EMEA director calls for EU networks to harmonise drug evaluation

The director of the European Medicines Agency (EMEA), Thomas Loenngren, has argued for European networks to be created to harmonise methodologies for evaluating the cost-effectiveness of medicines.

'We need networks within the EU .. to harmonise methodology, to be able to say if the approval of [a] product has value for money,' he said during the annual meeting of the European Federation of Pharmaceutical Industries Associations (EFPIA).

This network would bring together those involved in this area, particularly regulators and academics, he suggested.

Noting that the evaluation of cost-effectiveness is not the responsibility of EMEA but of the Member States, Loenngren considered that 30% of the medicines approved by EMEA presented obvious added value at the time of approval.

'For 70% of the products we don't have the data to say if there is value for money,' he said, adding that the product would need to be on the market for two to three years for this data to be obtained. 'How do you deal with those 70%? Should they be automatically reimbursed? We have a gap here.'

Loenngren argued for clinical trials to be carried out in 'clinical reality ... not only from a safety point of view but also from an efficacy and from a cost-effectiveness point of view'.

The national bodies competent to evaluate the cost-effectiveness of medicines - such as the UK's NICE, France's HAS or Germany's IQWiG - tend to drag their feet when it's a question of collaborating, he claimed, although IQWiG announced in April that it was going to collaborate with NICE to evaluate their respective modes of evaluation and to avoid duplication.

Christian Siebert, head of the Competitiveness in the Pharmaceuticals Industry and Biotechnology unit at the Entreprise DG in the European Commission said that Member States 'really want to work together to improve quality' and that for this they want 'clarity of criteria and method'.

Siebert is responsible for the Pharmaceutical Forum in the Enterprise DG which is to meet for the second time at the end of June. Launched in October 2005 by the European Commission, the Pharmaceutical Forum brings together MPs and representatives of Member States and associations representing several sectors.

Included among these is the pharmaceutical industry divided into three working groups respectively studying issues to do with patient information, the prices of drugs and their relative efficacy (cost-effectiveness).

Relative effectiveness is the theme for which discussions are the least advanced at the Forum. 'I am not impressed by the progress made by the group on relative effectiveness, said the Director General of the DG Entreprise, Heinz Zourek, at the EFPIA meeting. Although the two other groups appear to have taken some steps forward, this group has made 'very little progress, if any at all', Zourek said.

He believes that the pharma industry has great concerns that the cost-effectiveness evaluation could be used for other purposes, in particular for cost containment.