ModifiedCignaPolicy IP0670

Skyrizi Subcutaneous Prior Authorization Policy

Defines Cigna's prior authorization, coverage criteria, and limitations for Skyrizi subcutaneous for inflammatory conditions (Crohn's disease, plaque psoriasis, psoriatic arthritis, ulcerative colitis) for applicable benefit plans administered by Cigna.

Policy Summary

PayerCigna

PolicySkyrizi Subcutaneous Prior Authorization Policy

Policy CodePolicy IP0670

Change TypeSelected revisions and updates through 03/15/2026

Effective DateMar 15, 2026

Next Review DateN/A

Key ActionObtain prior authorization for Skyrizi subcutaneous with documentation of prescriber specialty and indication-specific requirements.

SourceLink

POLICY UPDATE CHANGES

New policy created describing prior authorization criteria for Skyrizi subcutaneous.

Ulcerative colitis initial therapy options modified by removing prior requirements for trial of a systemic therapy and certain pouchitis treatments.

Plaque psoriasis initial therapy note updated to allow exceptions based on prior biologic, Otezla/Otezla XR, or Sotyktu exposure/intolerance and clarified prescriber-determined methotrexate contraindication.

Crohn's disease initial therapy criteria were narrowed by removing several prior options (steroid/systemic therapy trials, fistula/surgical history options).

4FDA indications

Prior authAuthorization

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Coverage Criteria for Skyrizi (risankizumab-rzaa) Subcutaneous

FDA-Approved Indications

Approve Skyrizi SC for the FDA-approved indications when the following indication-specific criteria are met:

Indication selection: Patient has one of the FDA-approved indications: Crohn's disease, plaque psoriasis, psoriatic arthritis, or ulcerative colitis (see per-indication nodes).

See individual indication nodes below.

Crohn's Disease - Initial Therapy (A): Approve for 6 months if ALL: (i) Patient is > 18 years of age; AND (ii) According to the prescriber, the patient will receive induction dosing with Skyrizi intravenous within 3 months of initiating therapy with Skyrizi subcutaneous; AND (iii) The medication is prescribed by or in consultation with a gastroenterologist.

(Chunk 8)

Crohn's Disease - Continuation (B): Approve for 1 year if BOTH: (i) Patient has been established on therapy for at least 6 months; AND (ii) Patient meets at least ONE of: (a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline; OR (b) Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, blood in stool).

(Chunks 8-9)

Plaque Psoriasis - Initial Therapy (A): Approve for 3 months if ALL: (i) Patient is ≥ 18 years of age; AND (ii) Patient meets ONE of: (a) Patient has tried at least one traditional systemic agent for psoriasis for at least 3 months unless intolerant; OR (b) According to the prescriber, the patient has a contraindication to methotrexate; AND (iii) The medication is prescribed by or in consultation with a dermatologist.

Exception: a prior 3-month trial or intolerance to at least one biologic (other than the requested drug), Otezla/Otezla XR, or Sotyktu can substitute for the traditional systemic trial (Chunks 9-10).

Plaque Psoriasis - Continuation (B): Approve for 1 year if ALL: (i) Patient has been established on the requested drug for at least 3 months; AND (ii) Patient experienced a beneficial clinical response, defined as improvement from baseline in at least one of: estimated body surface area, erythema, induration/thickness, and/or scale; AND (iii) Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, itching, burning).

(Chunk 10)

Psoriatic Arthritis - Initial Therapy (A): Approve for 6 months if BOTH: (i) Patient is > 18 years of age; AND (ii) The medication is prescribed by or in consultation with a rheumatologist or a dermatologist.

(Chunk 9)

Psoriatic Arthritis - Continuation (B): Approve for 1 year if BOTH: (i) Patient has been established on therapy for at least 6 months; AND (ii) Patient meets at least ONE of: (a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline; OR (b) Compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain, morning stiffness, improved function, decreased soft tissue swelling).

(Chunk 11)

Ulcerative Colitis - Initial Therapy (A): Approve for 6 months if ALL: (i) Patient is ≥ 18 years of age; AND (ii) According to the prescriber, the patient will receive three induction doses with Skyrizi intravenous within 3 months of initiating therapy with Skyrizi subcutaneous; AND (iii) The medication is prescribed by or in consultation with a gastroenterologist.

(Chunk 11)

Ulcerative Colitis - Continuation (B): Approve for 1 year if BOTH: (i) Patient has been established on the requested drug for at least 6 months; AND (ii) Patient meets at least ONE of: (a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline; OR (b) Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, decreased rectal bleeding).

