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Crizanlizumab, Voxelotor, and L-Glutamine for Sickle Cell Disease: Effectiveness and Value

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Crizanlizumab, Voxelotor, and L-Glutamine for Sickle Cell Disease: Effectiveness and Value Crizanlizumab, Voxelotor, and L-Glutamine for Sickle Cell Disease: Effectiveness and Value Evidence Report Posted March 12, 2020 Updated February 9, 2021 Prepared for This evidence report was updated on February 9, 2021 with minor wording changes. ©Institute for Clinical and Economic Review, 2020 ICER Staff University of Calgary Pamela Bradt, MD, MPH Eldon Spackman, PhD Chief Scientific Officer Assistant Professor ICER Community Health Sciences & O'Brien Institute of Public Health University of Calgary Patricia G. Synnott, MALD, MS Director, Evidence Review ICER Rick Chapman, PhD, MS Director of Health Economics ICER Molly Beinfeld, MPH Research Lead, Evidence Synthesis ICER David M. Rind, MD, MSc Chief Medical Officer ICER Steven D. Pearson, MD, MSc President ICER The role of the University of Calgary is limited to the development of the cost-effectiveness model, and the resulting ICER reports do not necessarily represent the views of the University of Calgary. None of the above authors disclosed any conflicts of interest. How to cite this document: Bradt P, Spackman E, Synnott PG, Chapman R, Beinfeld M, Rind DM, Pearson SD. Crizanlizumab, Voxelotor, and L-Glutamine for Sickle Cell Disease: Effectiveness and Value. Institute for Clinical and Economic Review, January 23, 2020. https://icer.org/wp-content/uploads/2020/10/ICER_SCD_Evidence- Report_031220-FOR-PUBLICATION.pdf DATE OF PUBLICATION: March 12, 2020 Pamela Bradt served as the lead author for the report. Patricia Synnott led the systematic review and authorship of the comparative clinical effectiveness section in collaboration with Serina Herron-Smith and Avery McKenna. Patricia Synnott and Molly Beinfeld authored the chapter describing what ICER learned from patients (Chapter 2. Patient Perspectives). Eldon Spackman was responsible for the development of the cost-effectiveness model. Rick Chapman was responsible for oversight of the cost-effectiveness analyses and developed the budget impact model. Catherine Koola authored the section on coverage policies. David Rind and Steve Pearson provided methodologic guidance on the clinical and economic evaluations. We would also like to thank Foluso Agboola and Monica Frederick for their contributions to this report. ©Institute for Clinical and Economic Review, 2020 Page ii Evidence Report – Crizanlizumab, Voxelotor, and L-Glutamine for SCD About ICER The Institute for Clinical and Economic Review (ICER) is an independent non-profit research organization that evaluates medical evidence and convenes public deliberative bodies to help stakeholders interpret and apply evidence to improve patient outcomes and control costs. Through all its work, ICER seeks to help create a future in which collaborative efforts to move evidence into action provide the foundation for a more effective, efficient, and just health care system. More information about ICER is available at http://www.icer-review.org. The funding for this report comes from government grants and non-profit foundations, with the largest single funder being the Laura and John Arnold Foundation. No funding for this work comes from health insurers, pharmacy benefit managers, or life science companies. ICER receives approximately 19% of its overall revenue from these health industry organizations to run a separate Policy Summit program, with funding approximately equally split between insurers/PBMs and life science companies. Life science companies relevant to this review who participate in this program include Novartis. For a complete list of funders and for more information on ICER's support, please visit http://www.icer-review.org/about/support/. About the New England CEPAC The New England Comparative Effectiveness Public Advisory Council (New England CEPAC) – a core program of ICER – provides a public venue in which the evidence on the effectiveness and value of health care services can be discussed with the input of all stakeholders. The New England CEPAC seeks to help patients, clinicians, insurers, and policymakers interpret and use evidence to improve the quality and value of health care. The New England CEPAC Council is an independent committee of medical evidence experts from across New England, with a mix of practicing clinicians, methodologists, and leaders in patient engagement and advocacy. All Council members meet strict conflict of interest guidelines and are convened to discuss the evidence summarized in ICER reports and vote on the comparative clinical effectiveness and value of medical interventions. More information about the New England CEPAC is available at https://icer-review.org/programs/new-england-cepac/. The findings contained within this report are current