Increasingly, pharmaceutical companies are being asked – if not required – to demonstrate that their products deliver economic and clinical value to a wide range of stakeholders, including payers, providers, pharmacy benefit managers (PBMs), and patients.  In the past, regulatory approval alone was sufficient to successfully bring a new product to market (with subsequent reimbursement and pricing demands largely guaranteed), but this is no longer the case.  In order to remain competitive in today’s rapidly changing environment, pharmaceutical companies must shift their focus to smaller, more targeted patient populations.