; or (B) an amount as determined by the Secretary, taking into account— (i) the value of the drug to patients; (ii) the size of the affected patient population; (iii) the risk adjusted value of the Federal Government subsidies and investments related to the drug; (iv) whether the drug provided a significant improvement in health outcomes, compared to other therapies available at the time of the approval; (v) the extent to which the brand name drug manufacturer has recovered risk adjusted investments related to the drug, including the investments related to the invention, regulatory test data and any other relevant research and development costs