The European Commission, the European Parliament and the EU Member States are striving for a centralisation of benefit assessments or Health Technology Assessment (HTA) procedures that have so far been carried out at national level which are then to serve as the basis for national reimbursement price negotiations. General feasibility has already been tested at the European level within the framework of the so-called Joint Action Programme (EUnetHTA) Further information >>> Since March 24th 2021, a concrete version of a draft regulation has been available from the EU Commission which is to form the basis of the future European benefit assessment. On 27.10.2021, the Council published its
position at first reading. Further information >>>
It is intended that the benefit assessment
- be based on joint scientific consultations,
- to undertake a joint clinical evaluation,
- and to develop and implement a common methodology for evaluation.
Assessment with regard to economic, social and ethical aspects as well as the negotiation of drug prices and reimbursement amounts remains a national responsibility.
Information, data, analyses and other evidence that has already been provided at European level within the joint clinical evaluation are no longer to be submitted subsequently at national level. This means: if an EU-HTA is already available, it should be used for the benefit assessment at national level.
The implementation of a joint clinical evaluation at Union level will take place in stages and initially only apply to the treatment of oncological diseases. After a two-year transition period, medicinal products for rare diseases will be included and the remaining medicinal products within an eight-year period.
The European benefit assessment has major overlaps with the German “early benefit assessment according to AMNOG”. Large parts of today’s AMNOG benefit dossier (modules 2, 3 and 4) will in future be prepared on a European basis. The more closely the methodology is oriented towards German standards, the greater the significance of the European HTA will be for the negotiation of reimbursement amounts in Germany.
Get ready for the new European benefit assessment with us. We will support you with strategic planning, the analysis of the European specifics in relation to national assessment procedures and advise you on the negotiation of reimbursement amounts.