Lisdexamfetamine
Treatment of attention deficit hyperactivity disorder (ADHD) in patients diagnosed after the age of 18 years, with retrospective confirmation of symptoms present before age 12.
Decisions on record
- Meeting Mar 2020 Recommended Attention deficit hyperactivity disorder (ADHD)
- Meeting Jul 2019 Recommended Attention deficit hyperactivity disorder (ADHD)
- Meeting Jul 2014 Recommended 30 mg, 50 mg and 70 mg Vyvanse® Shire Australia Pty Ltd New listing (Major submission) Attention deficit hyperactivity disorder (ADHD) Authority required listing for the treatment of attention deficit hyperactivity disorder (ADHD), in patients diagnosed between the ages of 6-18 years inclusive who m
Access path
- Jul 2013Not recommended
vs methylphenidate OROS (Concerta); dexamphetamine in…
- ↻ resubmittedJul 2019Recommended · restricted
Evidence: RCT → Single-arm
- Mar 2020Recommended
Evidence: Single-arm → RCT
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended expanding the listing of lisdexamfetamine (LDX) to include treatment of patients with attention deficit hyperactivity disorder (ADHD) who are diagnosed after the age of 18. The PBAC’s recommendation was based on, among other matters, its assessment that the cost-effectiveness of LDX in adults would be acceptable if LDX was no more costly on a per day basis (at ex-manufacturer price) for this population than the drug cost per …PSD · Mar 2020
6.2 In addition to the advice and support received from the Australian ADHD Professionals Association and the Royal Australian & New Zealand College of Psychiatrists (RANZCP), the PBAC noted that the consumer comments were strongly supportive of thePSD · Mar 2020
5.18 The minor submission did not present a formal economic evaluation. Rather, it proposed that a proportion of the price premium awarded to Concerta (in 2006) and other long-acting formulations over IR MPH in the child/adolescent population also be awarded to LDX in adults (relative to IR DEX).PSD · Mar 2020
5.19 The minor submission stated that the clinical claim had not taken into account the additional benefits provided to adults by LDX due to once daily dosing. These benefits were acknowledged by the PBAC for long-acting stimulant therapies in the child/adolescent setting in its November 2006 recommendation for Concerta, 10PSD · Mar 2020
5.16 The minor submission claimed that, within the limits of the available evidence, LDX is at least non-inferior to short-acting stimulants IR DEX and IR MPH in terms of efficacy.PSD · Mar 2020
5.17 The submission also claimed that LDX is non-inferior in terms of safety versus IR DEX and IR MPH.PSD · Mar 2020
5.2 The PBAC noted and welcomed the input from individuals (194), health care professionals (18) and organisations (1) via the Consumer Comments facility on the PBS website. The comments from health care professionals described the benefits of treatment with LDX with respect to once daily dosing, such as improved compliance due to ease of use, and sustained response to the medication.PSD · Mar 2020
5.3 The PBAC also noted that ADHD Australia was in strong support of the requested change to the listing. The comments emphasised that not all patients with ADHD are afforded the benefit of diagnosis in their early life. The organisation stated that it has been advocating for equity of access for long-acting ADHD medications for some time.PSD · Mar 2020
Cost-effectiveness
cost-minimisation analysis; no numeric ICER calculated. PBAC based recommendation on cost-effectiveness being acceptable if LDX was no more costly on a per day basis (at ex-manufacturer price) than IR DEX.
The minor submission estimated there to be no financial implications to the PBS as all strengths would be priced the same. PSD · 2019
Decision context
PopulationAdults diagnosed with ADHD after age 18 years with retrospective confirmation of symptoms of ADHD present before age 12 years, requiring continuous coverage over 12 hours, with maximum daily dose not exceeding 70 mg.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2020 | Recommended | immediate release dexamfetamine (IR DEX) | — | RCT · ADHD-RS (ADHD-Rating Scale total score); CGI-I (Clinical Global Impressions-ADHD Improvement) |
| Jul 2019 | Recommended · restricted | — | — | Single-arm · Surrogate |
| Jul 2013 | Not recommended | methylphenidate OROS (Concerta); dexamphetamine in first-line setting | $15k–45k | RCT · ADHD-RS-IV total score mean change from baseline |
Consumer voice
Individuals and healthcare professionals reported significant quality of life improvements with LDX treatment, particularly noting once-daily dosing benefits and sustained response. However, individuals highlighted financial hardship from accessing the medication via private prescription due to adult ADHD diagnosis, and ADHD Australia advocated for equitable access to long-acting ADHD medications.
The comments from health care professionals described the benefits of treatment with LDX with respect to once daily dosing, such as improved compliance due to ease of use, and sustained response to the medication. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to adults diagnosed after age 18 with retrospective symptom confirmation; TGA label covers all ADHD diagnoses regardless of diagnostic age.