NICE won’t approve Abilify without more data

pharmafile | September 13, 2010 | News story | Sales and Marketing Abilify, BMS, NICE 

NICE is unlikely to approve Bristol-Myers Squibb’s schizophrenia drug Abilify unless the company can provide more data on its clinical effectiveness.

Abilify is under appraisal for the treatment of schizophrenia in adolescents aged between 15 and 17 years and NICE’s preliminary recommendation is not to approve it.

This could change if BMS and its partner Otsuka Pharmaceuticals can provide further clinical and cost-effectiveness evidence.

In particular NICE wants evidence on Abilify’s clinical effectiveness compared to current atypical antipsychotics treatments already used in the UK. These include: Janssen-Cilag’s Risperdal, Lilly’s Zyprexa, AstraZeneca’s Seroquel, Sanofi-Aventis’s Solian and Novartis’s Clozaril.

Dr Carole Longson, health technology evaluation centre director at NICE, said: “The independent appraisal committee could not assess whether aripiprazole [Abilify] is a cost-effective treatment option because it did not have sufficient information to do so.

“The next step in the NICE process is for the manufacturer to consider the Committee’s comments and respond to its request for further evidence.”

Abilify, which is also indicated for depression, works by inhibiting a brain receptor for dopamine, a key neurotransmitter that is overactive in the brains of people with schizophrenia.

Unlike other atypical antipsychotics, Abilify does not fully block or stimulate the receptors, but does a little of both, resulting in fewer side effects than other drugs in its class.

NICE’s preliminary recommendations are available for public consultation until 1 October 2010 and can be found here.

Ben Adams

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