030 Form

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Pharmacy Medical Policy Proton Pump Inhibitors Table of Contents Authorization Information Summary
Coverage Criteria Appendix Policy History
References

Policy Number: 030 BCBSA Reference Number: N/A Related Policies • Quality Care Dosing guidelines may apply and can be found in Medical Policy #621B

Prior Authorization Information

Policy ☒ Prior Authorization ☐ Step Therapy ☒ Quality Care Dosing ☐ Administrative Reviewing Department Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 To request for coverage: Providers may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

Individual Consideration for the atypical patient: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy Last Updated 11/2025 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☐ MED Policy applies to Commercial members with BCBSMA formulary:
• Managed Care (HMO/POS) • PPO/EPO
• Indemnity
• MEDEX with Rx plans • Managed Blue for Seniors Policy does NOT apply to: • Medicare Advantage
Provider Documentation Requirements: Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason. We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or that step therapy criteria has been met. Other documentation requirements, if any, are outlined in prior authorization criteria.
See Appendix for additional information.

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Summary This is a comprehensive policy covering prior authorization and quantity limit requirements for proton pump inhibitors (PPIs). Please refer to the chart below for the formulary status/requirements of the medications affected by this policy:

Drug Formulary Status
(BCBSMA Commercial Plan) Special Considerations Omeprazole Covered, QCD Limited Coverage - excluded from coverage under the pharmacy benefit for members 18 years of age and older Pantoprazole Covered, QCD Lansoprazole 30mg Covered, QCD Lansoprazole ODT Covered, QCD Rabeprazole Covered, QCD First Omeprazole Suspension Covered, QCD Non-Formulary, Non-Covered Esomeprazole PA, NFNC PA Required AND also meet Non- formulary exception criteria.

Limited Coverage - excluded from coverage under the pharmacy benefit for members 18 years of age and older Dexlansoprazole PA, NFNC, QCD Aciphex ® PA, NFNC, QCD Aciphex ® Sprinkle PA, NFNC, QCD Dexilant TM PA, NFNC, QCD Konvomep (omeprazole/sod bicarbonate) 2-84mg/ml susp PA, NFNC, QCD Nexium ® 40mg PA, NFNC, QCD Nexium packets PA, NFNC, QCD Omeprazole + Syrspend PA, NFNC Omeprazole/sodium bicarbonate PA, NFNC, QCD Omeprazole/Aspirin PA, NFNC, QCD Prevacid ® 30mg PA, NFNC, QCD Prevacid ® solutabs PA, NFNC, QCD Prilosec ® PA, NFNC, QCD Prilosec suspension PA, NFNC, QCD Protonix ® PA, NFNC, QCD Voquezna (vonoprazan) PA, NFNC, QCD Yosprala PA, NFNC, QCD Zegerid ® 40mg, Zegerid packets PA, NFNC, QCD PA – Prior Authorization; NFNC – Non-formulary, Non-Covered; QCD (Quality Care Dosing – refer to Policy 621b)
Length of Approval 12 months IMPORTANT COVERAGE INFORMATION Important Coverage Information Effective 1/1/2019: • As of 1/1/2019 Proton Pump Inhibitors are a Benefit Exclusion for any member which is 18 years or older unless an account has purchased a Rider.

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Non-Covered Over-the-counter products: Nexium® (esomeprazole) 20mg, Prilosec OTC®, Prevacid® (lansoprazole) 15mg, Omeppi 20mg, Zegerid 20mg capsules or omeprazole/sodium bicarbonate 20mg capsules are not covered because these medications are available without a prescription and therefore excluded from coverage under the pharmacy benefit.

Clinical Guideline Coverage Criteria

Esomeprazole and Dexlansoprazole Esomeprazole or Dexlansoprazole may be covered when the following criteria is met:

1. There has been previous treatment failure with or contraindication to omeprazole AND pantoprazole AND lansoprazole 30mg AND rabeprazole 20mg Yosprala (aspirin and omeprazole) and Aspirin/Omeprazole Yosprala (aspirin and omeprazole) or Aspirin/Omeprazole may be covered when ALL of the following criteria are met:
2. Documentation that the requested medication is being used for the secondary prevention of cardiovascular and cerebrovascular events; AND

3. There has been previous treatment failure with ALL of the following alternatives: a. Omeprazole plus OTC aspirin; AND b. Pantoprazole plus OTC aspirin; AND c. Lansoprazole plus OTC aspirin; AND d. Rabeprazole plus OTC aspirin All other Proton Pump Inhibitors Aciphex ®, Aciphex ® Sprinkle™, Dexilant ™, Konvomep (omeprazole/sodium bicarbonate) 2- 84mg/ml oral susp, Nexium ® 40mg, Nexium packets, Omeprazole/sodium bicarbonate 40mg, Omeprazole/sodium bicarbonate 20mg, Omeprazole + Syrspend, , Prevacid 30mg ®, Prevacid ® solutabs, Prilosec ®, Prilosec suspension, Protonix ®, Zegerid ® 40mg, or Zegerid packets
   may be covered when ALL of the following criteria is met:

4. There has been previous treatment failure with or contraindication to omeprazole AND pantoprazole AND lansoprazole AND rabeprazole AND esomeprazole. Potassium-Competitive Acid Blocker (PCAB) Voquezna (vonoprazan) may be covered when ALL of the following criteria are met:
5. Documentation of any ONE of the following diagnoses: a. For healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults;
   b. For maintaining healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults;
   c. For the relief of heartburn associated with non-erosive gastroesophageal reflux disease in adults (GERD). d. in combination with amoxicillin OR amoxicillin and clarithromycin for the treatment of Helicobacter pylori (H. pylori) infection in adults. AND

