CurrentMass General Brigham Health PlanPolicy N/A

Initial Step-Therapy Requirements — Proton Pump Inhibitors (PPIs)

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Defines initial pharmacy benefit step-therapy rules, first- and second-line PPI agents, quantity limits, approval duration, and prior-authorization conditions for Mass General Brigham Health Plan commercial/exchange members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyInitial Step-Therapy Requirements — Proton Pump Inhibitors (PPIs)

Policy CodePolicy N/A

Change TypeFormulary removal / step-therapy clarification

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateN/A

Key ActionSubmit a prior authorization at point of sale for prescriptions that do not meet the initial step therapy requirements.

SourceLink

POLICY UPDATE CHANGES

Policy updated to remove multiple PPI agents from the formulary and move them to nonformulary status effective 07/01/2026.

Step therapy table clarified dosage forms and Rx vs OTC status earlier (effective 06/01/2025).

Added omeprazole/sodium bicarbonate oral powder for suspension to the program as a second-line agent (effective 09/01/2023).

First-/Second-lineMedication tiers

180 daysLookback period

12 monthsApproval duration

Per-drugQuantity limits

PPI Step-Therapy Coverage Criteria

PPI step-therapy coverage criteria

Covered when the following tiered step-therapy conditions are met.

Tiered coverage applies as described below.

First-line coverage

First-line agents are covered without prior authorization (see Initial Therapy Tiers for the agent list).
If member does not meet initial step therapy requirements at point of sale, claim will deny and request must be submitted for prior authorization.

Second-line coverage conditions

Second-line medications will pay without prior authorization only if the member has filled at least two first-line medications within the past 180 days or has filled a second-line medication within the past 180 days.
Alternatively, prior authorization may be granted when the member has documented inadequate response to or intolerable side effects from two first-line medications.

New member documentation requirement

For members new to the plan (coverage effective date less than or equal to 90 days), submit medical records documenting current treatment with the requested drug to support continuation or approval; documentation must exclude samples and manufacturer patient assistance program supplies.

Approval duration and quantity limits

Approvals will be granted for up to 12 months.
Monthly quantity limits apply per drug and strength (see policy quantity limits).

If the member does not meet these requirements at point of sale, submit a prior authorization request and supporting documentation for review.

Initial Therapy Tiers

Initial therapy tiers

Tiering of initial therapy agents and rules for second-line eligibility.

First-line agents are covered without prior authorization.

First-line agents (examples listed in policy)

Omeprazole capsules (Rx only).
Pantoprazole tablets.
Lansoprazole 15 mg and 30 mg capsules (Rx only).
Esomeprazole capsules and tablets (Rx and OTC).
Rabeprazole tablets.
Esomeprazole packets for suspension (equivalency noted).

Second-line agents require evidence of prior fills or prior authorization demonstrating clinical failure to two first-line agents before coverage without PA is allowed; the lookback period to count fills is 180 days.

Continuation / Established Therapy

Continuation therapy

Rules for continuation of established therapy and handling of new members.

Continuation/established therapy is allowed when documentation shows the member is currently receiving the requested PPI.

New-to-plan members (<= 90 days coverage)

Submit medical records demonstrating the member is currently receiving the requested drug to support continuation or authorization; records must exclude samples and medications received via manufacturer's patient assistance programs.

Clinical failure documentation for continuation or second-line coverage

Documentation of inadequate response to two first-line medications supports approval of a second-line agent.
If member has filled at least two first-line medications or a second-line medication within the past 180 days, this fill history also supports coverage of the second-line agent without prior authorization.

Approvals granted for continuation are consistent with policy limits (approvals up to 12 months; applicable monthly quantity limits per drug/strength).

Step Therapy Operational Rules

Coverage status	Agents / notes
Covered	Omeprazole capsules (Rx only); pantoprazole tablets; lansoprazole 15 mg & 30 mg capsules (Rx only); esomeprazole capsules & tablets (Rx and OTC); rabeprazole tablets; equivalency: esomeprazole packets for suspension.

Requirement	Details / lookback
Must meet step-therapy criteria	Second-line medications will pay if the member has filled at least two first-line medications or a second-line medication within the past 180 days; otherwise requests reviewed against prior-authorization criteria or require documentation of inadequate response/side effects to two first-line agents.

Change effective date	Agents moved to nonformulary / removed from step-therapy
07/01/2026	Omeprazole/sodium bicarbonate packets for suspension; rabeprazole sprinkle capsules; dexlansoprazole capsules; Prilosec (omeprazole) packets for suspension; pantoprazole packets for suspension; lansoprazole ODT; Konvomep.

Prescribing and Documentation Requirements

Prior Authorization

Initial adjudication — nonconforming prescriptions will deny and require PA

Prescriptions that meet the initial step-therapy requirements will adjudicate automatically at the point of sale. If a prescription does not meet the initial step-therapy requirements, it will deny with a message that prior authorization (PA) is required; submit a PA request at point of sale for members who do not meet the initial step-therapy requirements.

Documentation Required

Provide medical records for new members and to document step failure

For members new to the plan (coverage effective date ≤ 90 days), submit medical records documenting that the member is currently receiving the requested drug (exclude samples and manufacturer's patient assistance programs). For second-line agents, authorization may be granted when the member has inadequate response or side effects to two first-line medications.

Step Therapy

Step-therapy failure requirement — two first-line fills or recent second-line fill

Second-line medications will be covered without PA only if the member has filled at least two first-line medications or has a prior second-line fill within the past 180 days; otherwise PA or documentation of inadequate response/side effects to two first-line agents is required.

Lookback period to count prior fills: 180 days
Alternative to fills: documentation of inadequate response or side effects to two first-line medications

Coding and Lookback

Referencesmixed

	1. AcipHex (rabeprazole) [prescribing information]. Wixom, MI: Waylis Therapeutics, LLC; July 2023.
	2. Dexilant (dexlansoprazole) [prescribing information]. Cambridge, MA: Takeda Pharmaceuticals America Inc; February 2025.
	3. Prevacid and Prevacid SoluTab (lansoprazole) [prescribing information]. Lexington, MA: Takeda Pharmaceuticals; August 2023.
	4. Prilosec OTC (omeprazole) [prescribing information]. Cincinnati, OH: P & G Health; October 2024.
	5. Prilosec oral suspension (omeprazole) [prescribing information]. Zug, Switzerland: Covis Pharma; March 2024.
	6. Protonix Oral (pantoprazole) [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; June 2023.
	7. Zegerid (omeprazole and sodium bicarbonate) [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals; July 2023.

Step lookback period

Lookback period (count prior fills)180 days

Key Definitions

First-Line

DefinitionFirst-Line agents are covered without prior-authorization (omeprazole capsules; pantoprazole tablets; lansoprazole 15 mg & 30 mg capsules; esomeprazole capsules & tablets; rabeprazole tablets; esomeprazole packets for suspension).

Second-Line

DefinitionSecond-Line agents will pay without prior authorization if the member has filled at least two first-line medications or a second-line medication within the past 180 days; otherwise coverage requires prior authorization with documentation of inadequate response or side effects to two first-line medications.

New member

DefinitionNew member = coverage effective date less than or equal to 90 days; medical records documenting current treatment with the requested drug must be submitted (excluding samples or manufacturer's patient assistance programs).