Limited Coverage Drugs - Special Authority Criteria

Generic Name / Strength / Form

esomeprazole 40 mg

Criteria	Approval Period
1. For gastroesophageal reflux disease (GERD), reflux esophagitis, duodenal ulcer, or gastric ulcer after documented failure or intolerance to adequate doses of ranitidine or cimetidine or other H2 blocker PLUS failure or intolerance to rabeprazole AND pantoprazole magnesium.	Indefinite
OR
2. For Barrett's esophagus, Zollinger-Ellison syndrome, connective tissue disease, e.g., lupus, scleroderma, CREST. PLUS failure or intolerance to rabeprazole AND pantoprazole magnesium.	Indefinite
OR
3. For eradication of Helicobacter pylori, as part of triple therapy PLUS failure or intolerance to rabeprazole AND pantoprazole magnesium.	Maximum 14 days

Exceptions considered regarding rabeprazole and pantoprazole magnesium trials for identified pediatric and pregnant/lactating patients, and for those with uncommon gastrointestinal conditions.
CREST is an acronym for the five main features of the limited form of scleroderma: Calcinosis, Raynaud’s disease, Esophageal dysmotility, Sclerodactyly, and Telangiectasia.
“Failure or intolerance to rabeprazole AND pantoprazole magnesium” is defined as documented failure or intolerance after an 8-week trial of the first option at adequate doses, followed by documented failure or intolerance after a 4-week trial of the second option at adequate doses.

Proton Pump Inhibitors Request for Coverage (PDF)
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