Cost-effectiveness of switching to insulin degludec from other basal insulins in real-world clinical practice in Italy

Figures & data

Table 1. Baseline demographics of patients with T1D and T2D included in the Italian cohort of the study.

Characteristic	T1D (n = 397)	T2D (n = 153)
Male, %	54.4	50.3
Age, years	47.3 (14.5)	65.6 (9.2)
BMI, kg/m^2	25.0 (3.8)	30.8 (5.5)
Diabetes duration, years	21.2 (13.6)	17.9 (9.7)
Duration of insulin treatment, years	20.9 (13.6)	7.5 (5.0)
HbA1c, %	8.2 (1.2)	8.4 (1.2)
Proportion basal–bolus, %	100	78
Prior insulin use, %
Glargine U100	73.8	42.5
IDet	23.9	54.2
Other	2.3	3.3

Values are mean (SD), unless otherwise stated.

Abbreviations. BMI, body mass index; IDet, insulin detemir; glargine U100, insulin glargine 100 units/mL; SD, standard deviation; T1D, type 1 diabetes; T2D, type 2 diabetes.

Figure 1. HbA_1c, insulin dose, and number of hypoglycemic events in patients with T1D at baseline and 6-months of follow-up. *p < 0.0001; **p = 0.011. Numbers of hypoglycemic events were based on data from 6 months pre-switch to switch vs switch to 6 months post-switch. Abbreviations. ETD, estimated treatment difference; n, number of patients; NS, not significant; RR, rate ratio; T1D, type 1 diabetes.

Figure 2. HbA_1c, insulin dose, and number of hypoglycemic events in patients with T2D at baseline and 6 months of follow-up. *p < 0.0001; **p = 0.049; ***p < 0.05. Numbers of hypoglycemic events were based on data from 6 months pre-switch to switch vs switch to 6 months post-switch. Abbreviations. ETD, estimated treatment difference; n, number of patients; RR, rate ratio; T2D, type 2 diabetes.

Table 2. Base-case long-term cost-effectiveness analysis of degludec vs other basal insulins in T1D and T2D.

	Degludec (€)	Other insulins (€)	Incremental cost (degludec – other insulins) (€)
T1D
Costs
Treatment	31,178	27,903	3,275
Management	5,891	5,993	−102
CVD	61,194	63,746	−2,552
Renal	63,284	65,815	−2,531
Ulcer/amputation/neuropathy	14,147	15,094	−947
Eye	18,902	20,931	−2,029
Non-severe hypoglycemia	572	635	−63
Severe hypoglycemia	195	1,554	−1,359
Total costs	195,362	201,672	−6,310
Effects
Undiscounted life expectancy (years)	28.087	27.816	0.271
QALY	10.325	9.544	0.781
ICER (cost per QALY)			Dominant
T2D
Costs
Treatment	20,596	17,706	2,890
Management	2,942	2,914	28
CVD	53,562	53,021	541
Renal	12,328	13,743	−1,415
Ulcer/amputation/neuropathy	7,460	7,527	−67
Eye	6,136	6,545	−409
Non-severe hypoglycemia	29	125	−96
Severe hypoglycemia	479	4,634	−4,155
Total costs	103,534	106,216	−2,682
Effects
Undiscounted life expectancy (years)	13.794	13.546	0.248
QALY	6.400	5.772	0.628
ICER (cost per QALY)			Dominant

In the EU-TREAT study, severe hypoglycemia was defined as events requiring the assistance of another person to actively administer carbohydrate, glucagon, or other corrective actions; non-severe hypoglycemia was defined as all other reported hypoglycemia. The costs with other insulins were calculated for the hypothetical cohort who continued their previous basal insulin regimen, based on the baseline data of the Italian patients from EU-TREAT. Dominant, higher effectiveness with lower cost. Cost and QALYs discounted with a discount rate of 3%.

