Abstract
The biotechnology revolution has coincided with another revolution in health care: the emergence of finance and economics as major issues in the use and success of new medical technologies. Health care finance has become a major social issue in nearly every nation, and the evaluation and scrutiny of the pricing and value of new treatments has become an industry unto itself. The most tangible effect of this change is the establishment of the so-called third hurdle for approval of new agents in many nations, after proving safety and efficacy. Beyond the traditional requirements for demonstrating the efficacy and safety of new agents, some nations, and many private health-care systems, now demand data on the economic costs and benefits of new medicines. Although currently required only in a few countries, methods to extend similar prerequisites are being examined by the governments of most developed nations. Many managed care organizations in the USA now prefer that an economic dossier be submitted along with the clinical dossier to make coverage decisions.
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Kolassa, E.M., Padwal, T.B. (2013). Economic Considerations in Medical Biotechnology. In: Crommelin, D., Sindelar, R., Meibohm, B. (eds) Pharmaceutical Biotechnology. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-6486-0_10
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