Loading…
This event has ended. Visit the official site or create your own event on Sched.

Sign up or log in to bookmark your favorites and sync them to your phone or calendar.

Trk 13: CER-Glob Health Econ [clear filter]
Sunday, June 26
 

8:30am

#26: The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health Technology Assessment
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

_x000D_
An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Payers play an important role in both national and global health care systems: their decision-making signals to manufacturers their likelihood to support the R&D required for innovative, new medicines. Only a small number of innovative medicines are approved annually. The large proportion of new drug candidates fail during the development, and the average R&D cost per approved new molecular entity is increasing. Providers and payers can be thought of as agents acting on behalf of patients and their covered beneficiaries. Payers are critical in expressing the willingness of health care systems to provide funds to support innovation. Manufacturers must understand, monitor, and anticipate the evolving payer environment to increase the likelihood of regulatory and commercial success for new products. Key tools such as pharmacoeconomic evaluation of cost-effectiveness and budget impact, as well as important processes such as health technology assessment are used in many developed countries. Understanding their varying role in different jurisdictions is critical for pricing and market access negotiations.

This tutorial, which is hosted with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), will introduce participants to the basic economics of drug development, pricing, contracting, and market access. It will address commonly used economic concepts, such as demand, supply, willingness to pay, monopoly, intellectual property, and value. Practical observations will be made on the similarities and differences in how health care systems approach these pricing and access practices and decisions, with an emphasis on the implications for stakeholder incentives. Examples will be used to illustrate key concepts as well as both routine and special cases.

Who should attend?

This tutorial is designed for industry professionals and academics with an interest to learn more about the economic perspective on drug development, incentives for innovation, and how different countries grapple with these difficult health sector resource allocation decisions.

Learning Objectives

• Explain what makes innovative medicines unique economic inputs into population health including how the patent system relates to the financing of global R&D;
• Describe in what way prices for innovative medicines are established, how this differs by system, as well as the evolving impact of pharmacoeconomics and health technology assessment;
• Discuss how the complex global network of public and private payers judge the value of innovative medicines.


Speakers
avatar for Louis Garrison

Louis Garrison

Professor, Pharmaceutical Outcomes Research and Policy Program, University of Washington
Dr. Garrison is Professor in the Pharmaceutical Outcomes Research and Policy Program in the School of Pharmacy, and Adjunct Professor in the Departments of Global Health and Health Services at the University of Washington, where he joined the faculty in 2004. He also co-directs the... Read More →
avatar for Jack Mycka

Jack Mycka

Global President and CEO, Medical Marketing Economics LLC (MME)
As MME’s Global President & CEO, Jack provides critical global support for strategic marketing and pricing decisions to clients in the biotech and pharmaceutical industries. As a recognized expert consultant since 2001, he has successfully completed engagements encompassing many... Read More →


Sunday June 26, 2016 8:30am - 12:00pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Monday, June 27
 

10:45am

#139: Measuring the Impact and Influence of Patient Input on Regulatory and Health Technology Assessment Decision Making: What Are the Key Considerations?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-568-L04-P; CME 1.25; IACET 1.25; RN 1.25

This interdisciplinary session will explain how, with increased patient engagement, both regulatory and health technology assessment agencies need to be able to assess and report on how patient input is being utilized and how it is informing the decision process.

Learning Objectives

Discuss how health technology assessment agencies and regulators engage with patients so that the assessment and decision making is utilizing patients’ viewpoints; Identify the challenges that agencies face to ensure that the patient’s viewpoints are embedded into their decision processes; Assess the types of parameters agencies are using to measure the impact patient engagement is having on their processes and decision making.

Chair

Neil McAuslane, PhD, MSc

Speaker

FDA Perspective
Theresa M. Mullin, PhD

Empowering Patients as Organizational Change Agents
Durhane Wong-Rieger, PhD, MA

HTA Perspective
Victoria Thomas, MSc



Chair
avatar for Neil McAuslane

Neil McAuslane

Director, Centre for Innovation in Regulatory Science (CIRS)
Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (CIRS, previously CMR International) and works in the area of regulatory and HTA strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology... Read More →

Speakers
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Programs, CDER, FDA
Theresa Mullin, Ph.D., serves as CDER’s Associate Director for Strategic Initiatives. She leads Patient-Focused Drug Development which includes implementation of the 21st Century Cures Act. She leads the CDER International program and heads the FDA delegation to ICH, IPRP and other... Read More →
avatar for Victoria Thomas

Victoria Thomas

Head of Public Involvement, Public Involvement Programme, National Institute For Health and Care Excellence (NICE)
Victoria Thomas has run the Public Involvement Programme at NICE since 2009, and has been with the Programme since 2001. Following a degree in Art History, Victoria has worked exclusively in the public and voluntary sector, specialising in healthcare quality improvement activities... Read More →
avatar for Durhane Wong-Rieger

Durhane Wong-Rieger

President and Chief Executive Officer, Canadian Organization For Rare Disorders (CORD)
Durhane Wong-Rieger, PhD, is President, Institute for Optimizing Health Outcomes; President; Canadian Organization for Rare Disorders; Chair, Consumer Advocare Network; Past-Chair, International Alliance of Patient Organizations; Co-Chair, HTAi Patient / Citizen Involvement IG; Board... Read More →


Monday June 27, 2016 10:45am - 12:00pm
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

10:30am

#224: Identifying Patient-Centered Outcomes for Use in Observational Research: Why and How
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-569-L01-P; CME 1.00; IACET 1.00; RN 1.00

The inclusion of valid, reliable patient-centered outcomes is increasingly important for observational studies. Yet, identifying such outcomes is challenging. This session will discuss resources for identifying and developing outcome measures.

