The objective of this report was to perform a systematic review of the beneficial and harmful effects of apremilast for the treatment of moderate-to-severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy. This is a resubmission based on new data submitted by the manufacturer and, therefore, can be considered an update of the original apremilast clinical review for this indication. Compared with the original protocol, the subgroup “psoriatic arthritis” was removed, as this was considered to be a separate indication rather than a subgroup, and two new comparators were added (secukinumab, ixekizumab) that had not been approved by Health Canada at the time of the original CADTH Common Drug Review (CDR) review.

Contents

• Clinical Review Report (Resubmission)
  • Abbreviations
  • Executive Summary
    • Introduction
    • Results and Interpretation
    • Conclusions
  • 1. Introduction
    • 1.1. Disease Prevalence and Incidence
    • 1.2. Standards of Therapy
    • 1.3. Drug
  • 2. Submission History
    • 2.1. Basis of Resubmission
  • 3. Objectives and Methods
    • 3.1. Objectives
    • 3.2. Methods
  • 4. Results
    • 4.1. Findings from the Literature
    • 4.2. Included Studies
    • 4.3. Patient Disposition
    • 4.4. Exposure to Study Treatments
    • 4.5. Critical Appraisal
    • 4.6. Efficacy
    • 4.7. Harms
  • 5. Discussion
    • 5.1. Summary of Available Evidence
    • 5.2. Interpretation of Results
    • 5.3. Potential Place in Therapy
  • 6. Conclusions
  • APPENDIX 1. Patient Input Summary
    • 1. Brief Description of Patient Group Supplying Input
    • 2. Condition-Related Information
    • 3. Current Therapy-Related Information
    • 4. Expectations About the Drug Being Reviewed
  • APPENDIX 2. Literature Search Strategy
  • APPENDIX 3. Excluded Studies
  • APPENDIX 4. Detailed Outcome Data
  • APPENDIX 5. Validity of Outcome Measures
    • Aim
    • Findings
    • Dermatology Life Quality Index
    • Medical Outcomes Study (Short Form [36] Health Survey)
    • Physician Global Assessment
    • Psoriasis Area and Severity Index
    • Psoriasis Symptom Diary
    • Conclusion
  • APPENDIX 6. Summary of Other Studies
    • 1. Objective
    • 2. Findings
    • 3. Summary
  • APPENDIX 7. Summary of Comparators
    • Introduction
    • Description of Manufacturer-Provided Indirect Treatment Comparison: Methods for the Manufacturer-Supplied Indirect Treatment Comparison
    • Quality Assessment of Included Studies
    • Evidence Network
    • Indirect Treatment Comparison Methods
    • Results
  • References
• Pharmacoeconomic Review Report
  • Abbreviations
  • Executive Summary
    • Background
    • Summary of Identified Limitations and Key Results
    • Conclusions
  • Information on the Pharmacoeconomic Submission
    • 1. Summary of the Manufacturer’s Pharmacoeconomic Submission
    • 2. Manufacturer’s Base Case
    • 3. Limitations of Manufacturer’s Submission
    • 4. Issues for Consideration
    • 5. Conclusions
  • APPENDIX 1. Cost Comparison
  • APPENDIX 2. Summary of Key Outcomes
  • APPENDIX 3. Additional Information
  • APPENDIX 4. Summary of Other Health Technology Assessment Reviews of Drug
  • APPENDIX 5. Reviewer Worksheets
    • Manufacturer’s Model Structure
    • Manufacturer’s Results
    • CADTH Common Drug Review Reanalyses
    • Price Reduction Scenarios
    • CADTH Common Drug Review Scenario Analyses
  • References
• Patient Group Input Submissions
  • Canadian Skin Patient Alliance
• CADTH Canadian Drug Expert Committee Final Recommendation
  • Recommendation
  • Reasons for the Recommendation
  • Background
  • Submission History
  • Summary of CDEC Considerations
  • Other Discussion Points

This review report was prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). In addition to CADTH staff, the review team included a clinical expert in the treatment of psoriasis who provided input on the conduct of the review and the interpretation of findings.

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, Ontario, Prince Edward Island, Saskatchewan, and Yukon.

You are permitted to make copies of this document for non-commercial purposes, provided it is not modified when reproduced and appropriate credit is given to CADTH. You may not otherwise copy, modify, translate, post on a website, store electronically, republish, or redistribute any material from this document in any form or by any means without the prior written permission to CADTH.

Please contact CADTH’s Vice-President of Corporate Services at ac.htdac@secivresetaroproc with any inquiries about this notice or other legal matters relating to CADTH’s services.

Apremilast (Otezla) CADTH Common Drug Review Pharmacoeconomic Report was prepared using DeltaPA data from IMS Health Canada Inc. The analyses, conclusions, opinions and statements expressed are those of the Canadian Agency for Drugs and Technologies in Health and not those of IMS Health Canada Inc.

This review report was prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). In addition to CADTH staff, the review team included a clinical expert in dermatology who provided input on the conduct of the review and the interpretation of findings.

Through the Common Drug Review (CDR) process, CADTH undertakes reviews of drug submissions, resubmissions, and requests for advice, and provides formulary reimbursement 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, Ontario, Prince Edward Island, Saskatchewan, and Yukon.

You are permitted to make copies of this document for non-commercial purposes, provided it is not modified when reproduced and appropriate credit is given to CADTH. You may not otherwise copy, modify, translate, post on a website, store electronically, republish, or redistribute any material from this document in any form or by any means without the prior written permission to CADTH.

Please contact CADTH’s Vice-President of Corporate Services at ac.htdac@secivresetaroproc with any inquiries about this notice or other legal matters relating to CADTH’s services.