ModifiedAmeriHealth Caritas VIP CarePolicy MA08.153c

Risankizumab-rzaa (Skyrizi) for Intravenous Use

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This policy governs medical-benefit coverage and medical necessity requirements for intravenous risankizumab-rzaa (Skyrizi) in adults with moderately to severely active ulcerative colitis or Crohn's disease. It applies to Medicare Advantage members when applicable Evidence of Coverage terms, clinical criteria, and dosing requirements are met; pharmacy-benefit Part D coverage is not addressed.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyRisankizumab-rzaa (Skyrizi) for Intravenous Use

Policy CodePolicy MA08.153c

Change TypeModified

Effective DateDecember 16, 2024

Next Review DateN/A

Key ActionWhen the member's dose, frequency, or regimen changes, submit the changes to the Company for a new approval.

SourceLink

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

ModifiedAmeriHealth Caritas VIP CarePolicy MA08.153c

Risankizumab-rzaa (Skyrizi) for Intravenous Use

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Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyRisankizumab-rzaa (Skyrizi) for Intravenous Use

Policy CodePolicy MA08.153c

Change TypeModified

Effective DateDecember 16, 2024

Next Review DateN/A

Key ActionWhen the member's dose, frequency, or regimen changes, submit the changes to the Company for a new approval.

SourceLink

POLICY UPDATE CHANGES

The policy was updated effective December 16, 2024 to communicate coverage criteria for intravenous risankizumab-rzaa for ulcerative colitis.

ICD-10-CM code K50.00 for Crohn's disease of small intestine without complications was added effective September 16, 2024.

HCPCS code J2327 for intravenous risankizumab-rzaa was added effective January 1, 2023.

HCPCS code C9399 for unclassified drugs or biologicals was removed effective January 1, 2023.

2covered inflammatory bowel disease indications

18+minimum age for covered therapy

600 mg IVCrohn's disease induction dose

1,200 mg IVulcerative colitis induction dose

49ulcerative colitis diagnosis codes added

Covered and Noncovered Uses

Ulcerative Colitis

Covered when ALL of the following criteria, including dosing and frequency requirements, are met:

ALL of the following

The individual is 18 years of age or older.
ONE of the following
- There is documentation of inadequate response, contraindication, or intolerance to corticosteroids, such as budesonide, prednisone, hydrocortisone, or methylprednisolone.
- There is documentation of inadequate response, contraindication, or intolerance to biologic therapy, such as infliximab (Remicade), adalimumab (Humira), golimumab (Simponi Aria), or vedolizumab (Entyvio).
- There is documentation of inadequate response, contraindication, or intolerance to immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate.
- There is documentation of inadequate response, contraindication, or intolerance to JAK inhibitors, such as tofacitinib (Xeljanz) or upadacitinib (Rinvoq).
- There is documentation of inadequate response, contraindication, or intolerance to S1P receptor modulators, such as ozanimod (Zeposia).
The treatment is prescribed by or in consultation with a gastroenterologist.
There is no concurrent use with any other biologic therapy, including tumor necrosis factor antagonists.
The individual has moderately to severely active ulcerative colitis.
Induction dosage is 1,200 mg administered by intravenous infusion at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12 and every 8 weeks thereafter.

Crohn's Disease

Covered when ALL of the following criteria, including dosing and frequency requirements, are met:

ALL of the following

The individual is 18 years of age or older.
ONE of the following
- There is documentation of failure, contraindication, or intolerance to a trial of corticosteroids, such as budesonide (Entocort EC), prednisone, hydrocortisone, or methylprednisolone.
- There is documentation of failure, contraindication, or intolerance to a trial of immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate.
- There is documentation of failure, contraindication, or intolerance to a trial of biologic therapy, such as certolizumab (Cimzia), adalimumab (Humira), infliximab (Remicade), ustekinumab (Stelara), or vedolizumab (Entyvio).

Other uses

The following use is not covered:

All other uses of risankizumab-rzaa (Skyrizi) for intravenous use are considered experimental/investigational and are not covered unless the indication is supported as an accepted off-label use, as defined in the Company's medical policy on off-label coverage for prescription drugs and biologics.

Subject to the applicable Evidence of Coverage, risankizumab-rzaa (Skyrizi) for intravenous use is covered under the medical benefits of the Company's Medicare Advantage products when the medical necessity criteria and dosing and frequency requirements in this policy are met.

For Medicare Advantage members, certain drugs may be available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This policy addresses only instances in which risankizumab-rzaa (Skyrizi) for intravenous use is covered under the member's medical benefit (Part B benefit). It does not address coverage under the member's pharmacy benefit (Part D benefit).

Induction Therapy Requirements

Ulcerative Colitis Initial Therapy

Ulcerative colitis induction requires all applicable criteria.

Ulcerative colitis induction

Age requirement: The individual is 18 years of age or older.Age >=18 years
ONE of the following prior therapy categories
- Corticosteroids, such as budesonide, prednisone, hydrocortisone, or methylprednisolone.
- Biologic therapy, such as infliximab, adalimumab, golimumab, or vedolizumab.

