OBJECTIVES: In Europe, the shift to a value-based pricing (VBP) approach in the UK, Germany and France underscores the policy objective of obtaining value for money through formal HTA processes. The German AMNOG reform enacted in 2011 represents a major step in standardizing the assessment and price negotiation procedure for new drugs. The UK also plans to implement a VBP by 2014 with an increased role for HTA in pricing decisions. This study explores key policy parameters and their plausible implications. METHODS: A critical review of recent developments in these three HTA systems was conducted. RESULTS: Key parameters such as the choice of comparator will continue to be critical during technology assessment, as evident in recent German IQWiG/GBA evaluations. Subsequent negotiation processes that take into account multiple criteria on top of value evaluation also play an important role in German and French pricing decisions. Additionally, developments associated with VBP will likely generate new challenges in the access environment for innovative drugs. A prominent example is the UK government’s proposition of discontinuing consideration of patient access schemes which have been a major access mechanism for innovative products. CONCLUSIONS: The passage of AMNOG in Germany and upcoming VBP reform in the UK ends the era of free pricing in major European markets. Although there are significant uncertainties about final form that VBP will take in both nations, the inherent risks to the pharmaceutical industry cannot be ignored. While the most proximate impact from these structural changes will likely be pricing pressure, potential delay to market caused by HTA processes and price negotiations are also likely headwinds. Finally, these developments could generate implications beyond Western Europe through international reference pricing and informal policy influencing other markets.