(Chunk 12)

Skyrizi (risankizumab-rzaa) subcutaneous is covered only for the FDA‑approved indications when the specific per‑indication criteria in this policy are met. Skyrizi subcutaneous for any other use is considered not medically necessary. Additionally, concurrent use with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is not medically necessary and should not be administered in combination due to potential for increased adverse events and lack of evidence for additive benefit. This does not preclude concurrent use of conventional synthetic disease‑modifying antirheumatic drugs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine) when clinically appropriate.

The appendix lists multiple biologic and targeted therapies by formulation, mechanism, and labeled indications but does not state any additional explicit exclusions beyond the policy’s main Conditions Not Covered statement. Use the appendix entries as a reference for drug class and indication mapping when evaluating combination‑therapy or alternative‑therapy questions.

Administration of Skyrizi in combination with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is not medically necessary. Combination therapy is generally not recommended because of a potentially higher rate of adverse events and lack of controlled clinical data supporting additive efficacy; therefore such concurrent regimens should be denied as excluded from coverage under this policy.

Within the provided appendix excerpts there are no additional or separate conditions explicitly labeled as ‘not medically necessary’ beyond the policy’s Conditions Not Covered language. The appendix serves to identify agents, formulations, mechanisms, and labeled indications and does not enumerate further noncoverage rules in these excerpts.

Provider Requirements and Prior Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Skyrizi SC. All approvals are provided for the duration noted in the policy (when expressed in months, 1 month = 30 days). Initial approval requires the medication to be prescribed by or in consultation with a clinician who specializes in the condition being treated (e.g., gastroenterologist for Crohn's disease/ulcerative colitis, dermatologist for plaque psoriasis, rheumatologist or dermatologist for psoriatic arthritis).

Prior authorization reference: Coverage Policy Number IP0670
Approval durations vary by indication (e.g., initial approvals typically 3–6 months; continuation approvals often 1 year)
Documentation: prescriber specialty or consultation must be documented with the request

Denial Risk

Denial Risk and Billing/Coding

Claims submitted without covered diagnosis/procedure codes or that do not meet the policy criteria will be denied. Concurrent use of Skyrizi with another biologic or a targeted synthetic oral small molecule drug for inflammatory conditions is considered not medically necessary and is a denial trigger (concurrent conventional synthetic DMARDs such as methotrexate may be allowed).

Initial Therapy Criteria

Initial therapy

Initial approvals are indication-specific with defined minimum prescriber specialty and induction requirements for certain GI indications.

Crohn's Disease - Initial: Patient > 18 years of age; AND prescriber states patient will receive induction dosing with Skyrizi IV within 3 months of initiating SC; AND medication prescribed by or in consultation with a gastroenterologist; approve 6 months.

(Chunk 8)

Plaque Psoriasis - Initial: Patient ≥ 18 years of age; AND patient has tried at least one traditional systemic agent for ≥ 3 months unless intolerant OR prescriber documents contraindication to methotrexate; AND medication prescribed by or in consultation with a dermatologist; approve 3 months. Exception: prior 3-month trial or intolerance to at least one biologic (other than requested), Otezla/Otezla XR, or Sotyktu can substitute for the traditional systemic trial.

(Chunks 9-10, 15)

Psoriatic Arthritis - Initial: Patient > 18 years of age; AND medication prescribed by or in consultation with a rheumatologist or dermatologist; approve 6 months.

Continuation Therapy Criteria

Continuation therapy

Continuation approvals are allowed when the patient has been established on therapy and demonstrates clinical benefit.

General continuation: Patient established on therapy for the specified minimum duration per indication (≥ 3 months for psoriasis; ≥ 6 months for Crohn's disease, psoriatic arthritis, and ulcerative colitis) AND demonstrated beneficial clinical response by at least one objective measure or improvement in at least one symptom compared with baseline.

Examples of objective measures include fecal markers, serum markers (CRP), imaging, endoscopy, DAPSA/MDA/etc., or documented symptom improvement (Chunks 9,11,12).

Definitions and Formulations

Skyrizi formulations — available presentations

Available subcutaneous formulations150 mg single-dose prefilled pen; 75 mg and 150 mg prefilled syringes; 180 mg and 360 mg single-dose prefilled cartridges for use with an on-body injector (cartridges used for Crohn's disease and ulcerative colitis).

Intravenous formulationIV infusion formulation available (risankizumab-rzaa IV) used for induction in Crohn's disease and ulcerative colitis with dosing at Weeks 0, 4, and 8 followed by SC maintenance every 8 weeks.

Indication-specific device useOn-body injector cartridges (180 mg or 360 mg) are specified for Crohn's disease and ulcerative colitis; other indications use pens or syringes as labeled.

