Guidance for companies to be developed after EMA and HTAs share views

A workshop between the European Medicines Agency (EMA) and health technology assessment bodies (HTAs) took place on Tuesday to share views on innovation.

The dialogue came about as some new medicines authorized by the European Commission based on the EMA’s scientific opinions fail to be reimbursed and/or used as expected because they fail to match the requirements of HTA bodies. This prompted a clear need to initiate early dialogue between medicines developers, the EMA and HTA bodies to discuss and agree on a development plan that generates data that both parties can use to determine a medicine's benefit-risk balance and value.

Guido Rasi, EMA executive director, said: “A strong interaction between regulators and HTAs is critical to enable innovation to reach patients, and ultimately for the benefit of public health. This is the first workshop where we have tried to bridge these two worlds together to share views.”