Methylphenidate Hydrochloride Extended Release
Treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6–18 years who have demonstrated a response to immediate release methylphenidate hydrochloride with no emergence of serious adverse events, and who require coverage beyond that provided by immediate release methylphenidate hydrochloride preparations.
Cost-effectiveness
No ICER presented; economic analysis section notes two methods for determining equi-effective doses but does not present a cost-effectiveness analysis or ICER.
Although not directly relevant to its decision, the PBAC noted that the limited clinical evidence provided make it difficult to determine the equi-effective doses of Ritalin LA and Concerta. PBAC · 2007
Decision context
PopulationChildren and adolescents aged 6–18 years with ADHD who have demonstrated a response to immediate release methylphenidate hydrochloride with no emergence of serious adverse events.
Why it was knocked back
- Insufficient evidence to establish non-inferiority to Concerta; trial design (single-dose crossover) does not allow extrapolation to real-life ongoing clinical practice; no adequate clinical comparison with immediate release methylphenidate provided; equi-effective doses between Ritalin LA and Concerta could not be reliably determined
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2007 | Not recommended | Concerta (extended release methylphenidate); immediate release methylphenidate | — | RCT · SKAMP-Attention score |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to ages 6–18 years with prior IR methylphenidate response; TGA label has no stated age or prior-treatment limits.