TABLE 1.

COA Availability by Drug Characteristics

Characteristic	Coverage decisions with COAs (n = 2,188)
≥1 FDA expedited review pathway, n (%)
Yes	989 (45.2)
No	1,199 (54.8)
Orphan designation, n (%)
Yes	885 (40.4)
No	1,303 (59.6)
Age indication, n (%)
Pediatric	540 (24.7)
Adult	1,648 (75.3)
Oncology indication, n (%)
Yes	381 (17.4)
No	1,807 (82.6)
Top 10 indications with decisions that included ≥1 COA, n (%)
Myasthenia gravis (n = 78)	70 (89.7)
Pulmonary arterial hypertension (n = 178)	155 (87.1)
Psoriasis (n = 367)	250 (68.1)
Duchenne muscular dystrophy (n = 82)	52 (63.4)
Neutropenia-myelosuppressive chemotherapy (n = 211)	75 (35.5)
Polyarticular juvenile idiopathic arthritis (n = 206)	53 (25.7)
Multiple sclerosis (n = 283)	64 (22.6)
Rheumatoid arthritis (n = 436)	92 (21.1)
Ulcerative colitis (n = 298)	60 (20.1)
Crohn disease (n = 298)	53 (17.8)

COA = clinical outcome assessment; FDA = US Food and Drug Administration.