CurrentHealth NetPolicy CP.CPA.209

Proton Pump Inhibitors

Defines prior authorization requirements, coverage criteria, and clinical documentation requirements for multiple proton pump inhibitor (PPI) products for Health Net (Centene-affiliated) commercial line of business.

Policy Summary

PayerHealth Net

PolicyProton Pump Inhibitors

Policy CodePolicy CP.CPA.209

Change TypeRoutine editorial updates

Effective DateNov 16, 2016

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation demonstrating the member meets the coverage criteria and required trial/failure of preferred generics when applicable.

SourceLink

POLICY UPDATE CHANGES

Removed esomeprazole strontium as product is discontinued.

Added references to generic rabeprazole as criteria would also apply.

Modified references from Aciphex Sprinkle (discontinued) to instead reference generic.

12 monthsstandard approval duration

Yesprior auth required

≥1 yrmin pediatric age (some forms)

4Q 2025most recent review

Coverage Criteria for Proton Pump Inhibitors

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inv-01: Initial Approval

Covered when ALL of the following are met:

Initial Approval - Indication: 1) Prescribed for one of the following uses: a) Symptomatic GERD (including heartburn or laryngopharyngeal reflux); b) Esophageal complications of GERD (e.g., erosive esophagitis, esophageal stricture, Barrett's esophagus, Schatzki's ring); c) Extra-esophageal complications (e.g., laryngopharyngeal reflux, vocal cord damage/nodules, asthma, laryngitis, pharyngitis); d) Peptic ulcer disease (e.g., gastric ulcers, duodenal ulcers, H. pylori, Zollinger-Ellison syndrome); e) Gastrointestinal bleed prophylaxis for NSAID use when the member meets at least one of: i) history of peptic ulcer disease; ii) age ≥ 60 years; iii) concurrent therapy with anticoagulants (e.g., warfarin, aspirin, clopidogrel) or oral corticosteroids (e.g., prednisone); f) Reduction of risk of upper gastrointestinal bleed in critically ill patients when the request is for Konvomep or Zegerid oral suspension.

Initial Approval - Age, formulation, and trial requirements: 2) For lansoprazole disintegrating tablets or rabeprazole sodium delayed-release sprinkle: age ≥ 1 year; 3) Member meets at least one of: a) Age < 12 years and request is for lansoprazole disintegrating tablets, rabeprazole sprinkle, or Prilosec packets; b) Presence of G-tube or significant dysphagia and request is for Prevacid SoluTabs, Prilosec packets, or omeprazole/sodium bicarbonate: failure of a ≥4-week trial of omeprazole and lansoprazole capsules at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced (chart note may be required); c) Member currently on clopidogrel and request is for Dexilant: i) failure of a ≥4-week trial of pantoprazole tablets at up to maximally indicated doses unless contraindicated or clinically significant adverse effects; ii) member must use generic dexlansoprazole unless contraindicated or clinically significant adverse effects are experienced; d) Request is for esomeprazole, lansoprazole disintegrating tablets, omeprazole suspension, omeprazole/sodium bicarbonate, or rabeprazole: failure of a ≥4-week trial of ALL preferred generics (omeprazole capsules, pantoprazole tablets, lansoprazole capsules) at up to maximally indicated doses unless all are contraindicated or cause clinically significant adverse effects; e) Request is for Dexilant: failure of a ≥4-week trial of ALL preferred generics at maximally indicated doses and member failed/intolerant/contraindicated to those agents — member must use generic dexlansoprazole unless contraindicated or clinically significant adverse effects are experienced.

Initial Approval - Dosing and duration: 4) For twice-daily (BID) dosing requests of non-preferred agents for conditions other than H. pylori or pathological hypersecretory conditions (including Zollinger-Ellison syndrome): member must be titrated up from once-daily dosing; 5) Requested dose does not exceed the FDA‑approved maximum recommended dose (refer to product dosing section).

Approval duration: 12 months or duration of request, whichever is less.

inv-02: Continuation Therapy

Covered continuation therapy when ALL of the following are met:

Continuation Approval: 1) Member currently receiving the medication via the Centene benefit or previously met initial approval criteria or is in continuity of care per state-specific addendums; 2) Member is responding positively to therapy; 3) If the request is for Dexilant, member must use generic dexlansoprazole unless contraindicated or clinically significant adverse effects are experienced; 4) If request is for a dose increase, the new dose does not exceed the FDA‑approved maximum recommended dose.

