ModifiedHealth NetPolicy CP PCH.40

Teriflunomide (Aubagio)

Governs medical necessity and prior authorization criteria for teriflunomide (Aubagio and generic) for treatment of relapsing forms of multiple sclerosis for Health Net members under the specified lines of business.

Policy Summary

PayerHealth Net

PolicyTeriflunomide (Aubagio) - Clinical/Medical Policy

Policy CodePolicy CP PCH.40

Change TypeModified — material updates to criteria and approvals

Effective DateFeb 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization; initial approvals are issued for 6 months and continued therapy approvals for 12 months per policy criteria.

SourceLink

POLICY UPDATE CHANGES

Policy/criteria section revised to also include generic teriflunomide and redirect brand Aubagio requests to generic teriflunomide unless contraindicated or clinically significant adverse effects are experienced.

Continued therapy approval duration was modified to a standard 12 months.

Removed requirement for documentation of baseline relapses/EDSS and specific measures of positive response.

6 moInitial approval

12 moContinued approval

14 mg/dayMax dose

Boxed

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7, 14 mgTablet strengths

Centene-ownedPolicy owner

Coverage and Medical Necessity Criteria

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial MS therapy: 1) Diagnosis of one of: clinically isolated syndrome, relapsing-remitting multiple sclerosis, or secondary progressive MS; 2) Prescribed by or in consultation with a neurologist; 3) Age ≥ 18 years; 4) Member is not concurrently prescribed other disease-modifying therapies for MS; 5) Member is not receiving leflunomide at the time of request; 6) For brand Aubagio requests, member must use generic teriflunomide unless contraindicated or clinically significant adverse effects are experienced; 7) Dose does not exceed 14 mg per day (1 tablet per day).dose <= 14 mg/day

Approval duration: 6 months

Continuation Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Continued MS therapy: 1) Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria; 2) Member is responding positively to therapy; 3) For brand Aubagio requests, member must use generic teriflunomide unless contraindicated or clinically significant adverse effects are experienced; 4) Aubagio is not prescribed concurrently with other disease-modifying therapies for MS; 5) If request is for a dose increase, the new dose does not exceed 14 mg per day (1 tablet per day).dose <= 14 mg/day

Approval duration: 12 months

Coverage for teriflunomide does not include treatment of primary progressive multiple sclerosis (PPMS). Requests where the documented diagnosis is primary progressive MS are not authorized under this policy.

All coverage decisions and the administration of benefits are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract). Providers should note that this clinical policy is a medical necessity guideline and does not guarantee payment; contractual and legal requirements govern final coverage determinations.

Indications that are not FDA‑approved and are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (e.g., CP.CPA.09 for commercial lines or HIM.PA.154 for the health insurance marketplace) and the member's evidence of coverage.

Codes and Dosing Information

Codes referencedmixed

N/A	No CPT/HCPCS/ICD codes listed in this policy window

inv-07: Maximum daily dose — 14 mg per day

Maximum daily dose14 mg per day

Tablet frequency1 tablet per day

Dose threshold contextDose limit applies to both initial and continued therapy requests

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for teriflunomide (Aubagio). Coverage decisions are made using the Health Plan's medical necessity guidelines and applicable administrative rules. Initial approvals are granted for 6 months; continued approvals (continuation therapy) are granted for 12 months where criteria for continuation are met.

Prior authorization required
Initial approval duration: 6 months
Continuation approval duration: 12 months

Documentation Required

Providers must submit documentation (e.g., office chart notes, laboratory results, or other clinical information) supporting that the member meets all approval criteria. Requests lacking adequate documentation may be denied.

Examples: chart notes, labs, other clinical information

Clinical Background

Teriflunomide is the principal active metabolite of leflunomide and acts as a pyrimidine synthesis inhibitor. It is an oral disease‑modifying therapy indicated for relapsing forms of multiple sclerosis in adults, which includes clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS. Clinicians should be aware of important safety considerations, including boxed warnings for hepatotoxicity and embryofetal toxicity, and contraindications such as pregnancy and severe hepatic impairment.

Definitions and Indications

inv-17: Relapsing forms of multiple sclerosis — includes clinically isolated syndrome, relapsing-remitting, active secondary progressive

DefinitionRelapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing-remitting MS, and active (secondary) progressive MS

FDA indication contextThese terms reflect the FDA‑approved indications for teriflunomide (Aubagio)

Coverage implicationMembers must have one of these diagnoses to meet initial therapy criteria

Policy Summary

PayerHealth Net

PolicyTeriflunomide (Aubagio) - Clinical/Medical Policy

Policy CodePolicy CP PCH.40

Change TypeModified — material updates to criteria and approvals

Effective DateFeb 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization; initial approvals are issued for 6 months and continued therapy approvals for 12 months per policy criteria.

SourceLink

On This Page

Insufficient documentation may result in denial

Note

Off‑Label and Non‑Covered Indications

Requests for teriflunomide (including brand Aubagio) for primary progressive multiple sclerosis are not authorized under this policy. Requests for non‑FDA indicated (off‑label) uses require sufficient documentation of efficacy and safety per the Health Plan's off‑label use policies (see CP.CPA.09 for commercial and HIM.PA.154 for marketplace) to be considered.

Primary progressive MS: not covered
Off‑label uses require documentation per off‑label use policy CP.CPA.09 or HIM.PA.154

Prior Authorization

Brand-to-Generic Redirection

For brand Aubagio requests, providers must redirect to generic teriflunomide unless the member has a contraindication to generic teriflunomide or has experienced clinically significant adverse effects that justify use of the brand product. Failure to follow redirection to the generic product may affect coverage.

Redirect brand Aubagio requests to generic teriflunomide unless contraindicated or adverse effects documented
Document reason for brand use if generic is not appropriate

Denial Risk

Denial Risk from Noncompliance

Coverage is subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable Health Plan administrative policies and procedures. Noncompliance with coverage documents, administrative rules, or failure to meet policy criteria may result in denial of the request.

Coverage subject to evidence of coverage, policy contract, and state/federal requirements
Noncompliance or unmet criteria may lead to denial