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ph-91068

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

Policy Number: PH-91068

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
10-01-2025

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Rabeprazole Sprinkle Delayed-release capsule (sprinkle)	Treatment of gastroesophageal reflux disease (GERD) in pediatric patients 1 to 11 years of age		2
Aciphex® (rabeprazole) Delayed-release 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 Short-term treatment of symptomatic GERD in patients 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) Delayed-release capsule*	Healing of all grades of erosive esophagitis (EE) in patients 12 years of age and older Maintenance of healed EE and relief of heartburn in patients 12 years of age and older Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD) in patients 12 years of age and older	*generic available	3
Konvomep® (omeprazole and sodium bicarbonate) Oral suspension	Treatment of active benign gastric ulcer in adults Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients		16
Nexium® (esomeprazole magnesium) Delayed-release capsule* Delayed-release oral suspension packet*	Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age Maintenance of healing of EE in adults Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults Short-term treatment in the healing of EE in pediatric patients 1 year to 11 years of age and of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age (delayed-release oral suspension only) Short-term treatment of heartburn and other symptoms associated with GERD in pediatric patients 1 year to 11 years of age (delayed-release oral suspension only)	*generic available	5
Prevacid®, Prevacid® SoluTab™ (lansoprazole) Delayed-release capsule* Delayed-release orally disintegrating tablet*	Short-term treatment of active duodenal ulcer in adults Eradication of H. pylori 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 drugs (NSAID)-associated gastric ulcer in adults Risk reduction of NSAID-associated gastric ulcer in adults Short-term treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 12 to 17 years of age and pediatric patients one to 11 years of age for the treatment of other symptoms associated with GERD Short-term treatment of erosive esophagitis (EE) in adults and pediatric patients 12 to 17 years of age and pediatric patients one to 11 years of age for healing and symptom release of all grades of EE Maintenance of healing of EE in adults Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults	*generic available	6
Prilosec® (omeprazole) Capsule* Delayed-release oral suspension packet	Short-term treatment of active duodenal ulcer in adults Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults Short-term treatment of active benign gastric ulcer in adults Short-term treatment of symptomatic gastroesophageal relflux disease (GERD) in patients 1 year of age and older Short-term treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 year of age and older Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older Long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults Short-term treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (delayed-release oral suspension only)	*generic available	4,7
Protonix® (pantoprazole) Delayed-release tablet* Delayed-release oral suspension packet*	Short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (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 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) syndrome	*generic available	8
Voquezna® (vonoprazan) Tablet	Healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults Maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults Relief of heartburn associated with non-erosive gastroesophageal reflux disease in adults In combination with amoxicillin and clarithromycin for the treatment of Helicobacter pylori (H. pylori) infection in adults In combination with amoxicillin for the treatment of H. pylori infection in adults		18
Zegerid® (omeprazole and sodium bicarbonate) Capsule* Oral 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 EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults Maintenance of healing of EE 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 Barrett's esophagus (BE), dyspepsia, gastroesophageal reflux disease (GERD), peptic ulcer disease (PUD), eradication of Helicobacter pylori (H. pylori), and Zollinger Ellison syndrome (ZES).(10,12-15,17) For GERD, guidelines recommend an 8-week trial of a PPI once daily before a meal. If maintenance therapy is required, the lowest effective dose should be used to control symptoms. For patients who have extraesophageal and GERD symptoms, twice-daily PPI therapy for 8-12 weeks is appropriate before further testing. For patients with symptoms that are refractory to once-daily PPIs, doubling the dose or increasing to twice-daily dosing is supported in guidelines.(10) Severe GERD will often require long-term anti-reflux treatment.(19) BE recommendations suggest at least daily dosing of a PPI and consideration of higher doses or twice-daily dosing if patients require more symptom control.(13) PPIs and potassium competitive acid blockers (PCAB) agents are recommended as part of first-line treatment regimens for treatment-naive and treatment-experienced patients with H. pylori. Dosages vary depending on the specific treatment regimen but range from standard doses used twice daily to double doses twice to three times daily.(17) PPIs are the drug of choice for suppressing acid secretion in ZES and should be started at empirical maximized dosage (e.g., omeprazole 60 mg/day, pantoprazole 120 mg/day, esomeprazole 120 mg/day, lansoprazole 45 mg/day, rabeprazole 60 mg/day, in divided, twice-daily dosages.(14,15)

In a systematic review of 12 randomized trials evaluating effectiveness of PPI doses and dosing regimens found no consistent difference in symptom improvement or esophagitis healing rates, therefore confirming little relevance in which PPI is selected for treatment.(15) The degree to which any differences would justify the selection of one PPI over another, particularly when considering cost-effectiveness, is unclear. Differences in dosage formulations and drug interactions may occasionally influence choice of PPI in individual cases.(10,12-13)

