Impact of the therapeutic positioning report in the P&R process in Spain: analysis of orphan drugs approved by the European Commission and reimbursed in Spain from 2003 to 2019

Table 2 Results of the regression analysis

Variable	Estimate	95% CI	\|Z\|	P value	P value classification
Univariate regression analysis
Existence of therapeutic alternative	1,029	0,3674 to 2,798	0,05485	0,9563	ns
Outcomes classification	1,5	0,5863 to 3,943	0,8389	0,4015	ns
Efficacy profile	0,754	0,2938 to 1,927	0,5917	0,554	ns
Safety profile	1,964	0,5944 to 7,735	1,055	0,2914	ns
Conditional approval	0,2674	0,0525 to 1,111	1,752	0,0798	ns
Multivariate regression analysis
Existence of therapeutic alternative	1,129	0,3821 to 3,280	0,2231	0,8234	ns
Outcomes classification	1,518	0,57 to 4,165	0,8289	0,4072	ns
Efficacy profile	0,8212	0,3092 to 2,193	0,3968	0,6915	ns
Safety profile	1,731	0,4964 to 7,141	0,8238	0,41	ns
Conditional approval	0,2995	0,057 to 1,292	1,562	0,1182	ns

The dependent variable in logistic regression was reimbursement status, stratified by P&R approved or P&R rejected (n = 75). CI Confidence interval; Z Z-score; ns: not significant

ISSN: 1750-1172