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Cover of Pharmacoeconomic Report: Eculizumab (Soliris)

Pharmacoeconomic Report: Eculizumab (Soliris)

Alexion Pharma Canada Corp.

Indication: Neuromyelitis optica spectrum disorder

CADTH Common Drug Review

CADTH’s findings remained aligned with the sponsor’s: the addition of eculizumab to standard of care (SOC) is not a cost-effective option at a willingness-to-pay (WTP) threshold of $50,000 per quality-adjusted life-year (QALY). CADTH accounted for some limitations, including changing the model’s relapse definition, selecting an alternate parametric distribution for time to first relapse, assuming lifelong treatment, capturing costs associated with administration and vaccination, and assuming eculizumab would be administered in outpatient clinics. In CADTH’s base case, eculizumab plus SOC was associated with an incremental cost-effectiveness ratio (ICER) of $1,508,152 per QALY gained compared with SOC alone in neuromyelitis optica spectrum disorder (NMOSD) patients who are anti-aquaporin-4 (AQP4) antibody positive. A price reduction of 96% would be required for eculizumab plus SOC to achieve an ICER below a WTP threshold of $50,000 per QALY.

The results of CADTH’s reanalysis are highly dependent on the treatment effects of eculizumab plus SOC compared to SOC alone. Several limitations were associated with the PREVENT trial (e.g., the absence of relevant outcomes related to subsequent relapses after the first relapse; high rates of major protocol deviation) that could not be addressed by CADTH. In the submitted model, the majority of the incremental clinical benefits were found to occur beyond the trial observed period; there is high uncertainty associated with this extrapolation. The cost-effectiveness of eculizumab compared to rituximab, mitoxantrone, or intravenous immunoglobulin (IVIG) is unknown in the absence of both direct and indirect treatment comparisons. Interpretation of the economic results therefore warrants careful consideration.

Version: Final

Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.

Disclaimer: The information in this document 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. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services.

While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH.

CADTH is not responsible for any errors, omissions, 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 contents of this document or any of the source materials.

This document may contain links to third-party websites. CADTH does not have control over the content of such sites. Use of third-party sites is governed by the third-party website owners’ own terms and conditions set out for such sites. CADTH does not make any guarantee with respect to any information contained on such third-party sites and CADTH is not responsible for any injury, loss, or damage suffered as a result of using such third-party sites. CADTH has no responsibility for the collection, use, and disclosure of personal information by third-party sites.

Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canada’s federal, provincial, or territorial governments or any third-party supplier of information.

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Copyright © 2020 Canadian Agency for Drugs and Technologies in Health.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK567498PMID: 33570892

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