Maintenance Therapy Requirements

Maintenance Therapy

After intravenous induction, maintenance therapy is administered subcutaneously.

Maintenance regimen: Following intravenous induction, administer 180 mg or 360 mg by subcutaneous injection at Week 12 and every 8 weeks thereafter; use the lowest effective dosage needed to maintain therapeutic response.180 mg or 360 mg SC at Week 12 and every 8 weeks

Required Prior Therapies

Step	Required prior therapy category	Documentation requirement
1	Corticosteroids; biologic therapy; immunomodulators; JAK inhibitors; or S1P receptor modulators	Document inadequate response, contraindication, or intolerance to at least one category.

Step	Required prior therapy category	Documentation requirement
1	Corticosteroids; immunomodulators; or biologic therapy	Document failure, contraindication, or intolerance to a trial of at least one category.

Authorization and Documentation Requirements

Prior Authorization

New Approval Required for Regimen Changes

Submit any change to the member’s approved dose, frequency, or regimen—including changes related to weight or incomplete therapeutic response—for a new approval before administration or billing.

The Company may conduct postpayment review and audit procedures for submitted claims.

Step Therapy

Ulcerative Colitis Prior Therapy

For moderately to severely active ulcerative colitis, document inadequate response, contraindication, or intolerance to conventional (nonadvanced) and/or advanced therapy before requesting coverage.

Corticosteroids, such as budesonide, prednisone, hydrocortisone, or methylprednisolone.
Biologic therapy, such as infliximab, adalimumab, golimumab, or vedolizumab.
Immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate.

Billing and Diagnosis Codes

CPT Procedure Code Number(s)CPT

N/A

ICD-10 Procedure Code Number(s)ICD-10

N/A

ICD-10 Diagnosis Code Number(s)ICD-10

K50.00	Crohn's disease of small intestine without complications
K50.011	Crohn's disease of small intestine with rectal bleeding
K50.012	Crohn's disease of small intestine with intestinal obstruction
K50.013	Crohn's disease of small intestine with fistula
K50.014	Crohn's disease of small intestine with abscess
K50.018	Crohn's disease of small intestine with other complication
K50.019	Crohn's disease of small intestine with unspecified complications
K50.10	Crohn's disease of large intestine without complications
K50.111	Crohn's disease of large intestine with rectal bleeding
K50.112	Crohn's disease of large intestine with intestinal obstruction

1–10 of 27

1/3

HCPCS Level II Code Number(s)HCPCS

J2327

Injection, risankizumab-rzaa, intravenous, 1 mg

Revenue Code Number(s)Revenue

N/A

HCPCS code added — effective January 1, 2023HCPCSCovered

J2327

Injection, risankizumab-rzaa, intravenous, 1 mg

HCPCS code removed — effective January 1, 2023HCPCSNot Covered

C9399

Unclassified drugs or biologicals

Ulcerative colitis ICD-10-CM codes added — effective December 16, 2024ICD-10Covered

K51.00
K51.011
K51.012
K51.013
K51.014
K51.018
K51.019
K51.20
K51.211
K51.212

1–10 of 49

1/5

Crohn's disease ICD-10-CM code added — effective September 16, 2024ICD-10Covered

K50.00

Crohn's disease of small intestine without complications

Clinical Context and Definitions

Inflammatory bowel disease (IBD) includes ulcerative colitis and Crohn’s disease. Ulcerative colitis primarily affects the colon and rectum, whereas Crohn’s disease can affect the entire digestive tract and extend deeply into the intestinal wall.

Moderately to severely active ulcerative colitis

StudyINSPIRE phase 3 induction study

Adapted Mayo score5–9

Endoscopic subscore2–3, based on central review

Diagnosis confirmationBiopsy-confirmed ulcerative colitis diagnosed at least 3 months before baseline

Moderately to severely active Crohn's disease

Studies

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyRisankizumab-rzaa (Skyrizi) for Intravenous Use

Policy CodePolicy MA08.153c

Change TypeModified

Effective DateDecember 16, 2024

Next Review DateN/A

Key ActionWhen the member's dose, frequency, or regimen changes, submit the changes to the Company for a new approval.

SourceLink

On This Page

The treatment is prescribed by or in consultation with a gastroenterologist.

There is no concurrent use with any other biologic therapy, including tumor necrosis factor antagonists.

The individual has moderately to severely active Crohn's disease.

The dosage is 600 mg administered by intravenous infusion at Weeks 0, 4, and 8. Maintenance doses are administered by subcutaneous injection.

Immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate.

JAK inhibitors, such as tofacitinib or upadacitinib.

S1P receptor modulators, such as ozanimod.

Concurrent therapy restriction: There is no concurrent use with any other biologic therapy, including tumor necrosis factor antagonists.No concurrent biologic therapy

Induction dose and frequency: Administer 1,200 mg by intravenous infusion at Week 0, Week 4, and Week 8.1,200 mg IV at Weeks 0, 4, and 8

Crohn's Disease Initial Therapy

Crohn's disease induction requires all applicable criteria.

