From the NICE website:
“NICE, the health and social care guidance body, has issued new draft guidance proposing to recommend aripiprazole (Abilify, Otsuka Pharmaceuticals Europe), for treating moderate to severe manic episodes in adolescents aged 13 and older with bipolar I disorder.”
HEDS provided the ERG for this - Lesley Uttley, Ben Kearns, Matt Stevenson, Ruth Wong and Shijie Ren. Two interesting issues are of note. First, no child utilities were available:
“The manufacturers were not able to identify any preference-based measures of health-related quality of life for paediatric bipolar disorder. Nor were they able to identify any reliable methods for mapping to these. Instead the manufacturers used EQ-5D data from an adult UK population with bipolar disorder.” (ERG report)
However, this didn’t appear to worry the Committee unduly. Second, modelling of treatment sequences was central to the submission and the ERG’s analysis, with the Committee concluding that:
“The Committee agreed that the base-case results suggested that a treatment strategy that includes aripiprazole is a cost-effective option when compared with a treatment strategy without aripiprazole. Given that each of the strategies was dominated by every other strategy in at least some of the probabilistic iterations, the Committee agreed that the results were not sufficiently robust to make a recommendation on the position of aripiprazole in the treatment pathway. The Committee concluded that aripiprazole should be recommended as an option for the treatment of moderate to severe manic episodes in bipolar I disorder in adolescents.” (Guidance document)
Modelling treatment sequences is becoming a hot topic in HTA, so watch out for more developments on this blog; we have an NIHR Doctoral Fellow – Jon Tosh - doing research on this.