Cigna Skyrizi Subcutaneous Prior Auth Update

Coverage Criteria for Skyrizi (risankizumab-rzaa) Subcutaneous

Indication-specific coverage criteria

Skyrizi SC is covered as medically necessary for FDA-approved indications when the following indication-specific criteria are met.

Indication: Patient has one of the FDA-approved indications: Crohn's disease, Plaque Psoriasis, Psoriatic Arthritis, or Ulcerative Colitis.

Crohn's Disease - Initial Therapy

Age: Patient is > 18 years of age.
Induction: According to the prescriber, the patient will receive induction dosing with Skyrizi intravenous within 3 months of initiating therapy with Skyrizi subcutaneous.
Prior therapies or disease specifics: Patient meets ONE of the following: a) tried or is currently taking corticosteroids, or corticosteroids are contraindicated; OR b) tried one other conventional systemic therapy for Crohn's disease; OR c) has enterocutaneous (perianal or abdominal) or rectovaginal fistulas; OR d) had ileocolonic resection.
Prescriber specialty: Medication prescribed by or in consultation with a gastroenterologist.

Crohn's Disease - Continuing Therapy

Established therapy: Patient has been established on therapy for at least 6 months.
Clinical response: At least ONE: when assessed by at least one objective measure the patient experienced a beneficial clinical response (examples: fecal markers, serum markers, imaging, endoscopic assessment, and/or reduced dose of corticosteroids) OR compared with baseline the patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool).

Plaque Psoriasis - Initial Therapy

Age: Patient is ≥ 18 years of age.
Prior therapy: Patient has tried at least one traditional systemic agent for psoriasis for at least 3 months unless intolerant OR has a contraindication to methotrexate.
Prescriber specialty: Medication prescribed by or in consultation with a dermatologist.

Plaque Psoriasis - Continuing Therapy

Established therapy: Patient has been established on the requested drug for at least 3 months.
Clinical response measures: Patient experienced a beneficial clinical response in at least one of: estimated body surface area, erythema, induration/thickness, and/or scale.
Symptom improvement: Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, itching, burning).

Psoriatic Arthritis - Initial Therapy

Age: Patient is > 18 years of age.
Prescriber specialty: Medication prescribed by or in consultation with a rheumatologist or a dermatologist.

Psoriatic Arthritis - Continuing Therapy

Established therapy: Patient has been established on therapy for at least 6 months.
Clinical response: At least ONE: when assessed by at least one objective measure the patient experienced a beneficial clinical response (examples: DAPSA, CPDAI, PsA DAS, LEI, SPARCC, Leeds Dactylitis, MDA, PsAID-12, or serum markers) OR compared with baseline the patient experienced improvement in at least one symptom (e.g., less joint pain, morning stiffness, fatigue, improved function, decreased swelling).

Ulcerative Colitis - Initial Therapy

Age: Patient is ≥ 18 years of age.
Induction: According to the prescriber, the patient will receive three induction doses with Skyrizi intravenous within 3 months of initiating therapy with Skyrizi subcutaneous.
Prescriber specialty: Medication prescribed by or in consultation with a gastroenterologist.

Ulcerative Colitis - Continuing Therapy

Established therapy: Patient has been established on the requested drug for at least 6 months.
Clinical response: At least ONE: when assessed by at least one objective measure the patient experienced a beneficial clinical response (examples: fecal markers, serum markers, endoscopic assessment, and/or reduced dose of corticosteroids) OR compared with baseline the patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or decreased rectal bleeding).

Prescriber specialty overarching: Initial approval requires Skyrizi SC to be prescribed by or in consultation with a physician who specializes in the condition being treated.

Informational Appendix — Not a criteria set

Informational listing of therapies and example indications (not coverage criteria).

Appendix content: Lists biologic and oral therapies with mechanism of action and example indications; consult main policy for coverage decision logic.

This appendix does not contain medical necessity criteria.

