Policy Considerations: Ex-US Payers and Regulators

Abstract

In response to a growing demand to demonstrate the value of health technologies, comparative effectiveness research (CER) is gaining importance worldwide. CER-based evidence is key to informing the process of health technology assessment (HTA), a policy-oriented form of systematic research that aims to assess the clinical, economic, social, and ethical effect of health technologies. In many countries around the world, the results of HTA are increasingly used to inform healthcare policy decisions, shaping care delivery and treatment strategies. In this chapter, HTA practices outside the USA are described, with a focus on the policy implications of HTA. To exemplify how CER is integrated into the HTA appraisal process and how HTA can be implemented within the context of different healthcare systems and reimbursement structures, the experience of England, Japan, and the Global Fund is presented. While England has a well-established and renowned HTA program that includes detailed CER guidelines, Japan has only recently started a two-year HTA pilot program with no CER guidelines, and the Global Fund has yet to embrace HTA practices. These three case studies serve as excellent examples of how HTA can be adopted to meet a country’s unique healthcare needs and outline some of the challenges to be overcome during the HTA implementation phase, including the generation of CER-based evidence.