DIA 2025 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-656-L04-P; CME 1.00; RN 1.00

Patient experience data (PED) is sought by regulators, payers, and value/health technology assessment (V/HTA) bodies globally and used in different ways. Actively including PED in scientific, regulatory, and V/HTA processes has been a recent feature of regulatory and HTA reform, notably FDA guidance on patient-focused drug development (PFDD) and the EU Joint Clinical Assessment framework. Evolving perspectives on V/HTA have brought attention to the role of PED and there is a need to more systematically integrate PED into payer decision-making. Yet, the PED needs and perspectives of different stakeholders must be better understood for PED to have meaningful impact on product development, evaluation, and related decision-making. Many questions remain. Where do patients believe they have the most impact? What is industry experience gathering and leveraging PED globally? Do government agencies believe their efforts to include patient perspectives are being impactful on evidence they finally review? How can the impact of PED on V/HTA increase and be optimized globally? We will explore options to increase the impact of PED on development, V/HTA, and access decisions through optimal coordination and information sharing, and highlight options and good practices for integrating PED into regulatory, V/HTA, and payer decisions. We will discuss learnings across various opportunities for leveraging PED through policies and processes that affect patient access. Perspectives on PED from patient-group, EMA, payer, and industry panelists will showcase differences and similarities in stakeholder views and evidence needs to inform PFDD, V/HTA, and payer decisions, ultimately impacting patient access. Panelists’ experiences provide a lens on how current processes are working in concert or opposition, and opportunities for meaningful multi-stakeholder collaborations maximize PED impact on access decisions.

Learning Objectives

Discuss patient-group, payer, regulator, and industry perspectives on PED, in general, and regarding how to optimize PED use in decision-making in their respective roles; List the benefits and challenges to integrating PED in regulatory, V/HTA, and payer decision-making, from various stakeholder perspectives; Describe two examples of good practices and recommendations for integrating PED into regulatory, V/HTA, and payer decisions.

Chair

Eleanor M. Perfetto, PhD, MS

Speaker

Panelist
Maxwell Isaacoff

Panelist
Magdalena Harrington, PhD

Panelist
Anna Hyde, MA