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EARLY DIALOGUE IN EUROPE: PERSPECTIVES ON VALUE, CHALLENGES, AND CONTINUING EVOLUTION

Published online by Cambridge University Press:  24 September 2018

Lina Balaisyte ,
Angelika Joos  and
Mickaël Hiligsmann
Lina Balaisyte
Affiliation:
Faculty of Health, Medicine and Life Sciences, Maastricht Universitybalaisyte.lina@gmail.com
Angelika Joos
Affiliation:
Global Regulatory Policy, MSD, Brussels, Belgium
Mickaël Hiligsmann
Affiliation:
Department of Health Services Research, CAPHRI Care and Public Health Research Institute, Maastricht University
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Abstract

Objectives:

This study aims to assess participants’ views on previous experiences, the current situation and future perspectives for early dialogue between the pharmaceutical industry, a regulatory agency and health technology assessment bodies (HTABs) in Europe.

Methods:

Eleven semi-structured interviews were arranged purposively with experienced people from the pharmaceutical industry, the European Medicines Agency, and an expert in Health Economics. The interview questions focused on the value of early dialogue, the challenges faced during the process of early dialogue, the best time to start an early dialogue, the kind of products most suitable for early dialogue, the current situation, and future perspectives for the early dialogue process. The interviews were recorded and then transcribed for open and axial coding to summarize the findings.

Results:

All interviewees agreed that early dialogue is a valuable process that helps to inform the development program and accordingly provide patients with faster access to new medicines. However, at this stage, the pharmaceutical industry acknowledged certain challenges: (i) Finding resources within pharmaceutical companies and HTABs to support early dialogues (ii) Requirements between regulators and HTABs in different countries diverge.

Conclusions:

This study revealed that people from the pharmaceutical industry perceive early dialogue as a valuable tool that can bring medicines to patients faster by streamlining development. However, the challenges mentioned above need to be mitigated to build a sustainable mechanism for early dialogue.

Keywords

Early dialogue (ED)Health technology assessment (HTA)AlignmentSynergiesRequirementsFuture perspectivesQualitativeEurope
Type
Policy
Information
International Journal of Technology Assessment in Health Care , Volume 34 , Issue 5 , 2018 , pp. 514 - 518
Copyright
Copyright © Cambridge University Press 2018 

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Footnotes

Sources of funding: None. This research received no funding from the pharmaceutical industry, agency, or non-profit sectors.

References

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