CurrentUnitedHealthcarePolicy CSOH2O25D0055.B

Respiratory Interleukins (Cinqair, Fasenra & Nucala) (Ohio Only)

Medical benefit drug policy governing use and medical necessity evaluation of benralizumab (Fasenra), reslizumab (Cinqair), and mepolizumab (Nucala) administered SC or IV for members covered under UnitedHealthcare in Ohio.

Policy Summary

PayerUnitedHealthcare

PolicyRespiratory Interleukins (Cinqair, Fasenra & Nucala) (Ohio Only)

Policy CodePolicy CSOH2O25D0055.B

Change TypeMaterial updates and coding removals

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization per this Medical Benefit Drug Policy and reference the Ohio Department of Medicaid Unified Preferred Drug List Criteria for clinical coverage and benefit routing.

SourceLink

POLICY UPDATE CHANGES

Coverage Rationale added language indicating Cinqair, Fasenra and Nucala are considered medically necessary in certain circumstances and for medical necessity clinical coverage criteria for non-oncology indications refer to the Ohio Department of Medicaid Unified Preferred Drug List Criteria.

Removed list of applicable HCPCS codes: J0517, J2182, and J2786.

Updated reference link to the Ohio Department of Medicaid Unified Preferred Drug List Criteria (no change to policy guidelines).

3drugs referenced

Ohio-onlystate applicability

Updatedrecent revision activity

Medical Necessity and Coverage Rules

Policy Summary

PayerUnitedHealthcare

PolicyRespiratory Interleukins (Cinqair, Fasenra & Nucala) (Ohio Only)

Policy CodePolicy CSOH2O25D0055.B

Change TypeMaterial updates and coding removals

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization per this Medical Benefit Drug Policy and reference the Ohio Department of Medicaid Unified Preferred Drug List Criteria for clinical coverage and benefit routing.

SourceLink

On This Page

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Medical necessity (non-oncology indications)

Covered when the following external criteria are met

Primary coverage logic: Cinqair, Fasenra, and Nucala are considered medically necessary in certain circumstances for non-oncology indications when the clinical coverage criteria in the Ohio Department of Medicaid Unified Preferred Drug List Criteria are satisfied.refer to Ohio Department of Medicaid Unified Preferred Drug List Criteria

Policy defers to the Ohio Medicaid PDL for specific initial and continuation criteria; InterQual may be used administratively per UnitedHealthcare guidance.

Policy language was revised to remove the prior statement that Cinqair (reslizumab), Fasenra (benralizumab), and Nucala (mepolizumab) were "proven and medically necessary" per InterQual criteria. The Coverage Rationale now states that these agents are considered medically necessary in certain circumstances, and directs providers to the Ohio Department of Medicaid Unified Preferred Drug List Criteria for the specific clinical entry and continuation requirements for non-oncology indications.

Requests for services that are described as unproven, or requests for services that do not meet the referenced clinical criteria, will be evaluated for medical necessity using Ohio Administrative Code 5160-1-01. Such services may be determined not medically necessary if they fail to meet OAC 5160-1-01 or applicable clinical coverage criteria referenced in this policy.

Prior Authorization, Documentation, and Provider Instructions

Prior Authorization

Prior authorization and benefit routing

Prior authorization decisions follow this Medical Benefit Drug Policy and require reference to the Ohio Department of Medicaid Unified Preferred Drug List Criteria; Fasenra and Nucala obtained for self-administration are processed under the pharmacy benefit.

Prior authorization determined per this Medical Benefit Drug Policy
Reference Ohio Department of Medicaid Unified Preferred Drug List Criteria for clinical coverage
Fasenra and Nucala for self-administration are obtained under the pharmacy benefit

Step Therapy

Step therapy reference — follow Ohio Medicaid PDL

Clinical coverage and any step therapy requirements are defined by the Ohio Department of Medicaid Unified Preferred Drug List Criteria; providers must follow that external preferred drug list for step therapy rules.

Policy refers providers to Ohio Medicaid PDL for clinical coverage and potential step therapy requirements

Documentation Required

Required supporting documentation

Providers must reference applicable federal, state (Ohio Administrative Code), or contractual benefit requirements and may need to submit documentation supporting medical necessity as specified by the Ohio Department of Medicaid Unified Preferred Drug List Criteria.

Check federal, state (OAC), or contractual requirements for benefit plan coverage
Provide documentation supporting medical necessity per Ohio Medicaid PDL when requested

Denial Risk

Denial triggers — OAC 5160-1-01 and referenced criteria

Requests described as unproven or those that exceed coverage or quantity limits will be evaluated for medical necessity using Ohio Administrative Code 5160-1-01; failure to meet referenced clinical criteria may lead to denial.

Services stated as unproven may be determined not medically necessary
Requests exceeding coverage or quantity limits evaluated under OAC 5160-1-01

Background

This policy covers specialty pharmacy biologic agents benralizumab (Fasenra), reslizumab (Cinqair), and mepolizumab (Nucala) used for respiratory indications. These products may be administered either subcutaneously or intravenously depending on the agent and indication. For benefit routing: Fasenra and Nucala obtained for patient self-administration are supplied under the pharmacy benefit, while Cinqair is administered in the medical setting. Clinical coverage criteria for non-oncology indications reference the Ohio Department of Medicaid Unified Preferred Drug List Criteria; UnitedHealthcare may use InterQual as an administrative tool where applicable.

Definitions and Administration Notes

Self-administration — definition and routing

DefinitionUse of Fasenra (benralizumab) and Nucala (mepolizumab) obtained and administered under the pharmacy benefit by the patient according to prescribing instructions.

Products referencedFasenra (benralizumab); Nucala (mepolizumab).

Benefit routingSelf-administered Fasenra and Nucala are obtained under the pharmacy benefit (not the medical benefit).

Administration routeSelf-administration per manufacturer/prescribing instructions (subcutaneous).

Coverage noteFasenra and Nucala are considered medically necessary in certain circumstances when referenced clinical criteria are satisfied.

OpenPayer

Respiratory Interleukins (Cinqair, Fasenra & Nucala) (Ohio Only)

Medical Necessity and Coverage Rules

Coding and Billing Notes

Prior Authorization, Documentation, and Provider Instructions

Background

Definitions and Administration Notes

J0517	previously listed HCPCS code (removed)
J2182	previously listed HCPCS code (removed)
J2786	previously listed HCPCS code (removed)