Abstract

The paper analyses some recent trends in the evolution of pharmaceutical markets and expenditure. The tension between an increasing difficulty of pharmaceutical R&D for new therapeutic indications and rigid budget constraints for States and institutional buyers can be faced through a further development and diffusion of value-based, performance- based, evaluation methods. The history of pharmaceutical pricing regulation in Italy and some of the challenges faced in the creation of a Single Market for medicines, show that pricing decisions cannot rely on cost plus methods, or on external reference pricing algorithms. Health technology assessment techniques can sustain a framework to assess and quantify the value of pharmaceutical innovation. In particular, Hta-based schemes tend to induce a continuous re-assessment of available evidence, before and after marketing authorization; this calls for a further improvement of information processing and analysis techniques by regulatory agencies, also based on observational data, such as those deriving from administrative database or registries.