Crossing the fourth hurdle

The fourth hurdle, the requirement that pharmaceutical manufacturers can demonstrate that their new products represent good value for money as well as being of good quality, effective and safe, is increasingly being required by healthcare systems. In crossing this ‘fourth’ hurdle, companies will usually need to demonstrate that their products are more effective than relevant comparators and that the increased cost is offset by the enhanced benefits. Decision makers, however, must draw their conclusions not only on the basis of the underpinning science but also on the social values of the people they serve.