Health services throughout Europe now operate within a cost-constrained environment, with new products increasingly being required to demonstrate value for money, through a Health Technology Appraisal (HTA) process, prior to their adoption for use. In the UK, formal assessment by NICE, SMC and AWMSG has become a familiar part of the pharmaceutical marketing process, although the influence of their recommendations now extend far beyond the UK. With a move to value-based pricing expected in 2014, this requirement will not only intensify, but will also be brought forward into the pre-launch period.