The policy considers concurrent use of Skyrizi with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition to be not medically necessary and therefore not covered. Combination therapy is generally discouraged because of a potentially higher rate of adverse events and lack of controlled clinical data demonstrating additive efficacy. The policy clarifies that this restriction does not apply to combining Skyrizi with conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine).

No appendix statements in these sections establish coverage criteria or alter coverage decisions. The appendix is informational only and lists agents, abbreviations, and example indications; it does not itself define medical necessity or prior authorization requirements.

The policy stance is that use of Skyrizi in combination with another biologic or a targeted synthetic oral small molecule drug for inflammatory conditions is considered not medically necessary. Providers should document and avoid concurrent biologic or targeted synthetic small-molecule therapy when requesting coverage. Conventional synthetic DMARDs may be used in combination per usual clinical practice and are specifically excluded from this restriction.

These appendix sections do not include explicit 'not medically necessary' statements; any exclusion or medical necessity determinations are stated in the main policy body rather than the appendix. Refer to the main policy coverage and conditions-not-covered sections for definitive denial criteria.

Coding and Code Appendix

No billing/coding lists in appendixmixed

No codes listed

Coding appendix key points

No billing/coding lists in appendixThe appendix contains an informational list of biologic and oral therapies but does not provide billing, CPT, or HCPCS codes.

Coding threshold entriesNo numeric thresholds or code-specific limits are specified in the appendix content.

Action for providers/payersRefer to the main policy coding sections and the applicable benefit plan document for coverage and billing codes; the appendix is informational only.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required for Skyrizi SC. Initial and continuation approvals have specific duration expectations and prescriber requirements; providers must obtain prior authorization before coverage. Initial approvals require a specialist prescriber or consultation and duration varies by indication (see criteria). Continuation approvals require documentation of treatment response as specified per indication.

Initial approvals: duration and specialist prescriber/consultation required (see indication-specific criteria).
Continuation approvals: require evidence of benefit (objective measures or symptom improvement) and specified established-on-therapy timeframes.
Approval durations: vary by indication (e.g., Crohn's disease initial = 6 months, plaque psoriasis initial = 3 months, psoriatic arthritis initial = 6 months; continuation typically = 1 year).

Note

Appendix: Informational Only

The appendix provides informational content only: mechanisms of action and example indications for many biologic and targeted therapies. This appendix content is for reference (examples of biologics, mechanisms, and indications) and does not establish additional coverage requirements.

Background and Policy Scope

Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) inhibitor approved for multiple inflammatory conditions including Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis. The subcutaneous formulation is addressed by this policy for maintenance therapy across those indications, while intravenous induction dosing is required for certain inflammatory bowel disease indications as specified in the criteria. Coverage under this policy is granted only when indication-specific criteria are met (including age, prescriber specialty, induction dosing for IBD where indicated, prior therapy requirements or documented contraindications, and evidence of clinical response for continuation approvals).

Definitions and Formulations

Skyrizi formulations — strengths and presentations

Available SC strengths for IBD (CD, UC)180 mg and 360 mg single‑dose prefilled cartridges for use with an on‑body injector (Crohn's disease and ulcerative colitis).

Available SC strengths for other indications150 mg single‑dose prefilled pen; 75 mg and 150 mg prefilled syringes for plaque psoriasis and psoriatic arthritis (and other non‑IBD indications).

IV formulation noteAn IV formulation is available for induction in Crohn's disease and ulcerative colitis (Weeks 0, 4, and 8) with subsequent SC maintenance every 8 weeks.

Abbreviations used in the appendix

SCSubcutaneous

IVIntravenous

OpenPayer

Inflammatory Conditions - Skyrizi Subcutaneous Prior Authorization Policy

Coverage Criteria for Skyrizi (risankizumab-rzaa) Subcutaneous

Coding and Code Appendix

Provider Actions, Prior Authorization, and Documentation

Background and Policy Scope

Definitions and Formulations