gastroesophageal reflux disease: DOA: 6 months

§  Treatment of healing of erosive esophagitis: DOA: 8 weeks

§  Maintenance of healing of erosive esophagitis: DOA: 6 months

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Voquezna [package insert]. Buffalo Grove, IL: Phathom Pharmaceuticals Inc.; November 2025.

2.     Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2026. https://online.lexi.com. Accessed February 04, 2026.

3.     Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 02/04/2026).

4.     Katz PO, Dunbar KB, Schnoll-Sussman FH, et al. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol. 2022;117(1):27-56.

5.     Chey WD, Howden CW, Moss SF et al. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2024;119:1730–1753.

6.     Laine L, Spechler S, Yadlapati R, et al. Vonoprazan is Efficacious for Treatment of Heartburn in Non-erosive Reflux Disease: A Randomized Trial. Clin Gastroenterol Hepatol. 2024;22(11):2211-2220.e10.

7.     Patel A, Laine L, Moayyedi P, Wu J. AGA Clinical Practice Update on Integrating Potassium-Competitive Acid Blockers Into Clinical Practice: Expert Review. Gastroenterology. 2024;167(6):1228-1238.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 20, 2026