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, however, on 3 April 2018, EU country parliaments adopted the European Commission’s (EC) new Directive (2018/0018) which outlines several activities required for a European Health Technology Assessment (EU HTA).
Rationale for the EU HTA Directive
Despite the achievements of the current voluntary collaborations, several crucial remaining issues cannot be addressed through voluntary participation. See Figure 1. The EU HTA Directive was proposed to address these shortcomings.
The development of the Directive took several years and included public consultation and impact assessment. On 31 January 2018, the European Commission requested EU member states to adopt the new Directive. Four countries expressed a “subsidiarity breach” but were denied due to lack of a majority.
The EU HTA Directive Sets Out Four Pillars of Work
There are four areas of joint HTA cooperation:
- Joint clinical assessments (JCA)
- Scientific consultations on the development of new products
- Mapping of emerging health technologies
- Voluntary cooperation on other areas (e.g., surgical procedures)
Joint assessments include pharmaceuticals and medical devices and diagnostics where clinical benefits are compared to existing treatments. This includes all EMA approved pharmaceuticals (including line extensions/new indications) as well as high-risk devices with high impact on patients, public health, and EU health systems.
National assessments include non-clinical assessment (economic, social, and ethical aspects) and national decisions on price and reimbursement. While the regulatory and HTA processes will remain separated as they have different purposes, opportunities exist to create synergies through mutual information-sharing and better alignment of the timing between the proposed JCAs and the centralised marketing authorisation.
The Next Steps: Three-year Drafting and Three-year Transition
The transition to a centralised HTA process will not happen immediately. The implementation procedure will be drafted over a three-year period, with the first HTAs through this new process to occur in 2022. The next three years, from 2022-2025, will be a phased or progressive transition period where joint clinical assessments will gradually increase.
How Should Manufacturers Prepare?
Manufacturers should begin now to adjust their evidence development plans for new product launches and indication extensions from 2019 onward. Key changes include: early scientific advice will now be facilitated by the EU, national pricing negotiations will all start with the same EU-assessed clinical data, and dual clinical assessments during the transition period will most likely be necessary since some member states may delay the adoption of the process during this time. Differentiating products at the country level will now rely more heavily on health economic and patient data, as well as pricing and contracting details.
Resources on the EU HTA Directive
Evidera's EU HTA Working Group
The Evidera EU HTA Working Group comprises methodological experts and thought leaders from across our core disciplines. The aim of the working group is to keep up-to-date on the EU HTA Directive and its implications to enhance our flexible and integrated response to evolving client priorities.