SMA populations. The evidence base for Zolgensma™ currently includes two Phase 3 studies (STR1VE-US Background Paper and SPR1NT) and Phase 1 START trials. While formal HTA recommendations have yet to be issued regarding the use of Zolgensma™, a number of jurisdictions have granted early access to the technology (such as with the ATU Framework in France; a system whereby exceptional use of drugs that do not have a marketing authorisation that treat serious or rare diseases with no other appropriate alternative treatments can be granted). Some insurance providers and payers in the US have also reimbursed the technology for use after ICER stated that the technology could potentially be considered cost effective at the expected price point. In the meantime, issues and queries that have been raised around Zolgensma™ (and similarly CAR T therapies), including the impracticality of stopping rules and more traditional performance-based agreements given the single-dose nature of the treatment. Some agencies have indicated that other mechanisms could be explored, such as payment by instalments while the patient continues to respond to therapy. In addition, there could be potential challenges and additional uncertainty created by the proximity of licensure of these two innovative “game-changing” treatments for an ultra-orphan condition. In jurisdictions where Spinraza™ has now been recommended for Type 1 SMA, the standard of care technically changes from best supportive care to an alternative, costly therapeutic. In cases such as these, where new comparators are approved prior to the assessment of new interventions there are additional challenges in determining the true value of the new offering. Considerations of Spinraza™ by country Agency, country Recommendation Key Uncertainties & Other Comments NICE, England SMC, Scotland Recommended for pre- Disease rarity, severity and end-of-life criteria symptomatic SMA and SMA 1-3; were all considered. The implementation of PBAC, Australia with an MEA an MEA was considered sufficient to mitigate uncertainties, with a 5 year review window. CADTH, Canada Recommended for symptomatic The benefit was considered in the context of SMA 1. SMA 2 & 3 later disease modifiers (absence of other treatments recommended under ultra-orphan of proven benefit and a substantial improvement pathway; both with MEA in place. in life expectancy and an ultra-orphan medicine); the SMC can accept greater uncertainty in the economic case. The economic case for pre- symptomatic SMA was not presented by the manufacturer. Recommended for symptomatic PBAC noted its requirement for further SMA 1-3 for children under 18 information regarding: years with MEA in place. This was • the Australian SMA patient population, extended to pre-symptomatic children in December 2020; not especially patient numbers and variations recommended for those over 19 • the cost effectiveness ratio of Spinraza™ as a years old. treatment option • availability of further clinical evidence • definition of the appropriate adult population to receive Spinraza™ as a treatment • how Spinraza™ performs in the context of rapid developments in SMA treatments and diagnosis. Recommended for symptomatic Strict eligibility criteria in place, including SMA 1 for children under 6 stopping rules. Evidence for other classes of SMA months with a price reduction. was not considered sufficient, but another HTA for these groups is underway. 49
Background Paper ICER, USA Spinraza™ was not considered While there was a net health benefit for to meet cost effectiveness Spinraza™ (including improved quality of life), BeNeLuxA thresholds. the current price of Spinraza™ “far exceeds – Belgium, common thresholds for cost-effectiveness”. Netherlands, Belgium – recommended for all Zolgensma™ was also reviewed by ICER and Luxembourg, patients eligible for treatment. it was noted that as it is administered as a Ireland and Austria. Netherlands – recommended for one-time dose, it offers less complexity than HAS, France subgroups of patients according Spinraza™. to age, disease severity and Key recommendations included: diagnosis. • To align reasonably with the benefits for Luxembourg, Austria and Ireland were not part of the decision patients and families, the price for Spinraza™ making. should be far lower than it is, and the price Recommended for all SMA for Zolgensma™ should be lower than patients (initially available to the hypothetical $4-5 million price the children under the ATU temporary manufacturer has suggested could be justified. scheme) To achieve the needed balance between incentives for innovation and health system affordability, all manufacturers should exercise their monopoly pricing power responsibly, setting prices that do not exceed a reasonable cost-effectiveness threshold. • Payers should negotiate outcomes-based contracts under which a substantial portion of treatment cost is at risk should patients not receive adequate clinical benefit. Outcomes measures should extend beyond death and permanent ventilation, which might not be able to capture near-term lack of benefit for some Type I patients and are inadequate measures for treatment of later-onset or presymptomatic patients. The evidence was assessed by the Dutch HTA however the coverage recommendations were broader in Belgium than in the Netherlands. The countries had different procedures for providing reimbursement beyond the patients specified in the HTA report (i.e. the Netherlands can only recommend treatment in populations that have undergone formal HTA). MEA with additional data collection requirements were implemented in both countries. The recommendation concerning Spinraza™ was the first positive recommendation from the BeNeLuxA collaborative. Temporary access to Spinraza™ (at list price) was arranged under the ATU framework after the EMA approval in 2017. During the HTA, it was considered that Spinraza™ provides substantial clinical benefit with moderate clinical added value. An MEA is in place (with costs also being recouped from the payment at full list price for the technology under the ATU framework). 50
Case Study Three: Transvaginal Mesh for Pelvic Organ Prolapse and Stress Background Paper Urinary Incontinence Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are stressful and quality-of-life-limiting dysfunctions. Up to 50% of women who have given birth are estimated to develop POP or SUI during their lives with up to one in five women requiring surgical intervention(90). Mesh augmented repair using synthetic polypropylene mesh was introduced in the 1990s on the basis that it successfully corrected incisional hernias and therefore would have comparable effects in correcting POP and SUI. A number of synthetic mesh products were approved for use by regulatory agencies, however due to the marketing process for surgical device, there was an average of 5 years between the approval of the first urogynecological implant and the first published RCT. The history of the use of the transvaginal mesh for POP and SUI is detailed below: • The Food and Drug Administration (FDA) in the US was the first agency to publish a safety report over the use of the transvaginal mesh for POP and SUI in 2008, based on an increasing number of reported complications. A lack of published studies was also noted. • In 2011, a second safety report was published outlining significant adverse effects without improvements in symptoms or quality of life. The FDA then imposed “Post marketing Surveillance Studies”. • In 2016, the FDA increased the risk of transvaginal meshes from Class II to Class III. In numerous lawsuits filed, only 12% of surgeons were found to be certified for POP and SUI surgeries. Current usage around the world: • In 2019, the FDA disallowed the sales of anterior transvaginal mesh implants; a petition for the continued – and targeted- use of the mesh in POP was started. • In 2017, NICE in the UK recommended that mesh augmented POP repair should be used only in research. In 2018, this use was paused and in 2019, NICE recommended specific types of mesh and procedure for targeted patients, and only as a last resort once the patient has been fully informed of her options. A mandatory register for surgeons is being established. • In Australia, transvaginal meshes are not recommended for use. However, suburethral slings for SUI are considered safe for use. The same recommendations apply in New Zealand. • In Canada, the posterior use of the mesh is not recommended. However, transvaginal meshes for anterior and apical repair can be used, but only for patients at high risk of recurrence with no other viable treatment options. • In Asia, there is a very diverse use of the mesh and self-cut (“ready-made”) mesh kits are used (although these are not licensed for use in countries such as Japan). • In South America there are no limitations on the use of transvaginal meshes for POP or SUI. • In the EU, transvaginal meshes can be used in the case of POP recurrence or in cases where the patient is at high risk of recurrence, with a certification system for surgeons and patients should be appropriately selected and counseled. However the recommendations still vary within countries, for example, in France the use of transvaginal meshes is not recommended, except in the context of clinical trials. In the Netherlands, transvaginal meshes are recommended for use in certain subgroups and the use and results from the mesh surgery is subject to regular audit. Generally speaking, the public has become very skeptical and the use of surgical repair for POP and SUI has decreased across the world. While there are variable guidelines and recommendations on the use of transvaginal mesh, it has become apparent that it is crucial that patients are well informed about their options and the uncertainty within the evidence base, outlining the potential advantages and disadvantages of the procedure. Appropriate credentialing of surgeons and the need for longer-term follow up is a unified theme across all of the recommendations reviewed. 51
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Attendees Rob Abbott Executive Director HTAi Canada HTAi Secretariat Rob Abbott is a pioneering strategy and social responsibility catalyst in Canada; a much sought-after facilitator, moderator and content-weaver; a coach to entrepreneurs and executives; and a professor of global management and strategy. Rob’s experience in medical life sciences includes appointments as a member of the Board and Executive Committee of the Canadian Genetic Diseases Network (CGDN), and the Canadian Gene Cure Foundation. He subsequently became CEO of CGDN, a role that required him to regularly discuss advances in gene- based medical research on the one hand, and the translation of that research into practical diagnostics and therapeutics on the other. He has also advised provincial and federal health authorities in Canada and abroad on a wide variety of issues, including the role of artificial intelligence and advanced robotics in the delivery of health care. Rob writes and speaks on strategic environmental issues regularly, and is the author of Uncommon Cents: Thoreau and the Nature of Business; Conscious Endeavors: Business, Society and the Journey to Sustainability; and co-author of the forthcoming book, The Future of Mining: 7 Steps to a Globally Sustainable Industry. Rob is also working on a book, called Walking Toward the Edge: From Heartbreak to Hope in an Age of Loss. Rob has taught courses and delivered lectures at several universities in North America including the University of Toronto, the University of British Columbia, and Harvard. He has also taught at universities in China, Thailand, and Mexico. Phone: 250-888-9406 Email: [email protected] Helen Anderson Program Medical Director BC Cancer Canada Organizational Member, HTAi Global Policy Forum Dr Anderson is a Medical Oncologist and Medical Director for the Provincial Systemic Therapy Program at BC Cancer, British Columbia, Canada. She completed her original medical degree in Auckland, New Zealand and doctorate at the University of London. She is an Associate Clinical Professor at the University of British Columbia. In her role, she has responsibilities for the Provincial Cancer Drug budget in the Province of British Columbia. She has been a member and chair of regional and pan Canadian HTA related committees and working groups and has a particular interest in decision making and implementation of new drugs and technologies in Oncology. Phone: 250-704-8244 Email: [email protected] 58
