ModifiedCareSourcePolicy N/A

Multiple Sclerosis and Crohn's Disease - Tysabri Utilization Management Medical Policy

Defines prior authorization, coverage criteria, dosing, and exclusions for Tysabri (natalizumab IV) when used to treat relapsing forms of multiple sclerosis and moderately to severely active Crohn's disease in adults.

Policy Summary

PayerCareSource

PolicyTysabri Utilization Management — MS and Crohn's Disease

Policy CodePolicy N/A

Change TypeOperational appendix updatesmaterial

Effective DateN/A

Next Review DateOct 9, 2024

Key ActionObtain prior authorization with required documentation and specialist prescribing for Tysabri per indication-specific criteria.

SourceLink

POLICY UPDATE CHANGES

Zymfentra was added to the list of biologics for Crohn's disease and infliximab formulation specified as IV; Entyvio and Rinvoq were clarified in exclusions.

Ocrevus Zunovo was added to the Appendix A list of disease-modifying agents used for multiple sclerosis.

1 yrapproval duration MS

6 moapproval duration Crohn's (initial)

300 mgdose per infusion

REMS TOUCHdistribution program

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Coverage Criteria for Tysabri (natalizumab)

Initial and Continuation Therapy — Multiple Sclerosis

Approve for 1 year if the patient meets ONE of the following (A or B):

MS A or B

A) Initial Therapy criteria
- A.iii.a or b: a) According to the prescriber, the patient has experienced inadequate efficacy or significant intolerance to one disease-modifying agent used for multiple sclerosis; OR b) According to the prescriber the patient has highly active or aggressive multiple sclerosis by meeting ONE of the following: (1) rapidly advancing deterioration in physical functioning [documentation required]; (2) disabling relapse(s) with suboptimal response to systemic corticosteroids [documentation required]; (3) MRI findings suggest highly active or aggressive MS [documentation required]; (4) manifestations of MS-related cognitive impairment [documentation required]
  See Appendix A for examples of disease-modifying agents
B.i (Receiving <1 year): Patient receiving Tysabri <1 year: Patient is ≥ 18 years of age; AND Patient has a relapsing form of multiple sclerosis; AND Medication is prescribed by or in consultation with a neurologist or MS specialist
Approve if all met
B.ii (Receiving ≥1 year): Patient receiving Tysabri ≥1 year: Patient is ≥ 18 years of age; AND Patient has a relapsing form of multiple sclerosis; AND Patient meets ONE of the following: (1) demonstrated beneficial clinical response by at least one objective measure; OR (2) stabilization or improvement in at least one symptom compared with baseline; AND Medication is prescribed by or in consultation with a neurologist or MS specialist
Objective measures examples (e.g., loss of relapses, MRI, functional measures) provided in policy companion notes

Initial and Continuation Therapy — Crohn's Disease

Approve for the duration noted below if the patient meets ONE of the following (A or B):

Crohn A or B

A) Initial Therapy criteria: Patient is ≥ 18 years of age; AND Patient has moderately to severely active Crohn's disease; AND Patient has tried at least two biologics for Crohn's disease (each biosimilar from same chemical counts as one product); AND Tysabri is prescribed by or in consultation with a gastroenterologist
Approve for 6 months when all criteria met; refer to Appendix B for examples of biologics
B) Currently Receiving (≥6 months established): Patient has been established on therapy for at least 6 months; AND Patient is ≥ 18 years of age; AND Patient meets at least ONE of the following: (a) when assessed by at least one objective measure the patient experienced a beneficial clinical response from baseline (examples: fecal markers, CRP, imaging, endoscopy); OR (b) compared with baseline the patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool); AND Medication is prescribed by or in consultation with a gastroenterologist
Approve for 1 year when all criteria met; objective measure examples include fecal markers, serum markers, MRE/CTE, endoscopic assessment, or reduced corticosteroid dose

Concurrent administration of Tysabri with other potent immunosuppressive agents, with another biologic, or with targeted synthetic oral small‑molecule drugs used for inflammatory conditions is not recommended due to the risk of added immunosuppression and lack of controlled clinical trial data supporting safety or additive efficacy. Examples of potent immunosuppressants include 6‑mercaptopurine, azathioprine, cyclosporine, and methotrexate, and Appendix B lists additional biologic and targeted agents for reference.

