Cigna Tysabri Prior Auth Policy Update

Coverage Criteria

Multiple Sclerosis

Tysabri is considered medically necessary for Multiple Sclerosis when ONE of the following is met (1 or 2):

1. Multiple Sclerosis - Initial Therapy

Age and diagnosis: Patient is >= 18 years of age AND documentation the patient has a relapsing form of multiple sclerosis
Examples: clinically isolated syndrome, relapsing remitting, active secondary progressive
Prior therapy or disease activity: Patient has experienced inadequate efficacy or significant intolerance to one disease-modifying agent used for MS OR prescriber states the patient has highly active or aggressive MS
If highly active/aggressive, meet one of: rapidly advancing deterioration in physical functioning; disabling relapses with suboptimal steroid response; MRI suggesting highly active disease; MS-related cognitive impairment
Prescriber requirement: Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

1. Multiple Sclerosis - Currently Receiving Tysabri

Receiving <1 year: Patient has been receiving Tysabri for < 1 year AND is >= 18 AND documentation of relapsing form of MS AND medication prescribed by/with neurologist
Approve
Receiving >=1 year: Patient has been receiving Tysabri >= 1 year AND is >= 18 AND documentation of relapsing form of MS AND patient meets one of clinical benefit criteria AND prescribed by/with neurologist
Clinical benefit defined by objective measures (e.g., MRI, EDSS, NEDA) or symptom stabilization/improvement

Dosing: Approve up to 300 mg IV no more frequently than once every 4 weeks

Crohn's Disease

Tysabri is considered medically necessary for Crohn's disease when ONE of the following is met (2.A or 2.B):

2.A Crohn's - Initial Therapy

Age and disease severity: Patient is >= 18 years of age AND has moderately to severely active Crohn's disease
Prior biologic trials: Patient has tried at least two biologics for Crohn's disease (biosimilars from same chemical count as one trial)
Refer to Appendix B for examples
Prescriber requirement: Medication is prescribed by or in consultation with a gastroenterologist

2.B Crohn's - Currently Receiving

Appendix drug inclusion

Appendices list included drugs and their mechanisms/indications; full medical necessity criteria not present in this extract.

Appendix inclusion: Drug is listed in Appendix A or Appendix B of policy IP0690

Listing implies subject to policy rules elsewhere in the document

Use of Tysabri (natalizumab) for ulcerative colitis is not covered. The policy explicitly lists ulcerative colitis among conditions for which efficacy data are limited and the drug is considered experimental or unproven. Concurrent administration of Tysabri with other potent immunosuppressants (for example, 6-mercaptopurine, azathioprine, cyclosporine, methotrexate), with another biologic, or with a targeted synthetic oral small molecule for an inflammatory condition is also not recommended and is considered unproven due to safety concerns and lack of controlled evidence.

Any use of Tysabri that is not specifically listed as medically necessary in this policy — including the concurrent combination therapies described below — is considered experimental, investigational, or unproven and therefore not covered. Examples called out in the policy include: concurrent use with other potent immunosuppressants, concurrent use with another biologic or a targeted synthetic oral small molecule for inflammatory conditions, and concurrent use with other disease-modifying agents for multiple sclerosis.

Coding and Dosing

Covered HCPCS CodesHCPCSCovered

J2323

Injection, natalizumab, 1 mg

Appendix A drug listing (no billing codes provided)mixed

No codes listed

Appendix B biologics/mechanisms and example indications (no billing codes provided)mixed

No codes listed

inv-11: Dosing interval — natalizumab

Dosing interval300 mg IV infusion no more frequently than once every 4 weeks

inv-12: Coding — placeholder

Coding

Provider Actions & Authorization Requirements

Note

No Denial Triggers in This Section

No denial triggers are present in this portion of the policy. Providers should still follow the listed prior authorization, documentation, and specialty prescriber requirements to avoid administrative delays.

