Pharmacy Policy Bulletin
Title:
Proton Pump Inhibitors
Policy #:
Rx.01.75
Application of pharmacy policy is determined by benefits and contracts. Benefits may vary based on product
line, group, or contract. Some medications may be subject to precertification, age, quantity, or formulary
restrictions (ie limits on non-preferred drugs). Individual member benefits must be verified.
This pharmacy policy document describes the status of pharmaceutical information and/or technology at the
time the document was developed. Since that time, new information relating to drug efficacy, interactions,
contraindications, dosage, administration routes, safety, or FDA approval may have changed. This Pharmacy
Policy will be regularly updated as scientific and medical literature becomes available. This information may
include new FDA-approved indications, withdrawals, or other FDA alerts. This type of information is relevant
not only when considering whether this policy should be updated, but also when applying it to current
requests for coverage.
Members are advised to use participating pharmacies in order to receive the highest level of benefits.
Intent:
The intent of this policy is to communicate the medical necessity criteria for proton pump inhibitors (PPIs) as provided
under the member’s prescription drug benefit.
Description:
Proton Pump Inhibitors (PPIs) suppress gastric acid secretion by inhibiting hydrogen-potassium
adenosinetriphosphatase (H+/K+ ATPase) on the surface of parietal cells, the final step in acid secretion. PPIs are the
most potent gastric acid suppression agents and are most effective when the parietal cells are stimulated to produce
acid post-prandially.
PPIs are useful in treating peptic ulcer disease (including prevention and treatment of NSAID induced gastric ulcers),
gastroesophageal reflux disease (GERD) with and without esophageal erosions, hypersecretory diseases, and
helicobacter pylori infections (as part of an antibiotic containing regimen).
According to the American College of Gastroenterology's recommendation for the diagnosis and management of
GERD, there is no major difference in efficacy between the different PPIs" when used for an 8-week course to heal
erosive esophagitis. However, no clear recommendation on pharmacologically equivalent doses among the PPIs exists
and some individuals report better response to one agent compared to others.
Policy:
INITIAL CRITERIA Brand proton pump inhibitor capsules and tablets (e.g., Aciphex® tablets, Protonix® tablets,
Dexilant® capsules, Prilosec® capsules), or generic esomeprazole is approved when there is documentation of BOTH
of the following:
1. An FDA or compendia approved indication; and
2. ONE of the following:
a. Inadequate response to a two-week trial or inability to tolerate THREE of the following generic proton
pump inhibitors:
i. omeprazole
ii. lansoprazole
iii. pantoprazole
iv. rabeprazole; OR
b. The medication is requested for the treatment of stage IV, advanced metastatic cancer or a severe
adverse health condition experienced as a result of stage IV, advanced metastatic cancer
Initial authorization duration: H. Pylori 14 days; all other indications 2 years
