RabeprazoleAPO-RABEPRAZOLE
Recommended GastroenterologyRestrictedNot applicable line
Gastro-oesophageal reflux disease (GORD), prevention of relapse of GORD, symptomatic treatment of GORD, and treatment of active duodenal or gastric ulcer.
1
Submissions
2022–22
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Mar 2022 Recommended Complex gastro-oesophageal reflux disease, scleroderma oesophagus, peptic ulcer
Access path
- TGA registered · APO-RABEPRAZOLE
TGA label narrower than the PBS population
- Mar 2022Recommended
vs rabeprazole 20 mg 30-tablet pack
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended the listing of rabeprazole 20 mg 28-tablet pack with a maximum quantity of 28 tablets.PSD · Mar 2022
5.2 The PBAC noted the pre-PBAC response proposed listing rabeprazole 20 mg 28-tablet pack with a maximum quantity of 30. The PBAC did not consider this request appropriate because of the potential wastage caused by breaking a 28 pack of rabeprazole to make up the quantity of 30.PSD · Mar 2022
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as no new clinical evidence or efficacy improvement claimed.
The PBAC noted that its recommendation was on a cost-minimisation basis and advised that, because rabeprazole 20 mg 28-tablet pack is not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over other currently listed rabeprazole 20 mg 30-tablet packs, or not expected to address a high and urgent unmet clinical need given the presence of an alternative therapy, the criteria prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009 for Pricing Pathway A were not met. PBAC · 2022
ICER / price too high
Decision context
PopulationPatients requiring short-term treatment courses of rabeprazole 20 mg for GORD or ulcer disease (4-8 weeks).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Recommended | rabeprazole 20 mg 30-tablet pack | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to short-term treatment courses of 4-8 weeks, while TGA label does not specify duration limits.