script.reportAU
Neurology

Methylphenidate hydrochloride extended release

Brand: Ritalin LA

PBAC's latest decision on Methylphenidate hydrochloride extended release: Not recommended (2007). Considered for 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.

PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
1
first 2007
Submissions
1
2007 → 2007

Eligible population

Children 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.

Therapy area
Neurology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
SKAMP-Attention score
Pivotal trial size
90 patients
Key trials
US05, US07
Comparator
Concerta (extended release methylphenidate); immediate release methylphenidate
Economic model
BIA only
ICER note
No ICER presented; economic analysis section notes two methods for determining equi-effective doses but does not present a cost-effectiveness analysis or ICER.

Why PBAC said no

Reasons cited in the latest PSD: 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

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