CurrentCareSourcePolicy N/A

Inflammatory Conditions - Skyrizi Intravenous Utilization Management Medical Policy

Defines prior-authorization medical-benefit coverage criteria, dosing, prescribing specialist requirement, and exclusions for Skyrizi IV induction therapy for adults with moderate to severe Crohn's disease or ulcerative colitis. Approvals are for three-dose induction regimens with statements on maintenance (SC) and combination therapy exclusions.

Policy Summary

PayerCareSource

PolicyInflammatory Conditions - Skyrizi Intravenous Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeRevisedClarified

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; approve Skyrizi IV only for patients meeting the stated induction criteria and dosing and require prescribing by or consultation with a gastroenterologist.

SourceLink

POLICY UPDATE CHANGES

Ulcerative colitis added as a newly approved condition during prior annual revision (06/26/2024).

Conditions Not Recommended for Approval: Concurrent use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug wording was changed (selected revision 09/11/2024).

2Covered Indications (induction)

3 monthsApproval duration

3Induction doses

Coverage Summary

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Scope: Defines prior-authorization medical-benefit coverage criteria, dosing, prescribing specialist requirement, and exclusions for Skyrizi IV induction therapy in adults with moderate to severe Crohn's disease or ulcerative colitis. Approvals are for three-dose IV induction regimens with statements on maintenance and combination therapy exclusions.

Indication overview: Skyrizi IV (risankizumab-rzaa) is an IL-23 blocker indicated for induction therapy in adults with moderate to severe active Crohn's disease and moderate to severe active ulcerative colitis. For Crohn's disease the IV induction regimen is 600 mg at Weeks 0, 4, and 8; for ulcerative colitis the IV induction regimen is 1,200 mg at Weeks 0, 4, and 8.

Maintenance note: Following IV induction, the recommended maintenance is Skyrizi subcutaneous injection (180 mg or 360 mg administered at Week 12, then once every 8 weeks thereafter), per the prescribing information.

Key Policy Stats & Timeline

Covered Indications (induction)2

Standard approval duration3 months

Induction doses approved3

Policy statusCURRENT

Last review date2024-09-11

Medical-Necessity Criteria and Dosing

FDA-Approved Indications - Crohn's Disease (Induction)

Approve three doses for induction if the patient meets ALL of the following (A, B, C, and D):

ALL of the following

ALL of the following
- Patient is ≥ 18 years of age
- The medication will be used as induction therapy
- Patient meets ONE of the following
  - Patient has tried or is currently taking a systemic corticosteroid, or a systemic corticosteroid is contraindicated in this patient
  - Patient has tried one other conventional systemic therapy for Crohn's disease
    Examples include azathioprine, 6-mercaptopurine, or methotrexate. A trial of mesalamine does not count. Exception: requirement for steroid/conventional agent may be waived if patient has already tried at least one biologic other than the requested medication. A biosimilar of the requested biologic does not count.
  - Patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas
  - Patient had ileocolonic resection (to reduce the chance of Crohn's disease recurrence)
- The medication is prescribed by or in consultation with a gastroenterologist

Dosing: Approve 600 mg as an intravenous infusion administered at Weeks 0, 4, and 8.

FDA-Approved Indications - Ulcerative Colitis (Induction)

Approve three doses for induction if the patient meets ALL of the following (A, B, C, and D):

ALL of the following

Patient is ≥ 18 years of age
The medication will be used as induction therapy
Patient meets ONE of the following
- Patient has tried one systemic therapy
  Examples include 6-mercaptopurine, azathioprine, cyclosporine, tacrolimus, or a corticosteroid such as prednisone or methylprednisolone. A trial of mesalamine does not count. A trial of one biologic other than the requested medication also counts. A biosimilar of the requested biologic does not count.
- Patient meets BOTH of the following (for pouchitis)

Dosing and Authorization Duration

ALL of the following

Crohn's disease dosing: Approve 600 mg IV infusion administered at Weeks 0, 4, and 8
Ulcerative colitis dosing: Approve 1,200 mg IV infusion administered at Weeks 0, 4, and 8
All approvals are provided for 3 months (adequate for three doses)
Extended approvals allowed if patient continues to meet the Criteria and Dosing
Requests for doses outside established dosing will be considered case-by-case by a clinician (Medical Director or Pharmacist)

Prescriber Requirement

Skyrizi IV must be prescribed by or in consultation with a physician who specializes in the condition being treated (gastroenterologist for CD/UC)

Conditions Not Recommended for Approval

Coverage of Skyrizi IV is not recommended in these situations:

ANY of the following

Concurrent use with another biologic for an inflammatory condition
Combination therapy generally not recommended due to higher adverse events and lack of controlled data
Concurrent use with a targeted synthetic oral small molecule drug used for an inflammatory condition
See Appendix for examples
Circumstances not listed in the Recommended Authorization Criteria

This policy does NOT exclude use of conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) in combination with Skyrizi IV

Combination therapy note: Concurrent use of Skyrizi IV with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is generally not recommended due to a potentially higher rate of adverse events and lack of controlled clinical data supporting additive efficacy.

