2 The technology

2.1

Aripiprazole (Abilify, Bristol-Myers Squibb and Otsuka Pharmaceuticals) has a UK marketing authorisation for the treatment of schizophrenia in people aged 15 years and older. The initial marketing authorisation for aripiprazole was for the treatment of schizophrenia in adults. Subsequently an extension was sought to include the treatment of schizophrenia in adolescents aged 13 to 17 years. The committee for Human Medicinal Products concluded that the proposed extension was approvable provided the population is restricted to people aged 15 years and older.

2.2

Aripiprazole is administered orally. The summary of product characteristics (SPC) states that the recommended dosage for aripiprazole is '10 mg/day administered on a once-a-day schedule without regard to meals'. It also states: 'Treatment should be initiated at 2 mg (using aripiprazole oral solution 1 mg/ml) for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg. When appropriate, subsequent dose increases should be administered in 5 mg increments without exceeding the maximum daily dose of 30 mg'.

2.3

The SPC lists the most commonly reported adverse reactions associated with aripiprazole treatment to include akathisia and nausea. For full details of adverse reactions, contraindications, special warnings and precautions for use, see the SPC.

2.4

Aripiprazole is available in 5 mg, 10 mg, 15 mg and 30 mg tablets. The acquisition cost of aripiprazole 5 mg, 10 mg and 15 mg is £97.67 for 28 tablets. The acquisition cost of aripiprazole 30 mg is £195.33 for 28 tablets. The acquisition cost of aripiprazole oral solution 1 mg/ml is £104.64 for 150 ml. Costs exclude VAT and are from the British national formulary [BNF] 59th edition. Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)