CurrentUnitedHealthcarePolicy CSINDO066.05

Ilaris (Canakinumab) (Indiana-only) Medical Benefit Drug Policy

Defines UnitedHealthcare Community Plan medical benefit coverage guidance for canakinumab (Ilaris) for members in Indiana and explains reliance on InterQual specialty pharmacy criteria for medical necessity determinations.

Policy Summary

PayerUnitedHealthcare

PolicyIlaris (Canakinumab) (Indiana-only) Medical Benefit Drug Policy

Policy CodePolicy CSINDO066.05

Change TypeRoutine reviewno material changes

Effective DateDec 1, 2024

Next Review Date

Key ActionObtain prior authorization using HCPCS J0638 and ensure treatment meets InterQual CP: Specialty Rx Non-Oncology Canakinumab criteria.

SourceLink

POLICY UPDATE CHANGES

Routine review; no content changes.

J0638HCPCS code listed for canakinumab

IndianaState scope

InterQualClinical criteria source

Coverage Criteria

InterQual-based Medical Necessity

Covered when InterQual CP: Specialty Rx Non-Oncology, Canakinumab (Ilaris) criteria are met.

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InterQual-based coverage: Member meets all clinical criteria as defined in the current InterQual guideline for canakinumab (Ilaris)per InterQual

Refer to InterQual for specific indication, dosing, prior therapy failures, and monitoring requirements

This policy does not list any explicit exclusions for canakinumab (Ilaris). Coverage determinations, including any exclusions that may apply, are governed by federal, state, and contractual requirements as well as applicable laws and other UnitedHealthcare policies that may affect coverage.

Treatment requests that do not meet the clinical criteria specified in the referenced InterQual guideline (CP: Specialty Rx Non-Oncology, Canakinumab (Ilaris)) or that conflict with applicable plan, federal, or state contractual requirements will be considered not medically necessary for the purposes of benefit determination.

Coding

Applicable HCPCS CodesHCPCS

J0638

Injection; canakinumab, mg

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Coverage is determined using the current InterQual Specialty Rx Non‑Oncology: Canakinumab (Ilaris) criteria; submit a prior authorization request per UnitedHealthcare procedures and include all requested clinical documentation.

Applicable code: HCPCS J0638 (Injection; canakinumab, mg)

Denial Risk

Denial Risk if InterQual Criteria Not Met

If the requested treatment does not meet the referenced InterQual criteria for medical necessity, the request may be denied. Providers should review InterQual requirements before submission to reduce the risk of denial.

Documentation Required

Documentation of Benefit and Guideline Alignment

Document and retain evidence that coverage decisions align with the member's federal, state, or contractual benefit requirements and with the InterQual guideline referenced in this policy. Include clinical rationale, prior therapy history, relevant labs/imaging, and InterQual-specific data elements when submitting authorization requests.

Step Therapy

InterQual-Directed Step Therapy

Follow InterQual-directed step therapy or sequencing requirements as specified in the InterQual guideline; such requirements may include trials of specific therapies, documented intolerance, or contraindications before approving canakinumab.

Initial Therapy Criteria

Initial therapy

Initial coverage decisions follow the InterQual CP: Specialty Rx Non-Oncology, Canakinumab (Ilaris) criteria.

Initial therapy authorization: Initial use must meet InterQual-specified indications, prior therapy requirements, and dosing parametersper InterQual

Prior authorization using HCPCS J0638 is expected; follow InterQual for any step therapy or sequencing requirements

Step Therapy / Sequencing

Step	Requirement
1	Follow the InterQual CP: Specialty Rx Non‑Oncology, Canakinumab (Ilaris) sequencing and step requirements as specified in the current InterQual guideline for medical necessity determinations.

Background

Canakinumab (Ilaris) coverage and medical necessity determinations rely on the current release of the InterQual CP: Specialty Rx Non-Oncology guideline. Refer to the InterQual criteria for the specific indications, dosing, prior therapy requirements, and monitoring that define when use of Ilaris is considered medically necessary.

Definitions

InterQual guideline referenced for medical necessity

InterQual guidelineInterQual CP: Specialty Rx Non-Oncology, Canakinumab (Ilaris)

Role in medical necessityDefines the clinical coverage criteria used to determine medical necessity for canakinumab (Ilaris)

Source versioningCoverage determinations reference the current release of the InterQual guideline

AccessInterQual criteria are referenced in the policy (link provided in source) for specific indications, dosing, prior therapy failures, and monitoring

ScopeUsed for medical benefit determinations within this UnitedHealthcare Community Plan policy for Indiana members

Site of Care

Note

Follow benefit, regulatory, and InterQual site-of-care rules for infusion

Site-of-care determinations (including infusion center use) must follow the member’s benefit plan, any applicable federal/state/contractual requirements, and InterQual guidance when applicable.