Table 2.
Patient demographics and clinical characteristics during the baseline period
| Baseline characteristics | Multiple sclerosis patients | ||
|---|---|---|---|
| N = 1902 | |||
| Approved patients | Denied patients | p valuea | |
| (n = 1633) | (n = 269) | ||
| Demographics | |||
| Age, mean ± SD [median] | 48.0 ± 11.6 [48] | 47.2 ± 11.1 [47] | 0.42 |
| Gender, female | 1362 (83.4%) | 213 (79.2%) | 0.09 |
| Year of index date | |||
| 2015 | 299 (18.3%) | 23 (8.6%) | < 0.0001 |
| 2016 | 802 (49.1%) | 107 (39.8%) | < 0.01 |
| 2017 | 532 (32.6%) | 139 (51.7%) | < 0.0001 |
| Region | |||
| Midwest | 356 (21.8%) | 48 (17.8%) | 0.14 |
| Northeast | 345 (21.1%) | 58 (21.6%) | 0.87 |
| South | 766 (46.9%) | 125 (46.5%) | 0.89 |
| West | 163 (10.0%) | 38 (14.1%) | 0.04 |
| Unknown | 3 (0.2%) | 0 (0.0%) | 1.00 |
| Insurance plan typeb | |||
| Cash | 37 (2.3%) | 2 (0.7%) | 0.10 |
| Commercial | 108 (6.6%) | 53 (19.7%) | < 0.0001 |
| Medicaid | 129 (7.9%) | 27 (10.0%) | 0.24 |
| Medicare | 399 (24.4%) | 54 (20.1%) | 0.12 |
| PBM, pharmacy benefit manager | 173 (10.6%) | 40 (14.9%) | 0.04 |
| Other/unspecified | 802 (49.1%) | 104 (38.7%) | < 0.01 |
| Clinical characteristics | |||
| Charlson Comorbidity Index, mean ± SD [median] | 0.5 ± 1.1 [0] | 0.4 ± 1.0 [0] | 0.11 |
| Condition-specific comorbidities | |||
| Abnormality of gait | 312 (19.1%) | 41 (15.2%) | 0.13 |
| Fibromyalgia/myalgia and myositis | 136 (8.3%) | 17 (6.3%) | 0.26 |
| Hemiplegia or paraplegia | 110 (6.7%) | 9 (3.3%) | 0.03 |
| Mood disorder diagnoses | 454 (27.8%) | 65 (24.2%) | 0.21 |
| Optic neuritis | 112 (6.9%) | 19 (7.1%) | 0.90 |
| Other autoimmune diseases | |||
| Lupus | 36 (2.2%) | 5 (1.9%) | 0.72 |
| Nephrotic syndrome | 51 (3.1%) | 4 (1.5%) | 0.14 |
| Rheumatoid arthritis | 50 (3.1%) | 11 (4.1%) | 0.38 |
| Sarcoidosis | 19 (1.2%) | 3 (1.1%) | 1.00 |
| Proxies for disease severity, mean ± SD [median] | |||
| Days between diagnosis and index date | 25.0 ± 323.6 [19] | 80.3 ± 330.2 [18] | 0.83 |
| Patients with MS exacerbations | 1081 (66.2%) | 161 (59.9%) | 0.04 |
| Number of MS relapse diagnoses/exacerbations | 1.2 ± 2.2 [1] | 0.9 ± 1.2 [1] | 0.05 |
| Number of MS relapse diagnoses in inpatient setting | 0.6 ± 2.0 [0] | 0.4 ± 1.1 [0] | 0.67 |
| Mobility indicators | |||
| Overall | 277 (17.0%) | 31 (11.5%) | 0.02 |
| Cane/crutch | 16 (1.0%) | 2 (0.7%) | 1.00 |
| Dalfampridine (Ampyra) | 203 (12.4%) | 22 (8.2%) | 0.05 |
| Specialty bed | 8 (0.5%) | 1 (0.4%) | 1.00 |
| Walker | 45 (2.8%) | 5 (1.9%) | 0.39 |
| Wheelchair | 23 (1.4%) | 2 (0.7%) | 0.56 |
| EDSS-derived disability claims, mean ± SD [median] | 4.4 ± 6.4 [1] | 4.2 ± 6.9 [1] | 0.54 |
| Condition-specific healthcare resource utilization | |||
