Mandated step therapy for dupilumab delays the inevitable

Figures & data

Table 1. Demographic characteristics and treatment timeline comparison between patients with and without step therapy mandates to obtain dupilumab coverage.

	Step therapy mandates	WITHOUT step therapy mandates	P-value
Age, Mean ± SD (n)	31.9 ± 21.7 (114)	39.1 ± 26.3 (332)	.008
0–5 years	8	19
6–11 years	15	43
12–17 years	14	43
18–64 years	69	145
65–100 years	8	82
Sex, n (%)			.94
Male	52 (45.6)	167 (50.3)
Female	62 (54.3)	165 (49.6)
Race, n (%)			.46
White/Caucasian	63 (55.3)	232 (69.8)
Black/African American	36 (31.5)	67 (20.2)
Asian	4 (3.5)	12 (3.6)
Native American	0 (0)	1 (0.3)
Other	11 (9.6)	20 (6.0)
Ethnicity, n (%)			.99
Non-Hispanic	5 (4.4)	17 (5.1)
Hispanic	109 (95.6)	315 (94.9)
Insurance provider % (n)			.0000003
Medicaid	54.0% (61/113)	20.4% (66/323)
Private	34.5% (39/113)	46.7% (151/323)
Medicare	10.6% (12/113)	29.1% (94/323)
Other	0.9% (1/113)	3.7% (12/323)
Mandate- related therapy delays ± SD (n)
Step Therapy delay, months	4.6 ± 4.99 (74)	0 ± 0 (281)	<.001
Step Therapy delay, appointments	1.4 ± 1.96 (74)	0 ± 0 (281)	<.001
Time between initial presentation and symptomatic improvement, days	693 ± 544 (92)	581 ± 448 (295)	.048
Appointments before symptomatic improvement once dupilumab initiated	6.0 ± 3.25 (92)	5.6 ± 3.76 (295)	.403

Table 2. General characteristics of cohort step therapy mandates.

Among patients with mandated step therapy	(N)	%
Therapy mandated
Topical calcineurin inhibitor	74	64.9
Systemic immunosuppressant	38	33.3
Topical phosphodiesterase-4 inhibitor*	17	14.9
Topical corticosteroid	12	10.5
Phototherapy	10	8.77
Oral corticosteroid	2	1.75
Number of steps mandated
1	77	67.5
2	34	29.8
3	3	2.6
Patients that eventually started dupilumab	74	64.9
Reasons for not starting dupilumab despite completing step requirements
Insurance denial	30	75
Patient did not desire	5	12.5
Copay cost	3	7.5
Age restriction	2	5

*Crisaborole was the topical phosphodiesterase-4 inhibitor used as this was the only approved molecule for AD within this category at the time that the study was conducted.