OBJECTIVES : To investigate the implications of the introduction, in the Italian clinical practice, of glycated albumin (GA), as an innovative glycemic marker for monitoring type-2 diabetes mellitus (DM) in patients affected by chronic kidney disease (CKD) – level 4 and 5 –, in comparison to the gold standard glycated hemoglobin (HbA1c).

METHODS : A Health Technology Assessment was conducted, considering the Italian NHS perspective. The EUnetHTA Core Model dimensions were deployed by means of literature evidence, health economics tools and specific validated questionnaires, considering a comparative approach regarding GA presence or absence.

RESULTS : Literature declared that GA would better estimate the glycemic control in diabetic patients with CKD, since the evaluation of glycemic control with HbA1c may be problematic due to altered erythrocyte lifespan and use of iron and/or erythropoietin therapy. The integration of GA could better identify a worst glycemic control than HbA1c alone (52% versus 19.2%), with important advantages in the decrease of cardiovascular events occurrence rate (45% versus 62%).

From an economic point of view, GA would lead to an overall economic saving equal to 2.09%, on annual basis, thus being the solution presenting a better trade-off between costs sustained and efficacy achieved (Cost-effectiveness Value: 6,325 versus 22,087).

Professionals’ perceptions (considering a 7-item Likert scale, ranging from -3 to +3) crystallized and confirmed literature evidence, declaring a better safety (1.60 versus 1.01) and effectiveness (2.12 versus 1.02) profile, in adding GA to the traditional instruments. An improvement in both patients and caregivers’ quality of life emerged (2.00 versus 0.88).

From an organizational perspective, despite marginal investments would be required for training courses and equipment updates, GA would lead to an overall improvement in the patients’ clinical pathway (2.25 versus 0.63).

CONCLUSIONS : Results demonstrated the strategic relevance of GA, in the optimization of glycemic monitoring in DM patient with CKD.