PBAC's latest decision on Travoprost with timolol maleate: Not recommended (2005). Considered for reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension who are not adequately controlled with either a beta-blocker or a prostaglandin.
PBAC outcome
Not recommended
2005
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
1
first 2005
Submissions
1
2005 → 2005
Eligible population
patients with open angle glaucoma or ocular hypertension who are not adequately controlled with either a beta-blocker or a prostaglandin
Therapy area
Ophthalmology
Evidence base
RCT
Primary endpoint
IOP reduction
Key trials
C-01-70, C-02-41, C-01-69, C-20-03
Comparator
concomitant travoprost 0.004% instilled once daily in the evening and timolol maleate 0.5% instilled twice daily
Economic model
not modelled
ICER note
No economic evaluation was modelled. A cost-minimisation approach was proposed but rejected by PBAC as inappropriate given non-inferiority was not demonstrated.
Why PBAC said no
Reasons cited in the latest PSD: evidence does not convincingly demonstrate additive beneficial effectiveness over travoprost component, uncertainty about non-inferiority compared with concomitant travoprost and timolol, pre-specified non-inferiority criteria not met at all time points in trials C-01-70 and C-02-41, no data provided to substantiate compliance benefit claim