Olmesartan Medoxomil, Amlodipine, HydrochlorothiazideAPO-OLMESARTAN/AMLODIPINE/HCTZ
Recommended CardiovascularRestrictedLater-line line
Treatment of hypertension in patients whose blood pressure is not adequately controlled by two of the following: an angiotensin II receptor antagonist, a dihydropyridine calcium channel blocker, or a diuretic.
1
Submissions
2013–13
On the record
—
ICER range
Cost-min
Cost basis
Access path
- TGA registered · APO-OLMESARTAN/AMLODIPINE/HCTZ
TGA label narrower than the PBS population
- Jul 2013Recommended
vs individual components given concomitantly (amlodipine…
- PBS listing · Restricted
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated
The submission presented a cost-minimisation analysis based on the claim that Sevikar HCT is non-inferior to its individual components given concomitantly. PSD · 2013
Decision context
PopulationPatients with hypertension whose blood pressure is not adequately controlled with two of the following: an angiotensin II receptor antagonist, a dihydropyridine calcium channel blocker, or a diuretic.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2013 | Recommended | individual components given concomitantly (amlodipine, hydrochlorothiazide, olmesartan); Exforge HCT (amlodipine, hydroc | — | RCT · Seated diastolic blood pressure and seated systolic blood pressure reduction |
Similar precedents
Olmesartan Medoxomil With Amlodipine91%Olmesartan Medoxomil With Hydrochlorothiazide84%Amlodipine (As Besylate) With Valsartan And Hydrochlorothiazide80%Amlodipine Besylate With Valsartan74%Valsartan With Hydrochlorothiazide75%Olmesartan Medoxomil73%Telmisartan With Amlodipine68%Perindopril Arginine With Amlodipine Besylate66%
Regulatory · TGA
Label narrower than PBS population — PBAC limits to patients uncontrolled on two agents; TGA allows replacement or add-on to any dual combination including those already controlled.