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. 2023 Apr 1;37(4):531–540. doi: 10.1007/s40259-023-00593-7

Table 2.

Coverage decision characteristics

Characteristics Total, no. (%) Biosimilar has no more restrictions than biologic, no. (%) Biosimilar has more restrictions, no. (%) p values
N 1,181 952 229
Cancer treatment 660 (55.9) 625 (65.7) 35 (15.3) < 0.001
Pediatric population 192 (16.3) 129 (13.6) 63 (27.1) < 0.001
FDA line of therapy < 0.001
 1 968 (82.0) 838 (88.0) 130 (56.8)
 2 213 (18.0) 114 (12.0) 99 (43.2)
First biosimilar 531 (45.0) 480 (50.4) 51 (22.3) < 0.001
Years since market launch, mean (SD) 2.5 (1.5) 2.5 (1.5) 2.6 (1.6) 0.362
No. of competitors < 0.001
 1 13 (1.1) 10 (1.1) 3 (1.3)
 2 364 (30.8) 361 (37.9) 3 (1.3)
 3+ 804 (68.1) 581 (61.0) 223 (97.4)
Disease prevalence 0.009
 < 200,000 242 (20.5) 212 (22.3) 30 (13.1)
 200,000–1,000,000 243 (20.6) 191 (20.1) 52 (22.7)
 > 1,000,000 696 (58.9) 549 (57.7) 147 (64.2)
Annual savings per patient < 0.001
 < $5,000 293 (24.8) 258 (27.1) 35 (15.3)
 $5,000–$9,999 350 (29.6) 294 (30.9) 56 (24.5)
 $10,000–$14,999 302 (25.6) 220 (23.1) 82 (35.8)
 > $15,000 236 (20.0) 180 (18.9) 56 (24.5)
Coverage of the reference products related to FDA label < 0.001
 Not more restrictive 334 (28.3) 208 (21.9) 126 (55.0)
 More restrictive 847 (71.7) 744 (78.2) 103 (45.0)
Cost-effectiveness measure availability of the reference product 0.549
 Available 930 (78.8) 753 (79.1) 177 (77.3)
 Not available 251 (21.3) 199 (20.9) 52 (22.7)
Plan size 0.932
 National 487 (41.2) 392 (41.2) 95 (41.5)
 Regional 694 (58.8) 560 (58.8) 134 (58.5)
Pharmacy benefit manager 0.048
 Big Threea 559 (47.3) 464 (48.7) 95 (41.5)
 Others 622 (52.7) 488 (51.3) 134 (58.5)

Percentages may not add up to 100% due to rounding. T tests and chi-square tests assessed the difference in characteristics by coverage decisions

aBig Three included CVS Caremark, Express Scripts, and OptumRx