Analisi di budget impact della nuova formulazione di insulina glargine 300 IU, Toujeo® per il Servizio Sanitario Nazionale in pazienti adulti con diabete mellito di tipo 1 e 2

Autori: Enrico Torre, Giorgio L. Colombo

INTRODUCTION

Diabetes mellitus is currently one of the main health challenges in economically advanced countries. Experts speak of a world epidemics and data on constantly rising incidence and prevalence turn diabetes into an economic emergency as well. In particular, most resources are spent on insulin-treated patients. Insulin therapy is the only treatment for type 1 diabetes (DMT1), whereas in type 2 diabetes (DMT2), insulin is only necessary when the beta cell function is seriously defective. In spite of the important progress made in diabetes management, glycemic control is still suboptimal. The risk and the fear of hypoglycemia and the fact that treatment is rather inflexible can cause insulin therapy to be delayed or insufficiently intense. The ideal insulin should have a flat, long action profile, allowing a single administration and the possibility to reproduce inter-individual and intra-individual levels, aimed at achieving constant doses and flexible administrations, and at preventing the feared hypoglycemic events. In order to satisfy these requirements, a new formulation of insulin glargine, Gla-300 (Toujeo®), was recently developed with three times higher concentration (300 units of active ingredient/ mL) than Glargine (Lantus®) (100 units of active ingredient/mL), the gold standard basal insulin.

MATERIALS AND METHODS

An impact analysis on the pharmaceutical budget, from the point of view of the Italian National Health System (SSN, Servizio Sanitario Nazionale), was carried out on a three-year time horizon, with the aim of estimating the economic consequences of introducing Gla-300 on the Italian market for treating adult patients with diabetes mellitus type 1 and 2. The analysis compared two scenarios: one in which Toujeo® is not available on the market, and another one in which Gla-300 is used to treat the target population. The analysis was developed by means of a dynamic simulation model in Microsoft Excel®. To implement the model, a series of input data were added for each scenario on the eligible population, on market shares, and on the cost items considered in the analysis, such as the cost of the drug therapy, the cost of administration, and the cost of any hypoglycemic events.

RESULTS

The results of the budget impact study show that, after introducing Toujeo®, with increasing market shares from 13.0% to 23.3% in the three analyzed years, it is possible to estimate a saving of about €5.7 million in the first year, €13.5 million in the second, and €18.1 million in the third year on SSN pharmaceutical spending.

CONCLUSIONS

The adoption of Gla-300 would be associated with a saving for the SSN, not to mention the clinical benefits for patients due to the lower risk of cardiovascular events induced by low blood sugar and to the lower risk of traumas and fractures from falling because of hypoglycemic events, the advantages in the quality of life, and the saving on indirect costs.

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