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ph-1068

Proton Pump Inhibitors (PPIs) Step Therapy with Quantity Limit Program Summary

Policy Number: PH-1068

This step therapy program applies to Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace formularies.

Quantity limits apply to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

The step therapy program is implemented with auto-grandfathering.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
04-01-2025

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Aciphex® Sprinkle™, Rabeprazole Sprinkle Capsule	Treatment of GERD in pediatric patients 1 to 11 years of age for up to 12 weeks		2
Aciphex® (rabeprazole)* Tablet	Healing of erosive or ulcerative gastroesophageal reflux disease (GERD) in adults Maintenance of healing of erosive or ulcerative GERD in adults Treatment of symptomatic GERD in adults and adolescents 12 years of age and older Healing of duodenal ulcers in adults Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence in adults Treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults	* generic available	1
Dexilant® (dexlansoprazole)* Capsule	Healing of erosive esophagitis in patients 12 years of age and older Maintenance of healed erosive esophagitis and relief of heartburn in patients 12 years of age and older Treatment of symptomatic non-erosive GERD in patients 12 years of age and older	* generic available	3
Konvomep® (omeprazole/sodium bicarbonate) Oral suspension	Treatment of active benign gastric ulcer Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients		16
Nexium® (esomeprazole magnesium)* Capsule Suspension packet	Treatment of GERD Risk reduction of NSAID-associated gastric ulcer H. pylori eradication to reduce the risk of duodenal ulcer recurrence Pathological hypersecretory conditions, including Zollinger-Ellison syndrome	* generic available	5
Prevacid®, Prevacid® SoluTab™ (lansoprazole)* Capsule Orally disintegrating tablet (ODT)	Short-term treatment of active duodenal ulcer in adults H. pylori eradication to reduce the risk of duodenal ulcer recurrence in adults Maintenance of healed duodenal ulcers in adults Short-term treatment of active benign gastric ulcer in adults Healing of non-steroidal anti-inflammatory drug (NSAID)-associated gastric ulcer Risk reduction of NSAID-associated gastric ulcer in adults Treatment of symptomatic GERD Treatment of erosive esophagitis Maintenance of healing of erosive esophagitis in adults Pathological hypersecretory conditions including Zollinger-Ellison syndrome in adults	* generic available	6
Prilosec® (omeprazole) Capsule* Suspension packet	Treatment of active duodenal ulcer in adults Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults Treatment of active benign gastric ulcer in adults Treatment of symptomatic GERD in patients 1 year of age and older Treatment of erosive esophagitis due to acid-mediated GERD in patients 1 month of age and older Maintenance of healing of erosive esophagitis due to acid-mediated GERD in patients 1 year of age and older Pathological hypersecretory conditions in adults	* generic available	7
Protonix® (pantoprazole) Tablet* Suspension packet	Short-term treatment of erosive esophagitis associated with GERD in patients 5 years of age and older Maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD Pathological hypersecretory conditions including Zollinger-Ellison syndrome in adults	* generic available	8
Voquezna® (vonoprazan) Tablet	Healing of erosive esophagitis Maintenance of healed erosive esophagitis Treatment of H. pylori infection		18
Zegerid® (omeprazole/sodium bicarbonate) Capsule* Suspension packet	Short-term treatment of active duodenal ulcer in adults Short-term treatment of active benign gastric ulcer in adults Treatment of heartburn and other symptoms associated with GERD in adults Treatment of erosive esophagitis due to acid-mediated GERD which has been diagnosed by endoscopy in adults Maintenance of healing of erosive esophagitis due to acid-mediated GERD in adults Reduction of risk of upper GI bleeding in critically ill adult patients (oral suspension only)	* generic available	9

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Overview

Current guidelines recognize the proton pump inhibitors (PPIs) as first-line therapy for the management of dyspepsia, gastroesophageal reflux disease (GERD), peptic ulcer disease (PUD), eradication of Helicobacter pylori (H. pylori), and Zollinger Ellison syndrome (ZES).(10-15,17)

