Table 5.
Cost-effectiveness analysis for point estimate of the ICER and sensitivity analyses.
| Differences | ICERa | One to three times GDP per capita in eurosb, c | |
|---|---|---|---|
| (95% CI) | |||
| Base case analysis (EQ-5D-5L at 6 months) | |||
| Costs | 84.17 | €26,347.61 | 4,587 – 13,761 |
| (−8.18, 176.52) | |||
| Outcomes | 0.0032 | ||
| (−0.0015, 0.0079) | |||
| Sensitivity analysis 1 (complete case analysis) | |||
| Costs | 98.42 | €28,062.05 | 4,587 – 13,761 |
| (−48.08, 244.91) | |||
| Outcomes | 0.0035 | ||
| (−0.0031, 0.0101) | |||
| Sensitivity analysis 2 (seemingly unrelated regression) | |||
| Costs | 66.09 | €19,667.97 | 4,587 – 13,761 |
| (−44.86, 177.05) | |||
| Outcomes | 0.0034 | ||
| (−0.0024, 0.0091) | |||
| Sensitivity analysis 3.1 (minimum drug price) | |||
| Costs | 63.18 | €18,649.54 | 4,587 – 13,761 |
| (−68.37, 194.73) | |||
| Outcomes | 0.0034 | ||
| (−0.0031, 0.0099) | |||
| Sensitivity analysis 3.2 (maximum drug price) | |||
| Costs | 78.86 | €22,767.93 | 4,587 – 13,761 |
| (−71.41, 229.14) | |||
| Outcomes | 0.0035 | ||
| (−0.0030, 0.0099) | |||
| Sensitivity analysis 4 (societal perspective) | |||
| Costs | 105.48 | €31,303.61 | 4,587 – 13,761 |
| (−136.19, 347.15) | |||
| Outcomes | 0.0034 | ||
| (−0.0031, 0.0099) | |||
| Sensitivity analysis 5 (ReQoL-10 as outcome measure) | |||
| Costs | 85.30 | €119.02 | |
| (−45.63, 216.22) | |||
| Outcomes | 0.72 | ||
| (−0.4880, 1.9212) | |||
| Sensitivity analysis 6 (MANSA as outcome measure) | |||
| Costs | 89.06 | €523.53 | |
| (−41.91, 220.03) | |||
| Outcomes | 0.17 | ||
| (0.01, 0.33) | |||
| Sensitivity analysis 7.1d | |||
| Bosnia perspective | €22,464.30 | 4,199 – 12,597 | |
| Sensitivity analysis 7.2 | |||
| Kosovo (UN Resolution) perspective | Dominant | 3,036 – 9,108 | |
| Sensitivity analysis 7.3 | |||
| Montenegro perspective | €30,514.02 | 6,124 – 18,372 | |
| Sensitivity analysis 7.4 | |||
| North Macedonia perspective | €61,293.59 | 4,139 – 12,417 | |
| Sensitivity analysis 7.5 | |||
| Serbia perspective | €47,205.13 | 5,095 – 15,285 | |
Measure for outcomes was ReQol-10 sum scores in sensitivity analysis 5 and MANSA scores in sensitivity analysis 6. Outcome measures for all other analyses in Table 5 used QALYs.
For base case analysis and sensitivity analyses 1 to 4, GDP per capita was calculated as the weighted GDP per capita of the five participating countries. The weights were proportions of participants from each country out of the total trial sample size. The formula used was: (€4198.69 x 17.31 + €3036.39 x 22.01 + €4139.38 x 17.52 + €6123.57 x 26.07 + €5094.54 x 17.09)/100 = €4,587. Three times of the GDP per capita was therefore calculated using €4,587 x 3 = €13,761.
For sensitivity analyses 7.1 to 7.5, GDP per capita was country-specific.
For sensitivity analyses 7.1 to 7.5, we ran two regressions for each analysis including a structural cost regression and a QALY outcome regression. Country-perspective ICER was calculated using coefficients from three interactions in terms of the two regressions. We followed the method proposed by Willke et al. (1998).