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.
Joint work plan (updated)
In April 2016 EMA and EUnetHTA published a report on the outcomes of the joint work plan:
- 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.
EMA and EUnetHTA will continue their collaboration and extend it through a multi-year programme led by EUnetHTA and funded by the European Commission to strengthen scientific and technical activities on HTA in Europe. It will cover:
- more structured interactions in the context of marketing authorisation applications, such as pre-submission dialogue and exchange at time of concluding the regulatory assessment;
- further improving regulatory reports to support HTA, for example by including patient reported outcomes;
- the development of scientific guidelines on the design of clinical development programmes in specific conditions.
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 - 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 scientific advice from regulators and HTA bodies
EMA offers scientific advice and protocol assistance in parallel with health-technology-assessment bodies. This procedure aims to allow medicine developers to gain feedback from regulators and HTA bodies at the same time, at any point in the developmental lifecycle of medicines. This helps them to establish the evidence that both parties will need to determine a medicine's benefit-risk balance and value as efficiently as possible.
EMA launched the parallel scientific advice procedure with HTA bodies with a pilot project in 2010. Since then, the Agency has been receiving an increasing number of requests from pharmaceutical companies who wish to obtain simultaneous feedback from the two parties. The requests cover a variety of therapeutic areas, including rare conditions. For more information, see Parallel scientific advice from regulators and HTA bodies.
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