Patient Support | SKYRIZI® (risankizumab-rzaa)

The IL-23 inhibitor from AbbVie indicated for the treatment of moderately to severely active Crohn's disease (CD) in adults.¹

AbbVie’s Commitment to Exceptional Access and Patient Support

Get Started With The Enrollment And Prescription Form

SKYRIZI COMPLETE helps patients access, start, and stay ON TRACK WITH their treatment

download the skyrizi complete enrollment & prescription form

Committed to Building Exceptional Access

If you have determined that SKYRIZI is the appropriate treatment, access could mean:

EXCEPTIONAL ACCESS

for eligible, commercial patients

STANDARD PRIOR AUTHORIZATION (PA) AND APPEAL PROCESSES

potential for one-time PA/appeal approval

SKYRIZI COMPLETE

SUPPORTING PATIENTS TOGETHER

Skyrizi Complete Offers 1-to-1 Support Throughout Every Stage of the Treatment Journey

ACCESS

Dedicated specialists to assist with timely and affordable access to treatment

START

1-to-1 support to ensure patients have the resources they need when they need them

STAY

Continued support and education to help patients along their journey

ENCOURAGE YOUR PATIENTS TO ENROLL IN

1-TO-1 SUPPORT

Nurse Ambassadors* and Insurance Specialists provide 1-to-1 support to help navigate insurance

AFFORDABILITY

Eligible commercially-insured patients may pay as little as $5 per dose on their prescription and can also be reimbursed for certain out-of-pocket costs related to IV administration, lab tests, and monitoring related to their SKYRIZI treatment.^†

ACCESS

No charge for eligible,
commercially insured patients
experiencing initial insurance
denial for up to 24 months^‡

STREAMLINED ENROLLMENT PROCESS

Get started with a single
enrollment form

*Nurse Ambassadors are provided by AbbVie and do not provide medical advice or work under the direction of the prescribing health care professional (HCP). They are trained to direct patients to speak with their HCP about any treatment-related questions, including further referrals.

Patients who are uninsured, or who are otherwise unable to pay for their medication, may be eligible for:

HOW TO ENROLL PATIENTS IN SKYRIZI COMPLETE

Help patients get the support they need to start and stay on track with their prescribed treatment plan.

Fill out the form with your patient

Sections 1-4 are required for enrollment into Complete. To request additional injection training support, fill out Sections 7 and 8.

Additional information required

Fill out the Site of Infusion Information in Section 6 and the Skyrizi Complete Prescription in Section 8b if you think your patient may experience an insurance access challenge.

Fax the form to Skyrizi Complete

Fax to 1‍.‍6‍7‍8‍.‍7‍2‍7‍.‍0‍6‍9‍0‍.

Inform your patient that they have been enrolled

Give your patient the SKYRIZI Getting Started Checklist to help them get personalized resources to stay on track. Tell them a Nurse Ambassador* will be calling, and the call may come from any area code.

GET STARTED WITH THE ENROLLMENT & PRESCRIPTION FORM

skyrizi complete enrollment & prescription form

COMPLETE APP

Track treatment

The Complete App is designed to help patients start and stay on track with their prescribed SKYRIZI treatment by helping them:

Access savings resources, including the Skyrizi Complete Savings Card and Skyrizi Complete Rebate
Log and keep track of treatments
Set customized medication reminders
Log and share symptoms with an HCP
Log medication lot number and medication expiration date

COMPLETEPRO.COM

Streamline the Rx process

CompletePro.com enables seamless enrollment in Skyrizi Complete and helps streamline the prescription process for your patients.

With CompletePro.com, you can help patients by:

Digitally enrolling patients into Skyrizi Complete, giving them access to important resources like a Nurse Ambassador*
Requesting medical and/or pharmacy benefit verifications and completing the PA
Sending prescriptions to the patient’s specialty pharmacy of choice with the option of including a savings card (if eligible)
Receiving alerts when a PA is going to expire and be informed of insurance changes in the new year
Using the Reimbursement Portal to submit, manage, and view claims for patient reimbursement for infused patients
Tracking where patients are in the prescription process

LEARN MORE ABOUT STREAMLINING THE PRESCRIPTION PROCESS WITH COMPLETE PRO:

Transcript

^†Eligibility: Available to patients with commercial insurance coverage for SKYRIZI^®(risankizumab-rzaa) who meet eligibility criteria. This co-pay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law. Offer subject to change or termination without notice. Restrictions, including monthly maximums, may apply. This is not health insurance. For full Terms and Conditions, visit www.SKYRIZICDSavingsCard.com or call 1.866.SKYRIZI for additional information. To learn about AbbVie's privacy practices and your privacy choices, visit https://privacy.abbvie.

