At the end of January 2018, the European Commission released a legislative proposal for ratification by the European Parliament and Council aimed to strengthen their input into health technology assessment (HTA).
Cooperation between EU member states and HTA bodies has been in place since the 1980s, and has seen several project-based initiatives via the European network for Health Technology Assessment (EUnetHTA) that aim to provide the sharing and transfer of information relating to HTA across the member states. However, the European Commission believes that there are limitations of the current approach, which include:
- Impeded and distorted market access, leading to delays and inequality in access to innovative health technologies
- Duplication of work for national HTA bodies, leading to inefficiency across multiple countries
- Unsustainability of HTA cooperation, as the project-based collaborative model at present relies on short-term funding and is inefficient
The European Commission proposal recommends a framework aimed to improve health technology availability, ensure operational efficiency, and improve business predictability. The proposal is based on a comprehensive impact assessment and mapping analysis of member states’ organisations, processes and methodologies. The framework aims to identify commonalities across member states that enable practical areas for sharing tools, methodologies and procedures across the EU. The framework specifically includes:
- Joint clinical assessments
- Joint scientific consultations
- Identification of emerging health technologies
- Voluntary cooperation between member states
The benefits for each member state to participate are claimed to include better evidence for decision-making, optimisation of HTA resources, and the pooling of expertise. While the framework highlights that joint clinical assessments will be conducted at an EU level, non-clinical assessments (economic, ethical, organisation etc.) are more sensitive to national and regional contexts and closer to decisions about pricing and reimbursement. For these reasons, non-clinical assessments will remain under the control of the member states.
DRG Abacus will be reviewing the proposal carefully so we can brief our clients on how it may impact their health economics and outcomes research (HEOR) evidence generation and HTA launch strategies for upcoming products in the European market. Understanding the full methods and processes of the joint clinical assessments will be critical, given the country-specific considerations that take place during appraisals of clinical effectiveness; for example, evaluating the generalisability of a clinical trial cohort to the local population. If accepted this year, it is anticipated that the policy will take 3 years to be applied, and a 3-year phased approach taken after that for member countries to come online.
At DRG Abacus, our HTA consultants can provide guidance and assistance for a product’s HTA evidence generation roadmap. We have 20 years of experience of HTA submissions and support across many European counties. We bring the technical, personal and strategic approach to supporting our clients. Get in touch with our expert HTA consultants at email@example.com to find out more.