ModifiedCentenePolicy CP.PMN.277

Clinical Policy: Ulcer Therapy Products

Prior authorization and medical necessity criteria for specific ulcer therapy products (Omeclamox-Pak, Pylera, Talicia, Voquezna and Voquezna combination packs) for members of Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyUlcer Therapy Products

Policy CodePolicy CP.PMN.277

Change TypeMaterial updates and product additions

Effective DateJun 1, 2022

Next Review Date

Key ActionSubmit prior authorization with supporting documentation showing diagnosis, prescriber specialty, age, product-specific dosing/duration, and clarithromycin-sensitivity when required.

SourceLink

POLICY UPDATE CHANGES

Added Voquezna Triple/Dual Pak and Voquezna (vonoprazan) with criteria for erosive esophagitis and non-erosive GERD.

For H. pylori infection, removed required redirection to generic Prevpac for all agents except Omeclamox-Pak and added clarithromycin-sensitivity requirements for clarithromycin-containing vonoprazan regimens.

Updated contraindications for Omeclamox-Pak to include coadministration with lurasidone and simplified Talicia dosing in Section V.

6Products requiring prior authorization

≥18 yrsMinimum age

10-14 daysTypical H. pylori durations

Up to 8 months

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Max Voquezna duration (erosive)

Coverage Criteria

Initial Therapy — Helicobacter pylori Infection

Covered when ALL of the following are met:

H. pylori initial approval

Diagnosis/Prescriber/Age: 1) Diagnosis of H. pylori infection; 2) Prescribed by or in consultation with a gastroenterologist or infectious disease specialist; 3) Age ≥ 18 years.
Product-specific step/alternatives: One of the following depending on product: a) Omeclamox-Pak — member must instead use the individual components concurrently (amoxicillin, clarithromycin, omeprazole) unless contraindicated or experience clinically significant adverse effects, or use generic Prevpac unless contraindicated; b) Pylera — member must instead use the individual components concurrently (bismuth subcitrate, metronidazole, tetracycline) unless contraindicated and the regimen must be prescribed with a PPI; c) Talicia — member must instead use the individual components concurrently (omeprazole, amoxicillin, rifabutin) unless contraindicated or must use bismuth quadruple therapy unless contraindicated; d) Voquezna/Voquezna Triple/Dual Pak — member must use bismuth quadruple therapy unless contraindicated; for clarithromycin-containing regimens H. pylori must be clarithromycin-sensitive; for Voquezna prescribe in combination with amoxicillin or amoxicillin and clarithromycin as specified.
Dose limits and durations: Dose does not exceed the product-specific maximums: Omeclamox-Pak — two omeprazole capsules, two clarithromycin tablets, and four amoxicillin capsules per day for 10 days; Pylera — 12 capsules per day for 10 days (with PPI); Talicia — 12 capsules per day for 14 days; Voquezna Triple Pak — two vonoprazan tablets, four amoxicillin capsules, and two clarithromycin tablets per day for 14 days; Voquezna Dual Pak — two vonoprazan tablets and six amoxicillin capsules per day for 14 days; Voquezna monotherapy combinations per labeling (vonoprazan 20 mg BID with amoxicillin ± clarithromycin for 14 days).

Initial Therapy — Erosive Esophagitis (Voquezna)

Covered when ALL of the following are met:

Erosive esophagitis initial approval: Request is for Voquezna; diagnosis of erosive esophagitis; age ≥ 18 years; failure of a ≥8 week trial of a PPI at up to maximally indicated doses unless clinically significant adverse effects are experienced or all PPIs are contraindicated; total Voquezna therapy does not exceed 8 months; dose does not exceed healing or maintenance dosing depending on indication (healing: 20 mg per day for 8 weeks; maintenance: 10 mg per day for up to 6 months); 1 tablet per day maximum.

Initial Therapy — Non-Erosive GERD (Voquezna)

Covered when ALL of the following are met:

Non-erosive GERD initial approval: Request is for Voquezna; diagnosis of non-erosive GERD with heartburn confirmed by both endoscopy and reflux monitoring; age ≥ 18 years; failure of two PPIs, each used ≥4 weeks at up to maximally indicated doses unless clinically significant adverse effects are experienced or all PPIs are contraindicated; dose does not exceed 10 mg per day and 1 tablet per day. Approval duration: 4 weeks.

Continued Therapy

Continued therapy: A. For H. pylori infection and erosive esophagitis: re-authorization is not permitted; members must meet the initial approval criteria. B. For non-erosive GERD: member must be currently receiving medication via the Centene benefit or have previously met initial approval criteria (or be in continuity of care), request must be for Voquezna, member must be responding positively to therapy, total Voquezna therapy must not exceed 6 months for continued use, and dose must not exceed 10 mg/day and 1 tablet/day if applicable.

