CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Aubagio (teriflunomide) — Coverage Criteria

Defines coverage criteria and authorization rules for teriflunomide (Aubagio) for treatment of relapsing forms of multiple sclerosis, clinically isolated syndrome, and related continuation therapy for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAubagio (teriflunomide) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for up to 12 months and ensure prescription is by or in consultation with a neurologist; do not prescribe concurrently with other disease‑modifying MS agents.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

FDA-approved for relapsing MSindication

must be neurologistprescriber specialty requirement

case-by-casepediatric exception

Coverage criteria for Aubagio (teriflunomide)

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Initial and Continuation Therapy Criteria

Covered when ALL of the following are met

FDA‑approved indication: Patient has a relapsing form of multiple sclerosis (includes clinically isolated syndrome, relapsing‑remitting disease, or active secondary progressive disease) as per the FDA‑approved indication.

Prescriber: Medication is prescribed by or in consultation with a neurologist.

Authorization duration and continuation: Request is for authorization up to 12 months for initial therapy (relapsing forms of MS or clinically isolated syndrome), or for continuation when the member is experiencing disease stability or improvement while on therapy; pediatric authorization (<18 years) may be granted when benefits outweigh risks.12 months

Concomitant therapy: Member will not use the requested medication concomitantly with other disease‑modifying multiple sclerosis agents.

Use of teriflunomide (Aubagio) for indications outside the FDA-approved indication and accepted compendial uses is considered experimental/investigational and not medically necessary. The approved indication covers treatment of patients with relapsing forms of multiple sclerosis—including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease—in adults; requests for other diagnoses should be denied as investigational.

Therapy with teriflunomide is limited to the FDA-approved population of patients with relapsing forms of multiple sclerosis (as defined above). Use for indications outside relapsing MS, clinically isolated syndrome, or active secondary progressive disease is not medically necessary and will not be authorized.

Prior authorization, documentation, and provider requirements

Denial Risk

Experimental / Investigational Exclusions

Uses outside the FDA‑approved indication and non‑compendial uses are considered experimental/investigational and are not medically necessary. Prior authorization will be denied for indications other than relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease in adults).

Denial Risk

Concomitant DMT Exclusion

Members must not be receiving the requested medication concomitantly with any other disease‑modifying multiple sclerosis (DMT) agent. Concomitant use with other DMTs is grounds for denial.

Ampyra and Nuedexta are NOT considered disease‑modifying agents and are exceptions to DMT listing.

Documentation Required

Prescriber and Diagnosis Documentation

The medication must be prescribed by or in consultation with a neurologist. Documentation of the MS diagnosis (relapsing form or clinically isolated syndrome) must be provided in the medical record at the time of prior authorization request.

Prescriber must be a neurologist or include documentation of neurologist consultation.
Provide clinical documentation supporting diagnosis (e.g., neurologist notes, MRI reports, relapse history).

Prior Authorization

Authorization Duration and Continuation Conditions

Prior authorization may be granted for up to 12 months for members diagnosed with relapsing forms of MS or clinically isolated syndrome. Continuation approvals (12 months) may be granted when the member demonstrates disease stability or improvement while receiving therapy.

Initial and continuation authorizations: up to 12 months.
Continuation requires documentation of clinical benefit or stability.

Key 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.

FDA‑approved populationIndication applies to adults with relapsing forms of MS as described above.

Scope of coverageThe FDA‑approved indication for relapsing forms of MS is considered a covered benefit when other policy criteria are met.

ExclusionsAll other indications outside the FDA‑approved relapsing forms of MS are considered experimental/investigational and not medically necessary.

Clinical background and drug information

Teriflunomide (Aubagio) is indicated for the treatment of patients with relapsing forms of multiple sclerosis, which includes clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease, in adults. All other indications are explicitly considered experimental/investigational and not medically necessary.