In studies comparing PPIs to one another, while some differences have been reported, the magnitude of differences (safety/efficacy) has been small and of uncertain clinical importance. The degree to which any differences would justify the selection of one vs. another PPI, particularly when considering cost-effectiveness, is unclear. Data suggests the similar efficacy of PPIs that has been observed in controlled clinical trials may not necessarily translate into equivalent effectiveness when these drugs are substituted for one another. Differences in dosage formulations and drug interactions may occasionally influence choice of PPI in individual cases.(10-13)

Safety

Aciphex is contraindicated in the following:(1)

Patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation
Patients receiving rilpivirine-containing products

Dexilant is contraindicated in the following:(3)

Patients with known hypersensitivity to any component of the formulation
Patients receiving rilpivirine-containing products

Konvomep is contraindicated in the following:(16)

Known hypersensitivity to any components of the formulation
Patients receiving rilpivirine-containing products

Nexium is contraindicated in the following:(5)

Patients with known hypersensitivity to substituted benzimidazoles or any component of the formulation
Patients receiving rilpivirine-containing products

Prevacid is contraindicated in the following:(6)

Patients with known severe hypersensitivity to any component of the formulation
Patients receiving rilpivirine-containing products

Prilosec is contraindicated in the following:(7)

Patients with known hypersensitivity to substituted benzimidazoles or any component of the formulation
Patients receiving rilpivirine-containing products

Protonix is contraindicated in the following:(8)

Patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation
Patients receiving rilpivirine-containing products

Voquezna is contraindicated in the following:(18)

Known hypersensitivity to vonoprazan or any component of Voquezna
Rilpivirine-containing products

Zegerid is contraindicated in the following:(9)

Patients with known hypersensitivity to substituted benzimidazoles or to any components of the formulation
Patients receiving rilpivirine-containing products

REFERENCES

Number	Reference
1	Aciphex prescribing information. Woodward Pharm Services LLC. July 2023.
2	~~Aciphex Sprinkle prescribing information. Aytu Therapeutics, LLC. December 2020.~~ Reference no longer used.
3	Dexilant prescribing information. Takeda Pharmaceuticals America, Inc. July 2023.
4	E~~someprazole strontium prescribing information. Amneal Pharmaceuticals LLC. March 2022.~~ Reference no longer used.
5	Nexium prescribing information. AstraZeneca Pharmaceuticals LP. July 2023.
6	Prevacid prescribing information. Takeda Pharmaceuticals America, Inc. August 2023.
7	Prilosec delayed-release suspension prescribing information. Covis Pharma. July 2023.
8	Protonix prescribing information. Wyeth Pharmaceuticals LLC. July 2023.
9	Zegerid prescribing information. Santarus Inc. July 2023.
10	Katz PO, Dunbar KB, Schnoll-Sussman FH, et al. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. The American Journal of Gastroenterology. 2022;117(1):27-56.
11	Drugs for GERD and peptic ulcer disease. Medical Letter Treatment Guidelines. 2022;64(1647):49-56.
12	Laine L, Barkun A, Saltzman J, et al. ACG Clinical Guideline: Upper Gastrointestinal and Ulcer Bleeding The American Journal of Gastroenterology 116(5):p 899-917, May 2021.
13	Shaheen N, Falk G, Iyer P, et al. ACG Clinical Guideline: Diagnosis and Management of Barrett’s Esophagus. American Journal of Gastroenterology 111(1):p 30-50, January 2016.
14	The Zollinger-Ellison syndrome: dangers and consequences of interrupting antisecretory treatment. Clinical Gastroenterology and Hepatology. 2012 Feb;10(2):199-202.
15	Zollinger-Ellison syndrome: classical considerations and current controversies. The Oncologist. 2014 Jan;19(1):44-50.
16	Konvomep prescribing information. Azuirty Pharmaceuticals, Inc. December 2022.
17	Chey W, Leontiadis G, Howden CW & Moss, S. F. Correction: ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. The American Journal of Gastroenterology, 113(7), 1102, 2018 https://doi.org/10.1038/s41395-018-0132-6
18	Voquezna prescribing information. Phathom Pharmaceuticals, Inc. November 2023

