CurrentCignaPolicy IP0252

Teriflunomide for Employer Plans: Standard/ Performance, Value/Advantage, Legacy, Total Savings Prescription Drug Lists

Cigna coverage policy governing prior authorization and medical necessity criteria for teriflunomide (Aubagio and generic) for treatment of relapsing forms of multiple sclerosis for employer plans.

Policy Summary

PayerCigna

PolicyTeriflunomide for Employer Plans: Standard/ Performance, Value/Advantage, Legacy, Total Savings Prescription Drug Lists

Policy CodePolicy IP0252

Change TypeCriteria additions and prescribing requirement

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and ensure teriflunomide is prescribed 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 ≥ 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.

Removed Extavia from the Appendix.

Policy name changed to add 'Oral - Other' and a policy statement was added.

PA requiredcoverage requirement

1 yrapproval length

2boxed warnings

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Combination use & non-relapsing MS

non-covered conditions

Employer onlybrand exception

Coverage Criteria for Teriflunomide

Initial Therapy — Approve for 1 year if ALL of the following are met

Approve for 1 year if ALL of the following are met

Initial Therapy criteria: i. Patient has a relapsing form of multiple sclerosis; AND ii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis; AND iii. Preferred product criteria is met for the product(s) as listed in the below table(s).

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

Currently Receiving Teriflunomide ≥ 1 Year — Approve for 1 year if ALL of the following are met

Approve for 1 year if ALL of the following are met

Continuation criteria: i. Patient has a relapsing form of multiple sclerosis; AND ii. Patient meets one of: (a) experienced a beneficial clinical response when assessed by at least one objective measure OR (b) experienced stabilization, slowed progression, or improvement in at least one symptom (e.g., motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, pain/numbness/tingling); AND iii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.

Examples of objective measures include MRI (gadolinium enhancing lesions, new/enlarging T2 lesions), EDSS stabilization or improvement, NEDA criteria, relapse reduction, MSFC, walking tests, or attenuation of brain volume loss.

Concurrent use of teriflunomide with other disease-modifying agents for multiple sclerosis is not covered. These agents are not indicated for combination use and additional data are required to determine whether combination therapy is safe or provides added efficacy. See the Appendix for examples of disease‑modifying agents not intended for concurrent use.

Use of teriflunomide (Aubagio and generic) for indications other than relapsing forms of multiple sclerosis is considered not medically necessary. The efficacy of teriflunomide has not been established for non‑relapsing forms of MS (for example, primary progressive MS).

Drugs, Appendix, and Coding

Drugs and Appendix productsmixed

Aubagio	teriflunomide tablets - Genzyme/Sanofi (brand)
teriflunomide tablets (generic)	bioequivalent generic product
Ocrevus Zunovo	ocrelizumab and hyaluronidase-ocsq (added to Appendix)

inv-06: Approval duration

Approval duration1 year

Applies toInitial therapy and continuation (currently receiving ≥ 1 year)

Authorization frequencyApprovals are provided for the duration noted (1 year) and require renewal thereafter

Provider Requirements and Administrative Actions

Prior Authorization

Prior Authorization Required

Prior authorization required for teriflunomide. Approvals are provided for 1 year. Teriflunomide must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.

Approval duration: 1 year
Prescriber requirement: neurologist or MS specialist
Prior authorization required

Step Therapy

Brand Exception for Employer Plans

For employer-sponsored plans only: a brand exception (Aubagio) is allowed when the patient has tried the bioequivalent generic teriflunomide tablets and cannot take the generic due to a formulation difference in inactive ingredient(s) that would cause a significant allergy or serious adverse reaction. Prior authorization is required for the brand exception.

Applies to employer plans only

Background

Teriflunomide is an oral disease‑modifying therapy indicated for relapsing forms of multiple sclerosis in adults. Multiple sclerosis is a chronic inflammatory demyelinating autoimmune disorder of the central nervous system with heterogeneous clinical courses; the policy notes that teriflunomide’s efficacy has not been established in non‑relapsing forms of MS, such as primary progressive MS, and therefore those uses are not covered.

Definitions

inv-13: Relapsing forms of MS

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

Clinical examplesClinically isolated syndrome; relapsing‑remitting MS; active secondary progressive MS

Policy contextRequired as an element of both initial and continuation approval criteria

inv-14: Objective measures of clinical response

Examples of objective measuresMRI findings (absence or decrease in gadolinium‑enhancing lesions; decrease in new or enlarging T2 lesions)

Disability scaleStabilization or reduced worsening on the Expanded Disability Status Scale (EDSS)

Policy Summary

PayerCigna

PolicyTeriflunomide for Employer Plans: Standard/ Performance, Value/Advantage, Legacy, Total Savings Prescription Drug Lists

Policy CodePolicy IP0252

Change TypeCriteria additions and prescribing requirement

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and ensure teriflunomide is prescribed by or in consultation with a neurologist or MS specialist.

SourceLink

On This Page

Member must have trial of generic teriflunomide tablets

Brand allowed only if generic not tolerated due to inactive ingredient(s) causing significant allergy/serious adverse reaction

Prior authorization required for brand exception

Documentation Required

Documentation and Coding

Providers must submit documentation supporting medical necessity as required by the prior authorization process. A definition for documentation was added to the policy; submit clinical records, objective measures of benefit (for continuation requests), and any other information requested by the reviewer to demonstrate that coverage criteria are met.

Include clinical assessment and objective measures of response for patients Currently Receiving Teriflunomide ≥ 1 year
Provide documentation showing trial and intolerance to preferred generic when seeking brand exception
Respond to any additional documentation requests from Cigna

Denial Risk

Coding / Claim Denial Risk

Claims submitted for services not accompanied by covered code(s) under this Coverage Policy will be denied as not covered. When billing, providers must use the most appropriate diagnosis and procedure codes as of the date of service.

Claims without covered codes per this policy will be denied
Use most appropriate codes as of the date of submission

Clinical outcomesRelapse reduction or absence of relapses; achievement of NEDA‑3 or NEDA‑4 criteria

Functional measuresImprovements on MSFC, six‑minute walk test, or 12‑Item MS Walking Scale; symptom improvement (motor, fatigue, vision, bowel/bladder, spasticity, walking/gait, pain/numbness)