Trandolapril With VerapamilTarka
Not recommended CardiovascularRestricted
the treatment of hypertension. Treatment should not be initiated with this fixed dose combination.
1
Submissions
2005–05
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Nov 2007 Not recommended Anti-hypertensive no PSD
Access path
- TGA registered · Tarka
TGA label equal than the PBS population
- Nov 2005Not recommended
Lack of clinical need in patients with hypertension for the combination, concerns about inappropriate substitution for…
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation approach adopted; no ICER calculated as only drug costs were included in the preliminary economic evaluation.
Decision context
Populationpatients with hypertension who are not being treated with this fixed dose combination
Why it was knocked back
- Lack of clinical need in patients with hypertension for the combination, concerns about inappropriate substitution for ACE inhibitor with thiazide combinations, unconvincing evidence of superiority over individual components in the requested doses, verapamil not a drug of choice in hypertension treatment, unclear clinical need given small number of patients on concomitant therapy, potential for use beyond requested restriction (hypertension and angina) without evidence of additive effect
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2005 | Not recommended | trandolapril and verapamil SR used concomitantly; trandolapril and verapamil SR used individually | — | RCT, Meta-analysis · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
Similar precedents
Trandolapril With Verapamil Hydrochloride-Sr78%Ramipril With Felodipine68%Lercanidipine With Enalapril67%Telmisartan With Amlodipine65%Valsartan With Hydrochlorothiazide65%Perindopril Arginine With Amlodipine Besylate65%Amlodipine (As Besylate) With Valsartan And Hydrochlorothiazide63%Amlodipine Besylate With Valsartan63%
Regulatory · TGA
Label equal than PBS population — Both texts specify treatment of hypertension with the same contraindication on initiating therapy; PBAC adds clarification but does not narrow the population.