BACKGROUND

  • Health Technology Assessment (HTA) agencies in Europe provide recommendations on medicines and other health interventions based on systematic clinical and/or economic evaluations which are conducted post marketing authorization by the European Medicines Agency (EMA). „

  • A robust economic evaluation will measure the monetary costs and benefits in the specific setting, relying on locally available data (e.g. the cost of alternative treatments or of medical services associated to the medicine being assessed). This naturally leads to some differences in the medical value of innovative treatments across the European Union (EU). „ 

  • Surprisingly, HTAs also reach different conclusions on the incremental therapeutic benefit of innovative medicines, although the data studied is predominantly the same for all markets (e.g. safety and efficacy data from RCTs). Although the underlying clinical data set is similar, HTAs diverge in their preference and interpretation of such data, e.g. in regards to trial design, relevant endpoints, appropriateness of defined patient subgroups or treatment comparators. „ 

  • The differences in the evaluation of a medicine’s clinical parameters and of its added therapeutic benefit can potentially confuse stakeholders such as patients, physicians or pharmaceutical manufacturers. „ 

  • Heterogeneity in the appraisal of same clinical data also contributes to the divergence in reimbursement status and delays accessibility of novel drugs to patients in different EU member states.