The clinical effectiveness agency for England and Wales says that it will recommend the atypical antipsychotic drug aripiprazole for people aged 15-17 years with schizophrenia.
The National Institute for Health and Clinical Effectiveness had said in September that it was unlikely to recommend Bristol-Myers Squibb Co.’s and Otsuka Pharmaceutical Co.’s aripiprazole (Abilify) for people aged 15-17 years, citing a paucity of data comparing it to three similar drugs that it already recommends for that age group.
However, the agency said on Dec. 1 that it had been persuaded by information later submitted by aripiprazole’s manufacturer comparing the drug to each of three other atypical antipsychotics – risperidone, quetiapine, and olanzapine – that are routinely used in U.K. clinical practice to treat young people. NICE also heard from experts who advised that because of varying adverse effects, more choice was beneficial in this patient group.
The NICE reviewers decided that aripiprazole, which costs approximately as much as olanzapine and quetiapine, "should be available on equal terms with other antipsychotic comparators (apart from risperidone)." Risperidone, the cheapest option among the drugs, is still NICE’s first choice for young patients with schizophrenia. Therefore, aripiprazole, which has a "good side-effect profile," is recommended only when risperidone cannot be tolerated, the agency said.
The therapeutic dose of aripiprazole, an oral medication, is 10-30 mg/day. Tablets of 5 mg, 10 mg, and 15 mg cost ?97.67 for 28; aripiprazole 30-mg tablets cost ?195.33 for 28.
Although aripiprazole has marketing approval throughout the European Union for the treatment of people aged 15 years and older with schizophrenia, it has not yet been appraised by NICE as a treatment option for adults. Assessing the drug for adults, NICE said, was outside the scope of the current guidance.
In another reversal on Dec. 1, NICE said that it would recommend Amgen’s romiplostim (Nplate) for the treatment of idiopathic thrombocytopenic purpura (ITP), a bleeding disorder caused by low platelet counts, after issuing negative draft guidance on the drug in March. Recently, NICE rejected eltrombopag (Revolade) another drug to treat ITP, calling it too expensive. Both drugs work by increasing platelet production and platelet counts in the body.
NICE’s final recommendation on romiplostim will depend on whether its manufacturer agrees to a patient-access scheme, the details of which have not been disclosed, the agency said.
Romiplostim is an intravenous injection administered weekly at a minimum dose of 1 mcg/kg and a maximum dose of 10 mcg/kg. The annual cost of treatment for a person weighing 80 kg would be ?8,020 at a dosage of 1 mcg/kg weekly, and ?80,204 at a dosage of 10 mcg/kg weekly, NICE said.
The public comment period on romiplostim ends in January; final guidance on aripiprazole is also expected in January.