Learning Objectives

Describe the need for standardized or harmonized outcome measures for use in observational clinical research studies; Identify challenges to identifying valid, reliable, standardized outcome measures for use in new studies; Discuss examples of disparate outcome measure definitions; Summarize resources that can assist researchers in selecting appropriate outcome measures.

Chair

Richard Gliklich, MD

Speaker

Panelist
Elise Berliner, PhD



Speakers
EB

Elise Berliner

Director, Technology Assessment Program, Agency For Healthcare Research and Quality (AHRQ)
Dr. Berliner is the Director of the Technology Assessment Program at the Agency for Healthcare Research and Quality (AHRQ). The Technology Assessment Program provides technology assessments to the Centers for Medicare & Medicaid Services (CMS) to inform Medicare coverage decisions... Read More →
avatar for Richard Gliklich

Richard Gliklich

Chief Executive Officer, Better Outcomes
Dr. Richard Gliklich is the CEO of Better Outcomes Corporation. He was founder and CEO of Outcome Sciences, a health information and services company. He led the company from inception through its acquisition by Quintiles. A graduate of Yale University and Harvard Medical School and... Read More →


Tuesday June 28, 2016 10:30am - 11:30am
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#246: Valuing the Signal and the Noise in Health Care Horizon Scanning
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-574-L04-P; CME 1.25; IACET 1.25; RN 1.25

Horizon scanning is a method for identifying and monitoring interventions and innovations that have potential to impact clinical care, patient outcomes and the broader health care system. Dedicated horizon scanning programs focused on American and international markets function as publicly available tools useful for setting research agendas; planning regulatory and coverage/payment decisions; and providing early alerts to patients, clinicians, and health technology assessors. In this forum, representatives from American- and European-based horizon scanning efforts will demonstrate how both hits (early captured innovations with major impacts) and misses (e.g., non-identified interventions, non-impactful interventions), and the broader horizon scanning system methodology can provide a useful view of emerging technologies and the future health care landscape.

Learning Objectives

Identify horizon scanning resources and findings; Describe uses for horizon scanning findings by research funders, technology assessment organizations and coverage/payer groups; Describe the use of horizon scanning for understanding the larger landscape of innovation in a variety of clinical areas.

Chair

Christian Cuevas, PhD

Speaker

Horizon Scanning Systems: Comparison of US and International Systems
Diane Robertson

Panelist
Elise Berliner, PhD

Panelist
Christian Cuevas, PhD



Chair
avatar for Christian Cuevas

Christian Cuevas

Senior Clinical Analyst, Health Technology Assessment Group, ECRI Institute
Clinical Analyst at ECRI Institute I worked on the Horizon Scanning program following the clinical development of close to 200 emerging oncology interventions and determining their potential to have an impact on the healthcare system. Postdoctoral Fellow at University Pennsylvania... Read More →

Speakers
EB

Elise Berliner

Director, Technology Assessment Program, Agency For Healthcare Research and Quality (AHRQ)
Dr. Berliner is the Director of the Technology Assessment Program at the Agency for Healthcare Research and Quality (AHRQ). The Technology Assessment Program provides technology assessments to the Centers for Medicare & Medicaid Services (CMS) to inform Medicare coverage decisions... Read More →
avatar for Diane Robertson

Diane Robertson

Director, Health Technology Assessment, ECRI Institute
Served as ECRI Institute's project manager for the AHRQ Healthcare Horizon Scanning Program for 5 years. More than 30 years (including 22 with ECRI Institute’s Health Technology Assessment program) leading projects, health technology research and analysis, writing, and publishing... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#247: Fit for Purpose and Modern Validity Theory in PROs
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-575-L01-P; CME 1.25; IACET 1.25; RN 1.25

Fit for purpose is an important consideration in patient-reported outcomes (PROs). This session will provide an overview of current validity theory and the thinking on the idea of fit for purpose, and situate the concept of fit for purpose within the broader topic of validity.

Learning Objectives

Articulate key concepts in modern psychometric validity theory; Describe the notion of fit for purpose as it relates to patient/clinician reported outcomes.

