SKYRIZI COMPLETE ENROLLMENT
Rheumatology
Moderate to Severe
Rheumatoid Arthritis
Active
Psoriatic Arthritis
Active
Ankylosing Spondylitis
Moderate to Severe
Juvenile Idiopathic Arthritis
Non-Infectious
Intermediate, Posterior and Panuveitis
Dermatology
Moderate to Severe
Chronic Plaque Psoriasis
Active
Psoriatic Arthritis
Moderate to Severe
Hidradenitis Suppurativa
Gastroenterology
Moderate to Severe
Crohn's Disease
Moderate to Severe
Pediatric Crohn's Disease
Moderate to Severe
Ulcerative Colitis
Moderate to Severe
Pediatric Ulcerative Colitis
Ophthalmology
Non-Infectious
Intermediate, Posterior and Panuveitis
US-MULT-200777
Resources for
Patient Access and support
YOUR SOURCE FOR SUPPORT
TO GET PATIENTS TIMELY ACCESS TO SKYRIZI
Ready to enroll your patient in Skyrizi Complete and start the process?
BILLING AND CODING
Clear guidance on billing and coding for SKYRIZI, including new NDC codes.
ACCESS AND REIMBURSEMENT
Forms and instructions to help patients with access and coverage.
SPECIALTY PHARMACIES
Contact details for specialty pharmacies
This information is for informational purposes only and is not intended to provide reimbursement or legal advice. The information presented here does not guarantee payment or coverage.
SKYRIZI COMPLETE ENROLLMENT AND PRESCRIPTION FORM
- Download and fill out the Skyrizi Complete Enrollment and Prescription form with your patient
- After submitting the form via fax, your patient will receive a call from a Nurse Ambassador*
- You may also complete the Pharmacy Prescription Form and fax it to your patient's specialty pharmacy
ACCESS GUIDE
Get helpful access information for new SKYRIZI patients, including information on Access Specialists, Dosing, and Skyrizi Complete Enrollment and Prescription forms.
PRIOR AUTHORIZATION INSTRUCTIONS
Follow this helpful checklist to request coverage of SKYRIZI.
*Nurse Ambassadors are provided by AbbVie and do not provide medical advice or work under the direction of the prescribing healthcare professional (HCP). They are trained to direct patients to speak with their HCP about any treatment-related questions, including further referrals.
GUIDE TO BILLING AND CODING
Your guide to relevent codes (including commercial and Medicare) as well as helpful tips for completing forms.
NDC CODES
NEW SKYRIZI
Pen
150 mg/mL
0074-2100-01
Carton of 1
NEW SKYRIZI
Prefilled Syringe
150 mg/mL
0074-1050-01
Carton of 1
SKYRIZI
Prefilled Syringe
75 mg/0.83 mL†
0074-2042-02
Carton of 2
†With the approval and availibility of the single 150 mg/mL injection, SKYRIZI will be unavailable as two 75 mg/0.83 mL prefilled syringes by the end of 2021.
Along with support from Skyrizi Complete, you can use the forms here to help patients with access and coverage for SKYRIZI.
APPEALS LETTER SAMPLE
Appeal a denied claim for SKYRIZI.
TEMPLATE
FORMULARY EXCEPTION LETTER
Request a formulary exception to allow coverage for SKYRIZI.
TEMPLATE
HIPAA AUTHORIZATION
Allow patients to authorize the release of health information related to their treatment with SKYRIZI.
TEMPLATE
CONTACT DETAILS FOR SPECIALTY PHARMACIES
A complete list of specialty pharmacies that provide product-specific support for SKYRIZI.
Use these guides and best practices to help
get patients timely access to SKYRIZI
SKYRIZI ONBOARDING
ADDITIONAL RESOURCES
INJECTION SUPPPORT VIDEOS
Injection Training Quick Tips
The resources on this page are provided for informational purposes only and are not intended as reimbursement or legal advice. The information presented here does not guarantee payment or coverage.
SKYRIZI COMPLETE ENROLLMENT AND PRESCRIPTION FORM
Download and fill out the Skyrizi Complete Enrollment and Prescription form with your patient. After submitting the form via fax, your patient will receive a call from a Nurse Ambassador.* You may also complete the Pharmacy Prescription Form and fax it to your patient's specialty pharmacy.
