Skyrizi (risankizumab-rzaa) coverage and prior authorization policy
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Defines clinical criteria, documentation, prescriber specialties, approval durations, continuation criteria, TB screening, quantity limits, dosing/admin guidance, and billing codes for risankizumab (Skyrizi) for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis for Wellmark Blue Cross and Blue Shield - Iowa.
Policy reviewed April 2026 with current effective date June 4, 2026; prior revision April 2025.
Coverage Summary
This policy ensures appropriate selection of patients for risankizumab (Skyrizi) based on FDA labeling, clinical guidelines, and clinical studies. It applies to the FDA-approved indications: moderate-to-severe plaque psoriasis (PsO) in adults who are candidates for systemic therapy or phototherapy, active psoriatic arthritis (PsA) in adults, moderately to severely active Crohn's disease (CD) in adults, and moderately to severely active ulcerative colitis (UC) in adults.
Initial approvals must be by or in consultation with the required specialty (see prescriber specialty requirement). The policy includes indication-specific initiation and 12-month continuation criteria, documentation and TB-screening requirements (negative TST or IGRA within 12 months for biologic/targeted synthetic–naïve persons), dosing/quantity limits, and billing guidance. The overall coverage stance is covered_with_criteria and prior authorization is required with supporting documentation and adherence to the listed quantity limits and J-code billing (J2327).
Initial Therapy Criteria (by indication)
FDA-Approved Indications - General
Covered when ALL of the following are met:
ALL of the following
- Member has a diagnosis that is an FDA‑approved indication for risankizumab (Skyrizi): moderate‑to‑severe plaque psoriasis (PsO), active psoriatic arthritis (PsA), moderately to severely active Crohn's disease (CD), or moderately to severely active ulcerative colitis (UC).
- Member has no contract exclusions to the requested therapy (member benefits must be verified).
Operational: Benefit coverage and exclusions determined by contract at time of service.
- For members naïve to biologic or targeted synthetic therapies associated with increased TB risk, documentation of a negative tuberculosis (TB) screening test (TST or IGRA) within 12 months prior to initiation, or documentation of appropriate evaluation/treatment if TB screening is positive.
- Member will not use risankizumab concomitantly with any other biologic drug or targeted synthetic drug for the same indication.
B) Initial Authorization - Psoriatic Arthritis (PsA)
Initial authorization — covered when ALL of the following are met for psoriatic arthritis:
ALL of the following
- Member has a diagnosis of active psoriatic arthritis (adult).
- Prescriber is a rheumatologist or dermatologist (initial approvals only).
ANY of the following
Mild to moderate disease — and one of the following:
- Member has had an inadequate response to a conventional synthetic disease‑modifying antirheumatic drug (csDMARD) such as methotrexate, leflunomide, or sulfasalazine given at adequate dose/duration.
- Member has intolerance or contraindication to methotrexate, leflunomide, or another csDMARD (see Appendix).
- Member has enthesitis.
- Member has severe disease.
C) Initial Authorization - Crohn's Disease (CD)
Initial authorization — covered when ALL of the following are met for Crohn's disease:
ALL of the following
- Member has a diagnosis of moderately to severely active Crohn's disease (adult).
- Prescriber is a gastroenterologist (initial approvals only).
- Request is for treatment of moderately to severely active disease consistent with the FDA‑approved indication.
D) Initial Authorization - Ulcerative Colitis (UC)
Initial authorization — covered when ALL of the following are met for ulcerative colitis:
ALL of the following
- Member has a diagnosis of moderately to severely active ulcerative colitis (adult).
- Prescriber is a gastroenterologist (initial approvals only).
- Request is for treatment of moderately to severely active disease consistent with the FDA‑approved indication.
Continuation / Renewal Criteria - All Indications
Continuation / renewal criteria — covered when ALL of the following are met (by indication):
ALL of the following
Plaque Psoriasis — renewal requires ONE of:
- Documentation of reduction in body surface area (BSA) affected from baseline.
- Documentation of improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning, cracking, pain).
Psoriatic Arthritis — renewal requires improvement in any of:
- Number of swollen joints.
- Number of tender joints.
- Dactylitis.
- Enthesitis.
- Axial disease.
- Skin and/or nail involvement.
- Functional status.
- C‑reactive protein (CRP).
Crohn's Disease — renewal requires ONE of:
- Documentation of remission (clinical and/or objective).
- Documentation of maintenance or improvement in signs and symptoms or disease activity scores (e.g., CDAI), stool/body‑weight/hematocrit/appearance on imaging or endoscopy, or other objective markers.
Ulcerative Colitis — renewal requires ONE of:
- Documentation of remission (clinical and/or endoscopic).