Chair

R.J. Wirth, PhD

Speaker

Current Thinking in Validity Theory
Jonathan D Rubright, PhD, MSc

Validity: US Regulatory Considerations
Ashley F. Slagle

How Does Fit for Purpose Fit in Validity Theory?
Michael Edwards, PhD, MA



Chair
avatar for R.J. Wirth

R.J. Wirth

President, Vector Psychometric Group, LLC
R.J. Wirth is President and managing partner at VPG. He trained in the L. L. Thurstone Psychometric Lab, receiving his PhD in Quantitative Psychology from the University of North Carolina – Chapel Hill. His research focuses on modern psychometrics with an emphasis on measurement... Read More →

Speakers
ME

Michael Edwards

Managing Partner, Vector Psychometric Group, LLC
Michael C. Edwards is a managing partner at VPG. He earned his PhD in Quantitative Psychology from the University of North Carolina – Chapel Hill. His research is generally focused on modern psychometrics with specific emphases on item response theory, factor analysis, and computerized... Read More →
avatar for Jonathan Rubright

Jonathan Rubright

Psychometrician, National Board of Medical Examiners
As psychometrician at the National Board of Medical Examiners, Jonathan shoulders operational responsibility for high-stakes medical exams and leads exam-related research. Prior to NBME, he worked at AICPA and also evaluated tests to support research on human subjects with impaired... Read More →
avatar for Ashley Slagle

Ashley Slagle

Principal, Scientific and Regulatory Consulting, Aspen Consulting, LLC
Dr. Slagle is a scientific and regulatory expert, providing advice on patient centered drug development to drug product developers. Formerly with the US FDA Clinical Outcome Assessment (COA) Staff, her experience includes over 15 years of policy analysis and outcomes research, including... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

2:00pm

#348: Interpreting Meaningful Change on PROs: When to Talk, When to Use Cumulative Distribution Functions, and When to ROC
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-572-L01-P; CME 1.25; IACET 1.25; RN 1.25

Methods to interpret the meaning of change in patient-reported outcome (PRO) scores often do not directly include perspectives of potential stakeholders. In this session, we will discuss how common and novel methods to define meaningful change can enhance insight into treatment benefit.

Learning Objectives

Distinguish when to use different methods to identify meaningful individual-level change and group-level differences on a patient-reported outcome; Recognize issues related to assessment frequency and missing data that impact the ability to assess treatment benefit.

Chair

Marian M Strazzeri, MS

Speaker

Panelist
Scott Komo, DrPH

Panelist
Cheryl D. Coon, PhD



Chair
avatar for Marian Strazzeri

Marian Strazzeri

Mathematical Statistician, OB, OTS, CDER, FDA
Marian Strazzeri currently works on clinical outcome assessments (COAs) and data standards within the Office of Biostatistics (OB) at FDA/CDER. Before joining FDA in her current capacity, she worked as a survey statistician at the National Center for Health Statistics (NCHS) in the... Read More →

Speakers
avatar for Cheryl Coon

Cheryl Coon

Principal, Outcometrix
Cheryl D. Coon, PhD is a psychometrician with over a decade of experience in the pharmaceutical field. She applies qualitative and quantitative methods to the development and evaluation of PRO instruments. During her years in the field, she has been involved in all stages of instrument... Read More →
SK

Scott Komo

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#370: Pricing, Patient Access, and What’s Next for Today’s Biopharma and Devices
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-573-L04-P; CME 1.25; IACET 1.25; RN 1.25

Industry leaders, public payers, policy makers and issue experts provide insights into today’s heated debate about drug pricing, patient access and the policy battles ahead. This forum will offer engaging presentations, moderated discussion, and participant Q&A.

Learning Objectives

Identify key issues affecting the treatment pricing and patient access landscape; Describe how to apply potential models for determining a treatment’s value; Discuss ways to integrate new ideas for communicating a product’s rationale for patients, treaters and payers.

Chair

Jane Horvath, MHA

Speaker

Panelist
Matt Salo

Panelist
Michael Gray, MBA

Panelist
John Hoffman, MBA



Chair
avatar for Jane Horvath

Jane Horvath

Market Access Lead, 3D Communications
Jane Horvath, MHSA, leads 3D's Market Access and Value Communications team. Jane brings nearly 25 years of experience in health policy and reimbursement. She was Merck’s Executive Director of Health Policy and Reimbursement for a decade, Deputy Director of the RWJF project at Johns... Read More →

Speakers
avatar for Michael Gray

Michael Gray

Vice President and Chief Operating Officer, The Resource Group, Ascension
Michael has executive oversight and thought leadership responsibility for the ongoing development, implementation, and management of The Resource Group’s Strategic Direction. He spent seven years as President and CEO of Mercy Resource Management Inc., with responsibilities for Corporate... Read More →
avatar for John Hoffman

John Hoffman

Senior Director, Health Policy, Advocacy and Quality, Johnson & Johnson
As the Senior Director, Health Policy, Advocacy & Quality for the Strategic Customer Group at J&J North American Pharmaceuticals, John's responsibilities include ensuring unencumbered access to all J&J NA Pharma products for patients and physicians. The Strategic Customer Group develops... Read More →
avatar for Matt Salo

Matt Salo

Executive Director, National Association of Medicaid Directors
Matt Salo was named Executive Director of the National Association of Medicaid Directors in February 2011. The association represents all 56 of the nation’s state and territorial Medicaid Directors, and provides them with a strong unified voice in national discussions as well as... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA