Aripiprazole: Therapeutic area: Major depressive disorder: Reimbursement Review
Abstract
<h4>What is major depressive disorder?</h4>• Major depressive disorder (MDD) is a serious mental health condition. MDD is a heterogeneous disorder that can be disabling and negatively impact an individual’s daily functioning and health-related quality of life (HRQoL). • MDD is a common disorder, with an annual prevalence in Canada ranging from 5.4% to 11.7% in adults. The economic impact of MDD is substantial, affecting productivity through presenteeism (the practice of being present at one's place of work for more hours than is required as a performative measure, despite impaired function and having reduced productivity levels or negative consequences) and absenteeism, as well as increased health care use related directly to MDD or comorbidities.<h4>What are the treatment goals and current treatment options for mdd?</h4>• Treatment goals for MDD are the alleviation of symptoms, improved HRQoL, and restoration of functional capacity and engagement in daily activities. • Current treatment options include antidepressant medications and psychotherapy (e.g., cognitive behavioural therapy, interpersonal therapy, and behaviour therapy), or a combination of these 2 types of treatment. Other treatments include transcranial magnetic stimulation, electroconvulsive therapy, IV ketamine, and intranasal esketamine.<h4>What is aripiprazole and why did canada’s drug agency conduct this review?</h4>• Aripiprazole is a drug that is available as an oral tablet. Health Canada has approved aripiprazole for use as an adjunct to antidepressants for the treatment of MDD in adult patients who had an inadequate response to prior antidepressant treatments during the current episode. • At the request of the participating public drug programs, Canada’s Drug Agency (CDA-AMC) reviewed aripiprazole to inform a recommendation on whether it should be reimbursed as adjunct treatment for MDD in adult patients who have had an inadequate response to at least 1 antidepressant. o.. CDA-AMC previously reviewed aripiprazole for this indication in 2014. The Canadian Drug Expert Committee (CDEC) issued a recommendation not to reimburse due to a lack of evidence regarding the comparative clinical benefit of adjunctive treatment with aripiprazole versus other available treatment strategies for the management of MDD. Since then, new relevant evidence has become available.<h4>How did cda-amc evaluate aripiprazole?</h4>• CDA-AMC reviewed the clinical evidence on the beneficial and harmful effects and compared costs of aripiprazole versus other atypical antipsychotics reimbursed by the provincial drug plans in Canada for MDD. Risperidone, quetiapine, olanzapine, and brexpiprazole were considered relevant treatments to compare with aripiprazole. • The clinical evidence was identified through systematic searches for available studies. • The review was also informed by 1 patient group submission in response to our call for input and by input from the participating public drug programs around issues that may impact their ability to implement a recommendation. • Two psychiatrists with expertise in the diagnosis and management of MDD participated as part of the review team, with representation from Ontario and the Prairies.<h4>What were the findings?</h4>CLINICAL EVIDENCE: • CDA-AMC reviewed the following clinical evidence: o.. 1 randomized controlled trial (RCT) comparing aripiprazole with olanzapine in 20 patients with MDD who did not experience a treatment response with paroxetine; o.. 1 indirect treatment comparison (ITC) of aripiprazole versus risperidone, quetiapine, olanzapine, and brexpiprazole; o.. 1 ITC of aripiprazole versus brexpiprazole; o.. 1 ITC of aripiprazole versus risperidone, quetiapine, and olanzapine. • The evidence suggests the following: o.. compared to risperidone, aripiprazole may have similar efficacy, specifically in terms of response rate, remission rate, symptom severity, and social function or HRQoL; o.. compared to quetiapine, aripiprazole may have similar effects on response rate, remission rate, symptom severity, and social function or HRQoL; o.. aripiprazole may result in a higher response rate compared to olanzapine, but this finding is very uncertain; o.. compared to olanzapine, aripiprazole may have similar effects on remission rate, symptom severity, and social function or HRQoL; o.. aripiprazole may result in a higher remission rate compared to brexpiprazole, but this finding is very uncertain; o.. compared to brexpiprazole, aripiprazole may have similar effects on response rate, symptom severity, and social function or HRQoL. • The overall safety of aripiprazole for MDD appeared to be comparable to that of risperidone, quetiapine, olanzapine, and brexpiprazole. • The findings of this report apply to short-term to medium-term treatment (e.g., 4 to 24 weeks). The evidence on long-term treatment with aripiprazole compared to other atypical antipsychotics remains unknown. ECONOMIC EVIDENCE: • Reimbursing aripiprazole as adjunctive treatment for MDD in adult patients who have had an inadequate response to antidepressant treatment is expected to increase costs to the public drug programs.
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