CurrentCommunity-CarePolicy N/A

Risankizumab (Skyrizi) — medical benefit coverage criteria for Crohn's disease and ulcerative colitis

Defines medical-benefit coverage criteria, quantity limits, and authorization period for risankizumab (Skyrizi) when prescribed by gastroenterology specialists for moderately to severely active Crohn's disease or ulcerative colitis.

Policy Summary

PayerCommunity-Care

PolicyRisankizumab (Skyrizi) — coverage criteria for moderately to severely active Crohn's disease and ulcerative colitis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateAug 1, 2024

Key ActionObtain prior authorization documenting gastroenterology specialist prescription, diagnosis of moderately to severely active disease, and that the patient is not currently established on risankizumab; approval authorizes therapy for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauth period

1 vial/28dmax q (CD)

2 vials/28dmax q (UC)

Up to 3fill limit

J2327HCPCS

Coverage Criteria for Risankizumab (Skyrizi)

Initial Therapy

Covered when ALL of the following are met

Crohn's disease initial criteria: Prescribed by a gastroenterology specialist

Crohn's disease initial criteria: Diagnosis of moderately to severely active Crohn's disease

Crohn's disease initial criteria: Not currently established on risankizumab (Skyrizi)

If approved, authorized quantity: up to 1 vial (600 mg/10 mL) per 28 days, up to 3 fills; authorization period 6 months.

Ulcerative colitis initial criteria: Prescribed by a gastroenterology specialist

Policy Summary

PayerCommunity-Care

PolicyRisankizumab (Skyrizi) — coverage criteria for moderately to severely active Crohn's disease and ulcerative colitis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateAug 1, 2024

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Ulcerative colitis initial criteria: Diagnosis of moderately to severely active ulcerative colitis

Ulcerative colitis initial criteria: Not currently established on risankizumab (Skyrizi)

If approved, authorized quantity: up to 2 vials (600 mg/10 mL each) per 28 days, up to 3 fills; authorization period 6 months.

This policy implicitly excludes requests for patients who are already receiving ongoing risankizumab therapy by requiring that the patient be not currently established on risankizumab (Skyrizi) as a condition of approval. Requests for continuation of treatment for patients already established on risankizumab are therefore outside the scope of the approval criteria and may be denied unless separate documentation supports continuation under other benefit provisions.

Coverage is limited to patients with a documented diagnosis of moderately to severely active disease. Specifically, the policy authorizes risankizumab only for: (1) Crohn's disease when the request documents moderately to severely active Crohn's disease, and (2) ulcerative colitis when the request documents moderately to severely active ulcerative colitis. Use for other indications is not supported by this document.

Coding and Authorization Period

Applicable HCPCS CodesHCPCS

J2327

Injection, risankizumab-rzaa, intravenous, 1 mg

Authorization period

Authorization periodIf approved, coverage is allowed for 6 months (subject to benefit changes).

Quantity-limit contextAuthorization period applies to initial approval; quantity limits and fills are described separately under Quantity Limits (up to 3 fills).

Review schedulePolicy last reviewed August 2024; next review date listed in brief as 2024-08-01.

Provider Requirements and Authorization Workflow

Prior Authorization

Prior Authorization Required

Prior authorization is required for risankizumab when prescribed for Crohn's disease or ulcerative colitis. Requests must document that the prescriber is a gastroenterology specialist and that the patient has a diagnosis of moderately to severely active disease. Authorization decisions will also consider whether the patient is already established on risankizumab.

Prescriber: Gastroenterology specialist required
Diagnosis: Moderately to severely active Crohn's disease or ulcerative colitis must be documented
Not currently established on risankizumab (initial therapy requirement)

Step Therapy

No step-therapy sequences or prior biologic requirements are specified in this policy. There are no mandated trials of alternative biologic agents before risankizumab may be considered.

Documentation Required

Required Documentation

Documentation must include the specialist prescriber status and clear diagnostic evidence of moderately to severely active disease. Operational details: include clinical notes, relevant diagnostic testing, and prior treatment history when applicable.

Include specialist credentials or clinic affiliation
Provide clinical assessment documenting disease severity
Attach relevant diagnostic test results and prior treatment history

Denial Risk

Denial Triggers

Denials may be issued if the prescription is not written by a gastroenterology specialist or if the documentation does not demonstrate a diagnosis of moderately to severely active disease. Missing required documentation or evidence that the patient is already established on risankizumab without meeting policy criteria are additional denial triggers.

Prescriber not a gastroenterology specialist
No documentation of moderately to severely active Crohn's disease or ulcerative colitis
Patient already established on risankizumab contrary to initial-therapy criteria

Background

Risankizumab (Skyrizi) is a biologic, intravenous formulation covered under this medical benefit policy for treatment of moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis. This policy restricts use to prescriptions written by a gastroenterology specialist and requires that the patient be not currently established on risankizumab. When approved, authorization and quantity limits differ by indication (see quantity limits and authorization period).

Definitions

Not currently established on risankizumab

DefinitionNot currently established on risankizumab: patient has not been receiving ongoing risankizumab (Skyrizi) treatment prior to the request.

Policy effectRequests for patients already receiving ongoing risankizumab are implicitly excluded by this criterion.

Documentation requiredProvider must document that the patient is not currently established on risankizumab as part of prior authorization submission.

Moderately to severely active

DefinitionModerately to severely active: as documented by the prescribing gastroenterology specialist (definition not further specified in this document).

Prescriber requirementDiagnosis must be recorded by a gastroenterology specialist who is the prescriber of risankizumab.

Coverage scopePolicy limits coverage to patients with a documented diagnosis of moderately to severely active Crohn's disease or ulcerative colitis per the specialist's documentation.