Perindopril Arginine With Amlodipine BesylateAPO-Perindopril Arginine/Amlodipine
Substitution therapy for hypertension and stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine given concurrently at the same dose level.
Decision on record
- Meeting Mar 2010 Recommended Hypertension
Access path
- TGA registered · APO-Perindopril Arginine/Amlodipine
TGA label narrower than the PBS population
- Mar 2010Recommended · restricted
Comparator changed: perindopril arginine and amlodipine besylate given concomitantly →…
- Mar 2010Recommended · restricted
Comparator changed: perindopril arginine and amlodipine besylate given concomitantly →…
- PBS listing · Restricted
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design
The PBAC accepted that perindopril with amlodipine was non-inferior in terms of comparative effectiveness and equivalent in terms of comparative safety over perindopril and amlodipine monotherapies. PBAC · 2010
Decision context
PopulationPatients stabilised on treatment with perindopril and amlodipine given concomitantly at the same dose level for hypertension and/or stable coronary heart disease.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2010 | Recommended · restricted | perindopril arginine and amlodipine besylate given concomitantly | — | Bioequivalence studies, meta-analysis |
| Mar 2010 | Recommended · restricted | perindopril and amlodipine given concomitantly | — | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC adds hypertension as explicit indication; TGA label omits hypertension, focusing only on coronary heart disease.