Cost-effectiveness analysis: should it be required for drug registration and beyond?

Cost-effectiveness analysis (CEA) is applied in situations where trade-offs exist, typically, greater benefit for an increased cost over an alternative therapy or strategic option versus usual care. CEA is useful where a new strategy is more costly but expected to be more effective or where a new strategy is less costly but less effective. A good example for the relevance of CEA is the unanimous recommendation of a US federal vaccine advisory panel to vaccinate 11-year-old girls against cervical cancer. This recommendation was at least partly because of data showing the relative cost-effectiveness of HPV vaccine. In this era of finite budgets, CEA may facilitate drug development, drug approval, patient segmentation and pricing model development throughout the drug lifecycle continuum.