CurrentAvMedPolicy N/A

Skyrizi SQ - Crohn's Disease & Ulcerative Colitis

Pharmacy prior authorization and step-edit policy for risankizumab (Skyrizi) SQ maintenance and IV induction for treatment of moderate-to-severe Crohn's disease and ulcerative colitis, including clinical criteria, dosing, benefit delineation (medical vs pharmacy), and exclusions regarding concomitant biologic use.

Policy Summary

PayerAvMed

PolicySkyrizi SQ - Crohn's Disease & Ulcerative Colitis

Policy CodePolicy N/A

Change Typeclarified

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the PA request form and provide documentation supporting diagnoses and prior therapy failures; incomplete information may delay or deny authorization.

SourceLink

POLICY UPDATE CHANGES

Notes that Skyrizi IV loading dose for CD & UC can only be billed under the medical benefit and provides associated NDC and J-code billing unit information.

2Covered Indications

IV vs SQAdministration Pathways

1Specialty Pharmacy Required

Coverage Summary

Subject: Skyrizi (risankizumab) for Crohn's Disease & Ulcerative Colitis. Coverage stance: covered_with_criteria. Scope: Pharmacy prior authorization and step-edit policy for risankizumab (Skyrizi) subcutaneous (maintenance) and intravenous (induction) regimens for treatment of moderate-to-severe Crohn's disease and ulcerative colitis, including clinical criteria for approval (diagnosis, specialist prescribing/consultation, prior therapy failures, and induction-to-maintenance sequencing), specified dosing schedules and billing units, delineation of benefits (IV induction billed under medical benefit; SQ maintenance billed under pharmacy benefit), and exclusions disallowing concomitant biologic immunomodulator use.

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Dosing Schedules & Definitions

Induction dosing schedule (Crohn's disease)600 mg IV administered over at least one hour at weeks 0, 4, and 8 (medical benefit).

Induction dosing schedule (Ulcerative colitis)1200 mg IV administered over at least two hours at weeks 0, 4, and 8 (medical benefit).

Maintenance dosing schedule (Subcutaneous)360 mg or 180 mg administered subcutaneously at week 12, then every 8 weeks thereafter (pharmacy benefit).

Definition - Induction (IV)Initial loading doses administered intravenously (Crohn's: 600 mg; UC: 1200 mg) at weeks 0, 4, and 8 billed under the medical benefit.

Definition - Maintenance (SQ)Subcutaneous dosing of 360 mg or 180 mg administered at week 12 and every 8 weeks thereafter, billed under the pharmacy benefit.

Induction Therapy - Medical Benefit (one-time approval)

One time approval for duration of 2 months, member to receive up to three (3) IV infusion doses. All maintenance criteria must be met for induction approval.

ALL of the following

Medication will be used as induction therapy
Member must meet all maintenance dose authorization criteria above
Medication being provided by: (location/site info and NPI/DEA of administering location must be provided)
Location and NPI/DEA of administering location required on request form
ONE of
- Crohn's disease - 600 mg administered by IV infusion over a period of at least one hour at week 0, 4 and 8
  600 mg = 600 billable units per dose; billed under medical benefit (NDC 00074-5015-01; J2327)
- Ulcerative colitis - 1200 mg administered by IV infusion over a period of at least two hours at week 0, 4 and 8
  1200 mg = 1200 billable units per dose; billed under medical benefit (NDC 00074-5015-01; J2327)

One time approval duration: 2 months; up to three IV infusion doses to be administered (weeks 0, 4, 8)

Billing Rule

IV Loading Dose Billed Under Medical Benefit

Skyrizi IV loading dose for Crohn's disease and ulcerative colitis must be billed under the medical benefit. Applicable codes: NDC 00074-5015-01 and J2327. Billing units: 600 mg = 600 billable units; 1200 mg = 1200 billable units.

Documentation Required

Administration Site and Provider Identification Required for Medical Benefit

For induction billed under the medical benefit, the request must include the administering location/site and the NPI or DEA number of the administering location; this information must be provided on request or the authorization may be delayed.

Maintenance Therapy - Pharmacy Benefit

All criteria must be met for approval. To support each line checked, all documentation, including lab results, diagnostics, and/or chart notes, must be provided or request may be denied.

ALL of the following

Member has ONE of the following diagnoses
- Moderate-to-severe active Crohn's disease
- Moderate-to-severe active Ulcerative colitis
Prescribed by or in consultation with a Gastroenterologist
Member meets ONE of the following:
- Member has tried and failed budesonide or high dose steroids unless there is a contraindication or intolerance
- DMARDs
  - 5-aminosalicylates (balsalazide, olsalazine, sulfasalazine)
  - oral mesalamine (Apriso, Asacol/HD, Delzicol, Lialda, Pentasa)
- Member has previously tried and failed at least one biologic medication other than the requested medication (e.g., Humira, Rinvoq, Stelara, Tremfya)
According to the prescriber, the member will receive three induction doses with Skyrizi intravenous within 3 months of initiating maintenance therapy with Skyrizi subcutaneous

Maintenance dosing: 360 mg or 180 mg administered subcutaneously at week 12 and every 8 weeks thereafter (use lowest effective dosage)

Pharmacy benefit dosing (NDCs 00074-1069-01/00074-1070-01/00074-1065-01)

Prior Authorization

Prior Authorization Required

Prescriber must complete and sign the prior authorization request form and provide supporting documentation (labs, diagnostics, chart notes) to substantiate diagnoses and prior therapy failures. Incomplete, incorrect, or illegible information may delay or result in denial of the authorization.

