CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tysabri Tyruko 1846 A Sgm P2023A

Defines prior authorization criteria, documentation, prescriber specialties, duration of approval, concomitant therapy exclusions, and dosing reference guidance for Tysabri and biosimilar Tyruko for adult Crohn's disease and relapsing forms of multiple sclerosis (including clinically isolated syndrome).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTysabri Tyruko 1846 A Sgm P2023A

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit chart notes or medical record documentation supporting prior medication trials and response for initial Crohn's requests; for continuation, submit documentation of positive clinical response or remission and ensure anti‑JCV antibody testing is documented.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes

2Covered therapeutic areas

12 monthsTypical authorization length

1Required test (anti-JCV antibodies)

Coverage Summary

Coverage stance: covered_with_criteria. Covered indications: FDA-approved uses for natalizumab (Tysabri and biosimilar Tyruko) including adult moderately to severely active Crohn's disease (with prior biologic use) and relapsing forms of multiple sclerosis, including clinically isolated syndrome. Typical authorization length: 12 months. Scope summary: defines prior authorization criteria, required documentation and prescriber specialties, duration of approval, concomitant therapy exclusions, and dosing reference guidance for Tysabri and Tyruko for adult Crohn's disease and relapsing forms of multiple sclerosis (including clinically isolated syndrome).

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Continuation Therapy Criteria (Maintenance)

Criteria for Continuation (Maintenance) Approval

Authorization of 12 months may be granted for continuation when ALL of the following are met:

ALL of the following

For Crohn's disease: Chart notes or medical record documentation supporting positive clinical response to therapy or remission
For Crohn's disease: Positive clinical response may be evidenced by low disease activity or improvement in signs and symptoms, demonstrated by improvement in any of the following from baseline: abdominal pain or tenderness; diarrhea; body weight; abdominal mass; hematocrit; appearance of the mucosa on endoscopy, CTE, MRE, or intestinal ultrasound; improvement on a disease activity scoring tool (e.g., CDAI score)
Examples of evidence listed
For MS or CIS: Documentation of disease stability or improvement while on therapy
Member has been tested for anti-JCV antibodies (ongoing requirement)

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization submission requirements

Submit chart notes, medical record documentation, or claims history supporting prior medication trials and response for initial Crohn's disease requests. For continuation requests, submit chart notes or medical record documentation supporting positive clinical response to therapy or remission.

Documentation Required

Anti-JCV antibody testing required

Members must be tested for anti-JCV antibodies prior to approval. Testing is required both at initiation and ongoing for continuation of therapy.

Documentation Required

Prescriber specialty requirement

The medication must be prescribed by or in consultation with the appropriate specialist: a gastroenterologist for Crohn's disease or a neurologist for multiple sclerosis.

Denial Risk

Concomitant therapy exclusion

Claims may be denied if the member is using the requested drug concomitantly with any other disease-modifying multiple sclerosis agents (Ampyra and Nuedexta excepted), immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, methotrexate), or TNF inhibitors (e.g., adalimumab, infliximab).

Clinical Evidence & Safety Considerations

Evidence and references include the Tysabri package insert (April 2023) and the Tyruko package insert (August 2023), multiple society guideline and systematic review citations (including ACG and AGA guidance and an evidence-based systematic review on IBD therapies). Safety note: Tysabri and Tyruko increase the risk of progressive multifocal leukoencephalopathy (PML); see the policy definition for PML and consider anti‑JCV antibody testing prior to and during therapy.

Definitions

PML (Progressive multifocal leukoencephalopathy)A known increased risk associated with Tysabri/Tyruko treatment

CDAI (Crohn's Disease Activity Index)A disease activity scoring tool used to assess clinical response or improvement in Crohn's disease

Background

Background: This policy covers FDA‑approved uses of natalizumab (Tysabri and biosimilar Tyruko) for moderately to severely active Crohn's disease in adults (with prior biologic use required per criteria) and for relapsing forms of multiple sclerosis including clinically isolated syndrome. The policy highlights the increased risk of progressive multifocal leukoencephalopathy (PML) associated with Tysabri/Tyruko and requires anti‑JCV antibody testing prior to initiation and for ongoing treatment; prescriber specialty and documentation requirements are specified for approvals.