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2. Trial and failure of, or contraindicated to, the following covered alternatives according to FDA labeling: a. For the treatment of heartburn associated with non-erosive GERD in adults: omeprazole AND pantoprazole AND lansoprazole
   b. For all other indications: omeprazole AND pantoprazole AND lansoprazole AND rabeprazole. Appendix Formulary Status For non-covered medications, in addition to the prior authorization criteria, the member must also have had a previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available. See section on individual consideration for more information if you require an exception to any of these criteria requirements for an atypical patient. Member cost share consideration A higher non-preferred cost share may be applied if an exception request is approved for coverage of a non-preferred or a non-formulary/non-covered drug. Forms To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below: https://www.bluecrossma.org/medical- policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf OR Print and fax, Massachusetts Standard Form for Medication Prior Authorization Requests #434 Individual Consideration (for Atypical Patients) Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.
   If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
   Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).
   To facilitate a thorough and prompt review of an exception request, we encourage the provider to include additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements; • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable; • Clinical literature from reputable peer reviewed journals; • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines

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Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to: Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043 Phone: 1-800-366-7778 Fax: 1-800-583-6289 Samples Requests based exclusively on the use of samples will not meet coverage criteria for exception. Additional clinical information demonstrating medical necessity of the desired medication must be submitted by the requesting prescriber for review.

Policy History

Date Action 11/2025 Added new FDA indication to Voquenza and updated formatting and references. 1/2024 Updated to add Voquezna ® to the policy. 11/2023 Reformatted Policy. 10/2023 Reformatted Policy and updated IC section to align with 118E MGL § 51A 7/2023 Reformatted Policy. 4/2023 Updated to add Omeprazole + Syrspend ® and Konvomep™ to the Policy as non-preferred. 2/2023 Updated to add FIRST-OMEPRA SUS to policy at parity with Omeprazole. 4/2022 Updated to add Authorized Generic of Dexilant(dexlansoprazole) to the policy. 2/2020 Updated to include Aspirin/Omeprazole to the policy. 1/2019 Updated to add Exclusion note & remove Omeprazole/Syrspend Suspension. 6/2018 Updated to add Lansoprazole ODT. 9/2017 Updated to add Omeppi 40mg and to clarify criteria for Lansoprazole & Rabeprazole. 6/2017 Updated address for Pharmacy Operations. 01/2017 Updated Criteria for Branded PPIs. 10/2016 Updated to Include Yosprala criteria. 4/2016 Updated to remove First Products which were discontinued. 8/2015 Updated Request Form title. 3/2015 Updated to include two First Suspensions without PA. 10/2014 Updated to include No PA for Omeprazole and pantoprazole. Also to exclude Nexium 20mg because available OTC. 2/2014 Updated ExpressPAth language, added Esomeprazole, Omeprazole/Syrspend Suspension , Aciphex® Sprinkle™, and rabeprazole . 6/2012 Updated 6/12 to include coverage for pantoprazole as a Step 1 product. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements. 10/2011 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 3/2011 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy statements. 1/2011 Updated to update pantoprazole criteria and to add coverage criteria for omperazole/sodium bicarbonate. 1/2011 Updated to reflect name change of Kapidex™ to Dexilant™ and to include coverage criteria for omeprazole/sodium bicarbonate: newly released generic of Zegerid®.

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11/2010 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 3/2010 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy statements. 1/2010 Updated to remove step therapy language and to implement new prior authorization criteria. Lansoprazole and Prevacid® 15mg moved to benefit exclusion. 11/2009 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 3/2009 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy 8/2009 Updated to include Kapidex™ as a Step 3 medication for Standard formulary and Blue 1/2009 Updated for Medicare Advantage formulary. 9/2008 Updated to include generic pantoprazole on Step 2, movement of Prevacid® to Step 2, 1/2008 Updated approval criteria to require previous treatment or paid claim point of sale criteria 11/2007 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ 3/2007 Updated to include Step 3 criteria for Prevacid and consolidation of Omeprazole into Step 11/20/2005 New policy, effective 11/20/2005, describing covered and non-covered indications.

References

1. Prilosec [package insert]. Wilmington, DE: AstraZeneca LP; 09/2012.
2. Prevacid [package insert]. Lake Forest, IL: TAP Pharmaceuticals Inc.; 09/2012.
3. Protonix [package insert]. Philadelphia, PA: Wyeth Laboratories; 05/2012.
4. Aciphex [package insert]. Teaneck, NJ: Eisai Inc., and Titusville, NJ: Janssen Pharmaceuticals Inc, 12/2014.
5. Nexium [package insert]. Wilmington, DE: AstraZeneca LP; 12/2014.
6. Omeprazole delayed-release capsules [package insert]. Mequon, WI: Kremers Urban, Inc.; 2003.
7. Zegerid [package insert]. San Diego, CA: Santarus.; 07/2023.
8. Aciphex Sprinkle [package insert]. Wood Cliff Lake, NJ: Eisai Inc., and Titusville, NJ: Janssen Pharmaceuticals Inc, 12/2014.
9. Voquezna [package insert]. Buffalo Grove, IL: Phathom Pharmaceuticals, Inc.; 07/2024.
10. Dexilant [package insert]. Deerfield, IL. Takeda Pharmaceuticals, Inc. 09/2012.