*Nurse Ambassadors are provided by AbbVie and do not provide medical advice or work under the direction of the prescribing healthcare professional (HCP). They are trained to direct patients to speak with their HCP about any treatment-related questions, including further referrals.
Resource dumped by HtmlRenderer
Resource path: /content/risahcp/en-us/support-and-resources/resources/resources-tab-2/jcr:content/contentpar/container_copy/containerparsys/container_240257867/containerparsys/container
Resource metadata: {sling.modificationTime=-1, sling.characterEncoding=null, sling.parameterMap={}, sling.contentType=null, sling.creationTime=-1, sling.contentLength=-1, sling.resolutionPath=/content/risahcp/en-us/support-and-resources/resources/resources-tab-2/jcr:content/contentpar/container_copy/containerparsys/container_240257867/containerparsys/container}
Resource type: nt:unstructured
Resource super type: -
Resource properties
jcr:primaryType: nt:unstructured
BENEFITS VERIFICATION CHART
Help patients confirm their insurance coverage and out-of-pocket costs.
INSURANCE COMPARISON
Simple steps to help patients choose their insurance coverage when it's time to pick a plan.
PATIENT BROCHURE
Prepare patients for treatment with SKYRIZI with information on plaque psoriasis, SKYRIZI efficacy, and more.
PASI SCORE CALCULATOR
Allows patients to enter the locations and severity of their symptoms and produce their current PASI score.
AAD RECOMMENDATIONS FOR TELEMEDICINE PREPAREDNESS
Tips for meeting with a dermatologist via phone or video chat from the American Academy of Dermatology Association.
A patient-friendly video with instructions on the full process of injecting SKYRIZI.
A quick-tip guide for patients on how to inject, whether they have injected before or are new to it.
150 mg/mL SKYRIZI PEN
150 mg/mL PREFILLED SYRINGE
looking for more resources?Offer enrollment to patients and submit forms
electronically with CompletePro.com
By registering through CompletePro.com, you can choose the
capabilities that are most relevant to you and your patients’ needs, such as:
Instant benefits verification:
- Patient out-of-pocket costs
- Any prior authorization requirements
- Pharmacy options available to the patient
- Patient eligibility for any drug discount from the pharmaceutical company
Online prescribing efficiencies:
- Complete a Prior Authorization and send it directly to the insurer
- Send a prescription directly to the patient's chosen pharmacy
- Send Skyrizi Complete Savings Card to your patient's preferred specialty pharmacy (with or without a prescription)
- Be notified via text, e-mail, or website in advance of patient's prior authorization expiration
- Easily access each patient's prescription fill status
Have you transitioned your patients?
Offer your patients the new 150 mg/mL
SKYRIZI Pen or 150 mg/mL prefilled syringe1
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
Indication
SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Important Safety Information
Infection
SKYRIZI® (risankizumab-rzaa) 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.
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 include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
SKYRIZI is available in a 150 mg/mL prefilled syringe and pen.
Please see Full Prescribing Information.
US-SKZD-210127
REFERENCE
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
STUDY DESIGN – IMMvent9
IMMvent was a phase 3, randomized, double-blind, double-dummy, active-controlled study to evaluate the efficacy and safety of SKYRIZI (150 mg) compared to HUMIRA® (adalimumab) in adult patients with moderate to severe plaque psoriasis over 44 weeks.
Patients treated with adalimumab during Part A:
- Non-responders (PASI <50) at Week 16 (n=38) were treated with SKYRIZI during Part B
- PASI 90 responders at Week 16 (n=144) continued treatment with adalimumab during Part B
- PASI 50 to <PASI 90 were re-randomized to either continue adalimumab or switch to SKYRIZI
Part A
In the first phase, patients were randomized 1:1 to either SKYRIZI (150 mg), given as a subcutaneous injection at Weeks 0 and 4 and every 12 weeks thereafter or HUMIRA, given as a subcutaneous injection, with an initial dose of 80 mg followed by 40 mg every other week starting 1 week after the initial dose over 44 weeks.
