To Örebro University

Background and aims: Randomised controlled trials and observational studies have shown lower risk of hypoglycemia in patients with type 1-diabetes (T1D) and type 2-diabetes (T2D) on treatment with insulinde gludec (IDeg) vs insulin glargine 100 units/mL (IGlar). This study assessed cost-effectiveness (C/E) of IDeg vs insulin treatment before switch to IDeg in a Swedish real-world setting in people with T1D and T2D.

Materials and methods: ReFLeCT is a prospective, observational study in T1D (n=566) and T2D (n=611) in seven European countries and comprised a four-week baseline period (pre-switch basal insulin) and a 12-month follow-up period (IDeg). Data from ReFLeCT was used to assess C/E of IDeg compared with basal insulin treatment prior to switching to IDeg. Basal insulin unit costs were weighted to represent the basal insulin present at baseline (T1D: IGlar 63.8%, Insulin detemir (IDet) 22.7%, other/missing 13.5%. T2D: IGlar 59.1%, IDet 20.8%, other/missing 20.1%). The Swedish original IGlar price was used as base case. IGlar biosimilar price was used in a sensitivity analysis. Where information on basal insulin at baseline was missing, the lowest basal insulin price (insulin NPH) was used as a conservative approach. C/E was analysed over a 1-year time horizon from a Swedish societal perspective (price level 2019). Only differences with p<0.05 were included in the analysis.

Results: Basal and bolus insulin doses at baseline were 25.0 IU and 27.3 IU (T1D) and 37.5 IU and 24.4 IU (T2D). At 12 months estimated basal and bolus insulin dose ratios were 0.91 (95% C.I. 0.83-0.91) and 0.87 (0.83-0.91) for T1D and 0.98 (0.95-1.01) and 0.96 (0.94-1.01) for T2D. For T1D riskratios (RR) for non-severe daytime hypoglycaemia was 0.85 (0.78-0.93), non-severe nocturnal hypoglycaemia 0.63 (0.52-0.76) and severe hypoglycaemia 0.28 (0.14-0.56). Corresponding RR for T2D were 0.56 (0.46-0.69), 0.38 (0.22-0.64) and 2.87 (0.33-24.65). In T1D IDeg was cost-saving compared to previous basal therapy (Table 1). In T2D, IDeg was highly cost-effective, with a cost per quality-adjusted life-year (QALY) of SEK 15,000-24,000 (Table 1). A treatment is considered cost-effective in Sweden if cost/QALY is below SEK 500,000. Sensitivity analyses showed that the results were robust to changes in efficacy and cost parameters in both T1D and T2D.

Conclusion: In this C/E-analysis, treatment with IDeg was cost-saving (T1D) or highly cost-effective (T2D) relative to the treatment used before switch in a Swedish setting after one year. C/E of IDeg in clinical practice is driven by lower insulin doses (T1D) and reduced risk of hypoglycaemia (T1D and T2D).