CurrentBlue Cross Blue Shield - IowaPolicy 05.01.69

Proton Pump Inhibitors (PPIs) quantity limit and step therapy

Defines medical necessity, step therapy and quantity limits for specific proton pump inhibitor (PPI) products (brand and generic), criteria for special formulations (sprinkles, packets, solutabs) and approval durations for Wellmark Blue Cross and Blue Shield - Iowa members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyProton Pump Inhibitors (PPIs) quantity limit and step therapy

Policy CodePolicy 05.01.69

Change TypeAdministrative revision (non-material)

Effective DateSep 20, 2025

Next Review Date

Key ActionObtain prior authorization for quantities exceeding the standard benefit allowance and document required prior trials, inability to swallow, and confirmatory diagnostic tests as applicable.

POLICY UPDATE CHANGES

Reviewed and revised August 2025 with current effective date September 20, 2025.

12Products listed (brand/generic and formulations)

30-90Quantity limits range (units per 30 days)

12Approval duration (months)

Coverage summary

Coverage stance: covered_with_criteria. Subject: Proton Pump Inhibitors (PPIs) quantity limit and step therapy. Scope summary: Defines medical necessity, step therapy, and quantity limits for specific PPI products (brand and generic) and specialized formulations (sprinkles, packets, solutabs) for Wellmark Blue Cross and Blue Shield - Iowa members. Policy purpose: to encourage appropriate prescribing quantities consistent with FDA-approved product labeling, promote use of more cost-effective generic PPIs prior to brand or higher-cost options when clinically appropriate, and align therapy with clinical guidelines to maintain optimal therapeutic outcomes. Effective date: 2025-09-20. Last review: 2025-08.

Quantity thresholds and limits (daily and per 30 days)

Esomeprazole strontium & Nexium — max daily<= 2 dosage units per day

Dexilant — max daily<= 1 dosage unit per day

Higher dose exceptionAllowed for Barrett's esophagus (biopsy-confirmed) or Zollinger-Ellison Syndrome (diagnostic test)

AcipHex Sprinkles — standard allowance30 capsules per 30 days

AcipHex Sprinkles — post-limit PAUp to 60 capsules per 30 days

Dexilant — standard allowance30 capsules per 30 days

Dexilant — post-limit PAUp to 60 capsules per 30 days

Esomeprazole Strontium — standard allowance60 capsules per 30 days

Esomeprazole Strontium — post-limit PAUp to 90 capsules per 30 days

Nexium — standard / post-limit60 capsules/packets per 30 days (standard); 90 capsules per 30 days (post-limit)

Prevacid Solutabs — standard / post-limit60 solutabs per 30 days (standard); 90 solutabs per 30 days (post-limit)

Prilosec packets — standard60 packets per 30 days

Protonix packets — standard / post-limit60 packets per 30 days (standard); 90 packets per 30 days (post-limit)

Initial and product-specific medical necessity criteria

General medical necessity for selected PPIs

Brand and generic AcipHex, brand and generic Dexilant, Esomeprazole strontium, and brand or generic Nexium may be considered medically necessary if ALL of the following are met:

Prior trial requirement: Patient must have tried and failed a therapeutic trial of at least two preferred PPIs (Prilosec (omeprazole), Prevacid (lansoprazole), and/or Protonix (pantoprazole)).
Quantity/dosing limits: The requested amount does not exceed 2 dosage units per day for Esomeprazole strontium and Nexium; or 1 dosage unit per day for Dexilant, unless the patient has a diagnosis of Barrett's esophagus confirmed by biopsy or Zollinger-Ellison Syndrome confirmed by a diagnostic test.Esomeprazole strontium and Nexium <= 2 dosage units/day; Dexilant <= 1 dosage unit/day

AcipHex Sprinkles (rabeprazole) specialized criteria

Brand and generic AcipHex Sprinkles may be considered medically necessary if ALL of the following are met:

AcipHex Sprinkles specialized criteria

Swallowing inability: Patient must be unable to swallow an intact capsule or tablet.
Prior trial with lansoprazole and omeprazole: Patient must have tried and failed a therapeutic trial of BOTH lansoprazole AND omeprazole when the capsules are opened and the contents are sprinkled on soft food or liquid without crushing or chewing the capsules or the granules unless Step Therapy Exception Criteria for Approval is met.
Quantity/dosing limits (unspecified): The requested amount does not exceed [unspecified dosage unit] per day unless the patient has a diagnosis of Barrett's esophagus confirmed by biopsy or Zollinger-Ellison Syndrome confirmed by a diagnostic test.unspecified
original text contains missing numerical dosage for this line

Prilosec packets, Protonix Packets, and Nexium Packets

These packet formulations may be considered medically necessary if ALL of the following are met:

