Background

Skyrizi is a humanized immunoglobulin (Ig)G monoclonal antibody.1 It binds to interleukin (IL) - 23, a naturally occurring cytokine involved in inflammatory and immune responses, that selectively binds to the p19 subunit of the IL - 23 cytokine and inhibits its interaction with the IL - 23 receptor.

Policy (Criteria)

Initial requests for Skyrizi induction may be approved if the following criteria are met:

1. Diagnosis of moderately to severely active Crohn's disease (CD)
2. One of the following:

• Frequent diarrhea and abdominal pain
• At least 10% weight loss
• Complications such as obstruction, fever, abdominal mass
• Abnormal lab values (e.g., C-reactive protein [CRP])
• CD Activity Index (CDAI) greater than 220 

3. Trial and failure, contraindication, or intolerance to one of the following conventional therapies:

• 6-mercaptopurine
• Azathioprine
• Methotrexate
• Corticosteroid (e.g., prednisone)

4. Will be administered as an intravenous induction dose

6. Prescribed by or in consultation with a gastroenterologist

DOSING: Induction: IV: 600 mg at weeks 0, 4, and 8.

Initial requests for Skyrizi induction may be approved if the following criteria are met:
 

1. Diagnosis of moderately to severely active ulcerative colitis
2. One of the following:

• Greater than 6 stools per day
• Frequent blood in the stools
• Frequent urgency
• Presence of ulcers
• Abnormal lab values (e.g., hemoglobin, erythrocyte sedimentation rate, C-reactive protein)
• Dependent on, or refractory to, corticosteroids

3. Trial and failure, contraindication, or intolerance to one of the following conventional therapies:

• 6-mercaptopurine
• Azathioprine
• Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
• Corticosteroid (e.g., prednisone) AND

4. Will be administered as an intravenous induction dose

5. Prescribed by or in consultation with a gastroenterologist

DOSING: Induction: IV: 1,200 mg at weeks 0, 4, and 8.

References

1.  Skyrizi™ [prescribing information]. North Chicago, IL: AbbVie, Inc.; April 2019.
2. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019 Feb 13. [Epub ahead of print].
3. Nast A, Gisondi P, Ormerod AD, et al. European S3-Guidelines on the systemic treatment of psoriasis vulgaris – Update 2015 – Short version – EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015;29(12):2277-2294.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2025 Forward