as of the date of publication. Readers should be aware that new evidence may emerge following the publication of this report that could potentially influence the results. ICER may revisit its analyses in a formal update to this report in the future. The economic models used in ICER reports are intended to compare the clinical outcomes, expected costs, and cost-effectiveness of different care pathways for broad groups of patients. Model results therefore represent average findings across patients and should not be presumed to represent the clinical or cost outcomes for any specific patient. In addition, data inputs to ICER models often come from clinical trials; patients in these trials and provider prescribing patterns may differ in real-world practice settings. ©Institute for Clinical and Economic Review, 2020 Page iii Evidence Report – Crizanlizumab, Voxelotor, and L-Glutamine for SCD In the development of this report, ICER’s researchers consulted with several clinical experts, patients, manufacturers and other stakeholders. The following clinical experts provided input that helped guide the ICER team as we shaped our scope and report. None of these individuals is responsible for the final contents of this report or should be assumed to support any part of this report, which is solely the work of the ICER team and its affiliated researchers. For a complete list of stakeholders from whom we requested input, please visit: https://icer-review.org/material/sickle-cell-disease-stakeholder-list/ Expert Reviewers Ashley Valentine, MRes Co-Founder of Sick Cells Consultant for Emmaus Life Sciences, CRISPR Therapeutics, and Community Patient Advisory Board for Global Blood Therapeutics. Sick Cells receives sponsorship and advocacy grants from various industry partners. Julie Kanter, MD Director of Adult Sickle Cell Disease Program University of Alabama Birmingham Dr. Kanter has consulted for both Novartis Pharmaceuticals and Global Blood Therapeutics, and has received in excess of $5,000 of honoraria from each company through service on advisory boards and travel support. She is serving on steering committees for both of the Novartis SOLACE trials of crizanlizumab. Her organization has received research funding for participation on trials of crizanlizumab, voxelotor, and L-glutamine for which she is the Site Principal Investigator. Keith Quirolo, MD Former Director of Pediatric Sickle Cell Program Former Clinical Director of Apheresis Program UCSF Benioff Children's Hospital Oakland No relevant conflicts of interest to disclose, defined as more than $10,000 in health care company stock or more than $5,000 in honoraria or consultancies during the previous year from health care manufacturers or insurers. Ahmar Zaidi, MD Comprehensive Sickle Cell Program Assistant Professor of Pediatrics Wayne State University School of Medicine, Central Michigan University School of Medicine Children's Hospital of Michigan Dr. Zaidi reports grants and personal fees from Emmaus Life Sciences, grants, personal fees and speaker bureau affiliation from Global Blood Therapeutics, and personal fees from Novartis. ©Institute for Clinical and Economic Review, 2020 Page iv Evidence Report – Crizanlizumab, Voxelotor, and L-Glutamine for SCD Table of Contents Executive Summary ............................................................................................................................ ES1 Background .................................................................................................................................... ES1 Insights Gained from Discussions with Patients and Patient Groups ............................................ ES3 Pain Relief ...................................................................................................................................... ES6 Comparative Clinical Effectiveness ................................................................................................ ES9 Long-Term Cost Effectiveness ...................................................................................................... ES16 Potential Other Benefits and Contextual Considerations ............................................................ ES25 Health Benefit Price Benchmarks ................................................................................................ ES27 Potential Budget Impact .............................................................................................................. ES29 1. Introduction ....................................................................................................................................... 1 1.1 Background .................................................................................................................................. 1 1.2 Scope of the Assessment ............................................................................................................
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