MAPPING BENEFIT-RISK DECISION-MAKING PROCESSES AND IDENTIFYING DECISION POINTS WITH THE POTENTIAL TO INCLUDE PATIENT PREFERENCE INFORMATION THROUGHOUT THE MEDICAL PRODUCT LIFECYCLE

Author(s)

Whichello C1, Schölin Bywall K2, Mauer J3, Watt S4, Cleemput I5, Pinto CA6, van Overbeeke E7, Huys I8, de Bekker-Grob EW1, Hermann R9, Veldwijk J1
1Erasmus University Rotterdam, Rotterdam, The Netherlands, 2Uppsala University, Uppsala, Sweden, 3Pfizer, Collegeville, PA, USA, 4Pfizer, New York, NY, USA, 5Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium, 6Merck & Co., Inc., Kenilworth, NJ, USA, 7University of Leuven, Leuven, Belgium, 8KU Leuven, Leuven, Belgium, 9AstraZeneca, Wilmington, DE, USA

OBJECTIVES: Patient preference information (PPI) has not been effectively integrated in decision-making throughout the medical product lifecycle (MPLC). A first step requires an understanding of existing processes and decision points to know how to incorporate PPI to improve patient-centric decision making. The aims were to: 1) identify the decision-making processes and decision points throughout the MPLC for stakeholders, and 2) determine which decision points have potential to include PPI.

METHODS: A 3-step approach was conducted, including a scoping literature review identifying relevant white and grey literature, validation meetings with stakeholders to confirm decision-making processes, and semi-structured interviews with representatives of 3 stakeholder groups (industry n=24, regulatory n=22, HTA n=24). The literature review was conducted using five scientific databases, and interviews were conducted within seven different European countries and the US.

RESULTS: Six decision points were identified for industry decision-making process:

Conference/Value in Health Info

2018-11, ISPOR Europe 2018, Barcelona, Spain

Value in Health, Vol. 21, S3 (October 2018)

Code

PMU100

Topic

Patient-Centered Research

Topic Subcategory

Stated Preference & Patient Satisfaction

Disease

Multiple Diseases

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