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There is increasing concern over the cost of pharmaceuticals. An approach to assessing the value of new pharmaceuticals compared with previous standards is cost-effectiveness analysis. Although cost-effectiveness analysis may not be able to directly answer societal questions about new drugs, it can make the underlying assumptions clear. As new pharmaceuticals are becoming more expensive, the issues concerning societal willingness-to-pay become more critical. This is especially true of biologics, where the cost of manufacture is much higher than for small molecules. Indeed, new biologics have gone from being unusual to dominating the market for new pharmaceuticals. Efficiency in manufacturing will need to be gradually addressed to make these life-saving therapies more widely available.