Prior Authorization

Prior Authorization & Prescriber Specialty Requirement

Prior authorization is required for Tysabri. Approvals are granted for the durations specified in the FDA‑Approved Indications (e.g., 1 year for multiple sclerosis when criteria are met; initial Crohn's disease approvals for 6 months). Prescriptions must be written by or in consultation with a specialist who treats the condition (e.g., neurologist for MS, gastroenterologist for Crohn's disease).

Approval durations: 1 year for MS (when criteria met); 6 months initial for Crohn's disease; 1 year for continuing Crohn's therapy when criteria met.
Prescriber specialty required: neurologist or MS specialist for MS; gastroenterologist for Crohn's disease.

Background

Tysabri (natalizumab) is an integrin receptor antagonist indicated for relapsing forms of multiple sclerosis and for inducing and maintaining response/remission in moderately to severely active Crohn's disease. The agent carries important safety considerations, including increased risk of progressive multifocal leukoencephalopathy (PML), and is managed under restricted distribution programs; policy context and exclusions note that it should not be used in combination with immunosuppressants or TNFα inhibitors.

Definitions

inv-22: Relapsing forms of multiple sclerosis

DefinitionRelapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults

inv-23: Moderately to severely active Crohn's disease

DefinitionModerately to severely active Crohn's disease: Crohn's disease with objective evidence of inflammation in adults who have had an inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies and inhibitors of TNFα

Prior biologic requirementInitial therapy requires the patient to have tried at least two biologics for Crohn's disease (each biosimilar from the same chemical counts as one trial)

Age requirementPatient must be ≥ 18 years of age for initial Crohn's disease therapy

Initial Therapy Criteria

Initial Therapy

Initial therapy criteria for MS and Crohn's disease

MS initial: Patient >=18; relapsing form of MS; prior inadequate efficacy or intolerance to one disease-modifying agent OR highly active/aggressive MS as defined; prescribed by/with neurologist

Approve for 1 year

Crohn's initial: Patient >=18; moderately to severely active Crohn's disease; tried at least two biologics for Crohn's disease; prescribed by/with gastroenterologist

Approve for 6 months

Continuation / Maintenance Criteria

Continuation Therapy

Continuation/maintenance criteria for current Tysabri recipients

MS continuation <1 year: Patient has been receiving Tysabri <1 year AND is >=18 AND has relapsing MS AND medication prescribed by/with neurologist

Approve (see MS criteria)

MS continuation >=1 year: Patient has been receiving Tysabri >=1 year AND is >=18 AND has relapsing MS AND shows benefit by objective measure or symptom stabilization/improvement AND medication prescribed by/with neurologist

Approve

Crohn's continuation: Patient has been established on therapy >=6 months AND is >=18 AND shows benefit by at least one objective measure or symptom improvement compared with baseline AND medication prescribed by/with gastroenterologist

Approve for 1 year

Step Therapy Requirements

Step	Requirement
1	Patient must have tried at least two biologic therapies for Crohn's disease (each biosimilar from the same chemical counts as one trial).

Step	Description
1	Initial step for Crohn's disease: see criteria for Initial Therapy (approve for 6 months when all initial therapy requirements are met).

Quantity Limits

inv-31: natalizumab — maximum dose per infusion: 300 mg

Maximum dose per infusion300 mg per infusion

Dosing frequencyAdministered by IV infusion no more frequently than once every 4 weeks

Site of Care

Billing Rule

Infusion site of care and specialist requirement

Infusion dosing and monitoring for Tysabri require an appropriate clinical setting (infusion center, hospital outpatient, or office). Approval requires the medication be prescribed by or in consultation with a specialist (neurologist for MS; gastroenterologist for Crohn's).

Dosing is up to 300 mg IV no more frequently than once every 4 weeks; site of care should be clinically appropriate and supported by evidence.
Specialist prescribing or consultation is required for authorization.

Biosimilar Information