Safety

Aciphex (rabeprazole) is contraindicated in the following:(1-2)

Patients with known hypersensitivity to rabeprazole
Patients receiving rilpivirine-containing products

Dexilant (dexlansoprazole) is contraindicated in the following:(3)

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

Konvomep (omeprazole and sodium bicarbonate) is contraindicated in the following:(16)

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

Nexium (esomeprazole) 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 (lansoprazole) is contraindicated in the following:(6)

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

Prilosec (omeprazole) is contraindicated in the following:(4,7)

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

Protonix (pantoprazole) 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 (vonoprazan) is contraindicated in the following:(18)

Known hypersensitivity to vonoprazan or any component of Voquezna
Patients receiving rilpivirine-containing products

Zegerid (omeprazole and sodium bicarbonate) 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 tablets prescribing information. Amneal Pharmaceuticals LLC. November 2023.
2	Rabeprazole delayed release capsule prescribing information. Sarras Health, LLC. December 2020.
3	Dexilant prescribing information. Takeda Pharmaceuticals America, Inc. February 2025.
4	Prilosec delayed-release capsule prescribing information. Chartwell RX, LLC. March 2023.
5	Nexium prescribing information. AstraZeneca Pharmaceuticals LP. July 2023.
6	Prevacid prescribing information. Takeda Pharmaceuticals America, Inc. August 2023.
7	Prilosec delayed-release oral suspension prescribing information. Covis Pharma US, Inc. March 2024.
8	Protonix prescribing information. Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. June 2023.
9	Zegerid prescribing information. Santarus, Inc. July 2023.
10	Katz PO, Dunbar KB, Schnoll-Sussman FH, Greer KB, Yadlapati R, Spechler SJ. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. The American Journal of Gastroenterology. 2021;117(1):27-56. doi:10.14309/ajg.0000000000001538
11	Reference no longer used.
12	Laine L, Barkun AN, Saltzman JR, Martel M, Leontiadis GI. ACG Clinical Guideline: Upper Gastrointestinal and Ulcer Bleeding. The American Journal of Gastroenterology. 2021;116(5):899-917. doi:10.14309/ajg.0000000000001245
13	Shaheen NJ, Falk GW, Iyer PG, et al. Diagnosis and Management of Barrett’s esophagus: an updated ACG guideline. The American Journal of Gastroenterology. 2022;117(4):559-587. doi:10.14309/ajg.0000000000001680
14	Halfdanarson TR, Strosberg JR, Tang L, et al. The North American Neuroendocrine Tumor Society Consensus Guidelines for Surveillance and Medical Management of Pancreatic Neuroendocrine Tumors. Pancreas. 2020;49(7):863-881. doi:10.1097/mpa.0000000000001597
15	Rossi RE, Elvevi A, Citterio D, et al. Gastrinoma and Zollinger Ellison syndrome: A roadmap for the management between new and old therapies. World Journal of Gastroenterology. 2021;27(35):5890-5907. doi:10.3748/wjg.v27.i35.5890
16	Konvomep prescribing information. Azuirty Pharmaceuticals, Inc. April 2024.
17	Chey WD, Howden CW, Moss SF, et al. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. The American Journal of Gastroenterology. 2024;119(9):1730-1753. doi:10.14309/ajg.0000000000002968
18	Voquezna prescribing information. Phathom Pharmaceuticals Inc. July 2024.
19	Yadlapati R, Gyawali CP, Pandolfino JE, et al. AGA Clinical Practice Update on the Personalized Approach to the Evaluation and Management of GERD: Expert review. Clinical Gastroenterology and Hepatology. 2022;20(5):984-994.e1. doi:10.1016/j.cgh.2022.01.025

