DutasterideAKM DUTASTERIDE
Treatment, in combination with an alpha-antagonist, of lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) where treatment is initiated by a urologist.
Decisions on record
- Meeting Nov 2009 Recommended Benign prostatic hyperplasia
- Meeting Jul 2009 Not recommended Benign prostatic hyperplasia
Access path
- TGA registered · AKM DUTASTERIDE
TGA label narrower than the PBS population
- Jul 2009Not recommended
uncertain clinical benefit, highly uncertain cost effectiveness, uncertainty in utilities applied to health states in…
- ↻ resubmittedNov 2009Recommended · restricted
Comparator changed: prazosin monotherapy → tamsulosin (alpha-antagonist monotherapy)
- PBS listing · Authority Required
Cost-effectiveness
On balance the PBAC concluded that the four year data from trial ARI40005 provided in the re-submission and incorporated in the economic model reduced the clinical and economic uncertainty and the ICER of between $15,000 – $45,000 was acceptable. PBAC · 2009
Decision context
PopulationMen with moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia, treated in combination with an alpha-antagonist, where treatment is initiated by a urologist.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2009 | Recommended · restricted | tamsulosin (alpha-antagonist monotherapy) | $15k–45k | RCT · IPSS |
| Jul 2009 | Not recommended | prazosin monotherapy | $15k–45k | RCT · IPSS score improvement |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to men over 50 years meeting certain criteria; TGA label includes all patients with symptomatic BPH and enlarged prostate.