Abbreviations. CVD, cardiovascular disease; ICER, incremental cost-effectiveness ratio; QALY, quality-adjusted life-year; T1D, type 1 diabetes; T2D, type 2 diabetes.

Table 3. Sensitivity analysis results.

	Discounted direct costs (€)			Discounted QALYs			ICER (€ per QALY gain)	Net Monetary Benefit (assuming ICER threshold of €30,000)
	Degludec (€)	Other insulins (€)	Incremental cost (degludec – other insulins) (€)	Degludec	Other insulins	Incremental QALY (degludec – other insulins)
T1D
Base case	195,362	201,672	−6,310	10.33	9.54	0.78	Degludec dominant	29,710
0% discount rate	347,850	360,978	−13,128	15.68	14.38	1.30	Degludec dominant	52,068
8% discount rate	94,869	97,071	−2,202	6.20	5.78	0.42	Degludec dominant	14,802
30-year time horizon	167,464	172,968	−5,504	9.70	9.01	0.70	Degludec dominant	26,504
10-year time horizon	58,699	58,845	−147	5.22	4.91	0.31	Degludec dominant	9,447
8-year time horizon (threshold for dominance)^a	45,980	46,037	−57	4.39	4.13	0.25	Degludec dominant	7,617
5-year time horizon	27,723	27,473	250	2.95	2.79	0.16	1,566	4,550
1-year time horizon	5,180	5,091	88	0.65	0.62	0.03	2,772	812
1-year time horizon (deterministic model)^b	1,744	1,652	91	0.86	0.83	0.03	2,832	809
Difference in HbA1c excluded	203,869	201,672	2,197	10.15	9.54	0.61	3,630	16,103
Upper 95% CI HbA1c	193,766	201,672	−7,906	10.38	9.54	0.83	Degludec dominant	32,836
Lower 95% CI HbA1c	196,257	201,672	−5,415	10.27	9.54	0.73	Degludec dominant	27,165
Difference in BMI excluded	195,191	201,672	−6,481	10.33	9.54	0.78	Degludec dominant	29,881
Upper 95% CI BMI	195,191	201,672	−6,481	10.33	9.54	0.78	Degludec dominant	30,001
Lower 95% CI BMI	195,315	201,672	−6,357	10.33	9.54	0.78	Degludec dominant	29,757
Difference in non-severe hypoglycemia excluded	195,302	201,672	−6,370	10.09	9.54	0.54	Degludec dominant	22,570
Difference in severe hypoglycemia excluded	196,870	201,672	−4,802	9.97	9.54	0.43	Degludec dominant	17,702
Upper 95% CI hypoglycemia	195,241	201,672	−6,431	10.44	9.54	0.89	Degludec dominant	33,161
Lower 95% CI hypoglycemia	195,574	201,672	−6,098	10.17	9.54	0.63	Degludec dominant	24,878
Difference in dose (basal and bolus) excluded	196,132	201,672	−5,540	10.33	9.54	0.78	Degludec dominant	28,940
Disutilities +10%	195,362	201,672	−6,310	9.69	8.84	0.85	Degludec dominant	31,750
Disutilities −10%	195,362	201,672	−6,310	10.53	9.80	0.72	Degludec dominant	27,910
Diminishing hypoglycemia disutility model	195,362	201,672	−6,310	10.89	10.28	0.61	Degludec dominant	24,610
Assuming new needle and SMBG test for  every injection	195,362	202,327	−6,965	10.33	9.54	0.78	Degludec dominant	30,365
Glargine U100 at baseline	200,697	209,377	−8,680	10.93	9.77	1.16	Degludec dominant	43,480
IDet at baseline	179,963	186,571	−6,607	8.52	7.72	0.80	Degludec dominant	30,607
12 month efficacy data^c	193,686	199,270	-5,584	10.06	9.67	0.39	Degludec dominant	17,284
T2D
Base case	103,534	106,216	−2,682	6.40	5.77	0.63	Degludec dominant	21,582
0% discount rate	139,690	143,029	−3,338	8.43	7.57	0.87	Degludec dominant	29,348
