CurrentCignaPolicy IP0560

Teriflunomide for Individual and Family Plans

Prior authorization and coverage criteria for teriflunomide (Aubagio and generic) for treatment of relapsing forms of multiple sclerosis for members on Cigna individual and family plans.

Policy Summary

PayerCigna

PolicyTeriflunomide for Individual and Family Plans

Policy CodePolicy IP0560

Change TypeMaterial and non-material updates

Effective DateNov 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation; prescriptions must be by or in consultation with a neurologist or MS specialist.

SourceLink

POLICY UPDATE CHANGES

Added a specialist prescribing requirement.

Added criteria for patients currently receiving teriflunomide for 6 1 year.

Added a definition for documentation.

Updated the preferred product multi-source brand language to current standards.

Ocrevus Zunovo was added to the Appendix.

PA requiredteriflunomide coverage

1 yearapproval duration

Hepatotoxicity/Embryofetalboxed warning

Individual & Familyline of business

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Coverage Criteria for Teriflunomide

FDA-Approved Indication - Initial Therapy

Approve for 1 year if the patient meets ALL of the following (i, ii and iii):

Initial Therapy Criteria: i. Patient has a relapsing form of multiple sclerosis; AND

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

Initial Therapy Criteria: ii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis; AND

Initial Therapy Criteria: iii. Preferred product criteria is met for the product(s) as listed in the below table(s).

FDA-Approved Indication - Patient Currently Receiving Teriflunomide ≥ 1 Year

Approve for 1 year if the patient meets ALL of the following (i, ii, and iii):

Continuation Criteria: i. Patient has a relapsing form of multiple sclerosis; AND

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

Continuation Criteria: ii. Patient meets one of the following (a or b):

ONE of: a) Patient experienced a beneficial clinical response when assessed by at least one objective measure; OR b) Patient experienced stabilization, slowed progression, or improvement in at least one symptom such as motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, or pain/numbness/tingling sensation;

Objective measures may include MRI changes (absence or decrease in gadolinium-enhancing lesions, decrease in new or enlarging T2 lesions), EDSS, NEDA criteria (NEDA-3 or NEDA-4), FSIQ-RMS, reduction/absence of relapses, six-minute walk test or 12-Item MS Walking Scale, MSFC score, and/or attenuation of brain volume loss.

Continuation Criteria: iii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.

Concurrent use of teriflunomide with other disease-modifying agents for multiple sclerosis (combination therapy) is not covered. The policy states these agents are not indicated for use in combination and refers to the Appendix for examples. Additional data are required to determine whether combining disease-modifying therapies is safe and provides added efficacy.

Teriflunomide is not covered for non-relapsing forms of multiple sclerosis. The policy specifies that the efficacy of teriflunomide has not been established in patients with non-relapsing MS (for example, primary progressive multiple sclerosis).

Use of teriflunomide for any indication other than relapsing forms of multiple sclerosis is considered not medically necessary. The policy notes this list of non-covered uses may not be exhaustive and will be updated as new published data become available.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required; 1-year approvals with specialist prescribing

Prior authorization is required for teriflunomide. Approvals are provided for 1 year when the initial or continuation criteria are met, and the medication must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.

Step Therapy

Preferred product / generic-try requirement for Aubagio

For Individual and Family Plans, the brand Aubagio requires prior authorization and the bioequivalent generic teriflunomide tablets must be tried unless the patient cannot take the generic because of a formulation difference in an inactive ingredient that would result in a significant allergy or serious adverse reaction.

Documentation Required

Submit documentation supporting diagnosis and policy criteria

Prior authorization requests must be submitted with documentation supporting the diagnosis and demonstrating that the patient meets the policy criteria; plan documents may supersede policy guidance.

Denial Risk

Denial risk if claims lack covered codes

Claims submitted without covered diagnosis or procedure codes under the Coverage Policy will be denied as not covered; when billing, providers must use the most appropriate codes as of the effective date of submission.

Definitions

Relapsing forms of multiple sclerosis — includes clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease

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

Clinical course examplesClinically isolated syndrome is the first clinical presentation that may represent MS but has not yet met full diagnostic criteria; relapsing‑remitting and active secondary progressive disease are other relapsing forms.

Typical onset and prevalenceMost patients present between ages 20–40; approximately 85%–90% have a relapsing pattern at onset.

Relevance to teriflunomide coverageTeriflunomide is indicated for treatment of relapsing forms of MS (as defined above) in adults and coverage criteria apply to these diagnoses.

Distinction from non‑relapsing MSPrimary progressive MS (a steady progression without relapses) is not a relapsing form and is listed separately in disease course descriptions.

Aubagio	teriflunomide tablets (brand)
teriflunomide (generic)	teriflunomide tablets (bioequivalent generic)
Ocrevus Zunovo	ocrelizumab and hyaluronidase-ocsq subcutaneous injection (added to Appendix)

OpenPayer

Teriflunomide for Individual and Family Plans

Coverage Criteria for Teriflunomide

Products and Appendix / Coding

Provider Actions, Prior Authorization, and Documentation

Definitions

Background