Esomeprazole Magnesium TrihydrateEsopreze
Recommended GastroenterologyRestrictedNot applicable line
Healing of peptic ulcers (gastric ulcers) associated with non-steroidal anti-inflammatory drug (NSAID) therapy (non-selective and COX-2 selective).
2
Submissions
2005–05
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2013 Recommended 20mg and 40mg modified release capsules Noxicid® Alphapharm Pty Limited Minor submission Alimentary tract disorders Listing of a new salt and form of esomeprazole (esomeprazole magnesium capsules) under the same conditions as the currently listed esomeprazole magnesium trihydrate tablets (Nexium®) w no PSD
- Meeting Nov 2010 Recommended Gastro-oesophageal reflux disease no PSD
- Meeting Jul 2010 Not recommended Gastroesophageal reflux disease (GORD). Patients requiring nonsteroidal anti-inflammatory drug therapy. Prevention of rebleeding of gastric or duodenal ulcers following treatment with Nexium IV solution by intravenous infusion. Pathological hypersecretory conditions including Zollinger-Ellison syndr no PSD
- Meeting Mar 2010 Recommended Acid related disorders, such as gastro-oesophageal reflux no PSD
Access path
- TGA registered · Esopreze
TGA label narrower than the PBS population
- Nov 2005Recommended · restricted
Listing: Restricted benefit → Restricted
- Nov 2005Recommended · restricted
Listing: Restricted benefit → Restricted
- PBS listing · Restricted
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission sought listing on cost-minimisation basis with esomeprazole considered equi-effective to omeprazole.
The submission sought listing on a cost-minimisation basis with esomeprazole 20 mg daily for 4 to 8 weeks considered equi-effective to omeprazole 20 mg daily for 4 to 8 weeks. PSD · 2005
Cost-effectiveness accepted
Decision context
PopulationAdults with gastric ulcers associated with NSAID (non-selective and COX-2 selective) therapy who require healing of peptic ulcers.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2005 | Recommended · restricted | omeprazole | — | RCT · ARD (absolute risk reduction) |
| Nov 2005 | Recommended · restricted | omeprazole | — | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to gastric ulcers not associated with H. pylori; TGA label covers all NSAID-associated gastric ulcers without this exclusion.