POLICY AGENT SUMMARY STEP THERAPY

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Targeted MSC	Available MSC	Final Age Limit	Preferred Status

	omeprazole cap delayed release	10 MG ; 20 MG ; 40 MG	M ; N ; O	Y
Aciphex	rabeprazole sodium ec tab	20 MG	M ; N ; O	O ; Y
Dexilant	dexlansoprazole cap delayed release	30 MG ; 60 MG	M ; N ; O	O ; Y
Konvomep	omeprazole-sodium bicarbonate for oral susp	2-84 MG/ML	M ; N ; O	N
Nexium	esomeprazole magnesium for delayed release susp pack ; esomeprazole magnesium for delayed release susp packet	10 MG ; 2.5 MG ; 20 MG ; 40 MG ; 5 MG	M ; N ; O	O ; Y
Nexium 24hr	esomeprazole magnesium tab delayed release	20 MG	M ; N ; O	O ; Y
Nexium ; Nexium 24hr ; Nexium 24hr clear minis	esomeprazole magnesium cap delayed release	20 MG ; 40 MG	M ; N ; O	O ; Y
Prevacid ; Prevacid 24hr	lansoprazole cap delayed release	15 MG ; 30 MG	M ; N ; O	O ; Y
Prevacid solutab	lansoprazole tab delayed release orally disintegrating	15 MG ; 30 MG	M ; N ; O	O ; Y
Prilosec	omeprazole magnesium for delayed release susp packet	10 MG ; 2.5 MG	M ; N ; O	N
Prilosec	Omeprazole Magnesium For Delayed Release Susp Packet 10 MG	10 MG	M ; N ; O	N
Prilosec	Omeprazole Magnesium For Delayed Release Susp Packet 2.5 MG	2.5 MG	M ; N ; O	N
Protonix	pantoprazole sodium ec tab	20 MG ; 40 MG	M ; N ; O	O ; Y
Protonix	pantoprazole sodium for delayed release susp packet	40 MG	M ; N ; O	O ; Y
Rabeprazole sodium dr spr	rabeprazole sodium capsule sprinkle dr	10 MG	M ; N ; O	N
Voquezna	vonoprazan fumarate tab	10 MG ; 20 MG	M ; N ; O	N
Zegerid	omeprazole-sodium bicarbonate powd pack for susp	20-1680 MG ; 40-1680 MG	M ; N ; O	O ; Y
Zegerid ; Zegerid otc	omeprazole-sodium bicarbonate cap	20-1100 MG ; 40-1100 MG	M ; N ; O	O ; Y

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist

	omeprazole cap delayed release	10 MG ; 20 MG ; 40 MG	60	Capsules	30	DAYS
	vonoprazan fumarate tab		30	Tablets	30	DAYS
	vonoprazan fumarate tab		30	Tablets	30	DAYS
Aciphex	rabeprazole sodium ec tab	20 MG	60	Tablets	30	DAYS
Dexilant	dexlansoprazole cap delayed release	30 MG ; 60 MG	60	Capsules	30	DAYS
Konvomep	omeprazole-sodium bicarbonate for oral susp	2-84 MG/ML	600	mLs	30	DAYS
Nexium	Esomeprazole Magnesium For Delayed Release Susp Pack 2.5 MG	2.5 MG	30	Packets	30	DAYS
Nexium	Esomeprazole Magnesium For Delayed Release Susp Packet 10 MG	10 MG	60	Packets	30	DAYS
Nexium	Esomeprazole Magnesium For Delayed Release Susp Packet 20 MG	20 MG	60	Packets	30	DAYS
Nexium	Esomeprazole Magnesium For Delayed Release Susp Packet 40 MG	40 MG	60	Packets	30	DAYS
Nexium	Esomeprazole Magnesium For Delayed Release Susp Packet 5 MG	5 MG	30	Packets	30	DAYS
Nexium 24hr	esomeprazole magnesium tab delayed release	20 MG	30	Tablets	30	DAYS
Nexium ; Nexium 24hr ; Nexium 24hr clear minis	esomeprazole magnesium cap delayed release	20 MG ; 40 MG	60	Capsules	30	DAYS
Prevacid ; Prevacid 24hr	lansoprazole cap delayed release	15 MG ; 30 MG	60	Capsules	30	DAYS
Prevacid solutab	lansoprazole tab delayed release orally disintegrating	15 MG ; 30 MG	60	Tablets	30	DAYS
Prilosec	Omeprazole Magnesium For Delayed Release Susp Packet 10 MG	10 MG	30	Packets	30	DAYS
Prilosec	Omeprazole Magnesium For Delayed Release Susp Packet 2.5 MG	2.5 MG	60	Packets	30	DAYS
Protonix	pantoprazole sodium ec tab	20 MG ; 40 MG	60	Tablets	30	DAYS
Protonix	pantoprazole sodium for delayed release susp packet	40 MG	60	Packets	30	DAYS
Rabeprazole sodium dr spr	rabeprazole sodium capsule sprinkle dr	10 MG	30	Capsules	30	DAYS
Voquezna	vonoprazan fumarate tab	10 MG	30	Tablets	30	DAYS
Voquezna	vonoprazan fumarate tab	20 MG	30	Tablets	30	DAYS
Zegerid	omeprazole-sodium bicarbonate powd pack for susp	20-1680 MG ; 40-1680 MG	60	Packets	30	DAYS
Zegerid ; Zegerid otc	omeprazole-sodium bicarbonate cap	20-1100 MG ; 40-1100 MG	60	Capsules	30	DAYS

