ModifiedCignaPolicy N/A

Proton Pump Inhibitors Drug Quantity Management Policy - Per Rx

Defines retail and home delivery maximum quantities per dispensing and clinical override criteria for multiple proton pump inhibitor products (dexlansoprazole, esomeprazole, lansoprazole, omeprazole including omeprazole+sodium bicarbonate, pantoprazole, rabeprazole, etc.). Specifies when quantity overrides are allowed (e.g., twice-daily dosing, pediatrics, hypersecretory conditions, extraesophageal GERD, H. pylori eradication, noncommercial dosing).

Policy Summary

PayerCigna

PolicyProton Pump Inhibitors Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeQuantity limits and clarifications (Konvomep kits added; terminology and duration clarified)

Effective Date

Next Review DateApr 2, 2025

Key ActionProviders must document the clinical reason for a quantity override (e.g., symptoms not controlled by once-daily dosing, extraesophageal GERD, hypersecretory conditions, pediatric age-based dosing, H. pylori treatment, noncommercial dosing) to obtain approval.

POLICY UPDATE CHANGES

New quantity limits for Konvomep kits (90 mL: 1 kit; 150 mL: 1 kit; 300 mL: 2 kits per dispensing) were added.

Throughout the policy, 'laryngopharyngeal reflux' was changed to 'extraesophageal gastroesophageal reflux disease (including laryngopharyngeal reflux)'.

Policy Statement clarified that 'one-time' approvals are provided for 30 days in duration.

Policy updated to reflect existing quantity limits when a product is obtained via home delivery.

MultipleProducts Covered

YesRetail/Home limits enforced

Coverage Summary

This policy defines per-dispensing retail and home delivery maximum quantities for multiple proton pump inhibitor (PPI) products including dexlansoprazole (Dexilant), esomeprazole (Nexium and generics; granules/packets and capsules), lansoprazole (Prevacid and SoluTab), omeprazole (including Prilosec packets and generic capsules), omeprazole+sodium bicarbonate formulations (Konvomep, Zegerid), pantoprazole (Protonix), and rabeprazole (Aciphex, Aciphex Sprinkle). Specific retail and home delivery quantity limits are set per product and formulation (examples: many lower-strength products = 30, 60, 90, 120 units retail and commonly 3× retail for home delivery) and the highest marketed strengths generally have no quantity limits.

Quantity overrides to permit increased per-dispensing amounts are allowed only under defined clinical circumstances and are product-specific. Typical override categories include documented need for twice-daily (BID) dosing (e.g., provide quantities such as 60 or 90 capsules/packets at retail and 180 or 270 for home delivery as specified), pediatric age-based dosing, hypersecretory conditions (higher quantities, e.g., 90 retail/270 home delivery), H. pylori eradication (including one-time overrides where noted), and noncommercial dosing scenarios (requested quantity up to specified maximums).

Thresholds

Age thresholdsMultiple product-specific age cutoffs (e.g., <1 year, ≤11 years, ≤16 years, ≤17 years, ≥5 years)

Quantity per dispensing - retailProduct-specific (examples: 30, 60, 90, 120 packets/capsules; Konvomep kits: 90 mL = 1 kit retail; 150 mL = 1 kit retail; 300 mL = 2 kits retail; one-time H. pylori override 46 capsules retail)

Quantity per dispensing - home deliveryTypically 3x retail (examples: 90→270, 60→180, 120→360 packets/capsules; Konvomep kits: 90 mL = 1 kit home delivery; 150 mL = 1 kit home delivery; 300 mL = 2 kits home delivery)

General Policy Statement

General policy statement

Per Rx product(s) is(are) covered as medically necessary when the following criteria is(are) met. Any other exception is considered not medically necessary.

General policy

Default quantity limits: Default retail and home delivery maximum quantity per Rx are set per product and formulation as specified in the policy (see product-specific nodes).
Override conditions: Quantity overrides allowed only under listed clinical circumstances per product.
Providers must document the clinical reason for a quantity override (e.g., symptoms not controlled by once-daily dosing, extraesophageal GERD, hypersecretory conditions, pediatric age-based dosing, H. pylori treatment, noncommercial dosing) to obtain approval for specified increased quantities per dispensing.