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical-benefit coverage of Skyrizi IV; approval is recommended only for patients meeting the stated criteria and dosing.

Documentation Required

Specialist prescribing/consultation requirement

Approval requires Skyrizi IV to be prescribed by or in consultation with a physician who specializes in the condition being treated — a gastroenterologist for Crohn's disease or ulcerative colitis.

Billing Rule

Approval duration and dosing

All approvals are provided for 3 months to allow for the three induction infusions. Dosing for induction must be documented as follows: Crohn's disease — 600 mg IV at Weeks 0, 4, and 8; Ulcerative colitis — 1,200 mg IV at Weeks 0, 4, and 8.

Denial Risk

Concurrent biologic or targeted synthetic oral small molecule drugs

Coverage is not recommended for concurrent administration with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition; combination therapy is generally not recommended and claims may be denied if used in combination outside the exceptions noted.

Documentation Required

Prior therapy evidence

Documentation should include evidence of prior therapies per the authorization criteria: for Crohn's disease, trial of or contraindication to systemic corticosteroid or trial of one conventional systemic therapy (examples: azathioprine, 6‑mercaptopurine, methotrexate) — or prior use of at least one biologic other than the requested agent as an exception; for ulcerative colitis, trial of one systemic therapy (examples: 6‑mercaptopurine, azathioprine, cyclosporine, tacrolimus, or systemic corticosteroid) or, for pouchitis, documentation of antibiotic/probiotic/corticosteroid enema/mesalamine enema trial. A trial of mesalamine does not count as a systemic agent for either condition. A biosimilar of the requested biologic does not count as the required prior biologic trial.

Coding and Appendix Examples

HCPCS (drug billing) impliedHCPCS

No codes listed

Relevant drug/therapy classes listed in Appendix (examples, not exhaustive)mixed

adalimumab (Humira and biosimilars)	TNF inhibitor - listed as biologic example
infliximab (Remicade and biosimilars)	TNF inhibitor - listed as biologic example
ustekinumab (Stelara)	IL-12/23 inhibitor - listed as biologic example
vedolizumab (Entyvio)	Integrin receptor antagonist - listed as biologic example
mirikizumab (Omvoh)	IL-23 inhibitor - listed as biologic example
tofacitinib (Xeljanz/XR)	JAK inhibitor - example targeted synthetic oral small molecule
ozanimod (Zeposia)	S1P receptor modulator - example targeted synthetic oral small molecule

Background and Evidence

Background: Skyrizi IV (risankizumab-rzaa) is an interleukin-23 (IL-23) blocker. IL-23 inhibition targets a pathway involved in inflammatory bowel disease pathophysiology and is the mechanism for risankizumab's therapeutic effect in Crohn's disease and ulcerative colitis.

Indication summary: Skyrizi IV is indicated for induction therapy in adults with moderate to severe active Crohn's disease and in adults with moderate to severe active ulcerative colitis. The approved IV induction regimens are 600 mg at Weeks 0, 4, and 8 for Crohn's disease and 1,200 mg at Weeks 0, 4, and 8 for ulcerative colitis. After completion of IV induction, recommended maintenance is Skyrizi subcutaneous injection (180 mg or 360 mg at Week 12, then every 8 weeks).

Guideline context: Clinical practice guidelines recommend biologic therapies for induction and maintenance of remission in adults with moderate to severe Crohn's disease and ulcerative colitis; while Skyrizi IV is a newly approved option for these indications, guidelines generally include biologics among recommended therapies for moderate to severe disease and state that effective induction agents should be continued for maintenance.

Evidence note: Primary reference is the prescribing information: AbbVie Skyrizi prescribing information (September 2023).

Definitions — 'Conventional systemic therapy'

Conventional systemic therapy (Crohn's disease)Examples include azathioprine, 6-mercaptopurine, or methotrexate; mesalamine does not count as a systemic agent for Crohn's disease.

Conventional systemic therapy (Ulcerative colitis)Examples include 6-mercaptopurine, azathioprine, cyclosporine, tacrolimus, or systemic corticosteroids; mesalamine does not count.

OpenPayer

Inflammatory Conditions - Skyrizi Intravenous Utilization Management Medical Policy

Coverage Summary

Medical-Necessity Criteria and Dosing

Conditions Not Recommended for Approval

Provider Actions and Authorization Requirements

Coding and Appendix Examples

Background and Evidence

Revision History