Product-specific coverage criteria and redirection rules

Policy includes product-specific coverage criteria with redirection and sensitivity requirements for H. pylori; vonoprazan has added indications requiring combination with antibiotics as labeled.

Voquezna clarithromycin-containing regimens: Require documentation that H. pylori is clarithromycin-sensitive when clarithromycin-containing vonoprazan regimens are requested.clarithromycin sensitivity documented

Added in 2Q2025

Talicia redirection: For H. pylori infection, Talicia requests may be redirected to bismuth quadruple therapy per policy redirection rules.N/A

Added in 2Q2025

Omeclamox-Pak exception: Omeclamox-Pak is retained as an exception to prior blanket redirection to generic Prevpac; contraindications updated to include coadministration with lurasidone.

Coverage is not authorized for non‑FDA approved indications that are not addressed in this policy unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 for commercial, CP.PMN.53 for Medicaid, or HIM.PA.154 for health insurance marketplace/ICHRA, or other applicable evidence of coverage documents.

Prior blanket redirection of all H. pylori agents to generic Prevpac has been removed except for Omeclamox‑Pak, which remains an exception. Specific redirection rules now apply (for example, Talicia may be redirected to bismuth quadruple therapy) as described in the product‑specific coverage rules.

Requests for continued therapy are limited. Re‑authorization for Helicobacter pylori infection and for erosive esophagitis is not permitted; members must meet the initial approval criteria and approval durations stated for initial therapy. Ongoing therapy beyond the initial allowed duration is not authorized.

When a clarithromycin‑containing vonoprazan regimen is requested for H. pylori, the policy requires documentation that the infecting organism is clarithromycin‑sensitive. Requests lacking documentation of clarithromycin sensitivity for clarithromycin‑containing regimens may be considered not medically necessary under the policy.

Coding

Product availability (no billing codes provided)NDC

NDCs not listed

Product availabilities described (pack/composition) but no NDC codes provided in this document section.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Omeclamox‑Pak, Pylera, Talicia, Voquezna, Voquezna Triple Pak, and Voquezna Dual Pak. Requests may be subject to step‑therapy redirection per the H. pylori criteria (see below). Failure to obtain prior authorization when required may result in claim denial.

Affected products: Omeclamox‑Pak, Pylera, Talicia, Voquezna (including Triple and Dual Pak)
Prior authorization must include supporting clinical documentation

Documentation Required

Documentation Required to Support Approval

Providers must submit documentation (e.g., office chart notes, diagnostic test results, H. pylori susceptibility testing when applicable, prior treatment records) that supports the member has met all approval criteria. Failure to provide adequate supporting documentation may result in denial.

Acceptable documentation: office notes, endoscopy/reflux monitoring reports, lab results, antimicrobial susceptibility testing, prior medication trials and dates

Background

These ulcer therapy products are indicated primarily for eradication of Helicobacter pylori infection. In addition, certain vonoprazan‑containing products (Voquezna and combination packs) have labeled indications that include healing and maintenance of erosive esophagitis and relief of heartburn in GERD; use should be consistent with the product‑specific dosing and indication requirements in the policy.

Definitions

H. pylori infection — definition and clinical context

DefinitionInfection by Helicobacter pylori associated with duodenal ulcer disease; targeted by combination antibiotic and acid‑suppressing regimens.

Typical indicationEradication of H. pylori infection and treatment of duodenal ulcer disease (active or recent history).

Common regimen componentsCombination antibiotic(s) plus an acid‑suppressing agent (PPI or vonoprazan) per product labeling.

Age requirement (policy)Most H. pylori indications require age ≥ 18 years for coverage under this policy.

Documentation requiredProvider must document diagnosis and supporting clinical information (e.g., office notes, lab results) to meet initial approval criteria.

PPI — Proton pump inhibitor definition and examples

Policy Summary

PayerCentene

PolicyUlcer Therapy Products

Policy CodePolicy CP.PMN.277

Change TypeMaterial updates and product additions

Effective DateJun 1, 2022

Next Review Date

Key ActionSubmit prior authorization with supporting documentation showing diagnosis, prescriber specialty, age, product-specific dosing/duration, and clarithromycin-sensitivity when required.

SourceLink

On This Page

Step Therapy

Step Therapy and Redirection Requirements

Step‑therapy and redirection requirements apply for H. pylori indications. Some product requests will be redirected to specified alternative regimens (e.g., bismuth quadruple therapy) or require trial/failure of individual components or generic Prevpac before approval. Illinois HIM requests are exempt from step therapy requirements per IL HB 5395 effective 01/01/2026.

