Main changes to the Directive announced in September 2018
Member states shall not carry out a clinical assessment or an equivalent assessment process on a health technology included in the List of Assessed Health Technologies.
European Parliament Changes
According to national needs, Member States should have the right to complement the Joint Clinical Assessments with additional clinical evidence and analyses to account for differences in comparators or the national specific treatment setting. Such complementary clinical assessments should be duly justified and proportionate and should be communicated to the Commission and the Coordination Group. After the transitional period, and before the harmonised system for HTA established under this Regulation becomes PPD mandatory, the Commission should submit an impact assessment report on the entire procedure that has been introduced.
That impact assessment report should evaluate, among other criteria:
- the progress made in relation to patients’ access to new health technologies and the functioning of the internal market
- the impact on the quality of innovation and on the sustainability of health systems
- the appropriateness of the scope of the Joint Clinical Assessments and the functioning of the support framework
- Will JCAs be in addition to national assessments?
- If both JCAs and national assessments are done, will this delay the access process? Is this a new hurdle to patient access?
Evidera has formed an internal working group dedicated to staying up-to-date with the latest developments on this Directive. Below are the latest updates and new resources to keep you informed.
WHITEPAPER: Joint Clinical Assessments: An Update after the European Parliament’s September 2018 Meeting
WHITEPAPER: The EU HTA Harmonization Initiative: What is the Significance to Manufacturers of the New Directive?
ON-DEMAND WEBINAR: New EU HTA Directive Set to Revolutionize HTA in Europe – How Will it Affect You?
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.
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.