The IL-23 inhibitor from AbbVie indicated for the treatment of moderately to severely active Crohn's disease (CD) in adults.1
US-MULT-230356
US-MULT-230356
The IL-23 inhibitor from AbbVie indicated for the treatment of moderately to severely active Crohn's disease (CD) in adults.1
National Commercial Formulary Coverage as of May 2023
National Commercial Formulary Coverage as of May 2023
If you have determined that SKYRIZI is the appropriate treatment, access could mean:
SKYRIZI COMPLETE
Nurse Ambassadors‡ and Insurance Specialists provide 1-to-1 support to help navigate insurance
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.§
No charge for eligible,
commercially insured patients
experiencing initial insurance
denial for up to 24 months||
Utilize a single enrollment
form to enroll your patients
into Skyrizi Complete
‡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:
Skyrizi Complete Offers 1-to-1 Support Throughout Every Stage of the Treatment Experience
Dedicated specialists to assist with timely and affordable access to treatment
1-to-1 support to ensure patients have the resources they need when they need them
Continued support and education to help patients along their journey
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.
‡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.
Track treatment
The Complete App is designed to help patients start and stay on track with their prescribed SKYRIZI treatment by helping them:
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:
§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?
HAVE YOU SEEN SKYRIZI'S
DOSING SCHEDULE?
Indications
Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.
Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
Important Safety Information
Hypersensitivity Reactions
SKYRIZI® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately.
Infection
SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves.
Tuberculosis (TB)
Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB.
Hepatotoxicity in Treatment of Crohn’s Disease
Drug-induced liver injury was reported in a patient with Crohn’s disease who was hospitalized for a rash during induction dosing of SKYRIZI. For the treatment of Crohn’s disease, evaluate liver enzymes and bilirubin at baseline and during induction (12 weeks); monitor thereafter according to routine patient management. Consider an alternate treatment for patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct your patient to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
Administration of Vaccines
Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines.
Adverse Reactions
Most common (≥1%) adverse reactions associated with SKYRIZI in plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.
Most common (>3%) adverse reactions associated with SKYRIZI in Crohn’s disease are upper respiratory infections, headache, and arthralgia in induction and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection in maintenance.
Lipid Elevations: Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12 in patients treated with SKYRIZI in Crohn’s disease.
Dosage Forms and Strengths: SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, and a 600 mg/10 mL single-dose vial for intravenous infusion.
INDICATIONS
Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.
Please see Full Prescribing Information.
US-SKZG-220547
REFERENCES
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.
*As of January 2023.
†The total population in the ADVANCE and MOTIVATE studies includes patients dosed with risankizumab-rzaa 1200 mg IV, which did not demonstrate additional treatment benefit over the 600 mg dose and is not a recommended regimen.
aThe bio-naïve subpopulation includes patients who were bio‑exposed but did not have an inadequate response, loss of response, or intolerance to biologics (13%).
bPrior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
cThe bio-naïve subpopulation includes patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (8%).
dClinical response was defined as a reduction of CDAI score ≥100 points from baseline.
CO-PRIMARY
ENDPOINTS
Endoscopic Responsea (>50% decrease in SES-CD) and Clinical Remissionb (CDAI <150) at Week 12
Endoscopic Responsea (>50% decrease in SES-CD) and Clinical Remissionb (CDAI <150) at Week 12
Endoscopic Responsea (>50% decrease in SES-CD) and Clinical Remissionb (CDAI <150) at Week 52
DURATION
12-week, randomized, double-blind, placebo-controlled, multi-center study
12-week, randomized, double-blind, placebo-controlled, multi-center study
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, corticosteroids, and Crohn's-related antibiotics
All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, corticosteroids, and Crohn's-related antibiotics
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
IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mgc or placebo at Weeks 0, 4, and 8
IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mgc or placebo at Weeks 0, 4, and 8
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:
Moderately to severely active CD:
Moderately to severely active CD:
| ADVANCE N=850 |
|
|---|---|
| CO-PRIMARY ENDPOINTS |
Endoscopic Responsea (>50% decrease in SES-CD) and Clinical Remissionb (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 mgc or placebo, at Weeks 0, 4, and 8 |
| INCLUSION CRITERIA |
Moderately to severely active CD:
|
| MOTIVATE N=569 |
|
|---|---|
| CO-PRIMARY ENDPOINTS |
Endoscopic Responsea (>50% decrease in SES-CD) and Clinical Remissionb (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 mgc or placebo, at Weeks 0, 4, and 8 |
| INCLUSION CRITERIA |
Moderately to severely active CD:
|
| FORTIFY N=382 |
|
|---|---|
| CO-PRIMARY ENDPOINTS |
Endoscopic Responsea (>50% decrease in SES-CD) and Clinical Remissionb (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:
|
aEndoscopic response was defined as a decrease in SES-CD >50% from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease, based on central reading. The sections evaluated on endoscopy are the: rectum, sigmoid and left colon, transverse colon, right colon and ileum (per SES-CD assessment).
bClinical remission was defined as a CDAI score <150 points.
cThe 1200 mg IV induction dose did not demonstrate additional treatment benefit over the 600 mg IV dose and is not a recommended regimen.
dThe bio-naïve subpopulation includes patients who were bio‑exposed but did not have an inadequate response, loss of response, or intolerance to biologics (13%).
ePrior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
fClinical response was defined as a reduction of CDAI score ≥100 points from baseline.
