Tamsulosin HydrochlorideAPO-Tamsulosin SR
Recommended UrologyUnrestrictedNot applicable line
Lower urinary tract symptoms due to benign prostatic hyperplasia (BPH)
3
Submissions
2 resub
2008–10
On the record
$15k–75k
ICER range
3 sourced ICERs · 2008–2010
ICER stated
Cost basis
Decisions on record
- Meeting Nov 2010 Recommended Symptoms associated with an enlarged prostate gland
- Meeting Nov 2008 Not recommended For the relief of lower urinary tract symptoms associated with benign prostatic hyperplasia.
- Meeting Mar 2008 Not recommended Enlarged prostate
Access path
- TGA registered · APO-Tamsulosin SR
TGA label equal than the PBS population
- Mar 2008Not recommended
unacceptably high and uncertain cost-effectiveness ratios, small incremental clinical benefit over placebo…
- ↻ resubmittedNov 2008Recommended
Comparator changed: placebo → prazosin and placebo
- Nov 2010Recommended · restricted
ICER dropped $75,000 → $45,000 (-40%)
- PBS listing · Unrestricted
RecommendedDeferredNot recommended
Cost-effectiveness
The PBAC recommended the listing of tamsulosin on the PBS as an unrestricted benefit on a cost-minimisation basis compared with prazosin. PBAC · 2010
ICER uncertain ×2ICER / price too high ×2Economic model disputedSurrogate endpointCost-effectiveness accepted
Decision context
Populationpatients with lower urinary tract symptoms due to benign prostatic hyperplasia
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2010 | Recommended · restricted | prazosin | $15k–45k | RCT · other |
| Nov 2008 | Recommended | prazosin and placebo | $15k–75k | RCT · IPSS |
| Mar 2008 | Not recommended | placebo | $15k–75k | RCT · IPSS |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA and PBAC indications cover relief/treatment of LUTS associated with BPH with no additional restrictions or narrowing.