Naomi Aronson Attendees Executive Director, Clinical Evaluation, Innovation, and Policy Blue Cross Blue Shield Association United States Organizational Member, HTAi Global Policy Forum Dr. Naomi Aronson leads BCBSA clinical effectiveness and policy engagement with government, regulatory agencies and policy consortia. Her areas of leadership include comparative effectiveness, patient centered research, safety surveillance, regulatory science and methodological standards. Previously, Dr. Aronson led the development of the BCBSA Technology Evaluation Center (TEC), now Evidence Street™ (ES), as a nationally recognized technology assessment program and an Evidence- based Practice Center (EPC) of the Agency for Healthcare Research and Quality (AHRQ). She is a member of the Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI), the Health Technology Assessment International Health Policy Forum, the National Academy of Medicine Genomics Roundtable, the New Drug Development Paradigms (NEWDIGS) initiative of the MIT Center for Biomedical Innovation, and the Medical Device Innovation Consortium (MDIC) National Evaluation System for Health Technology (NEST) Governing Committee. Prior to joining BCBSA, Dr. Aronson was a member of the Northwestern University faculty, specializing in the sociology of science and medicine. She also was a post-doctoral fellow in the Science, Technology and Society Program at the Massachusetts Institute of Technology. Phone: 847-217-7737 Email: [email protected] Indranil Bagchi Senior Vice President and Head of Global Value and Access Novartis Pharmaceuticals Corporation United States Organizational Member, HTAi Global Policy Forum Dr. Indranil Bagchi is Senior Vice President and Head of Global Value and Access at Novartis Oncology. In this role, Indranil drives the overall strategy on value demonstration and market access, through efforts on pricing & reimbursement, health economic modelling, outcomes research, real world evidence and health policy that increase access to our cancer medicines. Indranil has more than two decades of experience in market access across several major companies in the pharmaceutical industry. In 2014, Indranil received the ‘Outstanding 50 Asian Americans in Business’ award and in 2010, Indranil was recognized in Pharmaceutical Executive magazine’s annual roster of Emerging Leaders, “The New Breed of Leadership.” Indranil is a frequent speaker and contributor to forums, articles and conferences addressing issues related to access to medicines. Previously at Pfizer, he was Vice President and Global Head of Payer Insights and Access and prior to that, Indranil was Senior Director of Market Access at Wyeth Pharmaceuticals. Before Wyeth, Indranil was first with SmithKline Beecham and subsequently with GlaxoSmithKline with their Health Economics and Outcomes Research departments. Dr. Bagchi has an undergraduate degree in Pharmacy, a master’s degree in Pharmacy and Healthcare Administration and a doctoral degree in Pharmaceutical Socioeconomics. Email: [email protected] 59
Attendees Lindsay Bockstedt Vice President, Global Health Economics and Outcomes Research Medtronic United States Organizational Member, HTAi Global Policy Forum Lindsay Bockstedt, Ph.D. is Vice President of Global Health Economics and Outcomes Research at Medtronic, Inc. In her role, Dr. Bockstedt leads the organization's Global Health Economics and Outcomes Research (HEOR) strategy and a corporate HEOR Center of Excellence that works across the enterprise to support high priority initiatives on HEOR, real-world evidence, health technology assessment, and data-driven health policy research. Dr. Bockstedt holds an adjunct faculty position at the University of Minnesota’s Carlson School Management where she teaches a graduate level course on medical technology evaluation. She has authored articles on health care payment policy, observational research methods, and evaluations of medical technology. Her research focuses on medical technology diffusion, Medicare payment policy, hospital behavior, and applied econometrics. She received her Ph.D. and M.S. in health services research and policy from the University of Minnesota, and B.S. in public health from Rutgers University. Phone: 763-505-2588 Email: [email protected] Luciene Bonan Vice President, Global Health Economics and Outcomes Research Brazilian Ministry Of Health Brazil Organizational Member, HTAi Global Policy Forum Pharmacist with a master's degree in oncology and translational research, PhD in HTA. Experience in hospital pharmacy, oncology pharmacy, HTA, pricing and reimbursement, and currently act as Innovation Coordinator at Brazilian Ministry of Health. Email: [email protected] 60
Meindert Boysen Attendees Director Centre for Health Technology Evaluation NICE United Kingdom Organizational Member, HTAi Global Policy Forum Meindert is the Deputy Chief Executive and Director of the Centre for Health Technology Evaluation at the National Institute for Health and Care Excellence (NICE). He was previously responsible for running NICE’s technology appraisal and highly specialised technologies programmes, Meindert has a strong track record in health technology evaluation, occupying a senior technical and leadership role in NICE’s drug appraisal programme. Before joining NICE in 2004 Meindert worked for Eli Lilly in the Netherlands, and for the King’s Fund in London after graduating with an MSc in Health Policy Planning and Financing from the London School of Economics & Political Sciences. Meindert was previously on the Board of Directors for The International Society for Pharmacoeconomics and Outcomes Research (ISPOR), 2017 – 2020. Phone: 01618703146 Email: [email protected] LinkedIn: linkedin.com/in/meindert-boysen-pharmd-msc-63a498 Rachele Busca EMEA and Japan Health Economics Leader W.L. GORE & ASSOCIATES Italy Organizational Member, HTAi Global Policy Forum Graduated in Chemistry & Pharmaceutical Technology at Bologna University and completed education in Health Economics & Outcomes Research with a Master at the University of Milan and an MBA at the Bologna Business School. Market Access & Health Economics & Outcomes Research expert / Director level professional with over 15 years of experience in Medical Device, including Health Economics & Outcomes Research, Reimbursement & Access and Value strategies, delivering data and tools to effect reimbursement, funding and Health Technology Assessments at International level. Currently EMEA Leader Health Economics at W.L GORE – a Global Devices manufacturer known for innovation and a modern, distinctive company culture. Previously served for over 7 years the Italian Pharmaceutical business in Bayer, Recordati and consultancy group Pbe. Most recently as Director Pricing and Reimbursement Strategy at BTG and Principal Manager at Medtronic assisting several divisions: interventional pulmonology, cardiology, cardiac disease management, structural heart, peripheral products. Specialties: market access strategies, pricing, HEOR, incorporation of market access requirements into clinical, medical & commercial strategies, new market assessment, due diligence. Phone: +393427566362 Email: [email protected] 61
Attendees Barbara Calvert Director, Medical Products Reimbursement Abbott United States Organizational Member, HTAi Global Policy Forum Barbara is currently Director, Medical Products Reimbursement, responsible for obtaining reimbursement for new products, HTA and healthcare policy. She previously held positions with medical device and pharmaceutical manufacturers and healthcare providers. Phone: 202-262-4917 Email: [email protected] Jon Campbell Sr. VP for Health Economics Institute For Clinical And Economic Review United States Organizational Member, HTAi Global Policy Forum Jon (Jonathan D.) Campbell is Senior Vice President for Health Economics at the Institute for Clinical and Economic Review (ICER). Jon joined ICER’s senior management team as a leader in value assessment methods and application; he oversees the growth of ICER’s health economics efforts and leads the continued innovation of ICER’s value assessment methodology. Additionally, Jon continues to build bridges within the global health economics community through engagement with ICER’s Health Economic Council and through leadership and participation in health technology assessment societies and agencies. Further, Jon seeks creative value assessment solutions for ICER’s diverse stakeholders by prioritizing improved outcomes for patients. Jon is an author of over 100 peer-reviewed manuscripts in the field of value assessment as well as an author on ten ICER assessments. Jon is a former ICER Health Economics Council member and five-year external collaborator through his former role as Associate Professor with tenure at the University of Colorado Anschutz Medical Campus. He holds graduate training degrees in pharmaceutical outcomes research (PhD) and biostatistics (MS) from the University of Washington. He graduated with a BA in mathematics and chemistry from St. Olaf College. PubMed Publications: https://www.ncbi.nlm.nih.gov/myncbi/12qokyhvxd9/bibliography/public/ Phone: 617-528-4013 x7040 Email: [email protected] LinkedIn: linkedin.com/in/jon-campbell-45525111 62
Vania Cristina Canuto Santos Attendees Director CONITEC Brazil Organizational Member, HTAi Global Policy Forum Vania Canuto is Director of National Committee for Health Technology Incorporation (CONITEC) in Brazil. Vania’s education includes a Bachelor of Economics (Universidade Federal do Rio de Janeiro – UFRJ), a postgraduate of Pharmacoeconomics and Health Economics (Universidad Pompeu Fabra – UPF/Barcelona) and a Master of Science in Health Technology Assessment (Escola Nacional de Saúde Pública – ENSP/ Fiocruz). Phone: 5561981449924 Email: [email protected] Hector Castro Jaramillo Senior Technical Director Management Sciences For Health- MSH United States Chair, HTAi Latin America Policy Forum Doctor in Medicine and Surgery, MSc in Health Policy, Planning and Financing from the London School of Hygiene & Tropical Medicine (LSHTM) joint degree with the London School of Economics & Political Science (LSE), Specialized in Health Management and previous MSc in Occupational Health (Public Health Branch). Doctor in Public Health & Policy/Health Economics from the University of London (LSHTM). Former Takemi Postdoctoral Fellow at the T.H. Chan Harvard School of Public Health. Broad professional experience (over 20 years) as Chief Officer, Technical Advisor, Director and Manager in Strategic Planning, Quality Assurance, Health, Safety and Environment for Pharmaceutical and Health Insurance and Non-Governmental Organizations. Main focus of work has been on health systems` strengthening in areas such as quality assurance, assessment, strategic purchasing and provision of healthcare technologies (including medicines, devices and procedures). Ten years as consultant in health care access, health economics, health policy, priority setting, health technology assessment (HTA) and health systems´ reform, familiar with and relevant experience in health systems and markets in Low and Middle Income Countries- LMICs. Previous working experience includes: the US, United Kingdom, Colombia, Ecuador, Peru, Costa Rica, Brazil, Mexico, Chile, Turkey and Tunisia. Experience also as a researcher and lecturer for undergraduate and post graduate students in Latin America, the US and United Kingdom in topics such as: Global Health, Project Management, Public Health, HTA, GMP, ISO 9000, 14000, OHSAS 18000, BASCP and Health Quality Assurance, Health Planning, Research Methods, Health Economics. Former funding director of the HTA Institute of Colombia (IETS) and Director of Medicines & Technologies at the Ministry of Health and Social Protection of Colombia. Currently Senior Technical Director of Infectious Diseases, Health Financing, Technologies, Data & Impact at MSH and Chair of the Latin America Policy Forum. Former Director of the Board at HTAi (2018-2020). Phone: 571-320-7967 Email: [email protected] Twitter: @HectorECastroJ 63
Attendees Timothy Caufield Research Chair in Health Law and Policy, a Professor in the Faculty of Law and the School of Public Health, and Research Director of the Health Law InstituteUniversity of Alberta Canada Keynote Speaker Timothy Caulfield is a Canada Research Chair in Health Law and Policy, a Professor in the Faculty of Law and the School of Public Health, and Research Director of the Health Law Institute at the University of Alberta. His interdisciplinary research on topics like stem cells, genetics, research ethics, the public representations of science and public health policy has allowed him to publish over 350 academic articles. He has won numerous academic and writing awards and is a Fellow of the Royal Society of Canada and the Canadian Academy of Health Sciences. He contributes frequently to the popular press and is the author of two national bestsellers: The Cure for Everything: Untangling the Twisted Messages about Health, Fitness and Happiness (Penguin 2012) and Is Gwyneth Paltrow Wrong About Everything?: When Celebrity Culture and Science Clash (Penguin 2015). His most recent book is Relax, Dammit!: A User’s Guide to the Age of Anxiety (Penguin Random House, 2020). Caulfield is also the host and co-producer of the award winning documentary TV show, A User’s Guide to Cheating Death, which has been shown in over 60 countries, including streaming on Netflix in North America. Twitter: @CaulfieldTim Er Chen Director, US Health Economics and Value Demonstration Biomarin United States Organizational Member, HTAi Global Policy Forum Professional with 16+ years of experience in developing and executing health economic strategies to support commercialization and value demonstration for pipeline and in-line products (8+ years within pharma/biotech and 8 years in consulting). Email: [email protected] Seth Clancy VP, GHER Edwards LifeSciences United States Organizational Member, HTAi Global Policy Forum Seth is Vice President, Global Health Economic and Reimbursement (GHER) supporting the Transcatheter Heart Valve business unit at Edwards Lifesciences. Seth leads the development and implementation of evidence generation and market access strategies and has helped to address a complex and growing set of challenges related to health technology assessment, reimbursement and emerging evidence needs globally. Prior to joining Edwards in 2008, Seth worked at Cerner Lifesciences, where he served as Senior Research Associate, responsible for consultative services to biopharmaceutical companies in the areas of comparative effectiveness research, health technology assessment, and health economics. Seth holds an undergraduate degree from the University of California, Irvine and a Masters of Public Health from the University of California, Los Angeles. Phone: 949-250-2669 Email: [email protected] 64