Use of Tysabri in non‑relapsing forms of multiple sclerosis is not recommended. The safety and efficacy of Tysabri have not been established for primary progressive MS, which is an example of a non‑relapsing form of the disease.

Use of Tysabri for ulcerative colitis is not recommended because available efficacy data are limited. The policy therefore does not support coverage for this indication outside of the recommended authorization criteria.

Because Tysabri is associated with an increased risk of progressive multifocal leukoencephalopathy (PML), it is available only through the TOUCH® Prescribing Program. All prescriptions for Tysabri must be provided through the TOUCH REMS program, and clinicians should follow REMS requirements when prescribing and monitoring therapy.

Appendix B is provided for reference and is not an all‑inclusive list of agents or indications. Refer to the respective manufacturers' prescribing information for complete, up‑to‑date FDA‑approved indications and product labeling.

Combination therapy of Tysabri with other multiple sclerosis disease‑modifying agents is not recommended. These agents are not indicated for concurrent use, and insufficient data exist to support safety or additional efficacy from combination therapy.

Coding

No procedure or billing codes in appendixmixed

No codes listed

Appendix B — Listed Biologic and Oral Agents (informational)mixed

Adalimumab SC Products	Humira and biosimilars — examples of indications include AS, CD, JIA, PsO, PsA, RA, UC
Cimzia	certolizumab pegol SC injection — examples of indications include AS, CD, nr-axSpA, PsO, PsA, RA
Etanercept SC Products	Enbrel and biosimilars — examples of indications include AS, JIA, PsO, PsA, RA
Infliximab IV Products	Remicade and biosimilars — examples of indications include AS, CD, PsO, PsA, RA, UC
Zymfentra	infliximab-dyyb SC injection — examples of indications include CD, UC
Simponi / Simponi Aria	golimumab SC injection and IV infusion — examples vary by formulation (AS, PsA, RA, UC, PJIA)
Tocilizumab Products	Actemra IV and SC (and biosimilars) — inhibition of IL-6; indications include PJIA, RA, SJIA
Kevzara	sarilumab SC injection — inhibition of IL-6; indication RA
Orencia	abatacept IV infusion and SC injection — T-cell costimulation modulator; indications include JIA, PsA, RA
Rituximab IV Products	Rituxan and biosimilars — CD20-directed cytolytic antibody; indication RA

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Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for medical benefit coverage of Tysabri per the main policy criteria; approvals are provided for specified durations and require prescriptive and program compliance. However, the appendix chunks do not themselves specify prior authorization codes or automated authorization triggers.

Prior Authorization recommended for Tysabri (see policy criteria and dosing).
Approvals provided for specified durations (e.g., 6 months for initial Crohn's, 1 year for MS when criteria met).
Prescriber requirement: specialist or consultation with specialist for the treated condition (neurologist for MS, gastroenterologist for Crohn's).

Documentation Required

Documentation Required for MS Initiation

Documentation is required at initiation for multiple sclerosis and for some assessments noted in the criteria (e.g., MRI reports, chart notes, objective measures). The appendix provides agent lists and mechanisms but does not enumerate documentation elements.

Definitions and Abbreviations

Relapsing forms of multiple sclerosis — definition

DefinitionRelapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive MS.

TOUCH Prescribing Program — definition

DefinitionTOUCH Prescribing Program: a REMS restricted distribution program required for Tysabri due to risk of progressive multifocal leukoencephalopathy (PML).

TNF — definition and context

DefinitionTNF: Tumor necrosis factor (abbreviated TNF).

ContextReferenced in appendix as a mechanism target for biologics and in indication considerations for Crohn's disease (inhibitors of TNF‑α).

Background

Tysabri (natalizumab) is a monoclonal antibody that acts as an integrin receptor antagonist. It is indicated for treatment of relapsing forms of multiple sclerosis and for induction and maintenance of response in moderately to severely active Crohn's disease in adults who have had inadequate response to or intolerance of conventional therapies and anti‑TNF agents. Use of Tysabri carries a Boxed Warning for PML and its distribution is restricted through the TOUCH REMS program.

Revision History and Policy Changes

2024-10-09annual revisionLatest

Appendix A updated to add Ocrevus Zunovo to the list of disease-modifying agents for multiple sclerosis.

2024-09-11selected revision

Appendix B reorganized: examples of biologics for Crohn's disease moved from a note to Appendix B; concurrent-use exclusion language updated to specify concurrent use with a biologic or a targeted synthetic oral small molecule is not allowed.

2023-11-15