- Documentation of maintenance or improvement in signs and symptoms or objective markers such as stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on disease activity scoring tools (e.g., UCEIS, Mayo score).
- For all continuation requests: prescriber documentation (chart notes) supporting positive clinical response or maintenance of remission compared to baseline.
- Quantity and dosing must be consistent with FDA‑approved labeling and the policy quantity limits.
Other Denial Clause
Other denial clause and additional requirements:
ALL of the following
- Skyrizi (risankizumab‑rzaa) is considered not medically necessary if the member does not meet the criteria set forth in this policy.
- Members receiving samples or assistance program supply must meet initial approval criteria to receive coverage.
- For members naïve to biologic/targeted synthetic therapies, a negative TB test within 12 months is required prior to initiation; if TB screening is positive, further evaluation to exclude active TB and treatment of latent TB must be completed before starting therapy.
- Prior authorization decisions may include dosing limits and quantity limits per the policy (see Dosage, Administration, and Quantity Limits sections).
Continuation / Renewal Criteria (by indication)
Provider Actions: Documentation, Prescriber Requirements, and Billing Rules
Prior authorization required
Submit required documentation (chart notes, medical records, claims history) per indication to initiate prior authorization review. Initial approvals must be prescribed by or in consultation with the specified specialist for the indication (dermatologist for plaque psoriasis; rheumatologist or dermatologist for psoriatic arthritis; gastroenterologist for Crohn's disease and ulcerative colitis).
TB screening documentation
Provide documentation of a negative tuberculosis test (either TST or IGRA) within 12 months prior to initiating therapy for biologic/targeted synthetic-naïve members. If the TB test is positive, submit further testing to exclude active TB (e.g., chest x-ray) and documentation that latent TB treatment was started prior to initiating the requested medication.
Quantity limits and dosing constraints
Adhere to indicated quantity limits and dosing constraints per indication:
- Plaque psoriasis & PsA initiation: 2 kits (4 x 75 mg syringes) per first 28 days OR 2 x 150 mg syringes per first 28 days.
- Plaque psoriasis & PsA maintenance: 1 kit (2 x 75 mg syringes) per 84 days OR 1 x 150 mg syringe per 84 days.
- Crohn's disease initiation: 3 vials (600 mg per vial) per lifetime.
- Crohn's disease maintenance: 1 prefilled cartridge (360 mg/2.4 mL) per 56 days.
- Ulcerative colitis initiation: 6 vials (600 mg per vial) per lifetime.
- Ulcerative colitis maintenance: 1 prefilled cartridge (360 mg/2.4 mL) per 56 days.
Clinical response for continuation
For renewals, submit objective documentation demonstrating clinical improvement or remission as defined for the indication. Acceptable objective measures include (but are not limited to): reduction in BSA or improvement in signs/symptoms for plaque psoriasis; number of swollen/tender joints, dactylitis, enthesitis, axial disease, skin/nail involvement, functional status, or CRP for psoriatic arthritis; endoscopic mucosal appearance, CDAI or other disease activity tools, weight, hematocrit, abdominal findings for Crohn’s disease; and stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, endoscopic appearance, UCEIS or Mayo score for ulcerative colitis.
Prescriber Specialty Requirement (initial approvals only): initial prescriptions must be by or in consultation with the indicated specialist: for plaque psoriasis the prescriber must be a dermatologist; for psoriatic arthritis the prescriber must be a rheumatologist or dermatologist; and for Crohn's disease and ulcerative colitis the prescriber must be a gastroenterologist.
Applicable Codes
| J2327 | Skyrizi Injection, risankizumab-rzaa, intravenous, 1 mg |
Unproven / Exclusions
Background and Clinical Evidence
This policy is intended to ensure appropriate selection of patients for Skyrizi (risankizumab-rzaa) therapy based on product labeling, clinical guidelines, and clinical studies and applies to the FDA-approved indications for PsO, PsA, CD, and UC.
Definitions: BSA = Body Surface Area; TST = Tuberculosis skin test; IGRA = Interferon-gamma release assay.
Primary evidence sources cited in the policy include the Skyrizi package insert (AbbVie; June 2024), key clinical trials such as the UltIMMa-1 and UltIMMa-2 phase 3 trials for plaque psoriasis, and guideline organizations and publications referenced (examples: AAD-NPF, GRAPPA, ACG, AGA, EULAR guidance documents and relevant trials for inflammatory bowel disease and psoriatic disease).
Revision History
Policy current effective date set to June 4, 2026; reflects a non-material administrative update following April 2026 review.
Policy reviewed April 2026; document indicates review with no explicit new clinical policy statement (non-material administrative update).
Prior revision recorded April 2025 as part of the policy's revision history.
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