Illuminating the Role of Shared Decision-Making As the Hemophilia a Management Landscape Continues to Evolve: Progress in Practice
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CME Illuminating the Role of Shared Decision-Making as the Hemophilia A Management Landscape Continues to Evolve: Progress in Practice Course Director and Moderator Guy Young, MD Children's Hospital Los Angeles University of Southern California Keck School of Medicine Los Angeles, California Faculty Rebecca Kruse-Jarres, MD, MPH Washington Center for Bleeding Disorders Bloodworks Northwest Seattle, Washington Faculty Johannes Oldenburg, MD, PhD University Clinic Bonn Bonn, Germany What’s Inside 3 Introduction 6 Innovations in Hemophilia A Therapy: Current Status and Future Directions for Nonfactor Replacement Strategies 17 Extended Half-Life Replacement Clotting Factors for Hemophilia A: What Is Their Clinical Utility? 23 Shared Decision-Making: What Is Its Role in Hemophilia A Management? 31 Q&A and Concluding Remarks Participate in interactive questions, download activity slides, and obtain your instant CME credit online. This CME activity is jointly provided by Medical Learning Institute, Inc. and PVI, PeerView Institute for Medical Education. www.peerview.com/VEQ900 Activity Information Activity Description and Educational Objectives Johannes Oldenburg, MD, PhD In this activity, based on a recent satellite symposium at the 59th American Society of University Clinic Bonn Hematology Annual Meeting and Exposition (ASH 2017), experts in the management of Bonn, Germany hemophilia A consider the role of modified replacement clotting factors in the modern management of patients with this secondary hemostasis disorder, assess the potential Johannes Oldenburg, MD, PhD, has a financial interest/relationship or affiliation in the clinical impact of emerging nonfactor replacement strategies on the future management form of: of individuals with hemophilia A with and without inhibitors, and explore the growing Grant/Research Support from Baxter; Bayer; Biotest Pharmaceuticals Corporation; CSL need for shared decision-making with patients and their families as the number of Behring; Grifols; Novo Nordisk; Octapharma; Pfizer, Inc. therapeutic options continues to expand. The current evidence on each of these topics is Speakers Bureau participant with Baxter; Bayer; Biogen; Biotest Pharmaceuticals reviewed and accompanied by a discussion among the faculty panelists with respect to Corporation; Chugai Pharmaceutical Co., Ltd.; CSL Behring; F. Hoffmann-La Roche; Grifols; the practical applications of this information. Novo Nordisk; Octapharma; Pfizer, Inc.; and Swedish Orphan Biovitrum AB. Advisory Board for Baxter; Bayer; Biogen; Biotest Pharmaceuticals Corporation; Chugai Upon completion of this activity, participants should be better able to: Pharmaceutical Co., Ltd.; CSL Behring; F. Hoffmann-La Roche; Grifols; Novo Nordisk; • Apply key data on recent advances in replacement clotting factor technology when Octapharma; Pfizer, Inc.; and Swedish Orphan Biovitrum AB. managing patients with hemophilia A Johannes Oldenburg, MD, PhD, does intend to discuss either non-FDA-approved or • Analyze recent data on the efficacy, safety, and tolerability of emerging nonfactor investigational use for the following products/devices: therapies for the management of replacement strategies for the management of hemophilia A with and without hemophilia A. inhibitors • Identify the potential utility and impact of emerging nonfactor replacement strategies CME Reviewer on the treatment of hemophilia A with and without inhibitors Amer Assal, MD • Develop strategies designed to facilitate shared decision-making and maintain a Columbia University Medical Center therapeutic alliance with patients with hemophilia A and their caregivers and/or Blood and Marrow Transplantation Program families New York, New York Target Audience Amer Assal, MD, has no financial interests/relationships or affiliations in relation to this This activity has been designed to meet the educational needs of hematologists, activity. hematologist-oncologists, and other clinicians involved in the management of hemophilia. Medical Director Requirements for Successful Completion Kirk A. Tacka, PhD In order to receive credit, participants must view the activity and complete the post-test PVI, PeerView Institute for Medical Education and evaluation form. A score of 70% or higher is needed to obtain CME credit. There are no pre-requisites and there is no fee to participate in this activity or to receive CME Kirk A. Tacka, PhD, has no financial interests/relationships or affiliations in relation to this credit. Statements of Credit are awarded upon successful completion of the post-test and activity. evaluation form. Disclaimer Media: Enduring Material The information provided at