Methylphenidate HydrochlorideArtige
Treatment of attention deficit hyperactivity disorder (ADHD) in adults with a retrospective diagnosis of ADHD (diagnosed after age 18).
Decisions on record
- Meeting Mar 2022 Recommended Attention deficit hyperactivity disorder
- Meeting Mar 2020 Recommended Attention deficit hyperactivity disorder (ADHD)
- Meeting Jul 2012 Not recommended Attention deficit hyperactivity disorder in adults
- Meeting Mar 2010 Recommended Attention deficit hyperactivity disorder (ADHD) no PSD
- Meeting Jul 2009 Recommended Attention Deficit Hyperactivity Disorder (ADHD) no PSD
- Meeting Nov 2007 Recommended Attention Deficit Hyperactivity Disorder (ADHD) no PSD
- Meeting Jul 2007 Recommended Attention deficit hyperactivity disorder (ADHD)
- Meeting Jul 2007 Recommended Attention Deficit Hyperactivity Disorder (ADHD)
2 earlier decisions
- Jul 2007 Not recommended Attention Deficit Hyperactivity Disorder (ADHD)
- Nov 2006 Recommended Attention deficit hyperactivity disorder
Access path
- TGA registered · Artige
TGA label narrower than the PBS population
- Mar 2006Not recommended
uncertain extent of clinical benefit over comparator, uncertain cost-effectiveness, double-blind registration trials…
- Mar 2006Not recommended
uncertain extent of clinical benefit over the comparator, uncertain cost-effectiveness, no statistically significant…
- ↻ resubmittedNov 2006Recommended · restricted
Comparator changed: methylphenidate hydrochloride immediate release tablet (MPH IR) →…
- Jul 2012Recommended
Comparator changed: methylphenidate immediate release (MPH-IR) → methylphenidate extended…
- Mar 2020Recommended
Evidence: RCT → Cost-minimisation
- Mar 2022Recommended
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended expanding the listing of methylphenidate (Ritalin LA) to include treatment of patients with attention deficit hyperactivity disorder (ADHD) who 10PSD · Mar 2022
5.2 The PBAC noted the consumer input for this item indicating strong support for the expanded listing and considered that another treatment option for adult patients with a retrospective diagnosis of attention deficit hyperactivity disorder would be beneficial.PSD · Mar 2022
4.3 The submission proposed an approved ex-manufacturer price (AEMP) of $''''''''''', resulting in a dispensed price for maximum quantity (DPMQ) of $''''''''''. The proposed price is based on the AEMP of the 30 mg strength being ''''''% of the proposed AEMP of the 60 mg strength. This is consistent with the pricing approach accepted by PBAC when Ritalin LA 10mg was recommended for listing at the March 2010 meeting.PSD · Mar 2020
4.2 The PBAC noted and welcomed the input from individuals (131), health care professionals (21) and organisations (4) via the Consumer Comments facility on the PBS website. The comments from health care professionals described the benefits of treatment with Ritalin LA with respect to once daily dosing, such as improved compliance due to ease of use, and sustained response to the medication.PSD · Mar 2022
Individuals described the significant improvements in quality of life due to Ritalin LA, but also the financial hardship associated with having to access the medication via a private prescription due to a diagnosis of ADHD in adulthood.PSD · Mar 2022
Cost-effectiveness
This is a Category 3 submission (flow-on listing change with pricing adjustment) based on prior PBAC decision for LDX in March 2020. No de novo economic evaluation or ICER was conducted; the submission is a cost-minimisation analysis comparing Ritalin LA pricing to LDX post-price-reduction.
At the March 2020 PBAC meeting, the PBAC recommended expanding the listing of LDX in ADHD based on, among other matter, 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 patient per day of immediate release dexamfetamine. PBAC · 2022
Decision context
PopulationAdults with attention deficit hyperactivity disorder diagnosed after age 18 years, who have demonstrated a response to immediate-release methylphenidate with no emergence of serious adverse events and require continuous coverage over 8 hours.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Recommended | lisdexamfetamine (LDX) | — | Cost-minimisation · Cost-minimisation |
| Mar 2020 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
| Jul 2012 | Recommended | methylphenidate extended release (ER) used in patients diagnosed with attention deficit hyperactivity disorder (ADHD) ag | — | RCT · AISRS, CAARS |
| Nov 2006 | Recommended · restricted | methylphenidate immediate release (MPH-IR) | $15k | — |
| Mar 2006 | Not recommended | methylphenidate hydrochloride immediate release tablet (MPH IR) | — | RCT, Single-arm · remission defined as a score <1 on every item of the first 18-items of the SNAP-IV rating scale |
| Mar 2006 | Not recommended | methylphenidate hydrochloride immediate release tablet (MPH IR) | — | RCT |
Consumer voice
Health care professionals (21) and individuals (131) supported Ritalin LA, highlighting benefits of once-daily dosing and improved quality of life, while individuals also raised concerns about financial hardship from private prescription costs due to adult ADHD diagnosis. Two organizations (ADHD Australia and ADHD Foundation) strongly supported the listing change, advocating for equitable access t
The comments from health care professionals described the benefits of treatment with Ritalin LA 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 with retrospective ADHD diagnosis after age 18, prior methylphenidate response, and continuous 8-hour coverage requirement.