14 November 2011
Following a re-submission by the manufacturer, the Scottish Medicines Consortium (SMC) has accepted paliperidone palmitate▼ prolonged-release injection for use within NHS Scotland for specific adult patients* with schizophrenia. Paliperidone prolonged-release injection was non-inferior to risperidone prolonged-release injection in control of schizophrenia symptoms over three months, and more effective than placebo in preventing relapse.
* Paliperidone prolonged-release injection is licensed for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, it may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.
Readers should note that SMC recommendations only apply in Scotland and that the advice only applies to paliperidone palmitate prolonged-release injection, and not paliperidone prolonged-release tablets. The tablet formulation of paliperidone is not recommended for use by SMC.
Health professionals should follow the NICE clinical guideline on the management of schizophrenia. NICE recommends that depot or long-acting antipsychotics may be given after an acute episode of schizophrenia if the patient prefers, and to avoid covert non-adherence to oral medication. The choice of antipsychotic should be made in partnership with the person (and carer if appropriate) taking into account the relative potential of individual antipsychotics to cause extrapyramidal side effects, metabolic side effects (such as weight gain), and other side effects. A patient decision aid is available in the schizophrenia e-learning materials that include a chart of the relative side effect profiles of different antipsychotics. This may be helpful when considering which antipsychotic is most appropriate for a person to try first.
Paliperidone prolonged-release injection was rejected by SMC in July 2011 as the manufacturer did not present a ‘sufficiently robust clinical and economic case’. No new efficacy or safety data were presented in the re-submission, but further health economic evidence demonstrated the economic case.
Paliperidone is the active metabolite of risperidone. Paliperidone prolonged-release injection was non-inferior to risperidone prolonged-release injection for control of schizophrenia symptoms over a three month period. A similar one-year study failed to show non-inferiority. However, it has been suggested this may be due to a lower loading dose of paliperidone used in the one-year study. Paliperidone was more effective than placebo in preventing relapse, but there are no data on relapse for paliperidone compared with an active comparator. The overall adverse effect profile of paliperidone appears similar to risperidone. In addition, paliperidone is administered monthly, rather than every two weeks with risperidone.
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