Lurasidone Hydrochloride for Bipolar Disorder: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines

Details

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Project Status:
Completed
Project Line:
Health Technology Review
Project Sub Line:
Summary with Critical Appraisal
Project Number:
RC1244-000

Question

  1. What is the clinical effectiveness of lurasidone hydrochloride for the treatment of adults with bipolar disorder?
  2. What is the clinical evidence regarding the safety of lurasidone hydrochloride for the treatment of adults with bipolar disorder?
  3. What is the cost-effectiveness of lurasidone hydrochloride for the treatment of adults with bipolar disorder?
  4. What are the evidence-based guidelines regarding the use of lurasidone hydrochloride for the treatment of adults with bipolar disorder?

Key Message

This review included one systematic review, five primary studies, one economic study and two guidelines regarding the use of lurasidone hydrochloride for the treatment of adults with bipolar disorder. 

Based on findings from a network meta-analysis, lurasidone monotherapy of acute bipolar depression (mostly type I) was more efficacious than aripiprazole and ziprasidone monotherapy. Lurasidone was associated with less weight gain than olanzapine and quetiapine, and lower somnolence incidence than quetiapine and ziprasidone. 

Common adverse events of lurasidone therapy included nausea, somnolence, headache, dizziness, akathisia, fatigue, insomnia, tremor, Parkinsonism, nasopharyngitis, anxiety, depression, and extrapyramidal symptoms. Discontinuation of treatment due to adverse events was 9% or less. Metabolic related changes in weight, glucose and lipids were not clinically meaningful. 

Based on the US third-party payer perspective, lurasidone monotherapy resulted in an incremental cost-effectiveness ratio of $3,474 per remission gained when compared with quetiapine extended release for the treatment of adults with bipolar I depression.

Both good quality guidelines recommend lurasidone (monotherapy or adjunctive to lithium or valproate) as first-line treatment for acute bipolar depression. For maintenance therapy, lurasidone adjunctive may be appropriate as second line in patients who responded to lurasidone during a depressive episode.

Well-designed trials are needed that directly compare lurasidone monotherapy or lurasidone adjunctive therapy with other interventions. Cost-effectiveness studies of lurasidone that are conducted with respect to the Canadian health care perspective are also warranted. Current findings may not be generalizable to the Canadian context, and they should be interpreted with caution given their limitations. ​