Magnus Stueve1, Oliver Schnell2. 1. 1 Johnson & Johnson Medical GmbH, Norderstedt, Germany. 2. 2 Forschergruppe Diabetes e.V., Munich-Neuherberg, Germany.
Abstract
BACKGROUND: Various health technology assessment (HTA) agencies review new medical devices worldwide, and their recommendations can be useful in guiding clinical decision making. However, different agencies use different processes and methodologies, resulting in variation in recommendations. OBJECTIVES: The objectives were to review full HTAs for a new technology for diabetes management, flash glucose monitoring (FGM), with the aim of summarizing similarities/differences in processes, methodologies, and recommendations from the perspective of everyday clinical practice. METHODS: A literature review was conducted using online HTA resources. RESULTS: Four full HTAs were identified (Canary Islands, France, Catalunya, and Norway); one issued a conditional recommendation for patients with type 1 diabetes mellitus (T1DM) with controlled glycated hemoglobin (HbA1c) (Spain; Canary Islands), one issued a broader recommendation for patients with T1DM and T2DM (France), and two reported that there was insufficient evidence to support a recommendation (Spain [Catalunya] and Norway). The most comprehensive and stringent of the available HTAs were those in the Canary Islands and Norway, which included systematic literature reviews (SLRs), consultation with patient groups and clinicians, GRADE evidence quality assessments, and full economic models. Comprehensive HTAs either did not recommend FGM (Norway) or restricted the recommendation to a small subpopulation of the overall diabetes population (Canary Islands). CONCLUSION: HTAs represent a valuable additional resource for clinicians to consider alongside clinical evidence, guidelines, and consensus papers; however, interpreting recommendations requires an understanding of the processes behind these recommendations. In this review, comprehensive HTAs either recommended for a selected subpopulation based on RCT evidence or found insufficient evidence for a recommendation.
BACKGROUND: Various health technology assessment (HTA) agencies review new medical devices worldwide, and their recommendations can be useful in guiding clinical decision making. However, different agencies use different processes and methodologies, resulting in variation in recommendations. OBJECTIVES: The objectives were to review full HTAs for a new technology for diabetes management, flash glucose monitoring (FGM), with the aim of summarizing similarities/differences in processes, methodologies, and recommendations from the perspective of everyday clinical practice. METHODS: A literature review was conducted using online HTA resources. RESULTS: Four full HTAs were identified (Canary Islands, France, Catalunya, and Norway); one issued a conditional recommendation for patients with type 1 diabetes mellitus (T1DM) with controlled glycated hemoglobin (HbA1c) (Spain; Canary Islands), one issued a broader recommendation for patients with T1DM and T2DM (France), and two reported that there was insufficient evidence to support a recommendation (Spain [Catalunya] and Norway). The most comprehensive and stringent of the available HTAs were those in the Canary Islands and Norway, which included systematic literature reviews (SLRs), consultation with patient groups and clinicians, GRADE evidence quality assessments, and full economic models. Comprehensive HTAs either did not recommend FGM (Norway) or restricted the recommendation to a small subpopulation of the overall diabetes population (Canary Islands). CONCLUSION: HTAs represent a valuable additional resource for clinicians to consider alongside clinical evidence, guidelines, and consensus papers; however, interpreting recommendations requires an understanding of the processes behind these recommendations. In this review, comprehensive HTAs either recommended for a selected subpopulation based on RCT evidence or found insufficient evidence for a recommendation.
Entities:
Keywords:
diabetes; flash glucose monitoring; health technology assessment
Authors: Felix Aberer; Martin Hajnsek; Markus Rumpler; Sabine Zenz; Petra M Baumann; Hesham Elsayed; Adelheid Puffing; Gerlies Treiber; Thomas R Pieber; Harald Sourij; Julia K Mader Journal: Diabetes Obes Metab Date: 2017-03-16 Impact factor: 6.577