Preference-based Methods
ISPOR STATED-PREFERENCE METHODS SPECIAL INTEREST GROUP
Stated Preference Research in the European Union Working Group
Co-Chairs:
Axel Mühlbacher, PhD
Professor of Health Economics and Health Care Management
Hochschule Neubrandenburg
Neubrandenburg, Germany
Kevin Marsh, PhD
Senior Research Scientist and
Executive Director, Modeling and Simulation
Evidera
London, England, UK
Leadership Group:

Christy Choi, PhDc student, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA
Alejandra Duenas PhD, Full Professor, IESEG School of Management, Paris, France
Wolfgang Greiner, PhD, Professor, Bielefeld University, Bielefeld, Germany
Kara Haas, MD, MPH, BA, Director, Johnson & Johnson, Washington, DC, USA
Natalia Hawken, PhD, Manager, Evidera, Rotterdam, the Netherlands
Mickael Hiligsmann, PhD, Assistant Professor, Maastricht University, Maastricht, the Netherlands
Kimberley Hockley, PhD, MPH, BA, Global Benefit-Risk Management Scientist, Amgen, Uxbridge, England, United Kingdom
Ilya Ivlev, PhD, MD, NLM Fellow, Oregon Health & Science University, Portland, OR, USA
Christin Juhnke BSc, MA, Research Fellow, Hochschule Neubrandenburg, Neubrandenburg, Germany
Frank Liu, PhD, DPhil, Director, Outcomes Research, Merck & Co., Inc., Upper Gwynedd, PA, USA
Elisabeth Oehrlein, PhDc, Student, Dept. Pharmaceutical Health Services Research, University of Maryland, Baltimore, MD, USA
Theresa Ofili, BS, PharmD, MPH, RN, Assistant Professor of Pharmacy Practice, College of Pharmacy, Texas A&M, College Station, TX, USA
Jan Ostermann, PhD, MS, Associate Professor, University of South Carolina, Columbia, SC, USA
Elena Petelos, PhD, MPH, BSc, Greece
Thomas Poder, Researcher, CIUSSS de l'Estrie – CHUS, Sherbrooke, QC, Canada
Jiat Ling Poon, PhD, Research Scientist, Evidera, Bethesda, MD, USA
Janine van Til, PhD, MSc, Assistant Professor, University of Twente, Enschede, the Netherlands

Goal:

To map which stated preference methods are being used in the European regulatory environment.

The ISPOR working group will facilitate a more systematic consideration of preferences as part of regulatory decisions – approval, reimbursement and pricing. This group will describe of the use of preference in regulatory decision-making contexts based on the EU initiatives and pilot projects in the EU member states, including: the institution using preference data, the objective for its use, the method employed (or the methodological requirements if guidance is available), and the lesson from this experience. Examples of European stated preference use at the regulatory level.

Background:

Regulatory decision making, and specifically health technology assessment often involves subjective tradeoffs between multiple objectives and decision criteria. Beyond the evidence on clinical outcomes, value judgments are made about the importance of these outcomes.

Approval, reimbursement and pricing decisions frequently include benefit-risk tradeoffs - an assessment of whether clinical benefits justify the safety risks associated with a medical technology (pharmaceuticals, devices and diagnostics). The preferences of patients and other stakeholders in health care inform these trade-offs and support value judgments.

Stated preference methods are increasingly being used to elicit the preferences of patients, citizens, insurees or experts and other stakeholders in health care to inform and support value judgments. Multiple stated preference methods are used to elicit different stakeholder preferences to support health care decisions. (It is generally acknowledged that no single method is appropriate for all health care decisions [3, 6-8].) Background continued

Outline & Project Plan

Activities:

Stated Preference Methods Research in Health Care Decision Making: A Critical Review of Its Use in the European Regulatory Environment
November 2017 – 20th Annual European Congress, Workshop Presentation, Glasgow, Scotland, UK

Stated Preferences in Drug Evaluation: A Comparative Assessment of the Use of Stated Preference in the US, Canada, and the European Union
May 2017 – 22nd Annual International Meeting, Workshop Presentation, Boston, MA, USA

Work Product Timeline:

Initiation: October 2016
Planned Completion: September 2018

Activity Date

European perspective working group project discussed

November 2016

Working Group project proposal developed

April – July 2016

Working Group proposal submitted & revised

August – September 2016

Members solicited to work on project

October 2016

ISPOR Vienna Open Meeting

November 2016

Finalize proposal content, outline and timeline

December – January 2017

Request use of stated preference methods case studies

February 2017

Develop detailed list of pilot projects, reports and case studies in the European member states

February – March 2017

Key terms identified for systematic literature search Inclusion & exclusion criteria developed

March 2017

Search conducted & completed

April – May 2017

Develop framework for evaluating initiatives and pilot projects

April – May 2017

Working Group meeting ISPOR Boston

May 23, 2017

Workshop presentation ISPOR Boston

May 23, 2017

Data extraction & cleaning

June – July 2017

Develop manuscript sections

September – November 2017

Working Group meeting at ISPOR Glasgow;
Potential workshop to discuss state of the art and future development with regulatory agencies / Issue panel to discuss tools and policies or Forum

November 6-8, 2017

Article on presentation written and submitted to Value & Outcomes Spotlight

December 2017 – January 2018

Return to finish drafting manuscript sections

January 2018

Sections reviewed by leadership group

Mid-February 2018

Revisions & finalization of first draft

March 2018

Draft manuscript sent to ISPOR WG review group

April 1, 2018

Comments reviewed and discussed

Mid-April 2018

Authors revise sections

Late April – Mid May 2018

Preparation for forum presentation

Mid-May 2018

Forum presentation ISPOR Annual International Meeting

June 2018

Revised Draft finalized

Mid-June – Mid-July 2018

Review by ISPOR WG Review Group

Mid-July 2018

Revisions and finalize the manuscript for submission to Value in Health

August – September 2018

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Stated-Preference Methods SIG | Special Interest Groups Index