NICE has issued draft guidance recommending Lundbeck/Otsuka’s Abilify for the treatment of teenagers with bipolar disorder

Specifically, the Institute is saying yes to Abilify for treating moderate to severe manic episodes in adolescents aged 13 and older with bipolar I disorder.The drug is already NICE-approved to treat certain forms of schizophrenia.

Professor Carole Longson, director of the centre for health technology evaluation at NICE, said: “Bipolar disorder is a serious mental health condition which is characterised by episodes of mania and depression. During a manic episode, the young person usually experiences irritability, poor concentration, little need for sleep and poor temper control. They may also feel over-confident and be driven to take unnecessary risks.

“Acute manic episodes not only have a huge impact on the young person in terms of school, work and social life, but also on those around them – particularly their family or carers. Because of this it is really important that manic episodes are treated quickly and effectively so that young people and their families can return to normal in terms of schooling, work and family life as quickly as possible.”

For a course of treatment for 12 weeks, the 10mg dose of Abilify would cost £287.22, with the cost being the same for a 15 mg dose – NICE considered this cost effective and in line with other treatments. 

NICE has already published a clinical guideline on the overall management of bipolar disorder in adults, children and adolescents.

This new draft guidance focuses on the use of Abilify (aripiprazole) for the specific treatment of moderate to severe manic episodes in adolescents. NICE has also recommended Lithium and Lilly’s blockbuster antipsychotic Zyprexa for this disorder in those under 18 years of age.

Professor Longson continued: “As aripiprazole works at least as well as the existing treatment, our independent appraisal committee now recommends it as an option for treating moderate to severe manic episodes in adolescents with bipolar I disorder.”

NICE’s committee decided that an appraisal consultation document was not needed for this appraisal, so the recommendations could go straight to final draft or final appraisal determination.

This happens when the Committee recommends a treatment in line with its licensed indication, meaning it does not need more information from the manufacturer about its drug.