Introduction
Methods
Model Overview
Clinical Data
Characteristic | Mean (standard deviation) |
---|---|
Start age (years) | 53.94 (10.10) |
Duration of diabetes (years) | 7.05 (5.34)a |
Percentage male (%) | 48.28 |
HbA1c (%) | 8.23 (0.92) |
Systolic blood pressure (mmHg) | 134.83 (13.79) |
Diastolic blood pressure (mmHg) | 82.54 (9.32) |
Total cholesterol (mg/dl) | 180.00 (41.71) |
HDL cholesterol (mg/dl) | 43.84 (10.51) |
LDL cholesterol (mg/dl) | 99.96 (35.69) |
Triglycerides (mg/dl) | 191.82 (109.02) |
BMI (kg/m2) | 40.49 (5.26) |
Percentage smokers (%) | 15.33 |
Cigarettes per day | 14.70b |
Alcohol consumption (oz/week) | 6.87c |
Parameter | Mean (standard error) | ||
---|---|---|---|
Once-weekly semaglutide 0.5 mg | Once-weekly semaglutide 1 mg | Dulaglutide 1.5 mg | |
Physiological parameters (applied in the first year of the analysis) | |||
HbA1c (%) | − 1.52 (0.08) | − 1.72 (0.09)* | − 1.36 (0.09) |
Systolic blood pressure (mmHg) | − 2.82 (1.13) | − 3.93 (1.18) | − 4.19 (1.16) |
Diastolic blood pressure (mmHg) | − 0.83 (0.69) | − 2.03 (0.71) | − 1.04 (0.70) |
Total cholesterol (mg/dl) | − 8.24 (2.43) | − 4.59 (2.52) | − 1.45 (2.48) |
HDL cholesterol (mg/dl) | − 1.19 (0.46) | 0.35 (0.47) | 0.80 (0.46) |
LDL cholesterol (mg/dl) | − 3.49 (2.07) | − 0.74 (2.14) | 2.17 (2.11) |
Triglycerides (mg/dl) | − 23.71 (5.72) | − 24.66 (5.90) | − 25.54 (5.82) |
BMI (kg/m2) | − 1.95 (0.17) | − 2.73 (0.18)* | − 1.32 (0.18) |
Estimated glomerular filtration rate (ml/min/1.73 m2) | − 2.71 (0.83) | − 3.15 (0.88) | − 3.39 (0.83) |
Adverse event rates (applied in the first 3 years of the analysis) | |||
Non-severe hypoglycemia events, per 100 patient years | 3.37 | 2.49 | 1.13 |
Severe hypoglycemia events, per 100 patient years | 0.00 | 1.24 | 1.13 |
Proportion of non-severe hypoglycemic events that are nocturnal | 0.00 | 0.00 | 0.00 |
Proportion of severe hypoglycemic events that are nocturnal | 0.00 | 0.00 | 0.00 |
Treatment Duration, Intensification and Long-Term Parameter Progression
Costs, Resource Use and Utilities
Item | Once-weekly semaglutide 0.5 mg | Once-weekly semaglutide 1 mg | Dulaglutide 1.5 mg | Basal insulin (intensification) |
---|---|---|---|---|
Annual medication cost | 1237.94 | 1237.94 | 1237.94 | 411.90 |
Annual metformin cost | 39.81 | 39.81 | 39.81 | 39.81 |
Annual needle cost | 0.00 | 0.00 | 0.00 | 26.30 |
Annual SMBG testing cost | 0.00 | 0.00 | 0.00 | 77.98 |
Total annual cost | 1277.75 | 1277.75 | 1277.75 | 556.00 |
Sensitivity Analyses
Compliance with Ethics Guidelines
Results
Base Case Analysis
Health outcomes | Once-weekly semaglutide 0.5 mg | Dulaglutide 1.5 mg | Difference |
---|---|---|---|
Discounted life expectancy (years) | 11.61 (0.15) | 11.57 (0.15) | + 0.04 |
Discounted quality-adjusted life expectancy (QALYs) | 7.19 (0.09) | 7.16 (0.10) | + 0.04 |
Discounted direct costs (EUR) | 18,686 (399) | 18,706 (404) | − 20 |
ICER based on life expectancy and direct costs | Once-weekly semaglutide 0.5 mg dominant | ||
ICER based on quality-adjusted life expectancy and direct costs | Once-weekly semaglutide 0.5 mg dominant |
Health outcomes | Once-weekly semaglutide 1 mg | Dulaglutide 1.5 mg | Difference |
---|---|---|---|
Discounted life expectancy (years) | 11.63 (0.15) | 11.57 (0.15) | + 0.06 |
Discounted quality-adjusted life expectancy (QALYs) | 7.23 (0.10) | 7.16 (0.10) | + 0.07 |
Discounted direct costs (EUR) | 18,566 (402) | 18,706 (404) | − 140 |
ICER based on life expectancy and direct costs | Once-weekly semaglutide 1 mg dominant | ||
ICER based on quality-adjusted life expectancy and direct costs | Once-weekly semaglutide 1 mg dominant |
