Proton Pump Inhibitors

POLICY NUMBER

L.5.01.464

Aciphex (rabeprazole)

Dexilant (dexlansoprazole)

Nexium (esomeprazole)

Prevacid (lansoprazole)

Prilosec (omeprazole)

Protonix (pantoprazole)

Zegerid (omeprazole/sodium bicarbonate)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Proton pump inhibitors (PPIs) are effective for the treatment of a variety of acid-related disorders including peptic ulcer disease, treatment and prevention of gastroduodenal ulcers associated with NSAIDs, gastroesophageal reflux disease and its complications (e.g. esophageal strictures, Barrett’s esophagus), laryngopharyngeal reflux, Zollinger-Ellison syndrome, and eradication of Helicobacter pylori.

PPIs exert their pharmacologic effect by inhibiting H-K-ATPase, an enzyme present in the parietal cells of the stomach that is necessary for hydrogen ion transport into the gastric lumen (the final step in gastric acid secretion). Although the currently available PPIs differ in their bioavailability, peak plasma levels, and routes of excretion, it is unknown whether these differences have any clinical significance.

PPIs provide the most rapid symptomatic relief and heal esophagitis in the highest percentage of patients with GERD of any of the available medical treatments. The PPIs may be considered therapeutically interchangeable because of their comparable pharmacologic properties, clinical efficacy and safety profiles. Consistent results of clinical trials in patients with duodenal ulcers, gastric ulcers, GERD, hypersecretory conditions, and other acid-related disorders strongly suggest that there is a class effect of PPIs for these disorders, although differences in dosage formulations and drug interactions may occasionally influence choice of PPI in individual cases.

Therapeutic Drug Class LimitPPIs are limited to one prescription drug per therapeutic class within a 30 day supply.

Quantity Limits*

*For quantity limit overrides, the requested dose must be within FDA approved labeled dosage per the individual product’s specific prescribing information. 

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Dexilant (dexlansoprazole) may be considered medically necessary when ALL of the following criteria are met:

1. The individual is 12 years of age or older;

2. The individual has a documented diagnosis of ONE of the following:

   1. Erosive esophagitis;

   2. Heartburn; OR

   3. Symptomatic non-erosive gastroesophageal reflux disease (GERD)

3. ONE of the following:

   1. The individual has tried and failed (see definition of Medication Failure in Policy Guidelines section) at least ONE generic PPI; OR

   2. The individual has a documented intolerance, FDA-labeled contraindication, or hypersensitivity to ALL generic PPI alternatives;

4. The individual does not have any contraindication(s) to therapy with the requested agent; AND

5. The prescribed dosage is within the program quantity limit based on FDA-approved labeled dosage.

The requested agent may be considered medically necessary for a quantity greater than the program quantity limit when the prescribed dosage and duration of therapy is based on FDA-approved labeled dosage for the indication being treated per the individual agent’s prescribing information.

Zegerid (omeprazole-sodium bicarbonate) is considered not medically necessary as other formulary options exist for the treatment of duodenal ulcer, gastric ulcer, erosive esophagitis, and GERD.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. 

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Medication Failure

Medication failure is defined as disease progression at generally accepted doses (for >2 weeks use) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.

BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

01/01/2014: New policy added.

08/14/2015: Code Reference section updated for ICD-10.

10/27/2015: Policy section updated to state: Previous use of samples or vouchers/coupons will not be considered for authorization.

04/01/2016: Policy description updated to add generics rabeprazole and esomeprazole to the table regarding Maximum Daily Dosage. First policy statement revised to state that the intent of the PPI generic first program is to encourage the use of cost-effective preferred generic PPIs prior to the use of brand PPIs and high cost generic PPIs. Added generic esomeprazole to the first policy statement. Added policy statement that generic Zegerid will be covered if certain criteria are met. Investigative definition updated in policy guidelines section.

05/31/2016: Policy number L.5.01.464 added.

08/09/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

08/15/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

05/31/2018: Deleted outdated references from Sources section.

07/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug names to the top of the policy. Maximum daily dosage for PPIs updated in policy description. First policy statement criteria revised to state: The patient's medication history includes documented use and failure (≥ 3 months use) of a generic PPI. Coverage criteria for generic Zegerid revised to state: The patient has documented failure (≥ 3 months use) of all generic and OTC PPI medications. Sources updated.

10/01/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy title changed from "Proton Pump Inhibitors Generic First Program" to "Proton Pump Inhibitors." Policy description revised. Removed FDA approved indications and dosage table. Added generic drug names. Policy section updated to add that prior authorization is required and that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Revised policy statement to state that Nexium (esomeprazole) and Dexilant (dexlansoprazole) will be approved when the listed criteria are met. Policy Exceptions updated to remove statement regarding the proton pump inhibitor generic first program for FEP and State Health Plan members. Sources updated.

05/01/2021: Policy description updated to remove the maximum daily dosage table and add table listing the quantity limits for each drug. Removed Nexium (esomeprazole) from policy statement and revised medically necessary criteria for Dexilant (dexlansoprazole). Added statement that the requested agent may be considered medically necessary for a quantity greater than the program quantity limit when the prescribed dosage and duration of therapy is based on FDA approved labeled dosage for the indication being treated per the individual agent’s prescribing information. Added statement that Zegerid (omeprazole-sodium bicarbonate) is considered not medically necessary as other formulary options exist for the treatment of duodenal ulcer, gastric ulcer, erosive esophagitis, and GERD. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders," to add information regarding BCBSMS request for medical records, and to define medication failure. Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

06/03/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Policy statement criteria revised to change "member" to "individual." Sources updated.

SOURCE(S)

1. Aciphex prescribing information. Waylis Therapeutics LLC. January 2025. Last accessed April 2025.

2. Dexilant prescribing information. Takeda Pharmaceuticals America, Inc. February 2025. Last accessed April 2025.

3. Nexium prescribing information. AstraZeneca Pharmaceuticals LP. July 2023. Last accessed April 2025.

4. Prevacid prescribing information. Takeda Pharmaceuticals America, Inc. September 2023. Last accessed April 2025.

5. Prilosec prescribing information. Covis Pharma US, Inc. March 2024. Last accessed April 2025.

6. Protonix prescribing information. Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. July 2024. Last accessed April 2025.

7. Zegerid prescribing information. Santarus, Inc. July 2023. Last accessed March 2025.

CODE REFERENCE

None