Continuation Approval - Duration: Approval duration: 12 months or duration of request, whichever is less.

inv-03: Product-specific covered indications and dosing

Covered indications and dosing are specified per product and indication as follows

rabeprazole (Aciphex): Indications: Duodenal ulcers; Erosive esophagitis; H. pylori (triple therapy); Symptomatic GERD (healing and maintenance); Pathological hypersecretory conditions (including Zollinger-Ellison). Dosing: 20 mg PO QD (BID for H. pylori); pathological hypersecretory dosing 60 mg PO QD to 60 mg PO BID. Maximum dose: 20 mg/day (40 mg/day for H. pylori); up to 120 mg/day for hypersecretory conditions. Pediatric sprinkle: Age 1–11 years weight‑based dosing (weight <15 kg: 5–10 mg PO QD; weight ≥15 kg: 10 mg PO QD); maximum 10 mg/day.

dexlansoprazole (Dexilant): Indications: Healing of erosive esophagitis (60 mg PO QD); Maintenance of healed erosive esophagitis and symptomatic non‑erosive GERD (30 mg PO QD). Maximum doses: 60 mg/day for EE healing; 30 mg/day for maintenance/symptomatic GERD.

esomeprazole (Nexium): Indications: GERD including erosive esophagitis and symptomatic GERD; risk reduction of NSAID‑associated gastric ulcer. Adult dosing: 20–40 mg PO QD to BID. Pediatric dosing: age‑ and weight‑based regimens for ages 1 month to 17 years as listed. Maximum dose: up to 80 mg/day for some regimens; 40 mg/day for other indications as specified.

Requests for proton pump inhibitor therapy for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the Health Net off‑label use policy CP.CPA.09.

Safety and efficacy of proton pump inhibitors have not been established in patients younger than 1 year of age. Clinical trial evidence showed that lansoprazole was not more effective than placebo in symptomatic GERD for infants aged 1 month to 1 year, and available studies do not support use of rabeprazole sprinkle in patients 1 year of age.

Esomeprazole strontium is no longer referenced in this policy because the product has been discontinued; this removal was noted in the 4Q 2024 annual review and carried forward in subsequent updates.

Therapy with any proton pump inhibitor is contraindicated in patients with a history of hypersensitivity to the drug, other PPIs, substituted benzimidazoles, or any component of the formulation. Such contraindications may render a request inappropriate for coverage.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for the following proton pump inhibitors (PPIs): rabeprazole (Aciphex), rabeprazole sodium delayed‑release sprinkle, dexlansoprazole (Dexilant), esomeprazole (Nexium, Nexium 24HR, Nexium 24HR ClearMinis), omeprazole (Prilosec Packets), lansoprazole (Prevacid SoluTabs), and omeprazole/sodium bicarbonate formulations (Konvomep, Zegerid, Zegerid OTC).

Affected products: rabeprazole (Aciphex) and generic rabeprazole; rabeprazole sprinkle; dexlansoprazole (Dexilant) including generic redirection; esomeprazole (Nexium family); omeprazole (Prilosec Packets); lansoprazole (Prevacid SoluTabs); omeprazole/sodium bicarbonate (Konvomep, Zegerid, Zegerid OTC).

Documentation Required

Required Documentation

Providers must submit supporting clinical documentation (e.g., office notes, labs) demonstrating the member meets all approval criteria. The provider should document trials/failures, contraindications, intolerances, or clinical rationale when requesting non‑preferred or brand agents.

Submit chart notes showing prior trials (duration, dose) of preferred generics when step therapy is required.
Document contraindications or clinically significant adverse effects if bypassing step therapy.
For requests involving clopidogrel and Dexilant, document failure of pantoprazole trial and rationale for using dexlansoprazole (generic preferred).

Step Therapy

Step Therapy / Trial Requirements

Step‑therapy and trial requirements apply for many non‑preferred or brand PPIs: trials of preferred generic PPIs (omeprazole capsules, pantoprazole tablets, lansoprazole capsules) for ≥4 weeks at maximally indicated doses are required unless contraindicated or not tolerated. Specific agent‑based exceptions and pediatric age rules apply as outlined in criteria.

Esomeprazole, lansoprazole disintegrating tablets, omeprazole suspension, omeprazole/sodium bicarbonate, and rabeprazole: require failure of ALL preferred generics (omeprazole capsules, pantoprazole tablets, lansoprazole capsules) for ≥4 weeks.
Dexilant requests require failure of ALL preferred generics for ≥4 weeks and use of generic dexlansoprazole unless contraindicated.
For certain pediatric formulations (lansoprazole disintegrating tablets, rabeprazole sprinkle, Prilosec packets) age‑specific rules apply (see policy).

