‘Valuable collaboration’ between drug regulators and HTA bodies

by Gary Finnegan: Cooperation between medicines regulators and health technology assessment (HTA) bodies is helping to streamline clinical studies of new medicines, according to a new report.

The European Medicines Agency (EMA) and the European network for Health Technology Assessment (EUnetHTA) have been working together to create synergies between regulatory evaluation and health technology assessment (HTA) along the lifecycle of a medicine.

In a review of their work plan covering the period from November 2012 to December 2015, the EMA-EUnetHTA collaboration said its work is improving the efficiency and quality of processes for the benefit of public health in the European Union.

The report highlights efforts to generate data on medicines, pre- and post-authorisation, that reconciles regulatory and HTA requirements into one clinical development programme.

This is expected to improve the usefulness of the regulatory evaluation and the information derived from it for subsequent HTA. It will also enhance sharing experience and knowledge along the life-span of medicines.

EUnetHTA is a network of organisations (from EU Member States, EEA and accession countries) and a large number of relevant regional agencies and not-for-profit organisations that produce or contribute to HTA in Europe

Key achievements of the EMA-EUnetHTA cooperation since 2012 include:

• Joint regulatory/HTA scientific advice/early dialogue for medicine developers to reduce duplication, and to streamline and optimise the whole medicine development process for the benefit of patients
• Improved EMA assessment reports to address the needs of HTA bodies
• Approaches for collection of robust data post-authorisation
• Facilitating EUnetHTA’s pilot projects on rapid relative effectiveness assessment of pharmaceuticals
• Discussion on the therapeutic indication for medicines