GuanfacineIntuniv
Treatment of attention deficit hyperactivity disorder (ADHD) as add-on therapy to stimulants in patients aged 6-18 years who have failed to achieve an adequate response to optimised stimulant therapy.
Decisions on record
- Meeting Jul 2018 Recommended Attention deficit hyperactivity disorder (ADHD)
- Meeting Jul 2017 Recommended Attention deficit hyperactivity disorder (ADHD)
Access path
- TGA registered · Intuniv
TGA label narrower than the PBS population
- Jul 2017Recommended · restricted
vs atomoxetine for contraindicated/intolerant to stimulants…
- Jul 2018Recommended · restricted
Comparator changed: atomoxetine for contraindicated/intolerant to stimulants; placebo for…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of guanfacine, as a General Schedule Authority Required (Streamlined) benefit, as add-on therapy in conjunction with optimised stimulant therapy, for attention deficit hyperactivity disorder (ADHD) in patients experiencing residual moderate to severe ADHD symptoms.PSD · Jul 2018
6.2 The PBAC was satisfied that guanfacine (as add-on therapy) provides, for some patients, a significant improvement in efficacy over placebo in patients receiving optimised stimulant therapy and who are experiencing residual symptoms.PSD · Jul 2018
5.11 The minor resubmission updated its economic analysis using a lower price for guanfacine in the add-on therapy setting (DPMQ of $'''''''''' versus $'''''''''' in the previous submission).PSD · Jul 2018
5.12 The PBAC, in its July 2017 consideration, explicitly requested that any resubmission for the add-on indication should include a lower price and no other amendments to the economic model. A comparison of the economic incremental cost-effectiveness ratios (ICERs) between the two submissions is presented in the table below. The change in DPMQ was the only amendment made to the model.PSD · Jul 2018
5.8 The resubmission repeated its clinical claim from the July 2017 submission and described guanfacine, in combination with stimulant therapy, as superior in terms of comparative effectiveness and inferior in terms of comparative safety over placebo when used in combination with stimulant therapy in patients who have an unsatisfactory response on optimised stimulant therapy.PSD · Jul 2018
5.9 In its previous consideration, the PBAC noted that for add-on therapy, Trial 313 showed statistically significant improvements for guanfacine over placebo for all outcomes, although the clinical significance of the change in ADHD score was uncertain (paragraph 7.8, July 2017 PSD). 7PSD · Jul 2018
Cost-effectiveness
Using the updated requested effective DPMQ ($''''''''''), resulted in an ICER of $15,000/QALY – $45,000/QALY. PSD · 2018
Decision context
PopulationChildren and adolescents aged 6-18 years with ADHD diagnosed according to DSM-5 criteria, receiving maximum tolerated dose of stimulant (dexamphetamine, methylphenidate or lisdexamfetamine) for at least four weeks, experiencing residual moderate to severe ADHD symptoms resulting in impaired functioning in at least one setting.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2018 | Recommended · restricted | placebo | $15k–45k | RCT · Surrogate |
| Jul 2017 | Recommended · restricted | atomoxetine for contraindicated/intolerant to stimulants; placebo for those failing to achieve adequate response to stim | — | RCT · Change in ADHD-RS-IV total score; responder rates; symptomatic and syndromal remission |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to add-on therapy only; TGA allows monotherapy or add-on, and requires documented stimulant failure.