Ed Clifton Attendees Unit Head - Scottish Health Technologies Group Healthcare Improvement Scotland United Kingdom Organizational Member, HTAi Global Policy Forum Ed Clifton is the Unit Head of the Scottish Health Technologies Group (SHTG). SHTG is a national health technology assessment (HTA) agency that provides evidence support and advice to NHSScotland on the use of new and existing health technologies (excluding medicines). Ed’s focus for SHTG is to ensure that HTA is relevant, flexible and timely towards better quality health and care in Scotland. Prior to his current role, Ed has gained over 10 years of experience working as an economist within NHSScotland. He completed his qualifications in Economics and Health Economics at the University of Sheffield, where Ed was awarded the University of Sheffield Gilbert Prize in Economics. Email: [email protected] Alex Clyde Corporate Vice President of Global Health Policy, Reimbursement and Health Economics Medtronic United States Organizational Member, HTAi Global Policy Forum Alex Clyde is Corporate Vice President of Global Health Policy, Reimbursement and Health Economics for Medtronic, Inc. In this role, she leads a global team of more than 300 professionals and provides company-wide leadership on health policy, reimbursement and value-based health care issues. She chairs the company’s Global Reimbursement and Health Economics Leadership Council in addition to the cross-functional Global Value-Based Heath Care Council. She is a member of Medtronic’s Global Officers’ Group as well as the former Chair of the Medtronic Women’s Network Global Leadership Team. Alex is a member of the Health Care Payment Learning and Action Network’s (HCP-LAN) Guiding Committee which is charged by the Secretary of Health and Human Services with accelerating the health care system's transition to alternative payment models (APMs) by combining the innovation, power, and reach of the public and private sectors. She previously participated on the HCP-LAN’s Clinical Episode Payment Workgroup charged with identifying the most important elements of clinical episode payment models. She has also participated in various CMS technical advisory councils as well as other private and public sector initiatives to improve value in health care. Alex graduated from Colgate University with a B.A. in Economics and from Harvard University with a M.S. in Health Policy and Management. Email: [email protected] 65
Attendees Sophie Cros Director, Market Access & Health Economics, EMEA Abbott Belgium Organizational Member, HTAi Global Policy Forum Sophie is Director, Health Economics & Reimbursement of the Structural Heart division at Abbott for Europe, Middle East and Africa. In this position, she is responsible for defining E.M.E.A. strategies for market access and building interactions with health policy makers as well as building the evidence need to support funding and reimbursement for Abbott Structural Heart therapies. Sophie has 25+ years of experience and held various market access positions in the pharmaceutical sector before joining the MedTech Industry. Before joining Abbott, she was Director of Reimbursement and Health Economics at Medtronic European Headquarter for Western Europe at the Neurological business unit. Before serving in the Medical Devices industry, she held various positions at international and French level on Reimbursement, Pricing and Health Economics in the Respiratory and Dermatological area in GlaxoSmithKline, Pfizer and Novartis. Sophie is the Chair of the Market Access & Economic Policies Working Group at Medtech and seats at the HTAi Policy Forum since 2009. Sophie received her Pharmaceutical Doctorate in the Paris XI University and holds a Specialized Masters in Healthcare management from Ecole Superieure de Commerce de Paris. Phone: +32 478 824553 Email: [email protected] 66
Amadou Diarra Attendees Senior Vice President Global Policy & Government Affairs Bristol Myers Squibb United States Organizational Member, HTAi Global Policy Forum Amadou’s organization works closely with key stakeholders including patient support organizations, health care professionals, policymakers and industry associations. Amadou joined BMS’ Africa Division in 1991 holding positions of increasing responsibility. From 1999 to 2002 he led Secure the Future (landmark philanthropic program) before becoming General Manager in Indonesia (2002), Turkey (2005), Ireland & Nordics (2008), VP-Access Europe and then VP-General Manager- UK & Ireland (2010) with responsibilities including European Works Council Chair, Association of the British Pharmaceutical Industry Board Member, also being Health Technology Assessment Task Force and Reputation Strategy Group Chair. Amadou holds a Doctorate in Pharmacy, University of Tours (France), a MBA from École Supérieure de Commerce de Tours and completed the General Management Program (INSEAD). Amadou represents Bristol Myers Squibb as an American Associate of the Science & Technology in Society Forum (STSF), the Pharmaceutical Research and Manufacturers of America (PhRMA) International Section Executive Committee (ISEC), Council member of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) where he is the Chair and on the council of the Value & Access Committee. At Bristol Myers Squibb Amadou is a member of the Global Leadership Team as well as the Global Diversity & Inclusion Council and Sustainability Council. He is also Executive Sponsor for the Corporate Affairs Diversity & Inclusion Working Group. Email: [email protected] LinkedIn: linkedin.com/in/amadou-diarra-05b8121b Lea Drye Director of Clinical Science Services Blue Cross Blue Shield Association United States Organizational Member, HTAi Global Policy Forum Dr. Drye is Director of Clinical Science Services with the Office of Clinical Affairs, joining the team in 2016. Dr. Drye received graduate degrees in Statistics from the University of Wisconsin-Madison and Epidemiology from the Johns Hopkins Bloomberg School of Public Health. Dr. Drye develops medical reference policies and technology assessments for the Medical Policy Services group. She is engaged in BCBSA initiatives with regulatory agencies and industry stakeholders. Prior to coming to BCBSA, Dr. Drye was faculty at Johns Hopkins in the Epidemiology Department and the Center for Clinical Trials and Evidence Synthesis where she had more than 10 years of experience in the design, implementation and data analysis of randomized controlled clinical trials and observational studies. She taught classes in clinical trials to graduate students at Johns Hopkins, Fellows in federal regulatory agency programs and on the open courseware platform Coursera. Email: [email protected] 67
Attendees Rudy Dupree Biologist Dutch Health Care Institute (ZIN) Netherlands Organizational Member, HTAi Global Policy Forum Rudy Dupree is trained as a biologist and has been working for the Dutch National Healthcare Institute (ZIN) since 2011. Currently, he is a coordinator of the programme updating ZIN's HTA methodology, the goal of which is to make the HTA assessments future-proof. He has been working previously as a senior project manager for EUnetHTA and as a senior HTA assessor on both pharmaceutical and non-pharmaceutical interventions. Email: [email protected] Maria Dolors Estrada Sabadell Researcher AQuAS Spain Organizational Member, HTAi Global Policy Forum MD, PhD (Autonomous University of Barcelona). Specialist in Preventive Medicine and Public Health. Master in Health Care Services Management and Assessment, and Health Care Systems. She is a senior research of AQuAS and coordinator of CPG AQuAS’s group and member of the Scientific committee of Spanish National CPG programme. Other areas of interest are assessment of health technologies and development of patient-reported outcomes measures. She is a member of the Spanish Network of Epidemiology and Public Health (CIBERESP). She has worked in commissioned projects for the Catalan and Spanish Health Ministries and international research projects. She has published several THA reports, papers and GPC about different subjects and using either quality or quantitative methodology. Phone: 93 5513877 Email: [email protected] 68
Aikaterini Fameli Attendees Director GSK United Kingdom Organizational Member, HTAi Global Policy Forum Aikaterini Fameli is Global Oncology Policy Lead in Global Market Access and Pricing. In this role, she is responsible for devising and implementing comprehensive market access and HTA policy strategies to support key brands within Oncology, promote the acceptability and appropriate valuation of oncology endpoints and supporting access to new treatments for the benefit of cancer patients, healthcare systems and GSK. She represents GSK at Industry Associations related to HTA topics. Prior to GSK she was a Deputy Executive Director of the Greek National Medicines Agency, member of the Board of European Medicines Agency, participated at the Heads of Medicines Agencies Group and the EU HTA network. She joined GSK in 2016 holding an above country role for Government affairs in Europe providing Government Affairs support to mid-sized and cluster markets in Europe (Pharma and Vx) and leading on public policy developments on EU HTA. She is an economist and holds a PhD in Change Management in Healthcare. Email: [email protected] LinkedIn: linkedin.com/in/aikaterini-fameli-phd-mba-6023456b Christoph Glaetzer Vice President Global Market Access & Real World Evidence Janssen, Pharmaceutical companies of Johnson & Johnson United States Organizational Member, HTAi Global Policy Forum Overview • More than 20 years global experience in the development and implementation of pharmaceutical market access and commercialization strategies • Worked and lived in Europe, North America and Asia • Currently Vice President Global Market Access, covering Health Economics, Pricing, Patient Reported Outcomes (PRO) and Real-World Evidence (RWE) • Previous roles included the head of the regional Commercial and Access Strategy Organization for Janssen in Asia Pacific • Representative of Janssen at various international forum and initiatives (e.g. PhRMA, EFPIA, GHC, ISPOR, HTAi) • Champion of new Access and Pricing Concepts to improve Health Outcomes globally • International thought leader and speaker on Commercial Strategies, Health Care Policy and Pharmaceutical Market Access aspects • Educational background: Economist and Health Economist Phone: 609-495-7777 Email: [email protected] 69
Attendees Wim Goettsch Special Advisor HTA National Health Care Institute Netherlands HTAi Board Director Wim Goettsch, PhD is currently Special Advisor HTA at the Dutch National Health Care Institute He was the Director of the EUnetHTA JA3 (2016-2020) Directorate and Chair of the Executive Board of EUnetHTA between June 2016 and March 2018. Since 2019, he also has a position as an Associate Professor at Utrecht University (NL) where he is leading a new H2020 consortium with fifteen partners around Europe, called HTx, new methods for Health Technology Assessment (2019-2024). Between 2010 and 2013, he was the Deputy Secretary of the Medicinal Products Reimbursement Committee at Dutch National Health Care Institute. He is currently Director in the Board of HTAi (2019-2022). Before joining the National Health Care Institute, he worked as a research manager for the PHARMO Institute and was responsible for coordination of numerous pharmacoepidemiological and outcomes studies for international offices of pharmaceutical companies such as AstraZeneca, Novartis, Pfizer and GSK. He has a PhD in immunology and an advanced education in (pharmaco)- epidemiology and pharmaco-economics. He has more than 90 publications in peer-reviewed international journals. Email: [email protected] Twitter: @wim_werk LinkedIn: linkedin.com/in/wimgoettsch Alicia Granados Head of Global Health Technology Assessment (HTA) strategy Sanofi Genzyme Sanofi Spain Organizational Member, HTAi Global Policy Forum Alicia Granados is MD, PhD in PH and certified specialist in respiratory medicine. She serves at Sanofi as Head of Global Health Technology Assessment (HTA) Strategy within Global Market Access HSEI team. Joined Sanofi Genzyme in 2011. She has a clinical and academic background as researcher and associate professor at the School of Medicine of University of Barcelona. Dr Granados is an international specialist in health technology assessment (HTA) with more than 30 years of experience in health care, public and private practices , methods and policy development, at national and international level, including WHO and pharmaceutical industry. Founder President of HTAi. She has more than 60 scientific and health care policy papers published in international peer review journals. Phone: 34629198096 Email: [email protected] Twitter: @AliciaGranados LinkedIn: es.linkedin.com/in/aliciagranados 70