Omeclamox‑Pak: redirect to concurrent individual components (omeprazole, clarithromycin, amoxicillin) or generic Prevpac unless contraindicated
Pylera: require use of individual components concurrently (bismuth subcitrate, metronidazole, tetracycline) and prescribed with a PPI
Talicia: redirect to individual components or bismuth quadruple therapy unless contraindicated
Voquezna/Voquezna Triple/Dual Pak: require prior use of bismuth quadruple therapy unless contraindicated; clarithromycin‑containing regimens require documented clarithromycin sensitivity

Denial Risk

Clarithromycin Sensitivity Requirement

Clarify clarithromycin‑sensitivity requirement: for vonoprazan‑containing regimens that include clarithromycin (e.g., Voquezna Triple Pak or Voquezna prescribed with clarithromycin), the request must include documentation that H. pylori is clarithromycin‑sensitive (e.g., culture with susceptibility testing or validated molecular testing). Lack of documented clarithromycin sensitivity may result in non‑coverage or redirection to alternative therapy.

Applies to Voquezna Triple Pak and any Voquezna regimen that includes clarithromycin
Acceptable evidence: susceptibility testing results or documented local resistance profile when testing unavailable (with clinical justification)

Note

Product‑Specific Dosing and Indication

Product‑specific indications and dosing must be provided with the prior authorization request. Typical dosing regimens include: Omeclamox‑Pak — omeprazole 20 mg + clarithromycin 500 mg + amoxicillin 1,000 mg PO BID for 10 days; Pylera — three capsules PO QID for 10 days with omeprazole 20 mg PO BID; Talicia — four capsules PO TID for 14 days; Voquezna Triple Pak — vonoprazan 20 mg PO BID + amoxicillin 1,000 mg PO (total daily 4 capsules) + clarithromycin 500 mg PO BID for 14 days; Voquezna Dual Pak — vonoprazan 20 mg PO BID + amoxicillin 1,000 mg PO TID for 14 days; Voquezna (single agent) dosing varies by indication (H. pylori dual/triple regimens as above; erosive esophagitis healing 20 mg QD x8 weeks; maintenance 10 mg QD up to 6 months; non‑erosive GERD 10 mg QD for 4 weeks). Provide dose and treatment duration in the request.

State the exact product, indication, dose, frequency, and intended duration on the request
Ensure dosing does not exceed maximums listed for each product

Step Therapy

Step Therapy Redirection and Bypasses

Step therapy bypasses and modifications: redirection to Prevpac was removed for most agents in 2025 except Omeclamox‑Pak where Prevpac redirection may still apply; Talicia requests specifically include redirection to bismuth quadruple therapy. Illinois HIM line of business has a statutory bypass of step therapy per IL HB 5395 (effective 01/01/2026).

2025 change: removed required redirection to generic Prevpac for all agents except Omeclamox‑Pak
Talicia: added redirection to bismuth quadruple therapy
IL HIM: step therapy bypass per IL HB 5395

DefinitionProton pump inhibitor (PPI): an acid‑suppressing medication frequently used with H. pylori regimens.

Examples (policy examples)Omeprazole and lansoprazole are cited as representative PPIs; omeclamox‑pak and regimens list omeprazole 20 mg BID when paired with combination antibiotics.

Role in therapyUsed to reduce gastric acidity and improve antibiotic effectiveness in H. pylori eradication regimens and as comparator/failure criteria for Voquezna in GERD/erosive esophagitis.

Dosing notes from policyOmeprazole commonly used at 20 mg BID in H. pylori regimens (e.g., with Pylera or Omeclamox‑Pak); some Voquezna product criteria require prior failure of PPIs at maximally indicated doses.

Vonoprazan-containing multi-drug pack for H. pylori (Triple and Dual) — Voquezna Triple/Dual Pak

Product descriptionVoquezna Triple Pak: vonoprazan + amoxicillin + clarithromycin packaged as 14 daily administration packs (morning and evening).

Voquezna Triple dosingVonoprazan 20 mg BID (2 tablets/day) + amoxicillin 1,000 mg/day (4 capsules/day) + clarithromycin 500 mg BID (2 tablets/day) for 14 days.

Voquezna Dual dosingVonoprazan 20 mg BID (2 tablets/day) + amoxicillin 1,000 mg TID (6 capsules/day) for 14 days; available as 14 daily administration packs for morning, mid‑day, and evening dosing.

Product availabilityVoquezna Triple Pak: carton of 14 daily packs (tablets: vonoprazan 20 mg, clarithromycin 500 mg; capsules: amoxicillin 500 mg). Voquezna Dual Pak: carton of 14 daily packs (tablets: vonoprazan 20 mg; capsules: amoxicillin 500 mg).

Clarithromycin requirementClarithromycin‑containing vonoprazan regimens require documentation of H. pylori clarithromycin sensitivity per policy redirection/sensitivity rules.