Plenary Sessions

The healthcare sector has recently witnessed several landmark moments in the development of the next generation of medical care. While media attention has rightly focused on milestone regulatory approvals for several groundbreaking curative treatments and devices, the best is likely yet to come: over 2600 clinical trials of gene therapies are either completed or ongoing; nearly 1000 trials of regenerative medicine are in progress worldwide; and more than 7000 trials for medical devices ranging from bionic eye brain implants to spinal cord stimulators are underway. Disruption will not be limited to drugs and devices, however. Advances in the applications of 3-D printing as well as artificial intelligence have the potential to generate powerful new tools for disease prevention, diagnosis, and treatment. In short, innovations that have long been the stuff of science fiction may no longer be distant points on the horizon. Are we entering a “golden age” of disruptive innovation in medical care? What new challenges and opportunities will these technologies bring? How can a health sector attuned to an old way of doing things truly prepare for treatments that break the mold? This plenary session will begin with Keynote Remarks from Dr. Daniel Kraft, who will provide an overview of the current and future landscape, and will be followed by a discussion among leading experts. Emerging challenges and opportunities presented by disruptive technologies will be addressed from the perspective of a variety of stakeholders such as payers, manufacturers, and patients.

Moderator:

Clifford Goodman, PhD, Senior Vice President, The Lewin Group, Falls Church, VA, USA

Keynote Speaker:

Daniel Kraft, MD, Faculty Chair for Medicine, Singularity University, Founder and Chair, Exponential Medicine, Stanford, CA, USA

Speakers:

• Alexander Billioux, M.D., D.Phil., Assistant Secretary, Office of Public Health, Louisiana Department of Health, Baton Rouge, LA
• Timothy Caulfield, LLM, FRSC, FCAHS, Canada Research Chair, Professor, and Research Director, University of Alberta, Edmonton, AB, Canada
• Fleur Chandler, Health Economist and Project HERCULES Chair, Patient Advisory Board, Duchenne UK, London, UK
• Ron Philip, Chief Commercial Officer, Spark Therapeutics, Inc, Philadelphia, PA, USA

The medical implants market is one of the fastest-growing in healthcare. Yet alongside this rapid growth, the industry is facing increasing calls for regulation and oversight. As the demand for innovative medical devices accelerates, how can regulators ensure the highest level of health protection without hindering research and growth in the sector? This tension emerges from the two forces shaping the medical devices market. On the one hand, there are the companies who are driving innovation, eager to bring needed new advances to patients and clinicians as quickly as possible. On the other hand are the regulators, responsible for governing the parameters of these advances and protecting patients through requirements that may require more time to accumulate evidence prior to approval.

So how will the latest legislation fare? The new EU Medical Devices Regulation ((EU) 2017/745) will come into force on 26 May 2020 and is intended to “ensure a high level of safety and health while supporting innovation”. Other regulators such as the FDA are also instituting major changes to their medical device regulations. How will these new regulations better guarantee patients’ safety and strengthen confidence on the uptake and diffusion of medical devices? This plenary will explore how our healthcare systems can navigate these controversies surrounding medical devices, and it will identify implications and opportunities for the HEOR community. As well as asking what more needs to be done in terms of regulation, this plenary will also investigate the efficacy of guidance surrounding the generation of relevant real-world evidence to support better decision-making for medical devices. An outline of the medical devices landscape today and the forces shaping its growth will be followed by a discussion among major stakeholders, who will offer their perspectives on what can be done to improve regulation systems. Finally, we will consider how such systems can evolve to keep up with the rapidly-innovating world of medical devices. Join us for an investigation of one of the most pressing challenges facing contemporary healthcare.

Moderator:

Laurie Burke, MPH, Founder, LORA Group, LLC, Royal Oak, MD, USA

Speakers:

• Stephanie Christopher, MA, Medical Device Innovation Consortium, Arlington, VA, USA
• Paul Coplan, ScD, MBA, FISPE, Vice President & Head of Epidemiology and Real World Data Sciences Medical Devices and Office of Chief Medical Officer, Johnson and Johnson, New Brunswick, NJ, USA
• Stephen A. Hull, MHS, President & Founder, Hull Associates, LLC, Rockland, MA, USA
• Harindra Wijeysundera, MD, PhD, Vice-President, Canadian Agency for Drugs and Technologies in Health, Ottawa, ON, Canada

Promoting rapid and equitable access to promising therapies in an affordable manner is a laudable goal for all health systems. However, with the explosion of high cost, disruptive, and innovative drugs-- many of which are promising a cure--payers are facing a crisis of affordability. We are in an era with six-figure cancer treatments, curative and costly gene therapies, ultra-high cost drugs for treating Orphan diseases, and even expensive drugs for more common diseases. It is an exciting and promising time for patients, clinicians, and pharmaceutical companies, and a challenging time for payers who must now look beyond cost-effectiveness to address affordability. The ISPOR 2019 Top 10 HEOR Trends report identified drug spending and pricing as the top trend. In the United States, President Trump launched his Blueprint to Lower Drug Prices in May 2018, and a recent paper from the University of Chicago reported that average total drug spending per hospital admission increased 18.5% between 2015 and 2017. Affordability of pharmaceuticals has become a truly global issue. Is it time for a revolution in how we price, fund, and manage drugs? Are there innovative approaches that can promote access, manage affordability, and still foster innovation? What can be done to significantly improve the transparency of drug prices? How do we ensure equitable access to low- and middle-income countries and disadvantaged populations?

Moderator:

Colleen M. Flood, F.R.S.C., Director, University of Ottawa Centre for Health Law, Policy and Ethics, Ottawa, ON, Canada

Speakers:

• Muna Bhanji, RPh, Senior Vice President, Global Market Access, Merck
• Meindert Boysen, PharmD, MSc, Director, Centre for Health Technology Evaluation, NICE, Manchester, UK
• Lou Garrison, PhD, Professor Emeritus, The Comparative Outcomes, Policy, and Economics (CHOICE) Institute, University of Washington, Seattle, WA, USA
• Mark Trusheim, MS, BS, Strategic Director, NEWDIGS and Visiting Scientist MIT, Boston, MA