One- and Multi-Way Sensitivity Analyses
Analysis | Once-weekly semaglutide 0.5 mg versus dulaglutide 1.5 mg | Once-weekly semaglutide 1 mg versus dulaglutide 1.5 mg | ||||
---|---|---|---|---|---|---|
Difference in discounted quality-adjusted life expectancy (QALYs) | Difference in discounted direct costs (EUR) | ICER (EUR per QALY gained) | Difference in discounted quality-adjusted life expectancy (QALYs) | Difference in discounted direct costs (EUR) | ICER (EUR per QALY gained) | |
Base case | + 0.04 | − 20 | Once-weekly semaglutide dominant | + 0.07 | − 140 | Once-weekly semaglutide dominant |
Statistically significant differences only | 0.00 | 0 | Once-weekly semaglutide equally effective and equally costly | + 0.07 | − 99 | Once-weekly semaglutide dominant |
20-year time horizon | + 0.01 | − 21 | Once-weekly semaglutide dominant | + 0.04 | − 105 | Once-weekly semaglutide dominant |
10-year time horizon | + 0.02 | − 36 | Once-weekly semaglutide dominant | + 0.04 | − 53 | Once-weekly semaglutide dominant |
0% discount rates | + 0.08 | + 13 | 160 | + 0.14 | − 240 | Once-weekly semaglutide dominant |
5% discount rates | + 0.02 | − 26 | Once-weekly semaglutide dominant | + 0.05 | − 93 | Once-weekly semaglutide dominant |
HbA1c difference only | + 0.02 | − 61 | Once-weekly semaglutide dominant | + 0.03 | − 130 | Once-weekly semaglutide dominant |
BMI difference maintained for patient lifetimes | + 0.07 | − 20 | Once-weekly semaglutide dominant | + 0.15 | − 138 | Once-weekly semaglutide dominant |
UKPDS HbA1c creep for duration of the analysis (no change upon treatment intensification) | + 0.02 | − 107 | Once-weekly semaglutide dominant | + 0.06 | − 116 | Once-weekly semaglutide dominant |
Upper 95% CI of HbA1c estimated treatment difference | + 0.04 | − 113 | Once-weekly semaglutide dominant | + 0.09 | – 140 | Once-weekly semaglutide dominant |
Lower 95% CI of HbA1c estimated treatment difference | + 0.02 | − 56 | Once-weekly semaglutide dominant | + 0.06 | − 82 | Once-weekly semaglutide dominant |
Upper 95% CI of BMI estimated treatment difference | + 0.05 | − 74 | Once-weekly semaglutide dominant | + 0.08 | − 133 | Once-weekly semaglutide dominant |
Lower 95% CI of BMI estimated treatment difference | + 0.02 | − 35 | Once-weekly semaglutide dominant | + 0.06 | − 143 | Once-weekly semaglutide dominant |
Treatment switching at 2 years | + 0.03 | − 72 | Once-weekly semaglutide dominant | + 0.06 | − 64 | Once-weekly semaglutide dominant |
Treatment switching at 5 years | + 0.02 | − 71 | Once-weekly semaglutide dominant | + 0.07 | − 111 | Once-weekly semaglutide dominant |
Treatment switching at 7.5% HbA1c threshold (using UKPDS progression) | + 0.02 | − 157 | Once-weekly semaglutide dominant | + 0.10 | + 312 | 3137 |
Cost of complications + 10% | + 0.04 | − 24 | Once-weekly semaglutide dominant | + 0.07 | − 158 | Once-weekly semaglutide dominant |
Cost of complications − 10% | + 0.04 | − 16 | Once-weekly semaglutide dominant | + 0.07 | − 123 | Once-weekly semaglutide dominant |
Cost of consumables excluded | + 0.04 | − 24 | Once-weekly semaglutide dominant | + 0.07 | − 146 | Once-weekly semaglutide dominant |
Lee et al. BMI disutility applied | + 0.03 | − 20 | Once-weekly semaglutide dominant | + 0.08 | − 140 | Once-weekly semaglutide dominant |
Diminishing hypoglycemia disutility applied | + 0.04 | − 20 | Once-weekly semaglutide dominant | + 0.07 | − 140 | Once-weekly semaglutide dominant |
Currie et al. hypoglycemia disutility applied | + 0.04 | − 20 | Once-weekly semaglutide dominant | + 0.07 | − 140 | Once-weekly semaglutide dominant |