Skip to main content

Table 3 Impact of clinical and regulatory variables on the P&R approval according to logistic regression analysis

From: ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requiring a PASS would be more likely to be reimbursed in Spain

Variables

 

Coef

SE

t-value

p-value

[95% Conf Interval]

Sig

Therapeutic area

Oncologic

0.39

0.424

− 0.87

0.386

0.046

3.286

 

Outcomes classification

Survival

3.134

3.381

1.06

0.29

0.378

25.961

 

Therapeutic alternatives

No

0.823

0.58

− 0.28

0.782

0.206

3.279

 

Rarity of disease

Ultra-rare

0.822

0.685

− 0.24

.814

0.16

4.209

 

Safety

No PASS

0.055

0.068

− 2.34

0.02

0.005

0.627

**

Type of population

Paediatric

0.422

0.358

− 1.02

0.31

0.08

2.227

 

TPR conclusion

Positive

225.762

304.687

4.02

0

16.028

3180.004

***

Conditional approval

No

9.07

8.729

2.29

0.022

1.375

59.818

**

 

Constant

0.087

0.112

− 1.89

0.058

0.007

1.088

*

 

Mean dependent var

0.655

SD dependent var

0.478

 

Pseudo r-squared

0.472

Number of obs

87

 

Chi-square

52.947

Prob > chi2

0.000

 

Akaike crit. (AIC)

77.141

Bayesian crit. (BIC)

99.335

  1. SD Standard deviation, TPR Therapeutic Positioning Report
  2. ***p < 0.01, **p < 0.05, *p < 0.1