EVIDENCE REQUIRED BY HEALTH TECHNOLGY ASSESSMENT AND REIMBURSEMENT BODIES EVALUATING DIAGNOSTIC OR PROGNOSTIC ALGORITHMS THAT INCLUDE OMICS DATA.

OBJECTIVES: Multi-analyte assays with algorithmic analyses (MAAAs) use combinations of circulating and clinical markers including omics-based sources for diagnostic and/or prognostic purposes. Assessing MAAAs is challenging under existing health technology assessment (HTA) methods or practices. We undertook a scoping review to explore the HTA methods used for MAAAs to identify the criteria used for clinical research and reimbursement purposes. METHODS: This review included only non-companion (stand-alone) tests that are actionable and that have been evaluated by leading HTA or insurer/reimbursement bodies up to September 2017. RESULTS: Twenty-five reports and articles evaluating seventeen MAAAs were examined, most of which have been developed in oncology. The two main models used were the EUnetHTA Core model and the Evaluation of Genomic Applications in Practice and Prevention ACCE framework. Clinical validity and utility criteria were used, as were economic, ethical, legal, and social aspects. Economic evidence on MAAAs was scarce, and there is no consensus on whether the perspectives used are sufficiently broad to include all relevant stakeholders. CONCLUSIONS: Clinical utility and efficiency were the most used criteria, with stronger evidence needed linking the use of the algorithm with the clinical outcomes in real-life practice. HTA bodies must as well consider questions related to the analytical validity of MAAAs or with organizational aspects. The two main models, the EUnetHTA Core model and the ACCE framework, could be adapted to the assessment of MAAAs.

HTA Implementation Roadmap in Central and Eastern European Countries.

The opportunity cost of inappropriate health policy decisions is greater in Central and Eastern European (CEE) compared with Western European (WE) countries because of poorer population health and more limited healthcare resources. Application of health technology assessment (HTA) prior to healthcare financing decisions can improve the allocative efficiency of scarce resources. However, few CEE countries have a clear roadmap for HTA implementation. Examples from high-income countries may not be directly relevant, as CEE countries cannot allocate so much financial and human resources for substantiating policy decisions with evidence. Our objective was to describe the main HTA implementation scenarios in CEE countries and summarize the most important questions related to capacity building, financing HTA research, process and organizational structure for HTA, standardization of HTA methodology, use of local data, scope of mandatory HTA, decision criteria, and international collaboration in HTA. Although HTA implementation strategies from the region can be relevant examples for other CEE countries with similar cultural environment and economic status, HTA roadmaps are not still fully transferable without taking into account country-specific aspects, such as country size, gross domestic product per capita, major social values, public health priorities, and fragmentation of healthcare financing.

How Continuous Glucose Monitoring Can Motivate Self-management: Can Motivation Follow Behaviour?

OBJECTIVES: Motivation to adhere to clinical recommendations requires engagement, and the urgency to act is one of many factors that contribute to achieving glycemic benefits in people with type 2 diabetes (PwT2D). Continuous glucose monitoring (CGM) devices are associated with improved glycemic benefits. We conducted a qualitative assessment of PwT2D who found using CGM extremely beneficial and examined the potential for CGM to elicit motivation to engage in self-management behaviours. METHODS: Participants using CGM were recruited through social media and interviewed, and transcripts were analyzed (template analysis using thematic analysis) to generate coded responses and inductive themes by 2 raters. RESULTS: Thirteen participants (84.6% women, with a duration of T2D >5 years and CGM use for >6 months) were interviewed. Codes were organized around 3 themes: improved self-management, experience of glucose-sensing technology vis-à-vis general positive or negative experience, and positive impact of CGM on living with diabetes. Improved self-management was reflected in how the CGM technology provided personalized knowledge and ability to self-manage, particularly in contrast to finger pricking. Positive experience included motivation for behaviour changes as well as improved relationships with health-care providers and in social situations. This translated into a sense of improved health and an avoidance of complications. Negative experience included costs, concern over location of the sensor, and discomfort with the device. CONCLUSIONS: CGM technology profoundly impacts multiple aspects of self-management and care for PwT2D. Developing a validated instrument to assess identified constructs could contribute to developing interventions and leveraging benefits of this technology, particularly the motivational constructs of engagement and urgency.