CurrentNeighborhood Health Plan of Rhode IslandPolicy 1846-A

Natalizumab (Tysabri/Tyruko) — Coverage Criteria

Policy governing coverage and prior authorization criteria for natalizumab (Tysabri and biosimilar Tyruko) for Crohn's disease and relapsing forms of multiple sclerosis for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNatalizumab (Tysabri/Tyruko) — Coverage Criteria

Policy CodePolicy 1846-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit chart notes or medical records documenting prior medication history and clinical response; ensure anti-JCV antibody testing has been performed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsmax auth duration

2FDA-covered indications

Anti-JCVtesting required

GI/Neuroprescriber specialty

Coverage and Authorization Criteria

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Crohn's disease - Initial: Adult patient with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to or are unable to tolerate conventional Crohn's therapies and inhibitors of tumor necrosis factor alpha (TNF-alpha)n/a

Tysabri/Tyruko should not be used in combination with immunosuppressants

Crohn's disease - Authorization/Continuation: Member has received any other biologic indicated for the treatment of moderately to severely active Crohn's disease and has been tested for anti-JCV antibodies12-month authorization

Continuation requires documentation of clinical response or remission (improvement in symptoms, weight, hematocrit, endoscopic/imaging appearance, or CDAI)

Relapsing MS or CIS - Initial/Authorization: Member diagnosed with a relapsing form of multiple sclerosis (including relapsing-remitting and active secondary progressive disease) or clinically isolated syndrome; tested for anti-JCV antibodies12-month authorization

Must not be used concomitantly with other disease-modifying MS agents or immunosuppressants

For all indications, concomitant use of natalizumab with any other disease‑modifying multiple sclerosis agents or other immunosuppressants is prohibited and may result in denial of coverage. (Non‑disease‑modifying agents such as Ampyra and Nuedexta are exceptions to the ‘disease‑modifying’ classification but do not change the prohibition on immunosuppressants.)

Provider Requirements, Documentation, and Denial Risks

Denial Risk

Insufficient indication / documentation — denial risk

Requests lacking adequate indication or documentation will be denied. Examples include requests for non–FDA‑approved or non‑compendial indications without supporting rationale, absence of required chart notes or medical records, missing documentation of prior medication trials and responses for Crohn's disease initial requests, and lack of documentation of clinical response or remission for continuation requests. Additionally, requests that indicate concomitant use with other disease‑modifying MS agents, immunosuppressants, or other prohibited combination therapies may be denied.

Initial Crohn's requests must include documentation of prior medications tried and response to therapy (chart notes/claims).
Continuation Crohn's requests must include chart notes or medical records documenting positive clinical response or remission.
Anti‑JCV antibody testing required prior to authorization when applicable.
Concomitant use with other disease‑modifying MS agents or immunosuppressants is prohibited and may lead to denial.
Authorization may be granted for 12 months when criteria and documentation are met.

Key Definitions and Testing

Anti-JCV antibody testing — definition/requirement

DefinitionAnti-JCV antibody testing

PurposeAssess risk of progressive multifocal leukoencephalopathy (PML) associated with natalizumab therapy

Authorization impactMembers must be tested for anti-JCV antibodies to be eligible for up to a 12-month prior authorization

Related prescribing considerationPhysicians should consider whether expected benefit of natalizumab is sufficient to offset PML risk when initiating and continuing therapy

Background

Natalizumab (brand names Tysabri and biosimilar Tyruko) is indicated as monotherapy for relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS, and is indicated to induce and maintain response and remission in adults with moderately to severely active Crohn’s disease with evidence of inflammation after inadequate response to or intolerance of conventional therapies and anti‑TNF agents. Treatment carries a risk of progressive multifocal leukoencephalopathy (PML); providers should document consideration of the benefit–risk profile and perform anti‑JCV antibody testing as expected prior to initiation and for ongoing management.

Policy Revision History

2023-08policy_reference_update

Document references Tyruko (biosimilar) package insert August 2023 and Tysabri April 2023 in references; policy lists TYSABRI/TYRUKO and uses reference number 1846-A.

2023authorization_specification

Authorization duration clarified as 12 months for Crohn's disease, relapsing MS, and CIS when criteria met and anti-JCV antibody testing completed.

2023concomitant_therapy_prohibition

Policy explicitly prohibits concomitant use of the drug with other disease-modifying MS agents or immunosuppressants across all indications.

2023document_identifierLatest

Policy assigned reference number 1846-A for Tysabri/Tyruko coverage criteria and dosing/administration guidance.