CurrentUnitedHealthcarePolicy CSOH2026D0026.D

Tysabri (Natalizumab) — Ohio Medical Benefit Drug Policy

This policy governs medical benefit coverage and medical necessity evaluation for natalizumab (Tysabri) for members in the state of Ohio; it references use of InterQual criteria and Ohio Administrative Code for determinations.

Policy Summary

PayerUnitedHealthcare

PolicyTysabri (Natalizumab) — Ohio Medical Benefit Drug Policy

Policy CodePolicy CSOH2026D0026.D

Change TypeRoutine review (no content changes)

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization aligned with the current InterQual guideline for Natalizumab when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

Routine review; no content changes.

Ohio-onlyapplicability

InterQual referencedclinical criteria

J2323billing code

2026-06-01effective

Coverage and Medical Necessity Criteria

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The codes listed in this policy are provided for reference only. Listing a code does not imply that the service described by the code is covered or reimbursable. Benefit coverage for health services is determined by federal, state, or contractual requirements and applicable laws, which may mandate coverage for a specific service. Inclusion of a code in this policy does not guarantee payment.

Requests for services described as unproven or for which coverage or quantity limits apply will be evaluated under Ohio Administrative Code 5160-1-01 and the InterQual® clinical criteria. Services that do not meet the InterQual criteria or Ohio OAC medical necessity requirements may be considered not medically necessary and handled per policy.

Initial Authorization Requirements

Initial Therapy

Initial authorization is provided when the member meets the InterQual initial therapy criteria for natalizumab.

Initial authorization: Member meets InterQual initial therapy criteria for natalizumabsee InterQual

Policy refers to InterQual for specifics.

Step	Requirement
1	Any step therapy requirements are determined by the current InterQual guideline for Natalizumab (Tysabri); the policy defers to InterQual for specific sequencing or step requirements.

Provider Requirements and Decision Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for services governed by this policy. Coverage and medical necessity determinations are based on the current InterQual® criteria for natalizumab (Tysabri®). Providers must obtain authorization before initiating therapy when prior authorization applies under the member’s benefit plan.

Refer to the current InterQual® guideline: CP: Specialty Rx Non-Oncology, Natalizumab (Tysabri®).
Prior authorization requirements may vary by benefit plan; verify member-specific requirements prior to submission.

Step Therapy

Step Therapy (Per InterQual)

Step therapy and any required sequencing of therapies are governed by the InterQual® criteria referenced in this policy. The policy defers to InterQual for the specific clinical criteria that define required prior treatments, duration of prior therapy, and criteria for treatment failure or intolerance that allow progression to natalizumab.

Follow InterQual-defined step-therapy pathways and required documentation of prior agents and response.
If InterQual indicates step therapy is not required for a specific scenario, document clinical rationale per InterQual guidance.

Documentation Required

Documentation and Decision Sources

When requesting coverage or submitting documentation, reference and include any applicable federal, state (Ohio Administrative Code), or contractual requirements that may affect benefit determination. In Ohio, OAC 5160-1-01 may be used to evaluate services stated as unproven or subject to coverage/quantity limits. In the event of a conflict, federal, state (OAC), or contractual requirements govern.

Include member-specific contractual or state-mandated documentation when applicable.
For requests flagged as unproven or outside InterQual guidance, include supporting clinical evidence and reference OAC 5160-1-01 when applicable.

Denial Risk

Denial Triggers and Risks

Requests for services that are unproven or that fall outside the InterQual criteria or applicable Ohio Administrative Code requirements will be evaluated and may be denied. Lack of adequate documentation, failure to follow InterQual step-therapy requirements, or not meeting OAC/contractual criteria are common triggers for denial.

Ensure complete clinical documentation demonstrating how criteria are met per InterQual (including prior therapy history where required).
Provide rationale and supporting evidence for any request that deviates from InterQual guidance or contractual/state requirements.

Site-of-Care and Benefit-Specific Settings

Note

Infusion center site-of-care governed by plan/regulation

Site-of-care or benefit plan-specific settings for infusion (infusion center) may be governed by the member's federal, state (OAC), or contractual requirements; check those requirements before scheduling or billing.

Verify the member's plan and any federal/state (OAC) rules that may dictate site-of-care limitations or coverage.
Do not assume this policy supersedes contractual or regulatory site-of-care requirements.

Definitions and Reference Criteria

InterQual criteria

Clinical criteria sourceInterQual guideline for Tysabri (Natalizumab): CP: Specialty Rx Non-Oncology, Natalizumab (Tysabri)

Coverage determinationCovered when the member meets the specific clinical criteria enumerated in the current InterQual guideline for Tysabri (Natalizumab)

Where to find detailsRefer to the current release of the InterQual guideline for Tysabri for medical necessity clinical coverage criteria

Policy relianceThis policy defers to InterQual for the detailed clinical pathways and authorization requirements for natalizumab

Applicable useUsed to determine medical necessity for Tysabri (natalizumab) under this UnitedHealthcare policy

Clinical Background

Tysabri (natalizumab) is a monoclonal antibody indicated for certain conditions and is considered proven and medically necessary when the member meets the clinical criteria in the current InterQual® guideline for Tysabri (Natalizumab). UnitedHealthcare relies on the InterQual specialty guideline (CP: Specialty Rx Non-Oncology, Natalizumab) to define medical necessity and to guide prior authorization and clinical coverage decisions.