PBAC's latest decision on Trandolapril with verapamil: Not recommended (2005). Considered for the treatment of hypertension. Treatment should not be initiated with this fixed dose combination.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2005
Submissions
1
2005 → 2005
Eligible population
patients with hypertension who are not being treated with this fixed dose combination
Therapy area
Cardiovascular
Evidence base
RCT, Meta-analysis
Primary endpoint
OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null
Key trials
MPF/H9507, MPF/H9510, VT067, MPF/H9508*
Comparator
trandolapril and verapamil SR used concomitantly; trandolapril and verapamil SR used individually
Economic model
Cost-minimisation
ICER note
Cost-minimisation approach adopted; no ICER calculated as only drug costs were included in the preliminary economic evaluation.
Why PBAC said no
Reasons cited in the latest PSD: 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