Adrian Griffin Attendees VP, HTA and Access Policy Johnson & Johnson United Kingdom Organizational Member, HTAi Global Policy Forum Adrian has worked in the life sciences industry for over 25 years, predominantly in the fields of health economics, outcomes research, and reimbursement policy, with experience across the pharmaceutical, medical device, and diagnostic sectors. His present role is Vice President, HTA and Access Policy at Johnson & Johnson. Adrian is actively engaged in numerous multi-stakeholder forums where key issues of HTA and access policy are debated and shaped, such as the HTAi Policy Forum, and initiatives that have brought regulators and HTA agencies together with companies, thus improving transparency and appreciation of different stakeholder perspectives. Adrian served on the NICE Technology Appraisal Committee between 2003 and 2020 and was on the Board of Directors for ISPOR (the International Society for Pharmacoeconomics and Outcomes Research), between 2013-15. Phone: +44 7919303328 Email: [email protected] Sandro Gsteiger HTA Evidence Lead F. Hoffmann-La Roche Ltd Switzerland Organizational Member, HTAi Global Policy Forum Sandro Gsteiger holds the position of an HTA Evidence Lead within the Global Access Center of Excellence at F. Hoffmann-La Roche Ltd. In this role, he contributes to access evidence generation, strategy development, the development of novel HTA methods and the adaptation and implementation of such methods for use in practice. He has also contributed to HTA focused public-private partnerships such as those led by the Innovative Medicines Initiative. He has strong interest in HTA Science, evidence synthesis, HEOR methods and their application, and the evolving HTA landscape. He holds an MSc in mathematics (University of Fribourg, Switzerland), a PhD in statistics (Swiss Federal Institute of Technology in Lausanne), and an MSc in HTA from the University of Glasgow, UK. Email: [email protected] 71
Attendees Iñaki Gutierrez-Ibarluzea President HTAi Board of Directors Spain HTAi President BSc and MSc in Sciences from the University of the Basque Country UPV-EHU, Doctor in Sciences (NeuroScience) from the same university, Masters in Epidemiology from the University of Granada and the Andalusian School of Public Health and Masters in Bioethics from the University Ramon Llul and the Institute Borja of Bioethics. He is the current Director of Innovation of the Basque Foundation for Health Innovation and Research (BIOEF) https://www.bioef.org and the coordinator of Osteba, Basque Office for Health Technology Assessment. He has collaborated on the European Union funded projects such as InnoHTA (Innovation and HTA), EUnetHTA (European Network for HTA), PHGEN I and II (Public Health Genomics) ALCOVE (Alzheimer in Europe), PerMed (Personalised Medicine), DISCHARGE (cardiac imaging), VALIDATE-HTA, EXACT, CSA-PERMED, TBMED and SAFENMEDTECH and he is the visiting director of HTA and Market Access at Health Cluster Network, performing different functions. He has also coordinated various projects at the Spanish level such as: GENTecS (Group for the Evaluation of New Technologies in Health) and the Information Resources group. He was a member of the Board of Directors (2010-2012) and Secretary of the International Society HTAi (2012-2014). He has been the chairman of EuroScan International Network for the identification and evaluation of new and emerging health technologies in the period (2007-2010), vice-chair in the periods (2005-2007) and (2010-2011). He is currently the President of EuroScan. Iñaki was also an associated professor in the School of Nursing of Osakidetza Basque Health Service and has worked with the University of the Basque Country and the Open University of Catalonia in different academic activities. He has also participated as an advisor and evaluator in different call for funds at the local, regional, country (Spain, Poland, Korea and UK) and the European Union levels (FP7, COST and Horizon 2020). He has been a member of the International Scientific Committee of the Health Innovation Awards of the NHS-North West 2009 (United Kingdom). He has collaborated with the Spanish Ministry of Industry and the Spanish Observatory for Prospective Technological Studies and is a member and coordinator of the Task Force for Genomics and Public Health. He has also participated as expert advisor in the forum for social cohesion between the EU and Mexico (2010). Recently, he collaborated with WHO-Europe as expert advisor and evaluator on the program of Medical Devices for Countries with limited resources. Iñaki has been advising different HTA initiatives in Argentina, Brazil, Colombia, Costa Rica, Mexico, South Africa, Tunisia, Israel, the Horizon Scanning initiative of EEUU, Norway and Italy, WHO-EMRO region, WHO health technologies unit and is member of the HTA glossary committee. As a member of the Basque Ministry for Health Iñaki has relevant experience on Chronic diseases and its management (http://ec.europa.eu/research/innovation-union/pdf/active-healthy- ageing/basque.pdf ). In 2016 he served as co-chair of the ISPC of HTAi Tokyo 2017. He is finally, member of the Technical Advisory Group that assesses WHO around HTA and Universal Health Coverage. Author of more than 70 peer-reviewed articles, 50 monographies and 4 Clinical Practice Guidelines, 5 books and 4 book chapters. He is Associated editor of Frontiers in Pharmacology and Health Outcomes Research and HiNT journals and member of the editorial board of EUPHA and IJTAHC journals. Email: [email protected] 72
Niklas Hedberg Attendees Executive Board Chair / Chief Pharmacist EUnetHTA / TLV Sweden Organizational Member, HTAi Global Policy Forum Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). Niklas is the Chair of the EUnetHTA Executive Board and the TLV lead partner in EUnetHTA WP 3 Evaluation. Niklas has been working with pricing and reimbursement since 2001. Niklas started as a medical assessor and project leader in the agency, he was the Head of the Department for New Submissions between 2009 and 2014 and is since in his current position. Niklas has a broad experience of different aspects of value based evaluation and over time has seen the increasing importance for health technology assessment (HTA) both across health care systems and on local level to prepare accurate decision making. Phone: +46 730 222 058 Email: [email protected] Catherine Holliday Chief Executive Centre for Community-Driven Research Switzerland HTAi Board Director Catherine (Kate) is Chief Executive of the International Centre for Community-Driven Research (CCDR), a non- profit organisation driving a more person-centred health sector. Her professional work has focused on developing solutions to health system challenges and she has been actively involved in developing more equitable and systematic approaches to community engagement across the health system. She has significant experience working with government, industry, not- for-profit organisations as well as research and international organisations including ten years working in Geneva, Switzerland with the Australian Department of Foreign Affairs and Trade, the International Organisation for Migration, UNICEF and the GAVI Alliance. She has also worked as a nurse and researcher in Australia and the USA with roles including Head of Research at Cancer Council NSW Australia and Head of Policy and Strategy at the Kinghorn Cancer Centre (Sydney, Australia). She holds a Bachelor of Nursing degree, a graduate diploma in nutrition, a Masters in Health Promotion, a Masters in Health Science and her PhD thesis investigated the relationship between the global, social and economic drivers of research and how to translate results into policy, practice and population health. She founded CCDR in 2012 with the vision of creating a more person-driven health sector. CCDR’s mission is to build capacity to support people in the community, patients and their families, and facilitate meaningful connection between service providers, research organisations, the non-profit sector, practitioners, industry, government and the communities for which they provide a service or aim to benefit – all while giving communities and patients a voice in decision-making (www.cc-dr.org). Phone: +41 (0)76 442 9773 Email: [email protected] Twitter: @CCDR_GLOBAL 73
Attendees Li Ying (Grace) Huang Director Center for Drug Evaluation, Taiwan Taiwan HTAi Board Director Grace Huang is a director of the CDE/HTA, Taiwan. Before joining CDE/HTA in 2008, she worked for around ten years as a clinical pharmacist in a leadership role in the department of pharmacy in one of the major medical centers in Taipei. Grace currently serves on the board of Directors for the International Board of Directors for the INAHTA and HTAi. Phone: +886976506608 Email: [email protected] LinkedIn: linkedin.com/in/li-ying-grace-huang-6441857a Kyle Hvidsten Head, Health Economics & Value Assessment Sanofi United States Organizational Member, HTAi Global Policy Forum Mr Kyle Hvidsten serves as the Head of the Health Economics and Value Assessment Group for Sanofi's Specialty Care Business Unit. This business unit encompasses 5 therapeutic areas: Oncology, Neurology/Immunology, Dupixent, Rare Disease, and Rare Blood Disorders. These therapeutic areas represent many of the life-saving, life-changing medicines that Sanofi makes available to patients around the world as well as several of Sanofi's clinical development programs. Kyle's academic background includes degrees in life sciences and public health. Phone: 617-685-5796 Email: [email protected] Mohit Jain Vice President, Market Access EUMEA BioMarin United Kingdom Organizational Member, HTAi Global Policy Forum Mohit is responsible for Market Access in BioMarin, coordinating market access needs for the regional teams and heading the Global Centre of Excellence for Health Economics & Outcomes Research in BioMarin. BioMarin is a company focused on developing life transforming therapies for rare diseasepatients. Mohit has been with BioMarin for over eight years and prior to this worked in other companies including large pharma and rare diseases. By background a scientist and then worked in corporate finance before finding a calling in Market Access. Mohit’s academic interests in rare diseases are the application of HTA to rare diseases, particular interests are in innovative approaches such as SWTP or MCDA as well integration of RWE methods in HTA or greater integration of the patient voice. In addition, he has an interest in exploring industrial economics in the context of rare diseases access. Mohit is married with two lovely girls aged 11 and 13 years and escaping his home office for an occasional run. Email: [email protected] 74
Ivett Jakab Attendees Health Economist Syreon Research Institute / European Patients' Forum Youth Group Hungary Invited Patient Representative Ivett Jakab holds an MSc in Health policy, planning and financing (2016) and a BA in Business and Management (2014). She is working as a health economist at Syreon Research Institute, an independent private research institute based in Budapest, Hungary. She is leading the the Syreon Patient Policy Research Unit since 2020. She became the President of the EPF Youth Group in 2020, working to strengthen the young patients’ voice throughout Europe. She is a Board of Trustees member at the EUPATI Foundation. She was a member of the European Health Parliament’s (EHP) 4th edition in 2018, joining the Innovation and Value Committee. She graduated from the European Patients’ Forum (EPF) Summer Training for Young Patient Advocates (STYPA) program in 2018 and supported the 2019 edition as a team leader. Her research interests are in the evolving areas of HTA (e.g. extended value frameworks) and patient engagement in healthcare decision-making. Her mission is to bring the perspectives of different stakeholders in healthcare closer together. Email: [email protected] Rosanne Janssens Ph.D. Researcher KU Leuven Belgium Invited Speaker Rosanne Janssens is a Ph.D. researcher working on the PREFER project at the KU Leuven in Belgium, in the Regulatory Sciences & Pharmaco-Economics research unit. Her research focuses on designing, conducting, and analyzing patient preference studies in the context of drug development, regulatory benefit-risk assessment, and Health Technology Assessment. Her research methods may guide healthcare stakeholders (researchers, regulators, payers, patient organizations, clinicians) considering the use of preference studies and contributes to the debate regarding best practices for preference studies. Rosanne holds a Master's degree in Biomedical Sciences (KU Leuven, 2016, summa cum laude) with a specialization in Management and Communication. Using qualitative and quantitative methods, Rosanne’s Ph.D. research elucidates: 1) stakeholder views on patient preference studies, 2) the impact of patient characteristics and methodological choices on measured preferences in preference studies and 3) the potential use of results from preference studies in drug decision-making. Rosanne concluded a 10-month secondment at the European Medicines Agency (EMA), where she conducted research into the role of patient preferences in drug regulation and methods for increasing transparency and communication of uncertainties in regulatory benefit-risk assessment. Email: [email protected] LinkedIn: linkedin.com/in/rosanne-janssens-57a4a2aa 75
