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. 2021 Oct 19;12:754390. doi: 10.3389/fphar.2021.754390

TABLE 2.

Off-label request characteristics and univariate logistic regression analysis for treatment initiation (n = 708).

Characteristic Total n (%) Treatment initiated n = 583 n (%) Treatment not initiated n = 125 n (%) Odds ratio 95% CI for odds ratio lower upper p-value
Drug type
 Chemotherapy 144 (20) 122 (21) 22 (18) 1.239 0.750–2.046 0.402
 Targeted therapy 272 (39) 208 (36) 64 (51) 0.529 0.358–0.780 0.001
 Immunotherapy 292 (41) 253 (43) 39 (31) 1.691 1.119–2.553 0.013
Metastatic disease 491 (69) 417 (72) 74 (59) 1.731 1.161–2.581 0.007
Orphan disease 276 (39) 227 (39) 49 (39) 0.989 0.666–1.469 0.956
Marker or targetable mutation 179 (25) 157 (27) 22 (18) 1.725 1.051–2.832 0.031
Treatment line
 ≥2 377 (53) 318 (55) 59 (47) 1.342 0.911–1.977 0.136
 ≥3 109 (15) 90 (15) 19 (15) 1.018 0.595–1.743 0.947
Supporting evidence
 Sufficient 338 (48) 226 (45) 72 (58) 1.619 1.096–2.392 0.016
 Limited 322 (45) 278 (48) 44 (35) 0.596 0.399–0.899 0.012
 Inadequate 48 (7) 39 (7) 9 (7) 1.082 0.510–2.296 0.837
Financing
 Expanded access 210 (30) 187 (32) 23 (18) 2.094 1.290–3.400 0.003
 Charity 17 (2) 16 (3) 1 (1) 3.499 0.440–26.632 0.226
 Out-of-pocket 84 (12) 71 (12) 13 (10) 1.195 0.639–2.233 0.557
 Private insurance 178 (25) 152 (26) 21 (21) 1.343 0.839–2.148 0.219
 No planned source 219 (31) 157 (27) 62 (50) 0.374 0.252–0.556 <0.0005
Cost per month (ILS), Mean 54,703 56,274 47,313 1 1–1 0.125

ILS, New Israeli Shekels.