EMA, EUnetHTA to Continue Collaboration on Drug Assessments

Regulatory NewsRegulatory News | 14 April 2016 |  By 

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) released a report on Thursday touting progress made towards streamlining regulatory and health technology assessment (HTA) processes over the past three years.

In the EU, many countries rely on an HTA body to assess new drugs to determine whether they are cost effective before they are reimbursed by the countries' national health systems.

However, HTA bodies and regulators require different types of data when reviewing a drug. While regulators need to see data showing that a drug is safe and effective, HTA bodies want to see how well the drug performs against other interventions, and at what cost.

This discrepancy has often led to delays between when a drug is approved for marketing and when it is available for reimbursement.

To address this discrepancy, EMA and EUnetHTA began collaborating on a host of issues in an attempt to hasten access to new drugs after approval.

According to the two agencies, the key achievements during the second three-year phase of the collaborative agreement include efforts to provide joint regulatory and scientific advice to sponsors, retooling the information presented in European public assessment reports (EPARs) to better serve the needs of HTA bodies, collecting more robust postmarket data and beginning discussions on the importance of how therapeutic indications are worded.

These changes, the agencies say, will make it easier to conduct value assessments for new drugs, and reduce inefficiencies for both HTA bodies and industry.

Additionally, EMA and EUnetHTA have worked together to draft a framework that would allow EMA to share portions of EPARs with HTA bodies before they are finalized. Doing so, the agencies say, would further EUnetHTA's efforts to conduct rapid Relative Effectiveness Assessments (REAs).

Going forward, the two agencies say they will continue their cooperative efforts and have identified several areas for future work:

  • "To develop further understanding of the similarities and differences between the regulatory significant benefit used in the assessments of orphan drugs by EMA and the joint REAs by EUnetHTA in terms of objective and content";
  • Further discussions and sharing of experience on the engagements with patients to be included in the process of REA in [joint action 3] JA3.
  • joint development of terminology and definitions, e.g. in the field of Safety and Registries."

Report, EMA Press Release


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