Lurasidone (Latuda) is an atypical antipsychotic (AAP) indicated for the management of patients with clinical manifestations of schizophrenia. The manufacturer has submitted a resubmission requesting reimbursement for the 40 mg, 80 mg, and 120 mg strengths for the management of the manifestations of schizophrenia; the original approved indication and listing request for lurasidone when the drug was initially submitted to the Common Drug Review (CDR) in 2012 was for the acute treatment of patients with schizophrenia.
In January 2013, the Canadian Drug Expert Committee (CDEC) issued a recommendation that lurasidone not be listed. The key reason for the recommendation was a lack of evidence from randomized controlled trials (RCTs) to establish the comparative efficacy of lurasidone relative to other AAPs for the acute treatment of schizophrenia. The original CDR review included nine RCTs investigating the efficacy and safety of lurasidone for the treatment of schizophrenia. Seven of the trials were placebo-controlled, acute-treatment trials of six weeks duration designed to assess the efficacy of various doses of lurasidone ranging from 20 mg to 160 mg daily (Studies: 6 [N = 149], 196 [N = 180], 229, [N = 500], 231 [N = 478], 233 [N = 488], 2 [N = 460], and 49 [N = 356]). The remaining two trials (Study 237 and Study 254) were performed in stable patients. Four of the acute-treatment trials (Studies 2, 49, 231, and 233) included active comparators to verify assay sensitivity, but none were designed to compare lurasidone with the active treatments.
In May 2013, the manufacturer resubmitted lurasidone seeking a listing recommendation for the acute treatment of schizophrenia. The basis of the resubmission is: an indirect comparison (IDC) of lurasidone, aripiprazole, and ziprasidone; an open-label study of patients switched to lurasidone from another antipsychotic; the publication of Study 234, an open-label extension study of Study 233 (reviewed as a Supplemental Issue in the original CDR review based on unpublished information); Study 231E, an open-label extension of Study 231; and a lower confidential price.
This report was prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). Through the Common Drug Review (CDR) process, CADTH undertakes reviews of drug submissions, resubmissions, and requests for advice, and provides formulary listing recommendations to all Canadian publicly funded federal, provincial, and territorial drug plans, with the exception of Quebec.
The report contains an evidence-based clinical and/or pharmacoeconomic drug review, based on published and unpublished material, including manufacturer submissions; studies identified through independent, systematic literature searches; and patient-group submissions. In accordance with CDR Update — Issue 87, manufacturers may request that confidential information be redacted from the CDR Clinical and Pharmacoeconomic Review Reports.
The information in this report is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. The information in this report should not be used as a substitute for the application of clinical judgment with respect to the care of a particular patient or other professional judgment in any decision-making process, nor is it intended to replace professional medical advice. While CADTH has taken care in the preparation of this document to ensure that its contents are accurate, complete, and up-to-date as of the date of publication, CADTH does not make any guarantee to that effect. CADTH is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in the source documentation. CADTH is not responsible for any errors or omissions or injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the information in this document or in any of the source documentation.
This document is intended for use in the context of the Canadian health care system. Other health care systems are different; the issues and information related to the subject matter of this document may be different in other jurisdictions and, if used outside of Canada, it is at the user’s risk. This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada.
CADTH takes sole responsibility for the final form and content of this document, subject to the limitations noted above. The statements and conclusions in this document are those of CADTH and not of its advisory committees and reviewers. The statements, conclusions, and views expressed herein do not necessarily represent the views of Health Canada or any Canadian provincial or territorial government. Production of this document is made possible by financial contributions from Health Canada and the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Prince Edward Island, Saskatchewan, and Yukon.