Prior Authorization

Authorization Duration and Coverage Limits

Approval duration for authorized requests is limited to 12 months or the duration of the request, whichever is less. Coverage decisions remain subject to the member's plan documents and applicable terms, conditions, exclusions, and limitations.

Commercial line of business: approval duration = 12 months or duration of request, whichever is less.
Coverage is governed by the member's evidence of coverage/certificate of coverage and applicable administrative policies.

Billing Rule

Formulary Redirection / Step Edits

Formulary redirection and step edits may redirect branded or specific formulations to preferred generics or alternative formulations (e.g., redirection from Protonix packet to omeprazole or lansoprazole capsules; generic dexlansoprazole preferred over brand Dexilant).

Examples: redirection from Protonix packet to omeprazole and lansoprazole capsules for requests involving Prevacid SoluTabs, Prilosec packets, or omeprazole/sodium bicarbonate.
Dexilant: generic redirection applied where appropriate.

Denial Risk

Denial Risk — Noncovered Indications and Contraindications

Requests for indications not addressed by FDA approval or this policy may be denied unless sufficient off‑label evidence is submitted per off‑label use policies. Contraindications (e.g., hypersensitivity to PPIs or coadministration with rilpivirine) should be documented and may affect coverage.

Non‑FDA uses lacking sufficient evidence may be denied without appropriate off‑label justification (see CP.CPA.09).
Contraindications to document: hypersensitivity to PPIs/substituted benzimidazoles, formulation components, or coadministration with rilpivirine.

Note

Policy Governance and Provider Responsibility

Providers are expected to exercise professional judgment; this clinical policy is a guide to medical necessity and does not guarantee payment. The Health Plan may change or withdraw the policy; coverage remains subject to contractual terms and applicable law.

This policy guides medical necessity determinations but is not a contract or guarantee of payment.
Providers remain responsible for treatment decisions and must submit appropriate documentation to support coverage requests.

Definitions and Key Terms

EE — erosive esophagitis definition

TermErosive esophagitis (EE)

DefinitionDefined in appendix as 'erosive esophagitis' (EE).

Clinical contextListed as an esophageal complication of GERD and an indication for PPI therapy (healing and maintenance).

GERD — gastroesophageal reflux disease definition

TermGastroesophageal reflux disease (GERD)

DefinitionDefined in appendix as 'gastroesophageal reflux disease' (GERD).

Clinical contextListed as a primary indication for PPI therapy including symptomatic GERD and esophageal complications (e.g., EE).

Laryngopharyngeal reflux (LPR) — note on BID dosing recommendation and duration

ConditionLaryngopharyngeal reflux (LPR)

Recommended dosingAmerican Academy of Otolaryngology recommends twice-daily (BID) PPI dosing for a minimum of 6 months; BID shown superior to QD for LPR.

Treatment duration noteMinimum treatment period of 6 months with possibility of chronic treatment per guideline statement.

Pediatric age limitations — general statement on safety/efficacy in patients <1 year and agent-specific approvals

General safety statementSafety and efficacy of PPIs have not been established in patients <1 year of age.

Agent-specific pediatric approvalsDexilant established in pediatric patients ≥12 years; Prevacid established in ages 1–17 years; omeprazole established in ages 1–16 years; Nexium established in ages 1–17 years (up to 8 weeks); rabeprazole established in patients ≥1 year for up to 36 weeks.

Negative pediatric findingsLansoprazole was no more effective than placebo in patients 1 month to <1 year with symptomatic GERD; rabeprazole sprinkle studies do not support use in <1 year for GERD.

Health Plan — definition of a health plan adopting this clinical policy

DefinitionHealth Plan = a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC or its affiliates.

PurposeThe clinical policy is a guide to medical necessity used to assist in coverage decisions and administering benefits; it is not a contract or guarantee of payment.

GovernanceCoverage decisions and administration are subject to the plan's coverage documents, state/federal requirements, and Health Plan-level administrative policies and procedures.

OpenPayer

Proton Pump Inhibitors

Coverage Criteria for Proton Pump Inhibitors

Provider Actions, Authorization, and Documentation

Background on Proton Pump Inhibitors

Definitions and Key Terms