Attendees Brendon Kearney Consultant Physician Royal Adelaide Hospital (Central Adelaide Local Health Network) Australia Chair, HTAi Asia Policy Forum Professor Brendon Kearney has had an illustrious career with a list of achievements in the health services field that began as a junior hospital doctor in 1969, then advancing to senior managerial health positions. His dedication has seen him directly contributing to the development and improvement of the Australian healthcare system, proposing recommendations for change, developing state wide frameworks and displaying immense dedication to serving the Australian and in particular South Australian community. In 2005, Professor Kearney was awarded the prestigious Sidney Sax Medal by the Australian Healthcare Association in recognition of an individual who has made an outstanding contribution to the field of health services policy, organisation, delivery and non-clinical research. In 2003, Professor Kearney was awarded a Member in the Order of Australia for service to Medical Administration in South Australia, recognising his contribution to medical research promotion and his coordination for South Australia of the medical response team assisting victims of the Bali bombings. Professor Kearney is currently the chair of Health Policy Advisory Committee on Technology (HealthPACT) and EuroScan International Network whilst continuing a significant case load in South Australia. Phone: 780-401-4881 Email: [email protected] Anusha Kheir Head, Pricing & Access Center of Excellence Amgen United States Organizational Member, HTAi Global Policy Forum Anusha leads Amgen’s Pricing and Access Center of Excellence (PACE). Under Anusha’s leadership, her team delivers central access-related capabilities and insights for Amgen across the pipeline for all key markets. The PACE organization includes a world-class Modeling Center of Excellence, HTA Center of Excellence and Global Contracts, Pricing and Analytics. Anusha has over 20 years of industry experience across health economics, outcomes research, business development, research and development, strategic operations, alliance management, reimbursement access and policy. Prior to Amgen, she worked at the Lewin Group, IQVIA, Aurora Biosciences/Vertex and the UCSD Medical Center. Ms. Kheir has a Master’s in Public Health from Yale University in Health Policy and Infectious Disease Epidemiology, and a Bachelor’s in Science from UCSD. Email: [email protected] 76
Sukyeong Kim Attendees Senior Research Fellow National Evidence-based Healthcare Collaborating Agency Korea, Republic of Organizational Member, HTAi Global Policy Forum I'm senior research fellow of NECA, the national HTA agency of Korea. My major researches have been on HTA policy, pharmaceutical policy, and patient safety policy. I've got PhD and master in public health, especially health policy, and bachelor in pharmcy. Phone: +82-2-2174-2770 Email: [email protected] Megan Klopchin Consultant- Policy Research, Global Patient Outcomes & Real World Evidence Eli Lilly and Company United States Organizational Member, HTAi Global Policy Forum Megan Klopchin is a Consultant at Eli Lilly and Company in the Center of Expertise within the Global Patient Outcomes & Real World Evidence (GPORWE) department where her main priorities include overseeing its policy capability. Via this capability, GPORWE is externally engaged to address policy and environmental issues related to scientific standards and methods to appropriately support value assessments and the utilization of real world evidence. Prior to joining Lilly, Megan was a microbiologist for the federal government’s BioWatch Program which was housed at the Indiana State Department of Health. Megan received her Master of Public Health with a concentration in Health Policy and Master of Health Administration from Indiana University, and her bachelor’s degrees in biology and sociology from Millikin University in Decatur, Illinois. Megan enjoys volunteering for several local nonprofit organizations in Indianapolis where she resides, and she serves on the IU Richard M. Fairbanks School of Public Health Alumni Association Board. She is a member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and HTAi. At Lilly, she has been recognized as one of its Top 100 Innovators and recently received the Lilly Research Lab President’s Diversity and Inclusion Award. Phone: 317-225-9933 Email: [email protected] 77
Attendees Saskia Knies Senior Advisor,Health Economics and Personalised Medicine Zorginstituut Nederland (zin) Netherlands Organizational Member, HTAi Global Policy Forum Saskia Knies is senior advisor health economics and personalised medicine at the National Health Care institute (Zorginstituut Nederland) in the Netherlands. As senior advisor health economics Saskia is supervising pharmacoeconomic advisors working on assessments of pharmacoecononomic dossiers. In her role as senior advisor personalized medicine she is working as advisor on the H2020 HTx research project, mostly working on work package 4 ‘Implementation into systems and processes’. In addition, Saskia coordinates the Research Network ‘Health Technology Assessment’. In this research network the National Health Care Institute cooperates in scientific research with the University of Utrecht (department of Pharmacoepidemiology and Clinical pharmacology) and Erasmus University Rotterdam (Erasmus School of Health Policy & Management). From February 2014 till February 2016 she was the project leader of the revision of the Dutch health economic guidelines. In that role she was responsible for the process and the secretary of the external advisory commission. She holds a master’s degree in Health Science Research- HTA from Maastricht University. In January 2011 Saskia Knies defended her PhD thesis at the same university on the transferability of economic evaluations. She has been working as a researcher and advisor in the area since 2006. Email: [email protected] Helen Knight Programme Director – TA, HST and CSP NICE United Kingdom Organizational Member, HTAi Global Policy Forum Helen Knight is a Programme Director at the National Institute for Health and Care Excellence (NICE) responsible for the health technology assessment methods used to produce national guidance. With an academic background in biochemistry and health economics, she spent 6 years working as a health economist for a health outcomes consultancy before joining NICE in the Technology Appraisal Programme in 2007. She has extensive experience of health technology assessment over a wide range of technologies and disease areas. As Programme Director, she is responsible for the methods for developing and delivering of guidance within the Centre for Health Technology Evaluation. Email: [email protected] 78
Marguerite Koster Attendees Marguerite Koster United States Organizational Member, HTAi Global Policy Forum Marguerite Koster is the Director of Kaiser Permanente (KP) Southern California's Evidence-Based Medicine Services Unit, where she manages 13 evidence specialists and project managers who support the region's clinical practice guideline, medical technology assessment, and health system implementation programs. For more than 25 years, Marguerite has been actively involved in the advancement of evidence-based medicine and methodology standards for guideline development and technology assessment at KP's national and regional levels. She is a member of KP Southern California's Medical Technology Assessment Team (MTAT) and Medical Technology Deployment Strategy Team (MTDST), as well as the KP National Guideline Directors and Guideline Quality Committees and the KP Interregional New Technologies Committee (INTC). Marguerite has a long history of collaboration with other healthcare organizations, medical and professional societies, systematic reviewers, accreditation bodies and public policy groups. She was a member of the Institute of Medicine's (IOM) Committee on Standards for Systematic Reviews of Comparative Effectiveness Research which published the landmark report, Finding What Works in Health Care: Standards for Systematic Reviews, and a reviewer of the IOM Report, Clinical Practice Guidelines We Can Trust. She is a member of the Cochrane Governing Board, and a Past Chair of the Guidelines International Network/North America. Phone: 626-405-5462 Email: [email protected] Twitter: @MargueriteK_LA Jake Lebiecki Director - Intl Policy Pfizer United Kingdom Organizational Member, HTAi Global Policy Forum Jake Lebiecki, PhD, is a Senior Director and Market Access Methods & Capabilities Lead within Pfizer’s Chief Business Office. Jake plays a pivotal strategic & global role, which has a primary responsibility of coordinating and leading above-brand market access activities, processes improvements and standardization, and dissemination of new market access methodologies (such as pricing, value assessment) across the organisation. Before joining Pfizer in 2013, Jake worked for 6 years in strategic market access consulting, leading projects for a variety of pharmaceutical clients on pricing/ reimbursement, HTA, payer insights, and health economics in a broad range of therapeutic areas. He also holds a PhD in neuroscience. Phone: 07500998877 Email: [email protected] LinkedIn: uk.linkedin.com/in/jake-lebiecki-80474ab 79
Attendees Anne Lee Chief Pharmacist Healthcare Improvement Scotland United Kingdom Organizational Member, HTAi Global Policy Forum Anne Lee is the Chief Pharmacist and lead officer for the Scottish Medicines Consortium (SMC), based in Healthcare Improvement Scotland. SMC undertakes early health technology assessment (HTA) of all new medicines on behalf of NHS Scotland. Anne graduated in pharmacy from Heriot Watt University in Edinburgh in 1984, then spent many years in hospital pharmacy. She completed an MPhil on the causality of adverse drug reactions and also carried out research on adverse reaction reporting through the Medicines and Healthcare products Regulatory Agency’s yellow card scheme. Anne has published widely on medicines safety and has edited textbooks on Adverse Drug Reactions and Prescribing in Pregnancy and Breastfeeding. Anne joined SMC in 2005, initially to set up its horizon scanning programme and has been the lead officer since 2012. Responsible for delivery of SMC’s work programme, Anne has led an extensive change programme over recent years, aimed at increasing transparency, enhancing patient and public involvement and improving HTA of new medicines. Email: [email protected] Twitter: @LeeAnneMcS1 Martin Lerner Physician and Department Director Norwegian Institute Of Public Health (niph) Norway Organizational Member, HTAi Global Policy Forum Martin Lerner is physician and Department Director at the Department of Reviews and Health Technology Assessments within the Division for Health Services at the Norwegian Institute of Public Health (NIPH). His current responsibilities include horizon scanning and disinvestment of health technologies for the specialist health care in Norway as well as being involved in, and developing methodological approaches for, rapid reviews and more extensive HTAs. He also is NIPH's representative in the International Horizon Scanning Initiative (IHSI) and the international Health Tech Scan (iHTS), previously EuroScan. Martin Lerner is originally from Sweden and obtained his medical degree at the Karolinska Institute in Stockholm and has 15 years of clinical experience in cardiology and internal medicine. Prior to moving to Oslo, Norway, he spent 3.5 years in London, UK, where he studied Public Health but also got the opportunity to focus more on his family and other areas of interest, including getting a sommeliers’ degree. Email: [email protected] 80
Jan Liliemark Attendees Chief of department SBU Sweden Organizational Member, HTAi Global Policy Forum Jan Liliemark is professor in pharmacotherapy and program manager at the Swedish Council of Technology Assessment in Health Care and Social Services (SBU). The SBU delivers HTA-rapports on various methods within the health area, comprehensive rapports on a full subject area, rapid reviews on new methods, commentary rapports on other agencies full rapports and finally, a service for decision makers delivering rapid focussed rapports on specific questions. Jan Liliemark has a background in clinical practise, mainly clinical haematology and oncology between 1981 - 1998. The clinical experience is mainly within treatment of leukemias and lymphomas. Jan Liliemark has also a research background since 1978, mainly within the field of clinical pharmacology and clinical trials. J. has published more than 100 scientific, peer-reviewed papers on pharmacokinetics of anti- cancer drugs and clinical trials with nucleoside analogs. After 3-4 years as medical affairs manager at Schering-Plough, Nordic Biotech, he was scientific director at the Medical Product Agency (MPA) in Sweden 2001 - 2010. The MPA is the national competent agency which controls medicinal products and medical devices. Jan Liliemark oversaw the clinical assessments of new applications and the overall scientific quality of regulatory activities. He was also a member of its management board. Besides these professional positions, Jan Liliemark is also a member of the regional parliament in Stockholm and an active health care politician for the liberal party and chairman of the national board for recommendation of medical devices. Phone: +46705174651 Email: [email protected] Elizabeth Loughren Sr Consultant Kaiser Permanente - Southern California United States Organizational Member, HTAi Global Policy Forum Elizabeth Loughren is a managerial senior consultant at Kaiser Permanente who currently coordinates the Interregional New Technologies Committee and new medical technology evidence assessment support for physician-led product teams. Liz joined the Southern California Permanente Medical Group’s Evidence- Based Medicine Services team in 2003 after receiving a Master of Public Health degree in Healthcare Management and Policy from UCLA. She has managed medical technology assessment committees and performed rapid reviews of new and emerging technologies for many years. Phone: 213-444-9524 Email: [email protected] 81
