a1 University of York
a2 HTAi Policy Forum
As more countries use HTA to inform decisions on the reimbursement of health technologies, harmonization of evidence requirements between jurisdictions has been proposed, mainly on the grounds of improved efficiency. Harmonization has the potential to avoid duplication of effort for both manufacturers and HTA bodies involved in preparing and reviewing HTA submissions for innovative technologies. However, it also carries risks of loss of local control over decisions, the application of general data standards which are not universally accepted and slowing the rate of development of innovation in the analytical disciplines supporting HTA. This study reviews the issues associated with harmonization taking into account the perspectives of the multiple stakeholders. This study draws on experiences from recent initiatives intended to promote the harmonization of HTA and experience from related fields, particularly regulatory approval of new medical technologies.
This study summarizes discussion at the 2008 Health Technology Assessment International (HTAi) Policy Forum meeting. The aim of the meeting was to consider the views of multiple stakeholders, including international HTA bodies, healthcare technology manufacturers, governmental decision makers, and patient representatives, on the issue of harmonization of evidence requirements for HTA in decision making. The opinions expressed in this study are believed to be a fair reflection of the debate. However, not all participants, nor the organizations from which they come, necessarily agree with the whole content, for which the authors take full responsibility. The work was supported by funding from HTAi. Participants in the meeting are listed on page 517.