General Exclusions / Not Permitted

Safety and efficacy considerations noted by the health plan

ALL of the following

Concomitant therapy with more than one biologic immunomodulator prescribed for the same or different indications is considered experimental and investigational and will NOT be permitted
Use of samples to initiate therapy does not meet step edit/preauthorization criteria

Denial Risk

Concomitant Biologic Use Not Permitted

Requests for concomitant use of more than one biologic immunomodulator (for the same or different indications) will NOT be permitted; such combinations are considered experimental/investigational and lack established safety and efficacy.

Applicable Codes

Pharmacy NDCs (Subcutaneous)NDCCovered

00074-1069-01	Skyrizi SQ 360 mg/2.4 mL cartridge
00074-1070-01	Skyrizi SQ 360 mg/2.4 mL cartridge (alternate NDC)
00074-1065-01	Skyrizi SQ 180 mg/1.2 mL cartridge

Medical Benefit NDC / J-code (Intravenous induction)mixedCovered

00074-5015-01	Skyrizi IV 600 mg/10 mL
J2327	Injection, risankizumab-rzaa, 1 mg (billing units specified below)

Billing units for J2327mixed

600 mg	600 mg = 600 billable units per dose
1200 mg	1200 mg = 1200 billable units per dose

Note: IV induction loading doses must be billed under the medical benefit (NDC 00074-5015-01; J-code J2327), with 600 mg = 600 billable units and 1200 mg = 1200 billable units. Subcutaneous maintenance dosing is billed under the pharmacy benefit (NDCs for SQ cartridges listed on the PA form). For medical-benefit induction requests, the administering location and its NPI/DEA must be provided on the request form.

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prescriber must complete and sign the prior authorization request form and supply supporting documentation (labs, diagnostics, chart notes) to support the request. Incomplete, incorrect, or illegible information may delay or lead to denial.

Documentation Required

Administration Site and Provider Identification Required for Medical Benefit

For IV induction billed under the medical benefit, provide the location/site of drug administration and the NPI or DEA number of the administering location on the request form; missing site/provider identification may delay authorization.

Billing Rule

IV Loading Dose Billed Under Medical Benefit

The IV loading dose is billed under the medical benefit using NDC 00074-5015-01 and J2327. Billing units: 600 mg = 600 billable units per dose; 1200 mg = 1200 billable units per dose.

Denial Risk

Concomitant Biologic Use Not Permitted

Concomitant therapy with more than one biologic immunomodulator will not be permitted and is considered experimental/investigational; requests including multiple biologics risk denial.

Background & Definitions

Background: This PA form and policy outlines dosing and authorization requirements for risankizumab (Skyrizi) induction (intravenous) and maintenance (subcutaneous) regimens for Crohn's disease and ulcerative colitis. Induction involves FDA‑approved IV loading doses (Crohn's: 600 mg IV at weeks 0, 4, and 8; UC: 1200 mg IV at weeks 0, 4, and 8) administered under the medical benefit. Maintenance consists of subcutaneous dosing (360 mg or 180 mg at week 12, then every 8 weeks) billed under the pharmacy benefit. The policy restricts concomitant therapy with more than one biologic immunomodulator (considered experimental/investigational and not permitted) and requires verification of prior therapies via pharmacy paid claims or submitted chart notes. Prescriber signature and complete documentation (labs, diagnostics, chart notes) are required to support authorization.

Term	Definition
Induction (IV)	Initial loading doses administered intravenously (Crohn's: 600 mg; UC: 1200 mg) at weeks 0, 4, and 8 billed under medical benefit; Crohn's 600 mg infused over at least one hour (600 billable units); UC 1200 mg infused over at least two hours (1200 billable units).
Maintenance (SQ)	Subcutaneous dosing of 360 mg or 180 mg administered at week 12 and every 8 weeks thereafter, billed under the pharmacy benefit (NDCs for SQ cartridges: 00074-1069-01 / 00074-1070-01 for 360 mg; 00074-1065-01 for 180 mg).

Policy Summary

PayerAvMed

PolicySkyrizi SQ - Crohn's Disease & Ulcerative Colitis

Policy CodePolicy N/A

Change Typeclarified

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the PA request form and provide documentation supporting diagnoses and prior therapy failures; incomplete information may delay or deny authorization.

SourceLink

On This Page

OpenPayer

Skyrizi SQ - Crohn's Disease & Ulcerative Colitis

Coverage Summary

Induction Therapy - Medical Benefit (one-time approval)

Maintenance Therapy - Pharmacy Benefit

General Exclusions / Not Permitted

Applicable Codes

Provider Actions & Documentation Requirements

Background & Definitions

Clinical Evidence

Revision History