CurrentCignaPolicy N/A

Teriflunomide (Aubagio) prior authorization

This policy defines Cigna's prior authorization and medical necessity criteria for teriflunomide (Aubagio or generic) for treatment of relapsing forms of multiple sclerosis for members of Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTeriflunomide (Aubagio) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJul 23, 2025

Key ActionObtain prior authorization; initial and renewal approvals are for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearapproval duration

Boxedboxed warning

relapsingindication

1,000,000US prevalence

Coverage Criteria for Teriflunomide (Aubagio)

FDA-Approved Indication

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A) Initial Therapy

i. Patient has a relapsing form of multiple sclerosis;
ii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis;

B) Patient is currently receiving teriflunomide for ≥ 1 year

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

Teriflunomide (Aubagio and generic) is considered not medically necessary for any other uses not listed in this policy. This explicitly includes combination therapy with other disease‑modifying MS agents and use for non‑relapsing forms of multiple sclerosis (for example, primary progressive MS), as efficacy has not been established for these indications.

Provider Actions, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for teriflunomide. Initial and renewal approvals are granted for 1 year when the coverage criteria are met. Because of the specialized skills required for evaluation, diagnosis, and monitoring, teriflunomide must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., neurologist or MS specialist).

Approval duration: 1 year for initial and renewal when criteria met
Prescription requirement: Prescribed by or in consultation with a neurologist or physician who specializes in MS

Step Therapy

Combination Therapy Not Medically Necessary

Concurrent use of teriflunomide with other disease‑modifying multiple sclerosis agents is not medically necessary.

Do not prescribe teriflunomide in combination with other disease‑modifying MS agents

Documentation Required

Provider Specialty Requirement

Medication must be prescribed by or in consultation with a neurologist or MS specialist.

Prescriber requirement applies to initial and renewal approvals

Denial Risk

Claims and Coding Denial Risk

Claims submitted without covered diagnosis or procedure codes will be denied as not covered. Providers must bill using the most appropriate diagnosis and procedure codes as of the date of submission and ensure the service aligns with the applicable benefit plan and coverage criteria.

Claims lacking covered codes per the coverage policy will be denied as not covered
Use most appropriate codes as of the date of submission

Background and Drug Overview

Teriflunomide is an oral agent indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease. It acts as a pyrimidine synthesis inhibitor and is used to reduce disease activity in patients with relapsing MS.

Definitions

inv-09: Relapsing forms — examples (clinically isolated syndrome, relapsing-remitting, active secondary progressive)

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

Typical clinical coursePatients usually experience relapses and remissions; ~85–90% present with a relapsing pattern at onset which may later transition to secondary progressive MS.

ExamplesClinically isolated syndrome; relapsing‑remitting MS; active secondary progressive MS.

Age of onsetMost patients develop symptoms between ages 20–40, though children and older adults can be affected.

Clinical characterizationRelapsing forms may be further described as active (with clinical or MRI activity) or not active, and as worsening or stable.