BalsalazideColazide
Recommended GastroenterologyRestrictedNot applicable line
Treatment of mild-to-moderate active ulcerative colitis, and maintenance of remission, in patients who are intolerant to sulfasalazine.
1
Submissions
1 resub
2017–17
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2017 Recommended Ulcerative colitis
- Meeting Jul 2017 Deferred Ulcerative colitis no PSD
Access path
- TGA registered · Colazide
TGA label equal than the PBS population
- Nov 2017Deferred
vs mesalazine
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC deferred the request to increase the maximum quantity of the currently listed pharmaceutical item balsalazide (Colazide®) to 280 capsules, to allow further analysis of utilisation, and consideration of the impact that an increase in maximum quantity may have on wastage, as well as the impact of higher doses on quality use of medicines and the cost-effectiveness of balsalazide treatment.PSD · Nov 2017
6.2 The PBAC recalled that it recommended the listing of balsalazide on a cost-minimisation basis compared to mesalazine. The recommended maximum quantity was based on trial data and the dose of the comparator, mesalazine.PSD · Nov 2017
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. This is a minor submission for a pack size increase of an existing listing.
The PBAC recalled that it recommended the listing of balsalazide on a cost-minimisation basis compared to mesalazine. PBAC · 2017
Cost-effectiveness accepted
Decision context
PopulationPatients with mild-to-moderate active ulcerative colitis or in remission who are intolerant to sulfasalazine.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2017 | Deferred | mesalazine | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both texts describe identical indication: mild-to-moderate active ulcerative colitis treatment and remission maintenance in sulfasalazine-intolerant patients.