Atomoxetine HydrochlorideAPO-ATOMOXETINE
treatment of attention deficit hyperactivity disorder (ADHD) diagnosed between the ages of 6 and 18 years inclusive, by a paediatrician or psychiatrist according to the DSM-IV criteria
Decisions on record
- Meeting Mar 2016 Recommended Attention-deficit hyperactivity disorder no PSD
- Meeting Mar 2014 Recommended Strattera® Eli Lilly Australia Pty Limited Attention Deficit Hyperactivity Disorder To request that the current Authority Required listing for atomoxetine be changed to authority required (STREAMLINED) and the restriction wording be altered. no PSD
- Meeting Jul 2008 Recommended Attention Deficit Hyperactivity Disorder
- Meeting Jul 2008 Not recommended Attention Deficit Hyperactivity Disorder
- Meeting Nov 2006 Recommended Attention deficit hyperactivity disorder
Access path
- TGA registered · APO-ATOMOXETINE
TGA label narrower than the PBS population
- Nov 2005Not recommended
unacceptable and uncertain cost-effectiveness, uncertain utility valuations in economic model, concerns about…
- Nov 2005Not recommended
unacceptable and uncertain cost-effectiveness, reliability of the economic model considered uncertain, concerns about…
- Jul 2006Not recommended
uncertain cost-effectiveness due to unreliable economic model assumptions; biased delayed response assumption (50.4%…
- ↻ resubmittedNov 2006Recommended · restricted
ICER dropped $75,000 → $45,000 (-40%)
- Jul 2008Recommended · restricted
Listing: Authority Required → Authority required
- Jul 2008Recommended · restricted
Listing: Authority Required → Authority required
- PBS listing · Authority Required
Cost-effectiveness
No economic evaluation was presented in the submission
The PBAC recommended listing on a cost effectiveness basis over placebo at the new price proposed. The PBAC accepted that there is a clinical need for this product and that the restriction appropriately targets those patients most likely to benefit from treatment. PBAC · 2006
Decision context
Populationpatients with attention deficit hyperactivity disorder (ADHD) diagnosed between the ages of 6 and 18 years inclusive, by a paediatrician or psychiatrist according to the DSM-IV criteria
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2008 | Recommended · restricted | — | — | — |
| Jul 2008 | Recommended · restricted | — | — | RCT |
| Nov 2006 | Recommended · restricted | placebo | $15k–45k | RCT · Other |
| Jul 2006 | Not recommended | Placebo | $45k–75k | RCT · QoL |
| Nov 2005 | Not recommended | placebo | $15k–45k | Meta-analysis · ADHDRS-IV |
| Nov 2005 | Not recommended | placebo | $15k–45k | Meta-analysis · ADHDRS-IV response |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to ages 6–18 years, excluding adults covered by TGA label; requires specialist diagnosis (paediatrician or psychiatrist).