Dose presentationsSC: 150 mg pen; 75 mg and 150 mg syringes; 180 mg/360 mg cartridges for on-body injector. IV: infusion formulation provided for induction in CD and UC.

Skyrizi (risankizumab-rzaa) — mechanism and indications

Background

Skyrizi (risankizumab‑rzaa) is an interleukin‑23 (IL‑23) inhibitor available as both subcutaneous (SC) injection and intravenous (IV) infusion formulations. The SC formulation is indicated for Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis; the IV formulation is indicated for induction in Crohn’s disease and ulcerative colitis with IV induction followed by SC maintenance when appropriate. SC presentations include prefilled pens and syringes and on‑body injector cartridges for certain indications, while the IV formulation is administered in an infusion setting for induction as specified in the drug labeling.

Site of Care

Billing Rule

Site-of-care: IV induction in infusion center; SC per indication

IV induction doses are administered in an infusion setting as indicated; subcutaneous formulations (pens, syringes, on‑body injector cartridges) are used per the labeled indication and formulation availability.

IV induction for CD and UC is given at Weeks 0, 4, and 8 (infusion), followed by SC maintenance every 8 weeks.
SC formats include 150 mg pens, 75 mg/150 mg syringes, and 180 mg/360 mg prefilled cartridges for on‑body injector (for CD and UC).

Revision History

Policy Summary

PayerCigna

PolicySkyrizi Subcutaneous Prior Authorization Policy

Policy CodePolicy IP0670

Change TypeSelected revisions and updates through 03/15/2026

Effective DateMar 15, 2026

Next Review DateN/A

Key ActionObtain prior authorization for Skyrizi subcutaneous with documentation of prescriber specialty and indication-specific requirements.

SourceLink

On This Page

Note

Appendix Reference for Alternatives and Product Details

Appendix enumerates many biologic and targeted therapies (drug names, formulations, mechanisms, and labeled indications) that may be referenced for step/alternative therapies and exceptions.

Appendix lists product examples (e.g., Skyrizi, Stelara, Tremfya, Cosentyx, Taltz, Bimzelx, Ilumya, Entyvio, Omvoh, Rituximab products, Orencia, Kineret, etc.) with formulations and indications
Appendix includes oral targeted synthetic small molecule drugs (e.g., Otezla, Otezla XR, Sotyktu, Cibinqo, Rinvoq, Xeljanz/XR, Zeposia, Velsipity) and their mechanisms

Documentation Required

Documentation Requirements

Required documentation for prior authorization includes prescriber specialty/consultation and objective measures or documentation of disease activity when applicable (examples provided in the FDA-Approved Indications criteria).

Objective measures examples: fecal markers (fecal calprotectin, fecal lactoferrin), serum markers (C-reactive protein, ESR), imaging (MRE, CTE), endoscopic assessment, disease activity indices (DAPSA, CPDAI, PsA DAS, etc.)
Documentation must support initial vs continuation criteria (e.g., prior response compared with baseline, duration established on therapy)

Step Therapy

Step/Try Requirements for Plaque Psoriasis

Step-therapy note for plaque psoriasis: initial therapy generally requires a trial of at least one traditional systemic agent for ≥ 3 months unless the prescriber documents intolerance or an exception applies (exceptions include prior biologic use or prior intolerance to certain agents as described in the policy).

Traditional systemic agents examples: methotrexate, cyclosporine, acitretin, or a 3-month trial of PUVA
Exceptions include prior 3-month trial or intolerance to at least one biologic (other than the requested drug), Otezla/Otezla XR, or Sotyktu; biosimilars of the requested biologic do not count toward the step

Requirement	Details
Step therapy requirement
For plaque psoriasis initial therapy, patient must have tried at least one traditional systemic agent for ≥3 months unless intolerant. Examples include methotrexate, cyclosporine, acitretin, or a 3-month trial of PUVA. Exceptions to this trial requirement may be made if the patient has already had a 3-month trial of or prior intolerance to at least one biologic (other than the requested drug), Otezla/Otezla XR (apremilast), or Sotyktu (deucravacitinib); a biosimilar of the requested biologic does not count as a biologic trial.

Requirement

Details

Step therapy requirement

For plaque psoriasis initial therapy, patient must have tried at least one traditional systemic agent for ≥3 months unless intolerant. Examples include methotrexate, cyclosporine, acitretin, or a 3-month trial of PUVA. Exceptions to this trial requirement may be made if the patient has already had a 3-month trial of or prior intolerance to at least one biologic (other than the requested drug), Otezla/Otezla XR (apremilast), or Sotyktu (deucravacitinib); a biosimilar of the requested biologic does not count as a biologic trial.