CLIENT SUMMARY – STEP THERAPY

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
	omeprazole cap delayed release	10 MG ; 20 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Aciphex	rabeprazole sodium ec tab	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Dexilant	dexlansoprazole cap delayed release	30 MG ; 60 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Konvomep	omeprazole-sodium bicarbonate for oral susp	2-84 MG/ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Nexium	esomeprazole magnesium for delayed release susp pack ; esomeprazole magnesium for delayed release susp packet	10 MG ; 2.5 MG ; 20 MG ; 40 MG ; 5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Nexium 24hr	esomeprazole magnesium tab delayed release	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Nexium ; Nexium 24hr ; Nexium 24hr clear minis	esomeprazole magnesium cap delayed release	20 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Prevacid ; Prevacid 24hr	lansoprazole cap delayed release	15 MG ; 30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Prevacid solutab	lansoprazole tab delayed release orally disintegrating	15 MG ; 30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Prilosec	omeprazole magnesium for delayed release susp packet	10 MG ; 2.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Prilosec	Omeprazole Magnesium For Delayed Release Susp Packet 10 MG	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Prilosec	Omeprazole Magnesium For Delayed Release Susp Packet 2.5 MG	2.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Protonix	pantoprazole sodium ec tab	20 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Protonix	pantoprazole sodium for delayed release susp packet	40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Rabeprazole sodium dr spr	rabeprazole sodium capsule sprinkle dr	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Voquezna	vonoprazan fumarate tab	10 MG ; 20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Zegerid	omeprazole-sodium bicarbonate powd pack for susp	20-1680 MG ; 40-1680 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Zegerid ; Zegerid otc	omeprazole-sodium bicarbonate cap	20-1100 MG ; 40-1100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
	omeprazole cap delayed release	10 MG ; 20 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	vonoprazan fumarate tab		Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	vonoprazan fumarate tab		Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Aciphex	rabeprazole sodium ec tab	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Dexilant	dexlansoprazole cap delayed release	30 MG ; 60 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Konvomep	omeprazole-sodium bicarbonate for oral susp	2-84 MG/ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Nexium	Esomeprazole Magnesium For Delayed Release Susp Pack 2.5 MG	2.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Nexium	Esomeprazole Magnesium For Delayed Release Susp Packet 10 MG	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Nexium	Esomeprazole Magnesium For Delayed Release Susp Packet 20 MG	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Nexium	Esomeprazole Magnesium For Delayed Release Susp Packet 40 MG	40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Nexium	Esomeprazole Magnesium For Delayed Release Susp Packet 5 MG	5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Nexium 24hr	esomeprazole magnesium tab delayed release	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Nexium ; Nexium 24hr ; Nexium 24hr clear minis	esomeprazole magnesium cap delayed release	20 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Prevacid ; Prevacid 24hr	lansoprazole cap delayed release	15 MG ; 30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Prevacid solutab	lansoprazole tab delayed release orally disintegrating	15 MG ; 30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Prilosec	Omeprazole Magnesium For Delayed Release Susp Packet 10 MG	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Prilosec	Omeprazole Magnesium For Delayed Release Susp Packet 2.5 MG	2.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Protonix	pantoprazole sodium ec tab	20 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Protonix	pantoprazole sodium for delayed release susp packet	40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Rabeprazole sodium dr spr	rabeprazole sodium capsule sprinkle dr	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Voquezna	vonoprazan fumarate tab	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Voquezna	vonoprazan fumarate tab	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zegerid	omeprazole-sodium bicarbonate powd pack for susp	20-1680 MG ; 40-1680 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zegerid ; Zegerid otc	omeprazole-sodium bicarbonate cap	20-1100 MG ; 40-1100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

