The Health Technology Assessment Environment in Mainland China, Japan, South Korea, and Taiwan-Implications for the Evaluation of Diabetes Mellitus Therapies.

Background: Diabetes mellitus (DM) is associated with a significant global economic and humanistic burden. The condition presents a real challenge in Asia, which accounts for more than 60% of individuals with DM globally. Health technology assessment (HTA) is a field of scientific research used to inform policy and clinical decision making relating to the introduction and diffusion of health technologies.

Objectives: This article, examines the present use and predicted evolution of HTA with respect to pricing and reimbursement of drugs in mainland China, Japan, South Korea, and Taiwan. It makes specific reference to important assessment considerations for DM therapies, which should assist key stakeholders in choosing which data to capture, and what approaches to use, to help quantify the value of treatment.

Methods: The findings are informed by two Advisory Board discussions, a literature review, and the authors' personal experience.

Results: HTA already has a key role in South Korea and Taiwan, with current systems undergoing important changes. In contrast, in mainland China and Japan, HTA is not yet formally utilized, although this appears likely to change. Several elements are important for HTA to be meaningful and impactful for DM therapies, including a clear, transparent analytical framework for HTA that includes all relevant costs and outcomes; availability of local DM epidemiologic, economic, and quality-of-life data; acceptance of modeling as a core methodology; availability of real-life patient data; and recognition of specific evidence requirements associated with biosimilars. HTA has the potential to assist payors in making informed decisions about the coverage of DM medications.