^‡Eligibility criteria: Available to patients aged 63 or younger with commercial insurance coverage. Patients must have a valid prescription for SKYRIZI^® (risankizumab-rzaa) for an FDA approved indication and a denial of insurance coverage based on a prior authorization request on file along with a confirmation of appeal. For medical coverage, a pre-certification submission will be required. Continued eligibility for the program requires the submission of an appeal of the coverage denial every 180 days. Program provides for SKYRIZI^® (risankizumab-rzaa) at no charge to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier, and is not contingent on purchase requirements of any kind. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Offer subject to change or discontinuance without notice. This is not health insurance and program does not guarantee insurance coverage. No claims for payment may be submitted to any third party for product dispensed by program. Limitations may apply.

DO YOU KNOW ABOUT SKYRIZI'S
WELL-STUDIED SAFETY PROFILE?

EXPLORE SAFETY

HAVE YOU SEEN SKYRIZI'S
DOSING SCHEDULE?

REVIEW DOSING

	ADVANCE N=850
CO-PRIMARY ENDPOINTS	Endoscopic Response^a (>50% decrease in SES-CD) and Clinical Remission^b (CDAI <150) at Week 12
DURATION	12-week, randomized, double-blind, placebo-controlled, multi-center study
CONCOMITANT THERAPIES	All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, corticosteroids, and Crohn's-related antibiotics
DOSING	IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mg^c or placebo, at Weeks 0, 4, and 8
INCLUSION CRITERIA	Moderately to severely active CD: CDAI 220-450 Average daily SF ≥4 or APS ≥2 SES-CD ≥6 (≥4 for isolated ileitis), exluding the narrowing component 16-80 years old Bio-naïve^d or biologic failure^e

	MOTIVATE N=569
CO-PRIMARY ENDPOINTS	Endoscopic Response^a (>50% decrease in SES-CD) and Clinical Remission^b (CDAI <150) at Week 12
DURATION	12-week, randomized, double-blind, placebo-controlled, multi-center study
CONCOMITANT THERAPIES	All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, corticosteroids, and Crohn's-related antibiotics
DOSING	IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mg^c or placebo, at Weeks 0, 4, and 8
INCLUSION CRITERIA	Moderately to severely active CD: CDAI 220-450 Average daily SF ≥4 or APS ≥2 SES-CD ≥6 (≥4 for isolated ileitis), exluding the narrowing component 16-80 years old Biologic failure^e

	FORTIFY N=382
CO-PRIMARY ENDPOINTS	Endoscopic Response^a (>50% decrease in SES-CD) and Clinical Remission^b (CDAI <150) at Week 52
DURATION	52-week, randomized, double-blind, placebo-controlled, multi-center study
CONCOMITANT THERAPIES	All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, and Crohn's-related antibiotics Patients taking corticosteroids at the start of FORTIFY had their therapy tapered
DOSING	Subcutaneous injection of SKYRIZI 180 mg, SKYRIZI 360 mg or placebo starting at Week 12 and every 8 weeks after
INCLUSION CRITERIA	Moderately to severely active CD: Entry and completion of ADVANCE or MOTIVATE. Completion includes the final endoscopy of ADVANCE or MOTIVATE Achieved Clinical Response^f in ADVANCE or MOTIVATE studies

