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Elagolix for Treating Endometriosis

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Elagolix for Treating Endometriosis Elagolix for Treating Endometriosis Evidence Report June 15, 2018 Prepared for ©Institute for Clinical and Economic Review, 2018 ICER Staff/Consultants University of Colorado Skaggs School of Pharmacy Modeling Group* Steven J. Atlas, MD, MPH R. Brett McQueen, PhD Director, Primary Care Research and Quality Assistant Professor Improvement Network Department of Clinical Pharmacy Massachusetts General Hospital Center for Pharmaceutical Outcomes Research Geri Cramer, BSN, MBA Jonathan D. Campbell, PhD Research Lead, Evidence Synthesis Associate Professor Institute for Clinical and Economic Review Department of Clinical Pharmacy Center for Pharmaceutical Outcomes Research Patricia G. Synnott, MALD, MS Senior Research Lead, Evidence Synthesis Melanie D. Whittington, PhD Institute for Clinical and Economic Review Research Instructor Department of Clinical Pharmacy Varun Kumar, MBBS, MPH, MSc Health Economist Samuel McGuffin Institute for Clinical and Economic Review Professional Research Assistant Department of Clinical Pharmacy Celia Segel, MPP Program Manager Institute for Clinical and Economic Review Daniel A. Ollendorf, PhD Chief Scientific Officer *The role of the University of Colorado Skaggs Institute for Clinical and Economic Review School of Pharmacy Modeling Group is limited to the development of the cost-effectiveness Steven D. Pearson, MD, MSc model, and the resulting ICER reports do not President necessarily represent the views of CU. Institute for Clinical and Economic Review DATE OF PUBLICATION: June 15, 2018 Steven Atlas served as the lead author for the report. Geri Cramer and Patricia Synnott led the systematic review and authorship of the comparative clinical effectiveness section. Varun Kumar was responsible for oversight of the cost-effectiveness analyses and developed the budget impact model. Celia Segel authored the section on coverage policies and clinical guidelines. Daniel Ollendorf and Steven Pearson provided methodologic guidance on the clinical and economic evaluations. The role of the University of Colorado Pharmacy Modeling Group is limited to the development of the cost-effectiveness model, and the resulting ICER reports do not necessarily represent the views of CU. We would also like to thank Leslie Xiong and Erin Lawler for their contributions to this report. ©Institute for Clinical and Economic Review, 2018 Page i Evidence Report– Elagolix for Treating Endometriosis 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 20% 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. For a complete list of funders and for more information on ICER's support, please visit http://www.icer-review.org/about/support/. About 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. 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 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 New England CEPAC is available at http://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. ©Institute for Clinical and Economic Review, 2018 Page ii Evidence Report– Elagolix for Treating Endometriosis Acknowledgements 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/elagolix-stakeholder-list/ Expert Reviewers John C. Petrozza, M.D. Chief, Division of Reproductive Medicine & IVF Director, MGH Fertility Center Co-Director, MGH Integrated Fibroid Program Massachusetts General Hospital No relevant conflicts of interest to disclose, defined as more than $10,000 in healthcare company stock or more than $5,000 in honoraria or consultancies during the previous year from health care manufacturers or insurers. Casey Berna, MSW Endometriosis and Infertility Patient Advocate No relevant conflicts of interest to disclose, defined as more than $10,000 in healthcare company stock or more than $5,000 in honoraria or consultancies during the previous year from health care manufacturers or insurers. ©Institute for Clinical and Economic Review, 2018 Page iii Evidence Report– Elagolix for Treating Endometriosis Table of Contents Executive Summary ........................................................................................................................... ES 1 1. Introduction ....................................................................................................................................... 1 1.1 Background .................................................................................................................................. 1 1.2 Scope of the Assessment ............................................................................................................. 3 1.3 Definitions .................................................................................................................................... 6 1.4 Insights Gained from Discussions with Patients and Patient Groups .......................................... 7 1.5. Potential Cost-Saving Measures in Endometriosis ..................................................................... 9 2. Summary of Coverage Policies and Clinical Guidelines ................................................................... 10 2.1 Coverage Policies ....................................................................................................................... 10 2.2 Clinical Guidelines & Consensus Statements ............................................................................. 11 3. Comparative Clinical Effectiveness .................................................................................................. 13 3.1 Overview .................................................................................................................................... 13 3.2 Methods ..................................................................................................................................... 13 3.3 Results ........................................................................................................................................ 15 3.4 Summary and Comment ............................................................................................................ 40 4. Long-Term Cost Effectiveness .......................................................................................................... 43 4.1 Overview .................................................................................................................................... 43 4.2 Methods ..................................................................................................................................... 43 4.3 Results ........................................................................................................................................ 53 4.4 Summary and Comment ............................................................................................................ 60 5. Additional Considerations ................................................................................................................ 64 5.1 Other Benefits ............................................................................................................................ 65
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