8% discount rate	69,742	71,650	−1,908	4.44	4.03	0.41	Degludec dominant	14,268
30-year time horizon	102,641	105,429	−2,788	6.36	5.75	0.61	Degludec dominant	21,088
10-year time horizon	65,846	67,766	−1,920	4.34	3.97	0.37	Degludec dominant	13,020
5-year time horizon	37,848	38,886	−1,038	2.61	2.40	0.21	Degludec dominant	7,338
1-year time horizon (threshold for dominance)^a	8,151	8,328	−177	0.61	0.56	0.05	Degludec dominant	1,677
1-year time horizon (deterministic model)^b	1,906	2,056	−150	0.89	0.85	0.05	Degludec dominant	1,650
Difference in HbA1c excluded	105,060	106,216	−1,156	6.30	5.77	0.53	Degludec dominant	17,056
Upper 95% CI HbA1c	103,441	106,216	−2,775	6.43	5.77	0.66	Degludec dominant	22,455
Lower 95% CI HbA1c	103,742	106,216	−2,474	6.37	5.77	0.60	Degludec dominant	20,324
Difference in BMI excluded	103,534	106,216	−2,682	6.40	5.77	0.63	Degludec dominant	21,582
BMI upper and lower 95% CI analyses not  conducted due to insignificance	103,534	106,216	−2,682	6.40	5.77	0.63	Degludec dominant	21,522
Difference in non-severe hypoglycemia excluded	103,631	106,216	−2,585	6.15	5.77	0.38	Degludec dominant	13,985
Difference in severe hypoglycemia excluded	107,876	106,216	1,660	6.13	5.77	0.36	4,606	9,140
Upper 95% CI hypoglycemia	103,520	106,216	−2,696	6.43	5.77	0.66	Degludec dominant	22,526
Lower 95% CI hypoglycemia	103,561	106,216	−2,655	6.33	5.77	0.56	Degludec dominant	19,515
Difference in dose (basal and bolus) excluded	103,700	106,216	−2,516	6.40	5.77	0.63	Degludec dominant	21,416
Disutilities +10%	103,534	106,216	−2,682	6.19	5.52	0.68	Degludec dominant	23,022
Disutilities −10%	103,534	106,216	−2,682	6.44	5.86	0.58	Degludec dominant	19,962
Diminishing hypoglycemia disutility model	103,534	106,216	−2,682	6.32	5.76	0.55	Degludec dominant	19,182
UKPDS HbA1c progression equation	105,507	107,938	−2,431	6.19	5.64	0.56	Degludec dominant	19,231
Assuming new needle and SMBG test  for every injection	103,534	106,347	−2,813	6.40	5.77	0.63	Degludec dominant	21,713
Glargine U100 at baseline	111,433	118,970	−7,537	6.82	6.00	0.82	Degludec dominant	32,137
IDet at baseline	99,262	98,223	1,039	6.08	5.62	0.46	2,237	12,761

^a Time horizon necessary for dominance.

^b 1-year model based on hypoglycemia as the only complication.

^c 12-month efficacy data (change from baseline in HbA1c, rates of hypoglycemia, and basal and bolus insulin dose) were used in this sensitivity analysis of the T1D group. The same analysis was not feasible for the T2D group due the low number of patients and number of hypoglycemic events.

Abbreviations. BMI, body mass index; dominant, higher effectiveness with lower cost; CI, confidence interval; glargine U100, insulin glargine 100 units/mL; ICER, incremental cost-effectiveness ratio; IDet, insulin detemir; QALY, quality-adjusted life-year; SMBG, self-measured blood glucose; T1D, type 1 diabetes; T2D, type 2 diabetes; UKPDS, United Kingdom Prospective Diabetes Study.

Data availability statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.