Strengthening the Interface of Evidence-Based Decision Making Across European Regulators and Health Technology Assessment Bodies [Editor's Choice]

Oct 1, 2022, 00:00
10.1016/j.jval.2022.01.026
https://www.valueinhealthjournal.com/article/S1098-3015(22)00104-8/fulltext
Title : Strengthening the Interface of Evidence-Based Decision Making Across European Regulators and Health Technology Assessment Bodies [Editor's Choice]
Citation : https://www.valueinhealthjournal.com/action/showCitFormats?pii=S1098-3015(22)00104-8&doi=10.1016/j.jval.2022.01.026
First page : 1726
Section Title : HEALTH POLICY ANALYSIS
Open access? : Yes
Section Order : 1726

Objectives

Access to medicines in Europe depends on a benefit-risk decision taken by regulators and a relative effectiveness assessment performed by health technology assessment bodies (HTABs) to inform, as one element, a reimbursement decision. Although various similarities in evidence needs exist, understanding of their needs is currently suboptimal and therefore the evidence generated does not always meet their needs. Subsequently, delays in decision making can be expected, negatively affecting access. To overcome this, this study reviewed the evidentiary needs of European regulators and HTABs at European level and analyzed how their collaboration can further facilitate optimal evidence generation plans, evidence use, and evidence presentation.

Methods

Through systematic literature review, expert interviews, and pairwise comparison of assessment reports by the European Medicines Agency and European network for health technology assessment, respective clinical evidence requirements and impact of product-specific collaboration between European Medicines Agency and HTABs were established.

Results

Clinical evidence needs are quite similar but differences exist in comparator choice, preferred efficacy endpoints, and target population. Results of the impact of collaboration to date were mixed: preapproval joint advice procedures were successful and highly valued by all stakeholders; information exchange at the time of regulatory decision is coming together, yet the European Public Assessment Report can be further optimized; and collaboration on postlicensing evidence generation requirements shows potential but needs solidifying.

Conclusions

These findings demonstrate the potential to further improve the evidence utilization across stakeholders to avoid duplication and streamline decision making, to ultimately improve access to medicines for European patients.

Categories :
  • Decision & Deliberative Processes
  • Health Policy & Regulatory
  • Health Technology Assessment
  • Literature Review & Synthesis
  • Reimbursement & Access Policy
  • Study Approaches
  • Surveys & Expert Panels
Tags :
  • access to medicines
  • evidence needs
  • evidence-based decision making
  • health technology assessment bodies
  • regulators
Regions :
  • Western Europe
ViH Article Tags :