Hostname: page-component-586b7cd67f-tf8b9 Total loading time: 0 Render date: 2024-11-30T20:27:59.288Z Has data issue: false hasContentIssue false
  • English
  • Français

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 [email protected]
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
Get access Rights & Permissions [Opens in a new window]

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 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

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

References

REFERENCES

1.Bouvy, JC, Jonsson, P, Longson, C, Crabb, N, Garner, S. Health technology assessment in the context of adaptive pathways for medicines in Europe: Challenges and opportunities. Clin Pharmacol Ther. 2016;100:594–597.Google Scholar
2.CRIS Workshop. Early scientific advice from HTA agencies: How does the effective use of the various kinds of advice support a positive HTA recommendation? Surrey, UK: CIRS; December, 2015.Google Scholar
3.Cuche, M, Beckeman, R, van Weelden, M. Early dialogue with health technology assessment bodies: a European perspective. Int J Technol Assess Health Care. 2014;30:571–578.Google Scholar
4.Drummond, M. Health technology assessment and its interface with regulation, policy and management. Health technology assessment and health policy today: A multifaceted view of their unstable crossroads. New York: Springer International Publishing; 2011:3–14.Google Scholar
5.European Medicines Agency. Best practices in the European approach to ESA. London: European Medicines Agency; 2016:3–12.Google Scholar
6.CRIS Workshop. Commonality in evidentiary requirements across regulatory and HTA stakeholders. Surrey, UK: CIRS; September, 2016.Google Scholar
7.Leyens, L, Brand, A. Early patient access to medicines: Health technology assessment bodies need to catch up with new marketing authorization methods. Public Health Genomics. 2016;19:187–191. doi:10.1159/000446537.Google Scholar
8.Maignen, F, Osipenko, L, Pinilla-Dominguez, P, Crowe, E. Integrating health technology assessment requirements in the clinical development of medicines: The experience from NICE scientific advice. Eur J Clin Pharmacol. 2017;73:297–305. doi:10.1007/s00228-016-2174-2.Google Scholar
9.EMA-HTA Workshop. Bringing together stakeholders for early dialogue in medicines development. Report from the public workshop hosted by the European Medicines Agency in London on November 26, 2013. London: EMA.Google Scholar
10.IJzerman, MJ, Koffijberg, H, Fenwick, E, Krahn, M. Emerging use of early health technology assessment in medical product development: A scoping review of the literature. Pharmacoeconomics; 2017;35:1–14.Google Scholar
11.O'Brien, BC, Harris, IB, Beckman, TJ, Reed, DA, Cook, DA. Standards for reporting qualitative research: A synthesis of recommendations. Acad Med. 2014;89:1245–1251.Google Scholar
12.Polit, DF, Beck, CT. Nursing research: Principles and methods. Philadelphia: Lippincott Williams and Wilkins; 2004.Google Scholar
13.Harousseau, J, Pavlovic, M, Mouas, H, Meyer, F. Shaping European early dialogues: The Seed Project. In 18th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research: (plus poster) abstract PHP275 (Vol. 7), 2015.Google Scholar
14.European Medicines Agency. Enhanced early dialogue to facilitate accelerated assessment of PRIorityMEdicines (PRIME). EMA/CHMP/57760/2015. Committee for Medicinal Products for Human Use. London: European Medicines Agency; 2016.Google Scholar
15.Schee Genannt Halfmann, S, Evangelatos, N, Schröder-Bäck, P, Brand, A. European healthcare systems readiness to shift from ‘one-size fits all’ to personalized medicine. Per Med. 2017;14:63–74.Google Scholar
16.European Commission. Directorate-General for Health and Food Safety. HTA Network Reflection Paper on “Synergies Between regulatory and HTA issues on Pharmaceuticals”. Adopted by the HTA Network; 10 November, 2016. https://ec.europa.eu/health/sites/health/files/technology_assessment/docs/ev_20161110_co06_en.pdf (accessed August 14, 2018).Google Scholar
17.Tafuri, G, Pagnini, M, Moseley, J, et al. How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice. Br J Clin Pharmacol. 2016;82:965–973.Google Scholar
18.European Medicines Agency. Guidance for parallel consultation. London: European Medicines Agency; June 30, 2017.Google Scholar