Crohn's disease induction

Age requirement: The individual is 18 years of age or older.Age >=18 years
ONE of the following prior therapy categories
- Corticosteroids, such as budesonide, prednisone, hydrocortisone, or methylprednisolone.
- Immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate.
- Biologic therapy, such as certolizumab, adalimumab, infliximab, ustekinumab, or vedolizumab.
Concurrent therapy restriction: There is no concurrent use with any other biologic therapy, including tumor necrosis factor antagonists.No concurrent biologic therapy
Induction dose and frequency: Administer 600 mg by intravenous infusion at Weeks 0, 4, and 8.600 mg IV at Weeks 0, 4, and 8

JAK inhibitors, such as tofacitinib or upadacitinib.

S1P receptor modulators, such as ozanimod.

Step Therapy

Crohn’s Disease Prior Therapy

For moderately to severely active Crohn’s disease, document failure, contraindication, or intolerance to a trial of at least one required prior-therapy category.

Corticosteroids, such as budesonide, prednisone, hydrocortisone, or methylprednisolone.
Immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate.
Biologic therapy, such as certolizumab, adalimumab, infliximab, ustekinumab, or vedolizumab.

Documentation Required

Medical Necessity Records

Maintain records that establish medical necessity and provide them to the Company upon request, regardless of the provider’s participation status.

Acceptable records may include professional provider office records, hospital records, nursing home records, home health agency records, therapy records, and test reports.
Failure to produce requested information may result in denial of the service.
For dosing outside the policy requirements, include published peer-reviewed literature supporting the request.

Documentation Required

Clinical Criteria Documentation

The clinical record and authorization request must document every applicable coverage criterion for the diagnosed condition, including age, qualifying diagnosis and severity, prior therapy, specialist involvement, biologic use, and the requested dosing schedule.

Member is 18 years of age or older.
Diagnosis is moderately to severely active ulcerative colitis or Crohn’s disease.
Required prior-therapy history is documented: inadequate response, contraindication, or intolerance for ulcerative colitis; or failure, contraindication, or intolerance to at least one required category for Crohn’s disease.
Risankizumab-rzaa is prescribed by or in consultation with a gastroenterologist.
There is no concurrent use with another biologic therapy, including tumor necrosis factor antagonists.
Ulcerative colitis dosing: 1,200 mg by intravenous infusion at Weeks 0, 4, and 8, followed by 180 mg or 360 mg subcutaneously at Week 12 and every 8 weeks thereafter.
Crohn’s disease dosing: 600 mg by intravenous infusion at Weeks 0, 4, and 8; maintenance doses are administered subcutaneously.

Documentation Required

Exception Dosing Support

When requesting coverage for risankizumab-rzaa outside the stated dosing and frequency requirements, submit published peer-reviewed literature that supports the requested amount, interval, or regimen.

The literature must support the specific exception dosing requested.
The Company may use FDA information, recognized pharmacology compendia, and published peer-reviewed clinical research when updating dosing requirements.

Billing Rule

Drug Billing Documentation

If no specific HCPCS code is available for the administered drug, report the most appropriate unlisted code together with the corresponding National Drug Code (NDC).

Include both the applicable unlisted code and corresponding NDC documentation.

Denial Risk

Noncovered or Investigational Use

Risankizumab-rzaa for intravenous use is not covered for uses outside the policy’s covered moderately to severely active ulcerative colitis and Crohn’s disease indications unless the indication qualifies as an accepted off-label use under the Company’s policy for off-label coverage of prescription drugs and biologics.

Other uses are considered experimental/investigational and therefore not covered absent applicable accepted off-label coverage.

Denial Risk

Failure to Meet Clinical Criteria

Coverage may be denied when the request does not satisfy the clinical criteria for age, diagnosis and severity, required prior therapy, gastroenterologist involvement, concurrent biologic restrictions, or approved dosing and frequency.

The member must be 18 years of age or older and have moderately to severely active ulcerative colitis or Crohn’s disease.
Required prior-therapy failure, inadequate response, contraindication, or intolerance must be documented for the applicable condition.
The drug must be prescribed by or in consultation with a gastroenterologist.
Concurrent use with another biologic therapy, including tumor necrosis factor antagonists, is not permitted.
The requested dose and frequency must match the applicable policy requirements unless an exception is supported as required.

Denial Risk

Insufficient Supporting Documentation

A request may be denied when the medical records, requested supporting information, or published literature needed to evaluate medical necessity and exception dosing are not provided.

All documentation must be available to the Company upon request, including records from provider offices, facilities, agencies, therapies, and test reports.
Requests outside the stated dosing and frequency requirements require published peer-reviewed literature supporting the requested dosing.
The Company may review and audit services and claims, including services provided by nonparticipating providers.

ADVANCE and MOTIVATE phase 3 induction studies

Crohn's Disease Activity Index220–450

Simple Endoscopic Score for Crohn's diseaseAt least 6, or at least 4 for isolated ileal disease

Clinical remission in Crohn's disease

Clinical measureCrohn's Disease Activity Index (CDAI)

Remission thresholdCDAI below 150

Study contextDefinition used in the ADVANCE and MOTIVATE studies