Access to innovative oncology medicines in Europe

The incidence of cancer will increase within the next 5 years up to 15 million patients per year worldwide with a further increasing tendency. Therefore, there is a requirement for more emphasis on cancer prevention, research and effective anticancer drugs including a rapid licensing and market availability for the patients. In the EU, the centralized procedure (CP) of the European Medicine Agency (EMA) is mandatory for marketing authorization for anticancer drugs. A CP will result in one marketing authorization for all Member States granted by the European Commission. At variance, numerous independent healthcare sys-tems are in operation across the EU, and each Health Technology Assessment (HTA) body follows its own methodologies and scientific value judgements in the assessment of the ad-ditional clinical benefit of a new anticancer drug. Payer organisations in the various member states consider these assessments to a varying degree as input in their pricing and reim-bursement negotiations. At the same time international reference pricing and parallel trade have an inherent tendency to establish rather uniform price levels across member states. Consequently, drug access for patients differs considerably within the EU. Initiatives to im-prove the interface between the different stakeholders are currently on the way, but are unlikely sufficient to overcome these fundamental problems.