quetiapine prolonged release and quetiapine immediate release (Seroquel XL and Seroquel IR)

following a re-submission

quetiapine (Seroquel/Seroquel XL) is not recommended for use within NHS Scotland.

Indication under review: Treatment of major depressive episodes in bipolar disorder.

In monotherapy studies quetiapine was superior to placebo and compared favourably with two active comparators. Efficacy relative to current practice for the management of depression in the framework of bipolar disorder in NHS Scotland involving combination therapy with a mood stabiliser or an atypical antipsychotic plus an antidepressant was not demonstrated.

The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.

Quetiapine (Seroquel/Seroquel XL) is also licensed for preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment. The manufacturer’s submission related only to use in the treatment of major depressive episodes in bipolar disorder. Therefore, SMC cannot recommend its use for preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment.