; or (B) an amount as determined by the Secretary, taking into account— (i) the therapeutic efficacy of the covered drug; (ii) the size of the affected patient population in the United States and globally; (iii) the risk adjusted value of Federal subsidies and investments related to the covered; (iv) the extent to which the manufacturer of the covered drug has recovered risk adjusted investments related to the covered drug, including the investments related to the invention, regulatory test data, and any other relevant research and development costs