Omalizumab is being reviewed for the treatment of adults and adolescents (12 years of age and older) with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.

Omalizumab is available as a 150 mg single-use vial of sterile powder for reconstitution for subcutaneous injection at a cost of $612 per vial (Ontario Drug Benefit Formulary Exceptional Access Program, January 2016). At the recommended dose of 150 mg to 375 mg administered subcutaneously every two or four weeks, the annual cost of omalizumab ranges from $7,956 to $47,736.

Omalizumab was originally submitted to the CADTH Common Drug Review (CDR) for this indication in April 2005; however, a final recommendation by the Canadian Expert Drug Advisory Committee (CEDAC) was not issued since a request for reconsideration from the manufacturer was deemed to include new information requiring resubmission. Omalizumab was subsequently resubmitted by the manufacturer to CDR in October 2005, resulting in a CDEC recommendation of Do not Reimburse. The reasons for the recommendation were that three of the four blinded randomized controlled trials suggested no statistically significant improvements in acute asthma exacerbations leading to hospitalizations, emergency room visits, or physician visits, and only one of the trials was in a patient population treated with inhaled corticosteroids (ICS) with a long-acting beta2-agonist (LABA). Although all of the trials reported that omalizumab improved quality of life, CDEC noted that, at the submitted price, omalizumab was not cost-effective. In 2015, omalizumab was reviewed by CDEC for adults and adolescents with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment. It received a recommendation of Reimburse with Clinical Criteria and Conditions, with one of the conditions being a substantial price reduction.

Contents

• Abbreviations
• Summary
  • Background
  • Approach to This Review
  • Cost Comparison
  • Summary of the Published Economic Information
  • New Information Since 2006
  • Issues for Consideration
  • Conclusions
• APPENDIX 1. Cost Comparison Table
• APPENDIX 2. Review of the Existing Literature
• APPENDIX 3. Published Health Technology Assessment Reports
• APPENDIX 4. Other Potential Comparator Treatments
• References

Omalizumab (Xolair) Common Drug Review Pharmacoeconomic Report was prepared using PharmaStat 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 allergy and immunology 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 drug 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.

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