Lisdexamfetamine DimesilateVyvanse
Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients diagnosed between the ages of 6 and 18 years (inclusive) who have demonstrated a response to immediate release dexamphetamine sulphate with no emergence of serious adverse events and who require continuous coverage over 12 hours.
Decision on record
- Meeting Jul 2013 Not recommended Attention Deficit Hyperactivity Disorder (ADHD)
Access path
- TGA registered · Vyvanse
TGA label narrower than the PBS population
- Jul 2014Recommended
vs MPH-OROS (methylphenidate osmotic release oral system) for…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of lisdexamfetamine on a cost-minimisation basis with MPH-OROS in both children and adolescents. During the maintenance phase of Trial SPD 489-325 (FAS), the average daily doses of MPH-OROS and LDX were ''''''''''''''mg/day and ''''''''''''''mg/ respectively.PSD · Jul 2014
7.2 The PBAC accepted that a modest clinical need exists for alternative treatments for ADHD in children and adolescents as patient response to one treatment over another appears to be highly individualised.PSD · Jul 2014
6.18 The resubmission presents the following economic evaluations: Cost minimisation analysis versus MPH-OROS in children aged 6 to 12; Cost-utility analysis versus MPH-OROS in adolescents aged 13 to 17; and Cost-utility analysis versus “no pharmacological treatment” or “placebo” as proxy for standard of care in patients who have failed MPH-OROS.PSD · Jul 2014
6.19 The model presented in this resubmission is identical to that presented in July 2013, but with additional pre-modelling studies to update the model inputs. The ESC noted that disutilities associated with weight loss over time had still not been adequately accounted for, despite the inclusion of drug holidays as a proxy, and that this was a concerning limitation in the model.PSD · Jul 2014
6.15 A Summary of clinical claims for LDX by treatment setting are shown below:PSD · Jul 2014
Economic Treatment Patient Comparisons Clinical claim Evidence base evaluation setting population proposed Superior efficacy; Non- Adolescents Cost effectiveness inferior safety (caveat for (13-17 years) analysis “First-line” LDX vs MPH-OROS BMI effects) SPD489-325 Children Non-inferior efficacy; Non- Cost minimisation (6-12 years) inferior safety analysis 8PSD · Jul 2014
6.2 The PBAC noted and welcomed the input from individuals (7), health care professionals (22) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with lisdexamfetamine, including a significant improvement in children’s overall behaviour, an increased ability to complete work, a more convenient and manageable treatment regimen with fewer and more manageable side effects.PSD · Jul 2014
Cost-effectiveness
Economic evaluations presented (cost-minimisation analysis in children 6-12 years; cost-utility analyses in adolescents 13-17 years and in patients who failed MPH-OROS), but ICER values are redacted in the public summary document.
Decision context
PopulationChildren and adolescents aged 6-18 years with ADHD (diagnosed per DSM-IV with baseline ADHD-RS-IV total score ≥28) who have demonstrated a response to immediate release dexamphetamine sulphate with no emergence of serious adverse events and require continuous 12-hour coverage.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2014 | Recommended | MPH-OROS (methylphenidate osmotic release oral system) for first-line use; placebo for patients who have not demonstrate | — | RCT · ADHD-RS-IV total score (change from baseline) |
Consumer voice
Consumer input described significant improvements in children's behaviour and ability to complete work with lisdexamfetamine treatment, along with a more convenient regimen with fewer side effects. Concerns were raised about substantial financial strain on families accessing the medication through the private market and potential age-related diagnostic discrimination.
The comments described a range of benefits of treatment with lisdexamfetamine, including a significant improvement in children's overall behaviour, an increased ability to complete work, a more convenient and manageable treatment regimen with fewer and more manageable side effects. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to ages 6–18 years, prior dexamphetamine response, and 12-hour continuous coverage requirement; TGA label unrestricted by age or prior treatment.