Abstract
OBJECTIVES: The study aims at investigating the implications related to the introduction, in the Italian clinical practice, of glycated albumin (GA), as innovative glycemic control marker, for patients with type 2 diabetes assuming oral antiglycemic treatment (insulin-naïve), in addition to the traditional monitoring instruments (HbA1c/fasting plasma glucose). METHODS: A Health Technology Assessment was conducted, considering the Italian NHS perspective. Data were gathered using specific questionnaires (completed by 14 Italian professionals) and systematically searching medical literature, for the assessment of EUnetHTA dimensions.RESULTS: Literature review stated that the introduction of GA could: i) reflect shorter-term control of plasma glucose level, being helpful in patients with hemoglobinopathy; ii) be a predictor of the relative risk in the development of diabetes complications; iii) increase the number of patient achieving therapeutic success after 3 months of therapy (97.0% vs 71.6%). The perceptions of the professionals (considering a 7-item Likert scale, ranging from -3 to +3) crystallized literature evidence, declaring a better safety (0.11 vs 0.65) and effectiveness (0.53 vs 1.80) profile, in adding GA to the traditional instruments. From an economic point of view, GA introduction would lead to fewer patients requiring a therapy switch (-89.44%), with an economic advantage of -1.06% (12 months). The cost-effectiveness analysis demonstrated that the innovative pathway would be the preferable technology (CEV: 225.53 vs 237.74). Low-level perceptions resulted with regard to equity aspects (0.13 vs 0.72), due to GA limited accessibility, whereas it would improve both patients (1.33 vs 2.17) and caregivers (0.83 vs 1.50) quality of life. While GA, in the short time, requires training courses and equipment update, in the long run, there would contain the above drawbacks, showing GA organizational benefits (0.01 vs 0.30). CONCLUSIONS: The study showed the strategic relevance of GA, in the improvement of diabetic patient clinical pathway, freeing-up NHS resources.