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
From the public summary
Roehrborn CG, et The effects of transurethral needle The Journal of Urology; 162: al (1999). ablation and resection of the prostate on 92-7. pressure flow urodynamics parameters: analysis of the United States randomized study.PSD · Nov 2009
Trueman P, et al Prevalence of lower urinary tract BJU International; 83: 410- (1999). symptoms and self-reported diagnosed 415. 'benign prostatic hyperplasia', and their effect on quality of life in a community- based survey of men in the UK. 8. Results of Trials The following table shows the 48 month data from the ARI40005 (Roehrborn 2008) trial together with the 24 month data which was used in the previous submission.PSD · Nov 2009
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.