Product-specific Quantity Overrides (by product)

Dexlansoprazole 30 mg delayed-release capsules (Dexilant, generic) — Overrides

Dexlansoprazole 30 mg overrides

Uncontrolled on QD dosing: If prescriber documents patient's symptoms are not controlled by once daily dosing
Approve 60 capsules per dispensing at retail or 180 capsules per dispensing at home delivery (provides for 30 mg twice daily dosing).
Extraesophageal GERD: If patient has extraesophageal gastroesophageal reflux disease (including laryngopharyngeal reflux)
Approve 60 capsules per dispensing at retail or 180 capsules per dispensing at home delivery.

Esomeprazole granular/packet and capsule products — Overrides

Esomeprazole granules/packets and capsules overrides

Exclusions / Non-covered Exceptions

Per the general criteria introduction: per Rx product(s) are covered as medically necessary when the listed criteria are met. Any exception that does not meet the listed product-specific criteria is considered not medically necessary.

Konvomep kits are explicitly non-overridable: new quantity limits were added (90 mL = 1 kit; 150 mL = 1 kit; 300 mL = 2 kits per dispensing) and no clinical overrides apply.

Provider Actions & Prior Authorization

Prior Authorization

Quantity override requests

Providers must document the clinical reason for a quantity override (for example: symptoms not controlled by once-daily dosing, extraesophageal GERD, hypersecretory conditions, pediatric age-based dosing, H. pylori treatment, or noncommercial dosing) to obtain approval for the specified increased quantities per dispensing.

Documentation Required

Age- and indication-specific documentation

When requesting overrides for pediatric patients or specific indications (hypersecretory conditions, extraesophageal GERD, H. pylori), prescribers must state the patient's age and the indication to justify the higher quantity.

Applicable Codes

No CPT/HCPCS/ICD-10/NDC codes listed in this partmixed

No codes listed

Clinical Evidence & References

References include multiple manufacturers' prescribing information (2020–2023) and relevant clinical guidelines: ACG GERD guideline (2022), AGA clinical updates (2022–2023), and the ACG H. pylori guideline (2024).

Background

Background: This is Cigna's National Formulary Coverage Drug Quantity Management policy section for proton pump inhibitors (PPIs). It specifies FDA-approved dosing and availability/formulation notes for targeted products, establishes retail and home delivery maximum quantities per dispensing (with home delivery commonly permitting up to three times the retail quantity), and details the clinical circumstances in which quantity overrides may be granted—such as twice-daily dosing needs, pediatric age-based dosing, hypersecretory conditions, extraesophageal GERD (including laryngopharyngeal reflux), H. pylori eradication, and noncommercial dosing situations.

Quick facts

Products Covered (formulations and strengths)Multiple (various PPI tablets, capsules, packets, oral suspensions and kits including Dexilant, Nexium, Prevacid, Prilosec, Konvomep, Zegerid, Protonix, Aciphex)

Separate quantity limits enforcedYes — distinct retail and home delivery maximums (home delivery commonly allows up to 3x retail)

Clinical override categories (pediatrics, hypersecretory, extraesophageal GERD, H. pylori, noncommercial dosing)Several — pediatric age-based dosing, hypersecretory conditions (e.g., ZES), extraesophageal GERD (including LPR), H. pylori treatment, doses not matching commercial strengths

Revision History

03/22/2023Material Change

New quantity limits for Konvomep kits were added: 90 mL kit — 1 kit per dispensing (retail and home delivery); 150 mL kit — 1 kit per dispensing (retail and home delivery); 300 mL kit — 2 kits per dispensing (retail and home delivery). No clinical overrides apply to Konvomep.

04/19/2024Change

Terminology updated throughout the policy: 'laryngopharyngeal reflux' changed to 'extraesophageal gastroesophageal reflux disease (including laryngopharyngeal reflux)'.

04/02/2025Clarification (Material)Latest