Attendees Marco Marchetti Director National Center for HTA - Istituto Superiore di Sanita Italy HTAi Treasurer Marco Marchetti has graduated in medicine at Università Cattolica del Sacro Cuore (Rome) and postgraduate in Hygiene and Public Health and Legal Medicine. He his currently the Director of the National Center for Health Technology Assessment in the Italian National Institute for Health. He has been previusly the DIrector of the Health Technology Assessment (HTA) and Innovation Unit of the Fondazione Policlinico Universitario “Agostino Gemelli”, Università Cattolica del Sacro Cuore.He is also the European Director of the International Master Program in HTA and Management since 2001 (http:// www.ulyssesprogram.net/ ). He has been in the period 2007-2015 Director of Scientific-Technical Office of Institutional review board (IRB) - Ethical review board of the Università Cattolica del Sacro Cuore . He has been a referee for Health Technology research proposals in the year 2003 and 2008 by The NHS Health Technology Assessment Programme. - National Coordinating Office for Health Technology Assessment - UK.He was in charge of organizing the HTAi 2nd annual meeting “Bringing HTA into practice”, 20-22 June 2005. He is President of Local Organizing Committee of the 2017 Health Technology Assessment Meeting in Rome to be held on June 2017.He's chair of the Special Interest Subgroup of HTAi “Hospital based HTA”. He participates since the beginning in the activities of the European Network of Health Technology Assessment (http://www.eunethta.eu/ ). His expertise covers the following fields: hospital management, quality assurance, risk management, HTA, epidemiology, evidence based medicine, digital medicine impact evaluation. He has collaborated with the National Agency for Drugs and Regional Government in the assessment processes of different drugs and medical devices with a particular focus on innovative pricing scheme and payment by results.He has published more than 150 papers on national and international publications. Phone: +39 3386111294 Email: [email protected] Twitter: @mmarchetti31 LinkedIn: linkedin.com/in/marco-marchetti-b665952 82
Lisa Marsden Attendees Vice President Global Market Access And Pricing AstraZeneca United Kingdom Organizational Member, HTAi Global Policy Forum Prior to taking her role as Vice-President, Global Market Access & Pricing (GMAP) at AstraZeneca, Lisa was Therapeutic Area (TA) Head of Respiratory, GMAP, where she led on the Fasenra Market Access Strategy and Pricing Policy, as well as significantly upscaling talent and capabilities within the GMAP Respiratory TA. Lisa has held a number of senior leadership roles since joining AZ in 2004, and her appointment is another great example of our commitment to developing our internal talent. In 2016 she was VP, Market Access, Government Affairs, and the Business Unit Head of AZ Canada’s Established Brands portfolio. In 2006, Lisa was Director of Government Affairs for the Canadian operation before moving in 2012 to AZ’s UK-based head office to serve as the Global Director of Government Affairs, Payer and Brands. In this role, Lisa led the development and execution of strategies with the goal of strengthening patient access to AZ’s medicines across the world. Earlier in her career, Lisa worked at various levels of Government within Canada, and the province of Ontario. Lisa was a senior political advisor, advising elected Members of Parliament on a wide range of public policy matters, before serving as the VP of Government Affairs with the Retail Council of Canada, and prior to that the Restaurant Association. She has also served as the Chair of Project Work, a not-for- profit organisation that helps adults with mental illness to find meaningful employment, as well as being an active member of several business associations and a lecturer at Ryerson University. Phone: 07392103247 Email: [email protected] Newell McElwee Vice President Boehringer-Ingelheim Pharmaceuticals, Inc United States Organizational Member, HTAi Global Policy Forum Newell McElwee is Vice President, Health Economics and Outcomes Research at Boehringer Ingelheim Pharmaceuticals, Inc. He is a recognized leader in HEOR with 30+ years experience in the pharmaceutical industry. Prior to coming to Boehringer Ingelheim, Newell led outcomes research groups at Pfizer and Merck. He has been actively engaged with a number of outcomes research related organizations, including AHRQ, IOM/NAM, HTAi, ISPOR, SMDM, Academy Health and AMCP. He is also a member of the Tufts Medical Center CTSA Executive Advisory Committee. Newell received his PharmD from Mercer University and his MSPH (epidemiology) from the University of Utah. He completed a clinical pharmacy residency at Osteopathic Medical Center of Texas and a post- doctoral fellowship in clinical pharmacology and toxicology at the University of Utah Medical Center. Phone: 484-832-2429 Email: [email protected] 83
Attendees Suzanne Mcgurn President and Chief Executive Officer CADTH Canada Organizational Member, HTAi Global Policy Forum Ms. Suzanne McGurn joined CADTH in July 2020 as its President and Chief Executive Officer. She brings to the role a deep understanding of the complex issues surrounding the management of pharmaceuticals, medical devices, and clinical interventions in Canadian health systems. Prior to joining CADTH, Ms. McGurn’s distinguished career spanned clinical practice, patient support, and senior roles in government. Within the Ontario Ministry of Health, she served as the Assistant Deputy Minister of the Drugs and Devices Division and the Executive Officer of the Ontario Public Drug Programs. She also led the implementation of the pan-Canadian Pharmaceutical Alliance and served as its first chair. Ms. McGurn holds both a Bachelor of Nursing Sciences and a Master of Public Administration from Queen’s University. Email: [email protected] Lorena Mesa-Melgarejo Chief Qualitative Methods and Social Research Unit Iets - Instituto De Evaluación De Tecnologías En Salud Colombia Organizational Member, HTAi Global Policy Forum PhD in Public Health, Master in Health Economics, Master in Public Health, Nurse. Qualitative research expert. Email: [email protected] LinkedIn: linkedin.com/in/lorena-mesa-37626121 Andrew Mitchell Strategic Adviser, Evaluation Australia Government, Department of Health (PBAC&MSAC) Australia Organizational Member, HTAi Global Policy Forum Andrew Mitchell is Strategic Adviser, Evaluation in the Australian Government Department of Health. He has long experience in using clinical and economic evaluations of medicines and other health technology types, with a recent focus on precision medicine and genomic technologies. He has helped steer the development of several approaches to use this information systematically to guide resource allocation decisions in a publicly funded health care system. Phone: +61262897486 Email: [email protected] 84
Nicole Mittmann Attendees Chief Scientist and VP Evidence Standards CADTH Canada Organizational Member, HTAi Global Policy Forum Dr. Nicole Mittmann, Chief Scientist and Vice-President of Evidence Standards Dr. Nicole Mittmann is CADTH’s Chief Scientist and Vice-President of Evidence Standards. Dr. Mittmann leads CADTH’s shared science groups, including the Health Economics, Research Information Services, and Scientific Affairs teams. Dr. Nicole Mittmann joins CADTH from Cancer Care Ontario, where she held the position of Chief Research Officer. She holds a faculty position as an assistant professor at the University of Toronto in the Department of Pharmacology & Toxicology, and is an associate scientist at Sunnybrook Health Sciences Centre. Dr. Mittmann is also the co-chair of the Committee on Economic Analysis (CEA) at the Canadian Cancer Trials Group. Responsibilities include embedding economic parameters into clinical trials, economic evaluations, and guidelines development. In her academic capacity, Dr. Mittmann has conducted and collaborated on notable research in the areas of economic evaluations, outcomes research, and drug/patient safety. Research methodologies include the examination of large databases, economic methodologies, and decision analysis. Dr. Mittmann holds an MSc and PhD in pharmacology from the University of Toronto. Email: [email protected] Jani Mueller Sr Researcher CMeRC South Africa HTAi Board Director Debjani Mueller, MEng is a Senior Researcher at Charlotte Maxeke Medical Research Cluster, CMeRC. Jani continues to focus her effort on promotion, collaboration, and raising awareness of sustainable HTA development and implementation. Her main research interests are health technology assessment of medical devices and digital technology and the use of real-world data and real-world evidence in health care decisions. She is currently a board member of Health Technology Assessment international (HTAi) and is a founding member of the South African HTA Society, SAHTAS. She is an Associate Editor of the International Journal of Technology Assessment in Health Care (IJTAHC). Phone: +491637788204 Email: [email protected] LinkedIn: linkedin.com/in/debjani-b-mueller-4726884 85
Attendees Nuriya Musina Member Health Technology Assessment Association Russian Federation Organizational Member, HTAi Global Policy Forum Dr. Musina is an Associate Professor and Lecturer at the Department of Department of Management and Economics of Pharmacy, Saint Petersburg State Chemical Pharmaceutical University. She graduated from this Medical University with honors equivalent to Summa Cum Laude in 2003, received later a doctorate in Pharmacology from the same University in 2006. Dr. Musina is also a Head of Development and Communications at the Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation. Dr. Musina was a postdoctoral fellow and obtained a Master of Science Diploma in Economic Evaluation for Health Technology Assessment at the University of York, UK (2016). Dr. Musina is a Member of the Health Expert Board of the Council of Federation Committee on Social Policy of the Russian Federation. Being an author of educational and methodical manuals for pharmacists and more than 30 research publications, she is also a member of the editorial board of the scientific journal \"\"Pharmacoeconomics. Modern pharmacoeconomics and pharmacoepidemiology \"\", and is an active manuscript and grant reviewer. Dr.Musina has been the member of number of panels and committees at the national and International level dealing with HTA and pharmacoeconomics issues.\" Phone: +79036632520 Email: [email protected] Lynne Nakashima Senior Director, Provincial Pharmacy BC Cancer Canada Organizational Member, HTAi Global Policy Forum Lynne Nakashima is the Senior Director, Provincial Pharmacy at BC Cancer, Canada. BC Cancer leads the care of cancer patients throughout the province. My role is to help coordinate the funding, budgeting and formulary process, lead Pharmacy Professional Practice, and participate in national initiatives. Phone: 604-760-6204 Email: [email protected] Twitter: @BCCancer LinkedIn: linkedin.com/in/lynne-nakashima-b45a8b3a 86
Alexander Natz Attendees Secretary General European Confederation Of Pharmaceutical Entrepreneurs Belgium Invited Speaker Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (www.eucope.org) in Brussels and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective. From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements and licensing of pharmaceuticals. Dr. Natz has also worked in the field of competition law with the European Commission and in the pharmaceutical industry. As a research assistant at Duke University (USA) he has dealt with international pharmaceutical law. His doctorate was supervised by the former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling. Email: [email protected] Megan O’Brien Executive Director Merck United States Organizational Member, HTAi Global Policy Forum Megan O’Brien, PhD, MPH, is currently an Executive Director within the Global Center for Observational and Real World Evidence at MSD. In this role, Dr. O’Brien leads the Policy Evidence Research team. The focus of this team is to generate evidence to inform policy related discussions around access to pharmaceuticals, and to contribute to real-world evidence, HTA and value framework policies and standards development. In addition, she leads a company-wide HTA Council whose goal is to ensure the organization contributes to and is prepared for evolution in HTA. In previous roles at Merck, Dr. O’Brien was responsible for the development of economic models for several pharmaceutical products and for value evidence strategies and RWE studies for vaccines. Dr. O’Brien received a PhD in health economics from the Johns Hopkins Bloomberg School of Public health and a Masters Degree in Public Health from Emory University. Email: [email protected] 87
