Actual developments in European regulatory and health technology assessment of new cancer drugs: what does this mean for oncology in Europe?

In the EU, the centralized procedure (CP) of the EMA is mandatory for marketing authorization for innovative anticancer drugs. However, numerous independent healthcare systems are in operation across the EU, and each HTA body follows its own methodologies and scientific value judgements in the assessment of the added value of an innovative anticancer drug. Initiatives to improve the interface between the different stakeholders are currently on the way, but are unlikely sufficient enough to overcome these fundamental problems.