Aubagio (Teriflunomide) Denied by Insurance

Aubagio (teriflunomide) is an oral once-daily disease-modifying therapy (DMT) for adults with relapsing forms of multiple sclerosis, developed by Sanofi. It works by inhibiting an enzyme called DHODH (dihydroorotate dehydrogenase), which disrupts the proliferation of activated lymphocytes that drive MS inflammation. Teriflunomide has been FDA-approved since 2012 and is considered a first-line oral DMT option. Despite its long track record, insurance denials still occur — and patients deserve to know how to fight back effectively.

Why Insurance Denies Aubagio

Prior Authorization Denied: How to Appeal" class="auto-link">Prior authorization is required for Aubagio because it is a specialty drug for a chronic neurological condition. PA criteria typically include: a confirmed relapsing MS diagnosis supported by clinical history and MRI findings, neurologist attestation, and baseline labs (ALT/AST liver enzymes, CBC, blood pressure measurement) required before initiating the drug.

Step therapy requirements affect newly diagnosed or treatment-naive MS patients. Some plans treat Aubagio as a second-line agent, requiring trial of an interferon beta product (Avonex, Betaseron, Rebif) or glatiramer acetate (Copaxone) before approving an oral DMT. However, oral DMTs are increasingly recognized in neurological treatment guidelines as appropriate first-line options, especially for patients with adherence concerns about weekly injections.

Pregnancy contraindication complications create a unique denial scenario for Aubagio. Teriflunomide is teratogenic (known to cause birth defects) and carries an FDA black box warning against use in pregnancy. It also has an extremely long half-life and remains in the body for up to two years unless an accelerated elimination procedure using cholestyramine or activated charcoal is performed. Some insurers have used the black box pregnancy warning as a basis for denying Aubagio prescriptions for women of childbearing potential, even when effective contraception is in use and the patient has been properly counseled. This is not a sound basis for denial if the patient has signed the required counseling documentation and is using appropriate contraception.

Comparative efficacy concerns are sometimes raised by insurers who argue that higher-efficacy agents (such as natalizumab or ocrelizumab) should be tried before Aubagio if a patient has highly active disease. However, Aubagio is often preferred precisely because it offers a favorable balance of efficacy and tolerability for patients with less aggressive MS, and the prescribing neurologist's judgment about disease activity and appropriate treatment choice should be given significant weight.

Generic availability is increasingly affecting formulary placement. Generic teriflunomide has become available in some markets, and insurers may prefer the generic over brand Aubagio, potentially creating a brand-vs-generic denial similar to what Tecfidera patients face.

How to Appeal an Aubagio Denial

Provide your MS diagnosis documentation. Your appeal should include your neurologist's clinical diagnosis notes, the relevant MRI reports (typically showing white matter lesions consistent with MS), and your relapse history. The insurer needs to confirm you have a relapsing form of MS — RRMS is the most common, and all information documenting relapse frequency and MRI activity strengthens your case.

Address the pregnancy contraindication directly (if applicable). If your insurer cited pregnancy risk as a reason for denial, have your neurologist provide documentation that: you have received the required teratogenicity counseling, you are using effective contraception (or post-menopausal/post-hysterectomy and not at reproductive risk), and you understand the accelerated elimination procedure if needed in the future. The REMS program for Aubagio (the AUBAGIO REMS) documents this counseling, and your neurologist should confirm enrollment and compliance.

Challenge step therapy requirements. If step therapy is the denial reason, your neurologist should document why injectable first-line therapies are clinically inappropriate for you. Reasons may include needle phobia, history of injection site reactions to prior injectable DMTs, compliance concerns, or patient preference for an oral agent as a first-line option — all of which are recognized in shared decision-making guidelines for MS treatment.

Submit baseline labs. Aubagio requires baseline ALT/AST and CBC before initiation. Include these lab results in your appeal to demonstrate that you are medically appropriate to start the drug and that required safety monitoring has been planned.

Cite NCCN and AAN guidelines. Teriflunomide is recognized as an appropriate first-line DMT for relapsing MS by major neurological organizations. Reference these guidelines to support your physician's treatment choice.

Patient Assistance Programs

Sanofi offers Sanofi Patient Connection, which provides copay assistance and free drug for qualifying patients. Visit sanofius.com/en/patient-access or call 1-888-847-4877. Genzyme (a Sanofi company) also operates a dedicated MS Patient Assistance program through the Aubagio REMS program.

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Related Reading:

• How to Write an Insurance Appeal Letter
• What Is Medical Necessity?
• What Is Step Therapy?