It used to be that drugs were approved on the basis of their impact on markers of disease, however, over the last decade, long term studies measuring the effect of drugs on ultimate disease outcomes have yielded surprisingly unexpected results. As a result, no longer do you only need to convince regulators of the value of your new medicine, payers are likely to not reimburse for any new drugs unless outcome studies demonstrate improved outcomes over previously accepted treatments. However, these studies can last 3-6 years and cost as much as $500 million… Read more. (Source: Forbes, 12/2/13).
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