STEP THERAPY CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

TARGET AGENT(S)

PREREQUISITE AGENT(S)

Aciphex Sprinkle (rabeprazole) sprinkle capsule
Rabeprazole Sprinkle
Aciphex (rabeprazole) tablet*
Dexilant (dexlansoprazole) capsule*
Esomeprazole Strontium capsule
Konvomep (omeprazole/sodium bicarbonate) oral suspension
Nexium (esomeprazole magnesium) capsule*
Nexium (esomeprazole magnesium) suspension packet*
Prevacid (lansoprazole) capsule*
Prevacid Solutab (lansoprazole) orally disintegrating tablet (ODT)*
Prilosec (omeprazole) capsule*
Prilosec (omeprazole) suspension packet*
Protonix (pantoprazole) tablet*
Protonix (pantoprazole) suspension packet
Voquezna (vonoprazan) tablet
Zegerid (omeprazole/sodium bicarbonate) capsule*
Zegerid (omeprazole/sodium bicarbonate) suspension packet

Any generic proton pump inhibitor

*generic available

Target Agent(s) will be approved when ONE of the following is met:

The requested agent is eligible for continuation of therapy AND ONE of the following:

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy

1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
The patient has a medication history of use in the past 90 days, intolerance, or hypersensitivity to ONE prescription strength prerequisite agent OR
The patient has an FDA labeled contraindication to ALL prescription strength prerequisite agents.

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit criteria

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	Quantity limit for the Target Agent(s) will be approved when ONE of the following is met: The requested quantity (dose) does NOT exceed the program quantity limit OR The patient has ONE of the following: A diagnosis of a hypersecretory disease (i.e., Zollinger-Ellison Syndrome, Barrett's esophagitis, or esophageal stricture) OR Inadequate response to FDA labeled dosing with the requested agent OR A diagnosis of H pylori OR The requested quantity (dose) exceeds the program quantity limit AND ONE of the following: BOTH of the following: The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication OR BOTH of the following: The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR BOTH of the following: The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication Length of Approval: up to 12 months Hypersecretory disease (i.e., Zollinger-Ellison Syndrome, Barrett's esophagitis, or esophageal stricture) - up to 12 months Inadequate response to FDA labeled dosing - up to 12 months H. pylori treatment - one time

Module

Clinical Criteria for Approval

Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

The requested quantity (dose) does NOT exceed the program quantity limit OR
The patient has ONE of the following:
1. A diagnosis of a hypersecretory disease (i.e., Zollinger-Ellison Syndrome, Barrett's esophagitis, or esophageal stricture) OR
2. Inadequate response to FDA labeled dosing with the requested agent OR
3. A diagnosis of H pylori OR
The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
1. BOTH of the following:
  1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication OR
2. BOTH of the following:
  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
  2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
3. BOTH of the following:
  1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 12 months

Hypersecretory disease (i.e., Zollinger-Ellison Syndrome, Barrett's esophagitis, or esophageal stricture) - up to 12 months
Inadequate response to FDA labeled dosing - up to 12 months
H. pylori treatment - one time

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

Commercial _ PS _ PPIs_STQL _ProgSum_ 04-01-2025