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

		10 MG ; 20 MG ; 40 MG	M ; N ; O	Y
Aciphex		20 MG	M ; N ; O	O ; Y
Dexilant		30 MG ; 60 MG	M ; N ; O	O ; Y
Konvomep		2-84 MG/ML	M ; N ; O	N
Nexium		10 MG ; 2.5 MG ; 20 MG ; 40 MG ; 5 MG	M ; N ; O	O ; Y
Nexium 24hr		20 MG	M ; N ; O	N ; Y
Nexium ; Nexium 24hr ; Nexium 24hr clear minis		20 MG ; 40 MG	M ; N ; O	O ; Y
Prevacid ; Prevacid 24hr		15 MG ; 30 MG	M ; N ; O	O ; Y
Prevacid solutab		15 MG ; 30 MG	M ; N ; O	O ; Y
Prilosec		10 MG ; 2.5 MG	M ; N ; O	N
Prilosec		2.5 MG	M ; N ; O	N
Prilosec		10 MG	M ; N ; O	N
Protonix		20 MG ; 40 MG	M ; N ; O	O ; Y
Protonix		40 MG	M ; N ; O	O ; Y
Rabeprazole sodium dr spr		10 MG	M ; N ; O	N
Voquezna		10 MG ; 20 MG	M ; N ; O	N
Zegerid		20-1680 MG ; 40-1680 MG	M ; N ; O	O ; Y
Zegerid ; Zegerid otc		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
Aciphex	rabeprazole sodium ec tab	20 MG	60	Tablets	30	DAYS
Dexilant	Dexlansoprazole Cap Delayed Release 30 MG	30 MG	60	Capsules	30	DAYS
Dexilant	Dexlansoprazole Cap Delayed Release 60 MG	60 MG	30	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	60	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	60	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
		10 MG ; 20 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Aciphex		20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Dexilant		30 MG ; 60 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Konvomep		2-84 MG/ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Nexium		10 MG ; 2.5 MG ; 20 MG ; 40 MG ; 5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Nexium 24hr		20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Nexium ; Nexium 24hr ; Nexium 24hr clear minis		20 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Prevacid ; Prevacid 24hr		15 MG ; 30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Prevacid solutab		15 MG ; 30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Prilosec		10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Prilosec		2.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Prilosec		10 MG ; 2.5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Protonix		40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Protonix		20 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Rabeprazole sodium dr spr		10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Voquezna		10 MG ; 20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Zegerid		20-1680 MG ; 40-1680 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Zegerid ; Zegerid otc		20-1100 MG ; 40-1100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

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 ; SourceRx-Performance
Aciphex	rabeprazole sodium ec tab	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Dexilant	Dexlansoprazole Cap Delayed Release 30 MG	30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Dexilant	Dexlansoprazole Cap Delayed Release 60 MG	60 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Konvomep	omeprazole-sodium bicarbonate for oral susp	2-84 MG/ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
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 ; SourceRx-Performance
Nexium	Esomeprazole Magnesium For Delayed Release Susp Packet 10 MG	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Nexium	Esomeprazole Magnesium For Delayed Release Susp Packet 20 MG	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Nexium	Esomeprazole Magnesium For Delayed Release Susp Packet 40 MG	40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Nexium	Esomeprazole Magnesium For Delayed Release Susp Packet 5 MG	5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Nexium 24hr	esomeprazole magnesium tab delayed release	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
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 ; SourceRx-Performance
Prevacid ; Prevacid 24hr	lansoprazole cap delayed release	15 MG ; 30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Prevacid solutab	lansoprazole tab delayed release orally disintegrating	15 MG ; 30 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Prilosec	Omeprazole Magnesium For Delayed Release Susp Packet 10 MG	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
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 ; SourceRx-Performance
Protonix	pantoprazole sodium ec tab	20 MG ; 40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Protonix	pantoprazole sodium for delayed release susp packet	40 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Rabeprazole sodium dr spr	rabeprazole sodium capsule sprinkle dr	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Voquezna	vonoprazan fumarate tab	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Voquezna	vonoprazan fumarate tab	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
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 ; SourceRx-Performance
Zegerid ; Zegerid otc	omeprazole-sodium bicarbonate cap	20-1100 MG ; 40-1100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

STEP THERAPY CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

TARGET AGENT(S)

PREREQUISITE AGENT(S)

Rabeprazole Sprinkle capsule
Aciphex (rabeprazole) tablet*
Dexilant (dexlansoprazole) capsule*
Konvomep (omeprazole/sodium bicarbonate) oral suspension
Nexium (esomeprazole magnesium) capsule*
Nexium (esomeprazole magnesium) oral suspension packet*
Prevacid (lansoprazole) capsule*
Prevacid Solutab (lansoprazole) orally disintegrating tablet*
Prilosec (omeprazole) capsule*
Prilosec (omeprazole) oral suspension packet
Protonix (pantoprazole) tablet*
Protonix (pantoprazole) oral suspension packet*
Voquezna (vonoprazan) tablet
Zegerid (omeprazole/sodium bicarbonate) capsule*
Zegerid (omeprazole/sodium bicarbonate) oral 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 ONE of the following:
1. Has a medication history of use in the past 90 days to ONE prerequisite agent OR
2. Has an intolerance or hypersensitivity to ONE prerequisite agent OR
3. Has an FDA labeled contraindication to ALL prerequisite agent(s)

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
QL	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: Diagnosis of a hypersecretory disease (i.e., Zollinger-Ellison Syndrome, Barrett's esophagitis, or esophageal stricture) OR 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: H. pylori treatment - one time; All other indications - up to 12 months

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. Diagnosis of a hypersecretory disease (i.e., Zollinger-Ellison Syndrome, Barrett's esophagitis, or esophageal stricture) OR
2. 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: H. pylori treatment - one time; All other indications - up to 12 months

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 _ PPI_STQL _ProgSum_ 10-01-2025