Attendees John O'Donnell SVP, Worldwide Health Economics & Outcomes Research Bristol Myers Squibb Co. United States Organizational Member, HTAi Global Policy Forum John C. O’Donnell, MPP, PhD, is Senior Vice President, Worldwide Health Economics and Outcomes Research at Bristol-Myers Squibb. He leads a diverse Global team dedicated to defining, developing and delivering evidence of value to ensure patients, payers and providers have the best possible information about, and optimal access to medicines. He was the inaugural Chair of AcademyHealth’s Corporate Council, is an Institutional Council member of the International Society of Pharmacoeconomics and Outcomes Research. John received a PhD in Health Policy and Administration from the University of North Carolina at Chapel Hill. He has thirty years of experience in health services and outcomes research in industry, in academia and in US State and Federal governments, with 20 years of experience in the pharmaceutical industry. While in government and academia, John advanced health policy research in rehabilitation services, veterans’ health and the aged through his work with the US Department of Veterans Affairs and Duke University’s Center for the Study of Aging and Human Development. John is Adjunct Professor at the University of North Carolina at Chapel Hill. He has published in the areas of health economic evaluation, health and regulatory policy, health services research, geriatrics and rehabilitation and is a reviewer for leading journals including Medical Care, Value in Health, American Journal of Psychology, and the Archives of Internal Medicine. Phone: 484-788-4239 Email: [email protected] Elisabeth Oehrlein Assistant Vice President, Research and Programs National Health Council United States Invited Patient Representative Elisabeth M. Oehrlein, Ph.D., MS is Assistant Vice President, Research & Programs at the National Health Council, joining the organization in July 2018. In this role, Dr. Oehrlein crafts the NHC’s annual research and programmatic agenda in service to our mission and leads the NHC’s research and programmatic work on value, real-world evidence, and patient engagement. She is a mixed-methods researcher with expertise in epidemiologic, qualitative, and patient-engagement methods, as well as patient-focused medical product development. Her research interests include developing new methods for applying patient-provided information when developing real-world evidence to ensure studies reflect the “real world” as closely as possible, as well as developing new methods for patient-journey mapping. Dr. Oehrlein holds a BA degree from Franklin & Marshall College, an MS in Epidemiology from the University of Maryland School of Medicine’s Department of Epidemiology and Human Genetics, and a Ph.D. in Pharmaceutical Health Services Research with a concentration in Comparative Effectiveness Research/Patient-Centered Outcomes Research from the University of Maryland School of Pharmacy. She is an active member of the International Society for Pharmacoeconomics and Outcomes Research and holds leadership roles in the Patient-Centered and Real-World Evidence Special Interest Groups. Phone: 2027853910 Email: [email protected] 88
Daniel Ollendorf Attendees Director, Value Measurement & Global Health Initiatives Tufts Medical School Center for the Evaluation of Value and Risk in Health United States Chair, HTAi Global Policy Forum Dan Ollendorf is Director of Value Measurement and Global Health Initiatives at the Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts University Medical Center, as well as Assistant Professor of Medicine. An internationally recognized expert in health technology assessment (HTA), Dan’s research interests include expanding the use of HTA and economic evaluation in low- and middle-income settings (particularly rapidly-growing economies), as well as refinement and use of value assessment tools in the US and other high-income settings. Prior to joining CEVR, Dan was Chief Scientific Officer at the Institute for Clinical and Economic Review (ICER) for over 10 years. His 30 years of health care experience also include work in the hospital, informatics, insurance, managed care, and consulting sectors. Dan holds a Ph.D. in clinical epidemiology from the University of Amsterdam, a Master’s of Public Health from Boston University, and a Bachelor of Arts from the University of Rochester. He currently serves as a non-resident Fellow at the Center for Global Development, is a member of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) HTA Council Working Group, and is the Chair of the Health Technology Assessment International (HTAi) Global Policy Forum. Phone: +1 617 636 2581 Email: [email protected] Twitter: @dollendorf LinkedIn: linkedin.com/in/dan-ollendorf-5093452 Vitaly Omelyanovskiy General Director Center of Healthcare Quality Assessment and Control Russian Federation Organizational Member, HTAi Global Policy Forum Born on July 27, 1964 in Russia. In 1987 he graduated from Russian National Research Medical University with a specialization in “General Medicine”. In 1998 he graduated from the Russian Presidential Academy of National Economy and Public Administration with a specialization in “State and Municipal Management”. In 2002 he defended his first doctoral thesis in the RF on clinical and economic analysis and pharmacoeconomics. From 2012 to 2020 - Chief of the Research Laboratory of Technology and Healthcare Assessment of the Institute of Applied Economic Research of the Russian Presidential Academy of National Economy and Public Administration. Since 2015 - General Director of the Center for Healthcare Quality Assessment and Control of the Ministry of Health of the RF. Since 2020 – Head of the Department for Economics, Management and Health Technology Assessment of the Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the RF. He is Editor-in-Chief of the following academic journals: “Pharmacoeconomics. Modern Pharmacoeconomics and Pharmacoepidemiology” and “Medical Technologies. Assessment and Selection”. He is the author more than 150 research publications. He is President of the Russian HTA Branch of the ISPOR. Phone: +79269584070 Email: [email protected] 89
Attendees Wija Oortwijn Senior Researcher Radboud University Medical Centre Netherlands HTAi Vice President Wija Oortwijn holds a position as senior researcher in the field of global HTA at the Radboud University Medical Centre (Radboudumc) in Nijmegen and as associate professor at Leiden University Medical Centre (Public Health and Primary Care). She studied health sciences and holds a PhD in Medicine (priority setting for HTA). She has almost 30 years of relevant professional experience in HTA and health policy analysis around the globe, with her key expertise including health priority setting, policy evaluation and measuring the impact of research. Since 1992, she has been extensively involved in the development of HTA and health system strengthening around the world. She is a founding member of the Dutch Society for HTA (NVTAG) and the international HTA Society (HTAi). Currently, she is Vice President of HTAi, co-chairing the HTAi-ISPOR Good Practices Task Force on deliberative processes for HTA and is associate editor of the International Journal of Technology Assessment in Health Care. Furthermore, she was the scientific secretary of HTAi’s Global Policy Forum from June 2016 until June 2019. Phone: +31 24 3610389 Email: [email protected] Trygve Ottersen Director, Division for Health Service Norwegian Institute of Public Health Norway Organizational Member, HTAi Global Policy Forum Trygve Ottersen (MD, PhD) is director of the Division for Health Services at the Norwegian Institute of Public Health. The Division works with health services research; systematic reviews and health technology assessments (HTAs); dissemination and use of knowledge; and global health. Trygve is also associate professor at the Department of Community Medicine and Global Health at University of Oslo. Email: [email protected] LinkedIn: linkedin.com/in/trygve-ottersen-28440b41 90
Britta Paschen Attendees Pharmacist Merck Healthcare KGaA Germany Organizational Member, HTAi Global Policy Forum Britta Paschen is Pharmacist by training (Johann Wolfgang von Goethe University, Frankfurt am Main, Germany) and accomplished post-graduate diploma and master studies in Economics & Financial Management (Technical University Mannheim), Healthcare Economics (Stockholm School of Economics), Business Administration (London City School), and Health Outcomes Research (Harvard School of Public Health). After joining Merck KGaA in 1987, she gained comprehensive professional experience in various international Healthcare managerial and executive positions in Manufacturing and Supply, Quality Assurance, Business Development, Strategic Marketing, Transfer Pricing, Health Economics, Operational and Strategic Pricing, Market Access and Health Services Research. Currently Britta Paschen is the Head of Global Evidence & Value Development, directly reporting to the Chief Medical Officer of Merck Healthcare. Put in place in Q1 2014, the function is accountable for all strategic and operational aspects of evidence- based comparative value management for portfolio assets and brands, to maximize HTA- and access opportunities for the benefit of patients. Britta’s main areas of professional interest comprise healthcare systems analysis, funding and organization of health services, healthcare decision making, patient access, PFDD, and HTA requirements and proceedings. Britta’s team closely collaborates with all Global Merck Healthcare R&D platforms, Innovation Franchises and regions/key countries. Email: [email protected] Steven Pearson President Institute For Clinical & Economic Review United States Organizational Member, HTAi Global Policy Forum Steven D. Pearson, MD, MSc is the Founder and President of the Institute for Clinical and Economic Review (ICER), an independent non-profit organization that evaluates the evidence on the value of medical tests, treatments, and delivery system innovations to encourage collaborative efforts to improve patient care and control costs. Dr. Pearson is also a Lecturer in the Department of Population Medicine at Harvard Medical School. Previously, he has served as a Visiting Scientist in the Department of Bioethics at the NIH, a Special Advisor on Technology and Coverage Policy at the Center for Medicare and Medicaid Services, and the Vice Chair of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC). His publications include over 150 peer-reviewed articles and commentaries on the role of evidence in the health care system, and the book No Margin, No Mission: Health Care Organizations and the Quest for Ethical Excellence, published by Oxford University Press. Phone: 617-528-4013 Email: [email protected] 91
Attendees Gesa Pellier Head, Global Patient Access Novartis Pharma Switzerland Organizational Member, HTAi Global Policy Forum Gesa heads the Novartis Global Patient Access (GPA) team since 2013. In this role she is responsible for ensuring appropriate patient-centric, outcome-focused value demonstration and access plans and their execution for all Novartis Pharma therapy areas and products/programs, throughout development and post-approval, worldwide. Her responsibilities span the areas of market access, pricing & reimbursement, health economics and outcome research. Gesa has been with Novartis in Basel, Switzerland, since April 2005, originally in Development where she started as senior DRA Franchise Manager in Gastroenterology, then headed the DRA Business Franchise Teams in the Disease Areas Arthritis, Bone, Gastroenterology, Urology for Europe (2006 – 2007), thereafter was appointed to lead the DRA Global Business Franchise teams for the Disease Areas Immunology and Infectious Diseases, Transplantation, Ophthalmology, Dermatology, Gastroenterology, Urology (2007 – 2008), and subsequently was appointed Head DRA Europe Novartis Pharma General Medicine (2008-2013). In 2012, Greater China was added to her DRA responsibilities in addition to her continued Leadership of DRA Europe. Before joining Novartis, Gesa worked for 15 years in GlaxoSmithKline and its legacy companies, in a variety of Regulatory Affairs roles with increasing responsibility in country (Germany), Region (CEE) and Global (DRA TA head Oncology & Biotechnology). Gesa is a physician by training, graduating from Medicine University of Lübeck, Germany, in 1990. Phone: +41795722234 Email: [email protected] Franz Pichler Sr Director, Global Public Policy Eli Lilly and Company Australia HTAi Board of Directors/Organizational Member, HTAi Global Policy Forum Franz is a Senior Director in the Global Public Policy team at Eli Lilly. He specializes in international health policy issues relating to pharmaceuticals, focusing on HTA, digital health and market access. He supports regional policy in the Asia-Pacific, including chairing the PhRMA Japan Vision Task Force. Previously, he worked in Europe, including representing Lilly on the EFPIA HTA Working Group, the EuropaBio HTA and Market Access Group and being a participant of the IMI GetReal project. Franz is a member of the HTAi Board and is the society Secretary. He chairs the Business Development Group (BDC), is a member of the Scientific Development and Capacity Building Committee (SDCB) and the Asia Policy Forum Organising Committee (APFOC). In 2012, Franz co-founded the HTA-Regulatory Interactions Interest Group and chaired this IG until 2016. Franz joined Lilly in 2012 after serving as the manager of the HTA Programme at the Centre for Innovation in Regulatory Science (CIRS), a non-profit, independent medicines policy and research think tank. Prior to joining CIRS, Franz worked for over 10 years in molecular biology with specialties in functional genomics, population genetics and bioinformatics. He obtained his PhD in population genetics at the University of Auckland in 2002. Phone: 0466309763 Email: [email protected] LinkedIn: linkedin.com/in/franz-pichler-b86b6415 92
Anne-Pierre Pickaert Attendees Founder Care4Access France Invited Patient Representative Anne-Pierre brings over 20 years of experience with a wide range of healthcare stakeholders (charity, patient organisation, governmental agency, consultancy and pharmaceutical industry). Her skills and expertise in health communication, cancer prevention and market access, combined with her personal experience as a leukaemia survivor and member of patient organisations, give her a unique perspective on patient engagement, advocacy and equal access to adequate care. Anne-Pierre holds a MSc in Economic Evaluation for Health Technology Assessment from the University of York, a MSc in European Social Policy from the London School of Economics and a Diploma in Political Sciences from the Institut d’Etudes Politiques of Strasbourg. She worked as general delegate and program manager in cancer prevention through nutrition and lifestyle (World Cancer Research Fund & Institut National du Cancer [INCa]) and market access director (Kantar Health, Lundbeck & Sanofi). In order to have a greater impact on patient access to care, Anne-Pierre has founded Care4Access, a consultancy dedicated to patient engagement and advocacy and has also joined the Patvocates team. She is a volunteer for two patient organisations: Association Laurette Fugain and Entraide aux Greffés de Moelle Osseuse (EGMOS). She is a member of the campaign committee of the HTC Project and the Patient Advocacy Committee of the European Society for Bone Marrow Transplantation (EBMT PAC). Email: [email protected] Ali Powers Manager, Events HTAi Canada HTAi Secretariat Alicia (known as Ali) is an event organizer with over 15 years experience in every aspect of events management, including large and small conference management in national and international locations, workshop development, and annual gala productions. Ali’s experience also includes event work with professional sports teams, universities, hospital foundations, and health technology startup organizations. Before joining HTAi, Ali held a position in the Corporate Communications and Marketing department at Alberta Innovates. Ali has also executed over 60 weddings over the past decade and was recently shortlisted in the “future leader” category at the Edmonton Event Awards. Email: [email protected] 93
