Travoprost with timolol maleate, eye drops, 40 micrograms-5 mg (base) per mL (0.004%-0.5%), 2.5 mL, DuoTrav®, March 2007
Public summary document for Travoprost with timolol maleate, eye drops, 40 micrograms-5 mg (base) per mL (0.004%-0.5%), 2.5 mL, DuoTrav®, March 2007
Page last updated: 29 June 2007
Public Summary Document
Product: Travoprost with timolol maleate, eye
drops, 40 micrograms-5 mg (base) per mL (0.004%-0.5%), 2.5 mL,
DuoTrav®
Sponsor: Alcon Laboratories (Australia) Pty
Ltd
Date of PBAC Consideration: March 2007
1. Purpose of Application
The submission sought a change to the restricted benefit listing of
DuoTrav to include patients not adequately controlled on other
beta-blockers or other prostaglandin analogues.
2. Background
DuoTrav was recommended for listing at the PBAC’s July 2006
meeting on a cost minimisation basis with Xalacom® (latanoprost
0.005% with timolol 0.5%).
3. Registration Status
As at 8 September 2006 travoprost with timolol maleate
(DuoTrav®) was recorded in the Australian Register of
Therapeutic Goods (ARTG) as being indicated for the reduction of
elevated intraocular pressure in patients with open angle glaucoma
or ocular hypertension for whom single agent therapy provides
insufficient intraocular pressure reduction.
4. Listing Requested and PBAC’s View
Restricted benefit
Reduction of elevated intra-ocular pressure in patients with open
angle glaucoma, who are not adequately controlled with
beta-blockers or prostaglandin analogues.
Reduction of elevated intra-ocular pressure in patients with ocular
hypertension, who are not adequately controlled with beta-blockers
or prostaglandin analogues.
See Recommendation and Reasons for the PBAC’s
view
5. Clinical Place for the Proposed Therapy
This fixed combination product will provide a therapeutic
alternative where a single drug treatment for glaucoma or ocular
hypertension is not effective.
6. Comparator
The submission nominated concomitant administration of latanoprost
and timolol as the comparator.
7. Clinical Trials
A double masked, randomised parallel group, multicentre, active
control trial comparing the efficacy and safety of DuoTrav® to
concomitant latanoprost plus timolol in 156 patients previously
treated with latanoprost plus timolol was presented in the
submission.
This trial had not been published at the time of the
submission.
8. Results of Trials
The results of the key trial are summarised in the following
tables.
Mean IOP (mmHg), Change from Baseline (mmHg), and percent
IOP Change from Baseline (ITT Data)
| Treatment | Week 2 | Week 6 | Month 3 | |||
| 8AM | 8AM | 8AM | 10AM | 4PM | 8PM | |
| Travoprost 0.004%/timolol 0.5% | ||||||
| Mean IOP | 15.3 | 15.4 | 15.5 | 15.1 | 15.1 | 14.7 |
| Mean IOP Change | -0.1 | -0.0 | 0.1 | 0.5 | 0.5 | 0.4 |
| Mean % IOP Change | 0.0 | 0.3 | 1.2 | 4.6 | 4.5 | 3.4 |
| N | 73 | 73 | 73 | 71 | 71 | 71 |
| Xalatan 0.005%+Timolol 0.5% | ||||||
| Mean IOP | 15.4 | 15.6 | 15.5 | 14.8 | 14.9 | 14.8 |
| Mean IOP Change | -0.0 | 0.2 | 0.0 | 0.1 | 0.3 | 0.2 |
| Mean % IOP Change | -0.2 | 1.3 | 0.3 | 0.9 | 2.6 | 2.0 |
| N | 75 | 75 | 75 | 73 | 73 | 73 |
Estimates based on descriptive statistics
Mean IOP Change from Baseline (mmHg) Comparison (ITT
Data)
| Treatment | Baseline (mean IOP) | Week 2 | Week 6 | Month 3 | ||||||
| 8AM | 10AM | 4PM | 8PM | 8AM | 8AM | 8AM | 10PM | 4PM | 8PM | |
| Travoprost 0.004%/ | 15.4 | 14.6 | 14.5 | 14.4 | -0.1 | -0.0 | 0.1 | 0.5 | 0.5 | 0.4 |
| Tomolol 0.5% | ||||||||||
| Xalatan 0.005%+ | 15.4 | 14.7 | 14.6 | 14.7 | -0.0 | 0.2 | 0.0 | 0.1 | 0.3 | 0.2 |
| Timolol 0.5% | ||||||||||
| Difference | -0.0 | -0.1 | -0.1 | -0.3 | -0.1 | -0.2 | 0.1 | 0.4 | 0.2 | 0.2 |
| P-Value* | - | - | - | 0.8727 | 0.5025 | 0.8260 | 0.3883 | 0.5301 | 0.5735 | |
*P-Value from tow sample t-test
9. Clinical Claim
The submission described DuoTrav® as being no worse than
latanoprost plus timolol in terms of effectiveness and
toxicity.
10. Economic Analysis
Neither a preliminary economic evaluation nor a modelled economic
evaluation was presented.
11. Estimated PBS Usage and Financial Implications
The submission estimated that the likely number of packs dispensed
per year would be 10,000 – 50,000 by Year 3 of listing, while
the financial cost to the PBS minus any savings in use of other
drugs was estimated to be < $10 million per year.
12. Recommendation and Reasons
Based on the data presented in the submission, the PBAC recommended expanding the
current listing, on a cost minimisation basis as previously, to include patients not
adequately controlled on latanoprost. The PBAC noted that the sponsor agreed to the
wording of the restriction as proposed by the Secretariat.
Recommendation
TRAVOPROST with TIMOLOL MALEATE, eye drops, 40 micrograms-5 mg (base) per mL (0.004%-0.5%),
2.5mL
Amend the restriction to read:
Restricted benefit
Reduction of elevated intra-ocular pressure in patients with open angle glaucoma, who are not adequately controlled with timolol maleate 5 mg (base) per mL (0.5%) eye drops or latanoprost eye drops or travoprost eye drops;
Reduction of elevated intra-ocular pressure in patients with ocular hypertension, who are not adequately controlled with timolol maleate 5 mg (base) per mL (0.5%) eye drops or latanoprost eye drops or travoprost eye drops.
Maximum Quantity: ‡1
Repeats: 5
13. Context for Decision
The PBAC helps decide whether and, if so, how medicines should be
subsidised in Australia. It considers submissions in this context.
A PBAC decision not to recommend listing or not to recommend
changing a listing does not represent a final PBAC view about the
merits of the medicine. A company can resubmit to the PBAC or seek
independent review of the PBAC decision.
14. Sponsor’s Comment
Alcon accepts the Decision