this CME activity is for continuing education purposes only Release and Expiration Dates: December 27, 2017 - December 26, 2018 and is not meant to substitute for the independent medical judgment of a healthcare Time to Complete: 120 minutes provider relative to diagnostic and treatment options of a specific patient's medical condition. Recommendations for the use of particular therapeutic agents are based on Faculty & Disclosure / Conflict of Interest Policy the best available scientific evidence and current clinical guidelines. No bias towards or Before the activity, all faculty and anyone who is in a position to have control over the promotion for any agent discussed in this program should be inferred. content of this activity and their spouse/life partner will disclose the existence of any financial interest and/or relationship(s) they might have with any commercial interest Providership, Credit & Support producing healthcare goods/services to be discussed during their presentation(s): This activity has been planned and implemented in accordance with the accreditation honoraria, expenses, grants, consulting roles, speakers bureau membership, stock requirements and policies of the Accreditation Council for Continuing Medical Education ownership, or other special relationships. Presenters will inform participants of any (ACCME) through the joint providership of Medical Learning Institute, Inc. and PVI, off-label discussions. All identified conflicts of interest are thoroughly vetted by Medical PeerView Institute for Medical Education. The Medical Learning Institute, Inc. is accredited Learning Institute, Inc. for fair balance, scientific objectivity of studies mentioned in by the ACCME to provide continuing medical education for physicians. the materials or used as the basis for content, and appropriateness of patient care recommendations. The Medical Learning Institute, Inc. designates this enduring material for a maximum of 2.0 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with The associates of Medical Learning Institute, Inc., the accredited provider for this activity, the extent of their participation in the activity. and PVI, PeerView Institute for Medical Education do not have any financial relationships or relationships to products or devices with any commercial interest related to the content Providership of this CME activity during the past 12 months. This CME activity is jointly provided by Medical Learning Institute, Inc. and PVI, PeerView Institute for Medical Education. Course Director and Moderator Guy Young, MD Support Director, Hemostasis and Thrombosis Center This activity is supported by an educational grant from Genentech. Children's Hospital Los Angeles Professor of Pediatrics Disclosure of Unlabeled Use University of Southern California Keck School of Medicine The faculty of this educational activity may include discussions of products or devices Los Angeles, California that are not currently labeled for use by the FDA. Faculty members have been advised to disclose to the audience any reference to an unlabeled or investigational use. Guy Young, MD, has a financial interest/relationship or affiliation in the form of: Honoraria from Bioverativ Inc.; CSL Behring; and Grifols. No endorsement of unapproved products or uses is made or implied by coverage of these Advisory Board for Bayer Corporation; F. Hoffmann-La Roche Ltd; Genentech, Inc.; Kedrion products or uses in our reports. No responsibility is taken for errors or omissions in reports. Biopharma Inc.; Novo Nordisk A/S; and Shire. For approved prescribing information, please consult the manufacturer’s product labeling. Guy Young, MD, does intend to discuss either non-FDA-approved or investigational use for the following products/devices: therapies for the management of hemophilia A. The materials presented here are used with the permission of the authors and/or other sources. These materials do not necessarily reflect the views of PeerView or any of its Faculty partners, providers, and/or supporters. Rebecca Kruse-Jarres, MD, MPH Director, Washington Center for Bleeding Disorders About This CME Activity Bloodworks Northwest PVI, PeerView Institute for Medical Education, and Medical Learning Institute, Inc. are Seattle, Washington responsible for the selection of this activity’s topics, the preparation of editorial content, and the distribution of this activity. Our activities may contain references to unapproved Rebecca Kruse-Jarres, MD, MPH, has a financial interest/relationship or affiliation in the products or uses of these products in certain jurisdictions. The preparation of PeerView form of: activities is supported by educational grants subject to written agreements that clearly Consultant for Baxalta/Shire; CSL Behring; F. Hoffmann-La Roche Ltd/Genentech, Inc.; and stipulate and enforce the editorial