Attendees Hana Price Coordinator, Events HTAi Canada HTAi Secretariat Hana Price has over 10 years of experience in Event Management & Coordination, as well as Communications, Administration, Travel and Project Coordination. Throughout her career, Hana has held positions in various roles in the not for profit sector, including holding a long time role of Event Coordinator with the Institute of Health Economics, as well as taking on various project coordination roles and communication projects. Hana has organized several types of corporate events such as Consensus Development Conferences, Roundtables, Forums, Webinars, Policy Forums and Annual Meetings, both locally, nationally, and internationally. Email: [email protected] Sulabha Ramachandran Head, Real World Data, Modelling and Analytics GlaxoSmithKline - Value, Evidence And Outcomes United States Organizational Member, HTAi Global Policy Forum Sulabha Ramachandran, Ph.D. joined GSK, Value Evidence and Outcomes (VEO) in 2015 and is currently Head, Real World Data, Modelling and Analytics and a member of the VEO leadership team. In this role, her accountabilities include leadership for enterprise wide real-world data strategy, analytics and health economic modelling teams alongside a VEO region team providing scientific leadership and alignment across regions and LoCs. She is also accountable for leadership and oversight of the VEO protocol review committee driving excellence in methodology and innovation across VEO research. Recently, Sulabha has also championed VEO across several cross departmental initiatives to further advance integration, development and improvement within VEO. She has also served as the US chapter Lead for the Women Leadership Initiative at GSK. Sulabha is a health services researcher with over 15 years of experience in the pharmaceutical industry. Prior to GSK, Sulabha held several health outcomes leadership roles at AstraZeneca, working across various business units and therapy areas incl. respiratory, inflammation, oncology, neurosciences and infectious diseases. In these past roles, she has had accountabilities for payer evidence and pricing strategies, building enterprise -wide RWE capabilities and leading the planning and execution of integrated evidence plans for development and launch assets. Sulabha has a Ph.D. in Pharmaceutical Economics, Health Policy and Outcomes Research, with a minor in International Marketing and consumer behavior. She has published extensively in peer-reviewed journals and represents GSK externally on several real-world evidence cross-pharma engagements and public- private partnerships. Sulabha resides in West Chester, PA with her husband and their two children and works out of the Upper Providence office for GSK. Email: [email protected] 94
Gowri Raman Attendees Senior Program Officer Patient-Centered Outcomes Research Institute United States Organizational Member, HTAi Global Policy Forum Dr. Gowri Raman is a Senior Program Officer in the Office of Chief Engagement and Dissemination Officer (OCEDO) at PCORI, Washington D.C, USA. In this role, she oversees the New Technology Program which includes the Horizon Scanning projects and Emerging Technology and Therapeutics reports. In addition, she reviews results of PCORI-funded research projects, and supports identification and development of topics for PCORI-funded research initiatives. Before joining PCORI, Raman was the project director and an assistant professor at Tufts Medical Center, Boston, where she led the Center for Clinical Evidence Synthesis. She also previously served as the assistant director of the Agency for Healthcare and Quality- funded Tufts Evidence Practice Center. Raman has extensive peer-reviewed publications of Health Technology Assessments, horizon scans, systematic reviews and meta-analysis, and evidence reviews to support national and international Clinical Practice Guideline development. She is particularly interested in understanding the role of new and emerging health technologies in prevention and management of chronic disease conditions. Raman earned her medical degree from Thanjavur Medical College, India, and an MS in clinical and translational sciences research from Tufts University. Email: [email protected] LinkedIn: linkedin.com/in/gowri-raman-15093043 Andrea Rappagliosi Vice-President, Market Access, Public Affairs and Communications EMEA, Canada and LATAM Edwards LifeSciences Switzerland Organizational Member, HTAi Global Policy Forum Andrea joined Edwards Lifesciences as Vice-President of Market Access, Public Affairs and Communications EMEA, Canada and LATAM in September 2017. Born in Rome, Andrea received a law degree from the University of Rome, La Sapienza. Andrea began his professional career in the Italian Senate. Recently he worked in the Sanofi group as VP Public Affairs Europe and before as VP, Market Access, Health Policy and Medical Affairs at Sanofi Pasteur MSD. At SPMSD Joint Venture he was member of its Executive Committee from 2012 to 2016. Before, he worked at Baxter Healthcare, Serono International and GSK in different European and International positions in the public affairs and market access policy area. In the last ten years, Andrea represented the healthcare Industry in several European EU Commission and Member States initiatives such as the HTANetwork, EUnetHTA Joint-Action 3, and the EU Active & Healthy Aging Innovation Partnership. Andrea is a founding member of the HTAi Policy Forum. He was member of the High Level Pharmaceutical Forum (2005–2008). Phone: +41795968808 Email: [email protected] Twitter: @A_Rappagliosi LinkedIn: linkedin.com/in/rappagliosi 95
Attendees Adriana Robayo Executive Director IETS - Instituto de Evaluación Tecnológica en Salud Colombia Organizational Member, HTAi Global Policy Forum Medical physician (Universidad Nacional de Colombia) Nephrologist, Critical Care Specialist, Internist (Universidad Javeriana de Colombia) Specialist in Social Economy (Universidad de Los Andes) Specialist in Public Health Management, Occupational Health Management and Epidemiology (Universidad del Rosario-Universidad CES). She is currently pursuing a Master's degree in Clinical and Health Effectiveness at the Universidad de Buenos Aires. I have more than 20 years of clinical, academic, research, administrative and management experience as a member of different boards of directors of the country; among which are the president of the Colombian Association of Nephrology and Hypertension 2016 - 2018 and General Secretary of the Colombian Association of Scientific Societies 2018. I´m currently the Executive Director of the Institute of Technological Evaluation in Health - IETS. Phone: +573158738788 Email: [email protected] Twitter: @amrobayog LinkedIn: linkedin.com/in/adriana-robayo Alric Rüther Head International Affairs Institute for Quality and Efficiency in Health Care (IQWiG) Germany Organizational Member, HTAi Global Policy Forum Physician internal medicine & oncology German Cochrane Centre German Agency of HTA (DAHTA) Institute for Quality and Efficiency in Health Care (IQWiG): Head of Health Care Quality IQWIG: Head of International Affairs Phone: +49151-17444593 Email: [email protected] LinkedIn: linkedin.com/in/alric-alf-rüther-2b87536 96
James Ryan Attendees Group Director, Health Economics and Payer Evidence (Global Oncology) AstraZeneca United Kingdom Organizational Member, HTAi Global Policy Forum James Ryan is head of a Global Health Economics and Payer Evidence team at AstraZeneca, as well as leading on HTA Policy. A seasoned health economist with 25 years of experience, James has particular interest in the shaping and application of HTA, as well as impactful communication of payer evidence material. In addition to his contribution to HTAi, he is AstraZeneca’s representative on the EFPIA HTA Working Group. Following his MSc in Health Economics in 1997, James worked at the University of York as a health economic Research Fellow before joining consultancy, providing strategic and technical expertise to both pharma and the public sector. Prior to joining AstraZeneca in 2011, James was a Senior Health Economist at Bayer Healthcare UK focussing primarily on oncology compounds, where he was responsible for the generation of national and local health economic evidence and delivery of UK HTA submissions. Phone: +44 755 731 9740 Email: [email protected] LinkedIn: linkedin.com/in/james-ryan-b547243 Stefan Sauerland Head of Department Non-Drug Interventions Institute for Quality and Efficiency in Health Care (IQWiG) Germany Organizational Member, HTAi Global Policy Forum Stefan Sauerland joined IQWiG (Institute for Quality and Efficiency in Healthcare) in January 2010. Heading the Non-Drug Interventions Department, he is responsible for the scientific evaluation of non- drug therapies (including medical devices, surgery, dentistry and psychotherapy), diagnostic tests, and screening procedures. Within the German health care system, IQWiG is responsible for producing evidence-based reports, which inform reimbursement decisions on a national level. Prof Sauerland has 12 years of experience in surgical research (clinical trials, metaanalyses, practice guidelines). He holds an M.D. from University of Cologne and an M.P.H. from Düsseldorf University. In 2019, he was granted an adjunct professorship by University of Cologne, where he regularly teaches on evidence-based medicine and clinical research. Phone: ++49 151 14939863 Email: [email protected] 97
Attendees Keely Scamperle Director, Health Policy and Value-Based Solutions W. L. GORE and Associates United States Organizational Member, HTAi Global Policy Forum Keely Scamperle, MJ, CCP, CCS-P, CHC Keely is the Global Health Policy and Advocacy Leader supporting the Medical Products Division of WL Gore and Associates. With more than 25 years in the areas of Health Care Policy, Reimbursement, Market Access, Health Care Economics and Compliance, Keely’s expertise spans all facets of the highly complex legislative process, regulatory environment and intricacies of shaping today and tomorrow’s health care policy. Throughout her career, Keely has been a key advisor to critical decision makers in both the private and public arenas. Her prior leadership roles within a diverse set of health-technology companies has allowed Keely to drive legislative and health policy changes, effectively ensure quality care and optimum patient outcomes while minimizing economic impact to the health care system. Keely holds a Masters of Jurisprudence in Health Law from Loyola University, Chicago, IL, USA and a Bachelor of Science degree in Healthcare Administrative Services from Weber State University, Ogden, Utah, USA. She holds the professional designations of Certified Professional Coder (CPC), Certified Coding Specialist, Physician Based (CCS-P), and Certified in Healthcare Compliance (CHC). Phone: +1-469-215-4628 Email: [email protected] LinkedIn: linkedin.com/in/keelyscamperle Susan Shiff Senior Vice President and Head of the Center for Observational and Real-World Evidence (CORE) Merck/MSD United States Organizational Member, HTAi Global Policy Forum Dr. Shiff currently serves as Senior Vice President and Head of the Center for Observational and Real-World Evidence (CORE) at Merck, known as MSD outside the United States and Canada. Dr. Shiff has over 20 years of experience in the pharmaceutical industry as leader in the development and implementation of evidence, access, and pricing strategies for products globally. Before joining Merck in 2014, she was Vice President of Global Health Economics, Data Sciences and Evidence-Based Medicine at Teva Pharmaceuticals. Prior to that, Dr. Shiff was Vice President of Evidence-Based Medicine and Market Access in Global Primary Care as well as Vice President of HEOR and Epidemiology in Emerging Markets at Pfizer. She has also held senior positions at Roche and Johnson & Johnson. Dr. Shiff began her career at the Centers for Disease Control and Prevention. She holds an M.B.A. from Cornell University and a Ph.D. from the University of California at Los Angeles. Dr. Shiff currently serves on the Boards of Synthace Limited, Cara Therapeutics, Q-Centrix (a TPG Company), and the Merck Global Health Innovation Fund. In 2016, she was selected as one of FiercePharma’s Top 15 Women in Biopharma, in 2017 Proclinical named her as one of today's most inspiring women in the pharmaceutical industry, and in 2018 CB Insights named CORE as one of the most innovative Corporate Labs in healthcare. Email: [email protected] Twitter: @susan_shiff LinkedIn: linkedin.com/in/susan-shiff 98
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