OBJECTIVES: The primary objective of this study was to compare conclusions and methodologies of all published HTA reports appraising FreeStyle Libre™ Flash Glucose Monitoring system, a glucose sensing technology used by persons with diabetes to manage their condition, since launch in September 2014 through October 2018.

METHODS: The literature search conducted in October 2018 aimed to identify all FreeStyle Libre™ HTA reports produced by HTA body. Inclusion criteria did not specify a date or language restriction. Data was extracted and results were analyzed under four themes: (1) assessment of clinical evidence; (2) assessment of economic evidence; (3) engagement with stakeholders; and (4) conclusions/recommendations.

RESULTS: In total 17 HTA reports were included in this analysis. All HTA reports included an assessment of the clinical evidence and 13 considered economic evidence. Despite uncertainties in the evidence base, a majority of HTA bodies concluded that compared to self-monitoring of blood glucose, FreeStyle Libre™ system reduces the frequency and time in hypoglycaemia and improved patient satisfaction. The majority of HTA reports that considered cost-effectiveness (n=6) reported that FreeStyle Libre™ system is a cost-effective intervention versus SMBG. Aspects of methodology that contributed to the most variation that warrant further consideration include the approach to quality assessment, the assessment of early evidence and incorporating stakeholder feedback.

CONCLUSIONS: The evidence summarized in this review shows a wide range of results through the different HTA processes. This variation is due to the lack of clear processes of appraising medical devices. These issues are strongly related to delays in the availability of innovation for patients and clinicians. This review suggests that some of the challenges to conducting HTA in medical devices can be overcome by applying pragmatic approaches to adjust HTA processes and drawing on broader sources of evidence to support early adoption and help to manage the risks associated with uncertain evidence.