The Part A co-primary endpoints were
- PASI 90 and sPGA 0/1 at Week 16 compared to HUMIRA
Part B
Patients originally randomized to SKYRIZI received it throughout the study (Parts A & B). Among patients originally randomized to receive HUMIRA, those with a PASI 50 but less than PASI 90 response were re-randomized 1:1 to switch to SKYRIZI or continue HUMIRA.
The Part B primary endpoint was
- PASI 90 at Week 44 among those with PASI 50 to <90 after 16 weeks of adalimumab treatment
Key secondary endpoints included
- PASI 100 at Week 16
- PASI 100 at Week 44 for patients who were re-randomized at Week 16
Key inclusion criteria
- ≥18 years of age
- Diagnosis of chronic plaque psoriasis ≥6 months before Week 0
- Stable moderate to severe chronic plaque psoriasis based on ≥10% body surface area, with a PASI score ≥12, and an sPGA score ≥3
- Eligible for adalimumab therapy in accordance with local labels
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
Q2W=Once every 2 weeks
sPGA=static Physician's Global Assessment
Click to see HUMIRA® (adalimumab) Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
Q2W=Once every 2 weeks
sPGA=static Physician's Global Assessment
SELECTED BASELINE CHARACTERISTICS9,14
ADA=Adalimumab
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
US-SKZD-200400
STUDY DESIGN – IMMhance1,10
IMMhance was a phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the impact of treatment withdrawal and re-treatment of SKYRIZI compared to placebo in adult patients with moderate to severe plaque psoriasis.
Part A
In the first phase, patients were randomized 4:1 to SKYRIZI (150 mg), given as a subcutaneous injection at baseline, 4 weeks later, and every 12 weeks thereafter, or placebo.
The Part A co-primary endpoints were
- PASI 90 and sPGA 0/1 at Week 16
Part B
In the second phase of this study (Week 28 through Week 104), patients originally randomized to SKYRIZI who achieved sPGA 0/1 at Week 28 were re-randomized (1:2) to SKYRIZI (maintenance) or placebo (withdrawal). Beginning at Week 32, patients with sPGA ≥2 continued on SKYRIZI (150 mg) once every 12 weeks up to Week 88, with a final follow-up at Week 104.
The Part B primary endpoint was
- Percentage of patients with an sPGA 0/1 at 1 year
Key inclusion criteria
- ≥18 years of age
- Diagnosis of chronic moderate to severe plaque psoriasis ≥6 months before Week 0
- Stable plaque psoriasis based on ≥10% body surface area, with a PASI score ≥12 and an sPGA score ≥3
- Eligible for systemic therapy or phototherapy
Key secondary endpoints included
- PASI 75 at Week 16
- PASI 100 at Week 16
- sPGA 0 at Week 16
- DLQI 0/1 at Week 16
DLQI=Dermatology Life Quality Index
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 75=≥75% improvement in Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
Q12W=Once every 12 weeks
sPGA=static Physician's Global Assessment
SELECTED BASELINE CHARACTERISTICS10
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PBO=Placebo
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
aStratification factors at randomization.
US-SKZD-200400
STUDY DESIGN – UltIMMa-1 and UltIMMa-21,2
UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis. SKYRIZI (150 mg) was given as 2 subcutaneous injections at Weeks 0, 4, 16, 28, and 40. Patients were randomized 3:1:1 to receive SKYRIZI, ustekinumab, or placebo. At Week 16, patients on placebo were switched to SKYRIZI.
Active Comparator
The active comparator (ustekinumab) used for these studies was sourced from the European Union.
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
The co-primary endpoints were
- Percentage of patients with at least a 90% improvement in the PASI score (PASI 90) at Week 16 compared to placebo
- Percentage of patients with an sPGA score of clear or almost clear (0/1) at Week 16 compared to placebo
Key secondary endpoints included
- PASI 90 and PASI 100 at Week 52 compared to ustekinumab
Key inclusion criteria
- ≥18 years of age
- Stable (≥6 months) moderate to severe chronic plaque psoriasis, with or without psoriatic arthritis
- ≥10% body surface area, with a PASI score ≥12, and an sPGA score ≥3
- Eligible for systemic therapy or phototherapy and ustekinumab therapy in accordance with local labels
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
SELECTED BASELINE CHARACTERISTICS2
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PBO=Placebo
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
UST=Ustekinumab
aStratification factors at randomization.
US-SKZD-200400