| Rehabilitation and physical therapy services | |||
| Patients with ≥ 1 rehab/physical therapy claim | 264 (16.2%) | 33 (12.3%) | 0.10 |
| Number of rehab/physical therapy claims | 23.5 ± 33.4 [11] | 14.0 ± 17.6 [8] | 0.21 |
| Corticosteroid (CS) | |||
| Patients with ≥ 1 CS | 893 (54.7%) | 155 (57.6%) | 0.37 |
| Number of CS claims, mean ± SD [median] | 1.6 ± 2.6 [1] | 1.6 ± 2.3 [1] | 0.46 |
| Annualized average daily dose (mg), mean ± SD [median] | 1.3 ± 3.6 [0] | 1.3 ± 2.9 [0] | 0.36 |
| Maximum CS dose (mg), mean ± SD [median] | 7.5 ± 11.2 [0] | 7.8 ± 11.1 [0] | 0.44 |
| Number of patients w/high dose (15 mg/day) CS use | 149 (9.1%) | 25 (9.3%) | 0.93 |
| DMARD use | |||
| Anti-TNF drugs | 4 (0.2%) | 0 (0.0%) | 1.00 |
| Mean ± SD no. of Rxs | 0.0 ± 0.4 [0] | 0.0 ± 0.0 [0] | 0.42 |
| Other biologics | 10 (0.6%) | 1 (0.4%) | 1.00 |
| Mean ± SD no. of Rxs | 4.9 ± 3.8 [4] | 2.0 ± . [2] | 0.44 |
| Methotrexate | 23 (1.4%) | 2 (0.7%) | 0.56 |
| Mean ± SD no. of Rxs | 3.9 ± 3.3 [3] | 8.5 ± 2.1 [9] | 0.10 |
| Other non-biologics | 68 (4.2%) | 9 (3.3%) | 0.53 |
| Mean ± SD no. of Rxs | 4.0 ± 3.4 [3] | 4.8 ± 3.5 [4] | 0.44 |
| MS-related treatments | |||
| Plasmapheresis | 9 (0.6%) | 0 (0.0%) | 0.62 |
| Intravenous immunoglobulin | 10 (0.6%) | 1 (0.4%) | 1.00 |
| Other disease-modifying therapy | 1006 (61.6%) | 130 (48.3%) | < 0.0001 |
| All-cause healthcare resource utilizationc | |||
| Medical | |||
| Inpatient | |||
| Patients with ≥ 1 visit | 380 (23.3%) | 60 (22.3%) | 0.73 |
| Visits per patient, mean ± SD [median] | 2.0 ± 1.8 [1] | 1.9 ± 1.6 [1] | 0.92 |
| Days per visit, mean ± SD [median] | 5.9 ± 7.8 [3] | 5.1 ± 5.8 [3] | 0.52 |
| Outpatient | |||
| Patients with ≥ 1 visit | 1526 (93.4%) | 252 (93.7%) | 0.89 |
| Visits per patient, mean ± SD [median] | 12.2 ± 12.2 [8] | 10.0 ± 9.5 [7] | 0.01 |
| Other place of setting | |||
| Patients with ≥ 1 visit | 879 (53.8%) | 131 (48.7%) | 0.12 |
| Visits per patient, mean ± SD [median] | 6.8 ± 17.5 [3] | 9.4 ± 30.8 [3] | 0.58 |
| Prescription, mean ± SD [median] | |||
| Total prescriptions filled per patient | 50.8 ± 44.8 [39] | 42.3 ± 39.5 [29] | < 0.01 |
| Unique prescriptions filled per patient | 18.2 ± 13.1 [16] | 15.8 ± 12.0 [13] | < 0.01 |
DMARD disease-modifying antirheumatic drug, TNF tumor necrosis factor, EDSS Expanded Disability Status Scale
aStatistical comparisons were conducted using the Wilcoxon rank-sum test for continuous variables and chi-square test for dichotomous variables
bOther/unspecified insurance plan type includes processors, third-party-administered insurance, and unspecified plan types
cThe Symphony data list all visits that are not inpatient or outpatient, or surgery as “other”