CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Teriflunomide Aubagio 1808 A Sgm P2023

Defines coverage, prescriber requirements, duration of authorization, continuation criteria, pediatric allowance, and exclusion of non-FDA indications for teriflunomide (Aubagio) for members of the health plan.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTeriflunomide Aubagio 1808 A Sgm P2023

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionAuthorization of 12 months may be granted for covered indications and for continuation when member shows stability or improvement; prescriber must be a neurologist or consult a neurologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes

1Primary FDA-covered indication (relapsing MS)

12 moTypical authorization duration

1Required prescribing specialty (neurology)

0Listed procedure/drug codes provided

Coverage Summary

Key facts

Primary FDA-covered indication categoryRelapsing forms of multiple sclerosis (relapsing MS)

Typical authorization duration12 months

Required prescribing specialtyNeurology (must be prescribed by or in consultation with a neurologist)

Listed procedure/drug codes provided0

Initial Therapy Criteria (Covered Indications / Authorization)

Covered Indications / Authorization Criteria

Covered when ALL of the following are met:

Indication must be ONE of

Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults (FDA-approved).
Clinically isolated syndrome of multiple sclerosis (authorization of 12 months may be granted).

ALL of the following

Prescribed by or in consultation with a neurologist.
Member has no exclusions to the prescribed therapy.
Member will not use teriflunomide concomitantly with other disease modifying multiple sclerosis agents.
Ampyra and Nuedexta are not considered disease modifying and are exceptions.

Continuation of Therapy Criteria

Continuation of Therapy

Covered when ALL of the following are met:

Member has been receiving the requested medication and is experiencing disease stability or improvement while on therapy.

Authorization of 12 months may be granted.

Pediatric Use (Under 18 years)

Authorization may be granted for pediatric members less than 18 years of age when benefits outweigh risks.

Requires prescriber judgment of benefit vs risk; still must meet other prescriber and indication criteria.

Not Medically Necessary / Experimental

All other indications not listed as FDA-approved or compendial are considered experimental/investigational and not medically necessary.

Teriflunomide should not be used concomitantly with other disease-modifying multiple sclerosis agents; concurrent use may be non-covered.

Provider Actions & Requirements

Prior Authorization

Authorization required

Authorization of 12 months may be granted for covered indications and for continuation when the member shows stability or improvement. Prescriber must be a neurologist or in consultation with a neurologist.

Documentation Required

Prescriber specialty documentation

Documentation that the medication was prescribed by or in consultation with a neurologist should be available upon request.

Billing Rule

Concomitant therapy exclusion

Do not bill teriflunomide concurrently with other disease modifying multiple sclerosis agents. Concurrent use may result in non-coverage.

Denial Risk

Not covered for non-FDA/compendial uses

Claims for teriflunomide for indications other than the FDA-approved relapsing forms of MS or listed compendial uses are considered experimental/investigational and will be denied as not medically necessary.

Background

Teriflunomide (Aubagio) is FDA-approved for treatment of relapsing forms of multiple sclerosis in adults; policy aligns coverage to FDA-approved indications and permits pediatric use when benefits outweigh risks; continuation requires evidence of stability or improvement.

Definitions

TermRelapsing forms of multiple sclerosis

DefinitionIncludes clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease as per FDA labeling.

Source noteDefinition stated in FDA‑approved indication for teriflunomide (Aubagio).