APS=abdominal pain score; CD=Crohn's disease; CDAI=Crohn’s disease activity index; IV=intravenous; SC=subcutaneous; SES-CD=simple endoscopic score for Crohn’s disease; SF=stool frequency
References
US-SKZG-230070
Male, n (%)
88
(50)
189
(56)
Age (years),
mean (SD)
37.1
(13.4)
38.3
(13.3)
Disease duration
(years), mean (SD)
8.2
(7.1)
9.0
(8.8)
hs-CRP (mg/L),
median (IQR)
8.4
(2.8-21.9)
7.3
(2.8-21.8)
CDAI, mean (SD)
319.2
(59.4)
311.2
(62.4)
SES-CD, mean (SD)
13.8
(6.8)
14.7
(7.7)
Corticosteroid
use, n (%)
50
(29)
102
(30)
Biologics failure
history
0, n (%)
78
(45)
141
(42)
1, n (%)
41
(23)
100
(30)
>1, n (%)
56
(32)
95
(28)
Male, n (%)
99
(53)
92
(48)
Age (years),
mean (SD)
39.3
(13.5)
40.2
(13.6)
Disease duration
(years), mean (SD)
12.5
(9.7)
10.9
(7.7)
hs-CRP (mg/L),
median (IQR)
9.4
(3.6-28.2)
9.3
(3.5-23.0)
CDAI, mean (SD)
319.6
(69.8)
310.7
(63.6)
SES-CD, mean (SD)
15.0
(8.1)
14.4
(7.6)
Corticosteroid
use, n (%)
68
(36)
65
(34)
Biologics failure
history
0, n (%)
0
0
1, n (%)
88
(47)
92
(48)
>1, n (%)
99
(53)
99
(52)
FORTIFY |
Placebo
|
SKYRIZI
|
SKYRIZI
|
|
|---|---|---|---|---|
| BASELINE OF INDUCTION (ADVANCE, MOTIVATE) | ||||
Male, |
72 |
62 |
67 |
|
Age (years), |
38.0 |
39.2 |
36.2 |
|
Disease |
9.6 |
10.6 |
8.6 |
|
Baseline |
33 |
37 |
34 |
|
Baseline |
40 |
47 |
36 |
|
Biologics |
||||
0, n (%) |
31 |
40 |
34 |
|
1, n (%) |
49 |
34 |
42 |
|
>1, n (%) |
50 |
61 |
41 |
|
Baseline |
314.2 |
327.6 |
316.2 |
|
Baseline |
14.1 |
14.9 |
14.3 |
|
Baseline |
5.8 |
6.2 |
5.9 |
|
Baseline |
1.9 |
2.0 |
1.9 |
|
Baseline FCP (mg/kg), |
904.0 |
1666.0 |
1622.0 |
|
Baseline |
7.9 |
8.7 |
10.6 |
|
| Week 0 of Maintenance | ||||
CDAI at |
111.6 |
117.6 |
125.4 |
|
SES-CD at |
7.9 |
7.8 |
8.3 |
|
SF at |
1.4 |
2.1 |
1.9 |
|
APS at |
0.6 |
0.6 |
0.6 |
|
FCP at Week 0 (mg/kg), |
300.0 |
361 |
485.5 |
|
hs-CRP at Week 0 (mg/L), |
3.6 |
3.7 |
4.0 |
|
Disease duration (years), mean (SD)
9.6 (8.8)
9.3 (8.1)
Baseline immunomodulator use, n (%)
40 (24.4)
40 (28.4)
Baseline steroid use, n (%)
51 (31.1)
42 (29.8)
Biologics failure history
0, n (%)
41 (25.0)
39 (27.7)
1, n (%)
60 (36.6)
51 (36.2)
>1, n (%)
63 (38.4)
51 (36.2)
Baseline CDAI, mean (SD)
307.4 (64.9)
308.9 (61.1)
Baseline SES-CD, mean (SD)
14.0 (7.1)
14.3 (7.4)
Baseline SF, mean (SD)
5.8 (2.7)
5.9 (2.6)
Baseline APS, mean (SD)
1.9 (0.5)
1.8 (0.5)
Baseline FCP, median (min,max)
794.5
(30, 11378)
1543.0
(30, 14649)
Baseline hs-CRP, median (min,max) (mg/L)
7.6
(0.3, 181)
10.1
(0.3, 129)
CDAI at Week 0, mean (SD)
133.6 (80.6)
137.2 (67.7)
SES-CD at Week 0, mean (SD)
7.6
(0.3, 181)
8.5 (7.3)
SF at Week 0, mean (SD)
1.8 (1.8)
2.1 (1.8)
APS at Week 0, mean (SD)
0.7 (0.6)
0.7 (0.6)
FCP at Week 0, median (min,max) (mg/kg)
307
(30, 28013)
424
(30, 14804)
hs-CRP at Week 0, median (min,max) (mg/L)
4.1
(0.2, 53.4)
3.9
(0.2, 258)
Includes randomized subjects who received at least one dose of study drug, who had baseline eligible SES-CD ≥6 (≥4 for isolated ileal disease), and who received 12-week SKYRIZI IV treatment.
APS=abdominal pain score; CDAI=Crohn’s disease activity index; FCP=fecal calprotectin; hs-CRP=high-sensitivity C-reactive protein; IQR=interquartile range; IV=intravenous; SC=subcutaneous; SD=standard deviation; SES-CD=simple endoscopic score for Crohn’s disease; SF=stool frequency
References
US-SKZG-230070
Intention-to-treat 1A population, Non-responder imputation - COVID-19
Data Limitations: Data was not multiplicity controlled, and not powered to demonstrate statistical difference in treatment effect for SKYRIZI vs placebo (induction responders). No statistical or clinical conclusions can be made.
Clinical Remission: Defined as a CDAI score <150 points.
Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100)* to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.
*Clinical response was defined as a reduction of CDAI score ≥100 points from baseline.
CDAI=Crohn's disease activity index
REFERENCE
US-SKZD-210908