Health technology assessment bodies
The European Medicines Agency has been working closely with health technology assessment (HTA) bodies since 2008. Regional and national HTA bodies provide recommendations on medicines and other health technologies that can be financed or reimbursed by the healthcare system in a particular Member State or region. Recently, they have been gaining a greater influence on the access of novel medicines to patients, mainly due to increased pressure on healthcare budgets.
Regional and national HTA bodies provide recommendations on medicines and other health technologies that can be financed or reimbursed by the healthcare system in a particular Member State or region. In countries where health technology assessment is in place, payers, pricing and reimbursement agencies or HTA bodies rely upon these assessments to:
- determine reimbursement status;
- provide information on benefits and harms of new treatments compared to available treatment options;
- support the price negotiation process.
The assessment criteria used by HTA bodies differ between Member States, in accordance with regional and national legislation.
The Agency recognises that some new medicines that receive marketing authorisation fail to be reimbursed or used as expected. A close interaction between regulators, HTA bodies and other relevant bodies is critical to enable patients' access to important new medicines and hence for the benefit of public health. This aims to reduce developmental resources, by re-shaping and focusing medicine development programmes to generate data relevant for regulators, HTA bodies and other stakeholders.
Interaction with European HTA bodies
Since 2010, the Agency has been working closely with the European Network for Health Technology Assessment (EUnetHTA), a network of government-appointed organisations from European Union Member States, the European Economic Area and accession countries and a large number of relevant regional agencies and non-for-profit organisations that produce or contribute to HTA in Europe.
The EMA-EUnetHTA collaboration aims to harness synergies between regulatory evaluation and HTA along the lifecycle of a medicine.
Joint work plan 2017-2020
In November 2017, EMA and EUnetHTA published a joint work plan for 2017-2020:
This outlines key areas of collaboration, including areas where major progress has already been made, such as:
- parallel consultation with regulators and HTA bodies;
- exchange of information on the outcome of the regulatory assessment at the time of marketing authorisation as part of EUnetHTA's new framework for production of relative effectiveness assessments;
- optimisation of post-authorisation data generation tools, such as patient registries, to serve data needs for various decision-makers.
In addition, EMA and EUnetHTA agreed to collaborate in a number of other areas, including:
- exploring how HTA bodies and regulators apply the concepts of unmet medical need and therapeutic innovation in view of possible synergies;
- understanding the conceptual similarities and differences between the significant benefit of orphan medicines versus their added therapeutic value.
The work plan is complementary to actions included in EUnetHTA Joint Action 3, which runs until 2020.
The activities in this work plan will feed into the implementation of the areas for collaboration identified in the reflection paper from the HTA network on Synergies between regulatory and HTA issues on pharmaceuticals. EMA and EUnetHTA will develop these activities in close cooperation with the European Commission.
EMA and EUnetHTA will continue to explore further areas of collaboration within their respective remits. They will monitor progress on the work plan and update it as necessary.
Outcomes of joint work plan 2012-2015
In April 2016 EMA and EUnetHTA published a report on the outcomes of their first joint work plan, running from 2012-2015:
- Report on the implementation of the EMA-EUnetHTA three-year work plan 2012-2015
- EMA-EUnetHTA three-year work plan
Between 2012-2015, EMA and EUnetHTA:
- participated in each other's pilot projects to explore efficient processes by which regulators and HTA bodies can give medicine developers simultaneous feedback on their development plans;
- updated the EPAR template. They also discussed options to display key effects observed for a medicine in a structured manner, making value judgment in scientific decision-making more transparent;
- explored approaches for collecting robust post-authorisation data relevant for both organisations, including patient registries;
- worked to facilitate a framework to allow timely provision of information from the regulatory benefit-risk assessment reports in the rapid relative effectiveness assessments of medicines;
- held discussions on the therapeutic indication for medicines which will contribute to the future development of principles for optimisation, as well as an exchange of views on how to document the scientific reasoning behind it.
The first joint EMA-EUnetHTA project responded to a political recommendation to consider how the assessment of the benefits and risks of a medicine contained in European public assessment reports (EPAR) can best be used to inform the assessment of the relative effectiveness of new medicines for HTA purposes in EU Member States. This has resulted in a series of improvements to the EPAR template. EMA and EUnetHTA have published the outcomes of this project in a scientific journal.
Beyond this project, EMA and EUnetHTA continued to collaborate and exchange infomation in a number of key areas to improve the efficiency of processes by ensuring that data generated by sponsors is relevant for the needs of both regulatory authorities and HTA bodies.
For full details on previous interactions between the Agency and EUnetHTA, see the meeting minutes:
- Minutes of the EMA/EUnetHTA meeting - 5 July 2018
- Minutes of the EMA/EUnetHTA meeting - 15 December 2017
- Minutes of the EMA/EUnetHTA meeting - 8 June 2017
- Minutes of the EMA/EUnetHTA meeting - 7 December 2016
- Minutes of the EMA/EUnetHTA meeting - November 2015
- Minutes of the EMA/EUnetHTA meeting - May 2015
- Minutes of the EMA/EUnetHTA meeting - December 2014
- Minutes of the EMA/EUnetHTA meeting - May 2014
- Minutes of the EMA/EUnetHTA meeting - December 2013
- Minutes of the EMA/EUnetHTA meeting - May 2013
- Minutes of the EMA/EUnetHTA meeting - November 2012
- Minutes of the EMA/EUnetHTA meeting - February 2012
- Minutes of the EMA/EUnetHTA meeting - March 2011
- Minutes of the EMA/EUnetHTA meeting - June 2010
- Minutes of the EMA/EUnetHTA meeting - February 2010
Parallel consultations from regulators and HTA bodies
EMA offers consultations in parallel with EUnetHTA as of July 2017. This aims to allow medicine developers to obtain feedback from regulators and HTA bodies on their evidence-generation plans to support decision-making on marketing authorisation and reimbursement of new medicines at the same time.
The procedure is a single gateway for parallel consultations with EMA, EUnetHTA and HTA bodies on their evidence-generation plans.
Consultations can take place before or after the product is made available on the market. The objective is to help generate optimal and robust evidence that satisfies the needs of both regulators and HTA bodies.
This initiative replaces the parallel scientific advice procedure by EMA and HTA bodies which required medicine developers to contact Member States' HTA bodies individually.
EMA and EUnetHTA hold bilateral meetings on a regular basis.
For more information, see Parallel consultation with regulators and health technology assessment bodies.