Packets (Prilosec, Protonix, Nexium) criteria

Swallowing inability: Patient must be unable to swallow an intact capsule or tablet.
Contraindication or prior trial: Patient must have a contraindication to OR tried and failed a therapeutic trial of BOTH lansoprazole AND omeprazole when the capsules are opened and the contents are sprinkled on soft food or liquid without crushing or chewing the capsules or the granules.
Quantity/dosing limits: The requested amount does not exceed 2 dosage units per day unless the patient has a diagnosis of Barrett's esophagus confirmed by biopsy or Zollinger-Ellison Syndrome confirmed by a diagnostic test.<= 2 dosage units/day unless qualified diagnosis

Prevacid Solutabs (brand and generic) specialized criteria

Brand and generic Prevacid Solutabs may be considered medically necessary if ALL of the following are met:

Prevacid Solutabs specialized criteria

Swallowing inability: Patient must be unable to swallow an intact capsule or tablet.
Contraindication or prior trial or NG/G tube: Patient must have a contraindication to OR tried and failed a therapeutic trial of BOTH lansoprazole AND omeprazole when the capsules are opened and the contents are sprinkled on soft food or liquid without crushing or chewing the capsules or the granules; OR is unable to swallow capsules related to a medical condition or due to a nasogastric or gastrostomy tube.
Quantity/dosing limits: The requested amount does not exceed 2 dosage units per day unless the patient has a diagnosis of Barrett's esophagus confirmed by biopsy or Zollinger-Ellison Syndrome confirmed by a diagnostic test.<= 2 dosage units/day unless qualified diagnosis

Not medically necessary

Medications included in this policy are considered not medically necessary if the above criteria are not met.

Not medically necessary: Patient does not meet the specific product criteria (e.g., required prior trials, inability to swallow, or diagnoses that allow higher dosing).

Actions required of providers

Prior Authorization

Prior authorization required for quantities above standard benefit allowance

Prior authorization is required for quantities exceeding the member’s standard benefit allowance. Post-limit prior authorization (PA) quantity limits apply and vary by product (for example, up to 60 or 90 units per 30 days depending on the product). Providers must obtain PA for quantities above the standard benefit allowance to have coverage considered.

Documentation Required

Document prior trials and diagnoses

Providers must document prior therapeutic trials and relevant diagnoses to support medical necessity and any higher dosing or specialized formulation requests.

Document trials/failures of preferred PPIs (lansoprazole and omeprazole; and/or others as specified such as pantoprazole)
Document inability to swallow intact capsules/tablets when requesting sprinkles, packets, or solutabs
Provide biopsy confirmation for Barrett’s esophagus when used to justify higher dosing
Provide diagnostic test confirmation for Zollinger-Ellison Syndrome when used to justify higher dosing

Billing Rule

Approval duration

Authorizations issued under this policy will be approved for a duration of 12 months.

Denial Risk

Potential denial if criteria not met

If the specified criteria are not met (such as required prior PPI trials, documented inability to swallow intact dosage forms, contraindications, or confirmation of qualifying diagnoses), the medication will be considered not medically necessary and may be denied.

Approval duration and post-limit prior authorization quantities

Approval duration12 months

AcipHex Sprinkles — standard / post-limit per 30 daysStandard: 30 capsules; Post-limit PA: up to 60 capsules

Dexilant — standard / post-limit per 30 daysStandard: 30 capsules; Post-limit PA: up to 60 capsules

Esomeprazole Strontium — standard / post-limit per 30 daysStandard: 60 capsules; Post-limit PA: up to 90 capsules

Nexium — standard / post-limit per 30 daysStandard: 60 capsules/packets; Post-limit PA: up to 90 capsules

Prevacid Solutabs — standard / post-limit per 30 daysStandard: 60 solutabs; Post-limit PA: up to 90 solutabs

Prilosec / Protonix packets — standard / post-limit per 30 daysPrilosec: 60 packets standard; Protonix: 60 packets standard, up to 90 packets post-limit

Background and definitions

Rationale: The criteria are designed to encourage appropriate prescribing quantities and step therapy to promote use of cost-effective generic PPIs before brand or higher-cost options when clinically appropriate, consistent with FDA product labeling and clinical guidelines. The policy includes special formulations (sprinkles, packets, solutabs) with specific criteria for patients unable to swallow intact dosage forms, and allows exceptions for confirmed diagnoses such as Barrett's esophagus (biopsy-confirmed) and Zollinger-Ellison Syndrome (diagnostic test-confirmed) to permit higher dosing when clinically indicated.

Dosage unit: The policy uses the term ‘dosage unit’ per day as the allowable daily dosing metric (e.g., 1 or 2 dosage units per day); the exact milligram amount per dosage unit depends on the product labeling.

OpenPayer

Proton Pump Inhibitors (PPIs) quantity limit and step therapy

Coverage summary

Initial and product-specific medical necessity criteria

Actions required of providers

Policy identifier and codes

Guidelines and evidence referenced

Background and definitions

Revision history