FORTIFY		Placebo (Induction Responder) N=130	SKYRIZI 180 mg SC N=135	SKYRIZI 360 mg SC N=117
BASELINE OF INDUCTION (ADVANCE, MOTIVATE)
	Male, n (%)	72 (55.4)	62 (45.9)	67 (57.3)
	Age (years), mean (SD)	38.0 (12.8)	39.2 (14.7)	36.2 (12.6)
	Disease duration (years), mean (SD)	9.6 (8.2)	10.6 (10.2)	8.6 (7.1)
	Baseline immunomodulatorimmuno- modulator use, n (%)	33 (25.4)	37 (27.4)	34 (29.1)
	Baseline steroid use, n (%)	40 (30.8)	47 (34.8)	36 (30.8)
	Biologics failure history
	0, n (%)	31 (23.8)	40 (29.6)	34 (29.1)
	1, n (%)	49 (37.7)	34 (25.2)	42 (35.9)
	>1, n (%)	50 (38.5)	61 (45.2)	41 (35.0)
	Baseline CDAI, mean (SD)	314.2 (64.2)	327.6 (68.2)	316.2 (59.6)
	Baseline SES-CD, mean (SD)	14.1 (7.1)	14.9 (7.2)	14.3 (7.0)
	Baseline SF, mean (SD)	5.8 (2.7)	6.2 (3.1)	5.9 (2.7)
	Baseline APS, mean (SD)	1.9 (0.5)	2.0 (0.4)	1.9 (0.5)
	Baseline FCP (mg/kg), median (min,max)	904.0 (30, 11378)	1666.0 (30, 28800)	1622.0 (30, 14649)
	Baseline hs-CRP (mg/L), median (min,max)	7.9 (0.3, 181)	8.7 (0.4, 151)	10.6 (0.3, 129)

Week 0 of Maintenance
	CDAI at Week 0, mean (SD)	111.6 (69.5)	117.6 (66.8)	125.4 (62.7)
	SES-CD at Week 0, mean (SD)	7.9 (6.4)	7.8 (6.4)	8.3 (7.3)
	SF at Week 0, mean (SD)	1.4 (1.7)	2.1 (1.9)	1.9 (1.7)
	APS at Week 0, mean (SD)	0.6 (0.5)	0.6 (0.5)	0.6 (0.5)
	FCP (mg/kg) at Week 0, median (min,max)	300.0 (30, 22912)	361 (30, 28800)	485.5 (30, 14804)
	hs-CRP (mg/L) at Week 0, median (min,max)	3.6 (0, 42)	3.7 (0, 48)	4.0 (0, 258)

AbbVie’s Commitment to Exceptional Access and Patient Support

Get Started With The Enrollment And Prescription Form

SKYRIZI COMPLETE helps patients access, start, and stay ON TRACK WITH their treatment

Committed to Building Exceptional Access

EXCEPTIONAL ACCESS

for eligible, commercial patients

STANDARD PRIOR AUTHORIZATION (PA) AND APPEAL PROCESSES

potential for one-time PA/appeal approval

SUPPORTING PATIENTS TOGETHER

ACCESS

START

STAY

ENCOURAGE YOUR PATIENTS TO ENROLL IN

1-TO-1 SUPPORT

AFFORDABILITY

ACCESS

STREAMLINED ENROLLMENT PROCESS

HOW TO ENROLL PATIENTS IN SKYRIZI COMPLETE

GET STARTED WITH THE ENROLLMENT & PRESCRIPTION FORM

COMPLETE APP

COMPLETEPRO.COM

LEARN MORE ABOUT STREAMLINING THE PRESCRIPTION PROCESS WITH COMPLETE PRO:

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

ADVANCE N=850

MOTIVATE N=569

FORTIFY N=382

ADVANCE

Placebo N=175

SKYRIZI 600 mg IV N=336

MOTIVATE

Placebo N=187

SKYRIZI 600 mg IV N=191

FORTIFY

Placebo (Induction Responder) N=130

SKYRIZI 180 mg SC N=135

SKYRIZI 360 mg SC N=117

FORTIFY

Placebo (Induction Responder) N=164

SKYRIZI 360mg SC N=141

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

ADVANCE
N=850

MOTIVATE
N=569

FORTIFY
N=382

Placebo
N=175

SKYRIZI 600 mg IV
N=336

Placebo
N=187

SKYRIZI 600 mg IV
N=191

Placebo
(Induction Responder)
N=130

SKYRIZI
180 mg SC
N=135

SKYRIZI
360 mg SC
N=117

Placebo (Induction Responder)
N=164

SKYRIZI 360mg SC
N=141

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