The EU HTA Harmonization Initiative: What is the Significance to Manufacturers of the New Directive?
Comparative clinical benefit assessments are at the core of Health Technology Assessments (HTAs) in Europe. HTAs are a multi-disciplinary process considering input and evidence from medical, social, and economic sources. They are used to inform the design of health policies that allow the safe and effective use of new technologies within individual health systems and their specific conditions. Currently, HTAs are conducted separately by individual European countries using their own assessment criteria. This multiplicity of HTA methodologies can create considerable work for manufacturers, which currently need to submit HTAs to multiple European Union (EU) member states.
The idea of a pan-EU HTA has long been discussed, but has taken considerable time and effort to come to fruition. On 31 January 2018, the European Commission (EC) requested EU Member States to adopt a new proposed Directive (2018/0018) which outlined several activities required for a European Health Technology Assessment (EU HTA). Despite being vetoed by Germany, France, the Czech Republic, and Poland, the Directive was adopted on 3 April 2018 and is expected to be implemented on 30 March 2019.
A white paper was written, which aims to outline the new Directive, highlighting the changes from existing HTAs, and to provide commentary on the potential impact of this legislation to key stakeholders, manufacturers in particular.
Download the white paper now.
Evidera has formed an internal working group dedicated to staying up-to-date with the latest developments on this Directive. Visit the website for more info