AUBAGIO (teriflunomide)

AUBAGIO (teriflunomide)

SELF ADMINISTRATION - ORAL

Indication for Prior Authorization:

• Relapsing forms of multiple sclerosis (MS): Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

Coverage Criteria:

For diagnosis of Multiple Sclerosis:

• Patient has a documented diagnosis of relapsing forms of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) AND
• Not used in combination with another disease-modifying therapy for MS AND 
• Prescribed by or in consultation with a neurologist AND
• For Brand Aubagio:
  • Trial and failure or intolerance to generic teriflunomide

Reauthorization Criteria:

For diagnosis of Multiple Sclerosis:

• Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression ) AND
• Not used in combination with another disease-modifying therapy for MS AND
• Prescribed by or in consultation with a neurologist AND
• For Brand Aubagio: 
• Trial and failure or intolerance to generic teriflunomide

Dosing:

For diagnosis of Multiple Sclerosis:

• Recommended adult dose: 7 mg or 14 mg orally once daily
• Rosuvastatin: the dose of rosuvastatin should not exceed 10 mg once daily in patients taking Aubagio
• Aubagio is contraindicated in patients with severe hepatic impairment, pregnancy, hypersensitivity, current leflunomide treatment

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is Not Covered for the Following:

The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

• Use in combination with leflunomide
• Use in combination with any other disease modifying therapy (e.g., natalizumab [Tysabri®], mitoxantrone [Novantrone®], alemtuzumab [Campath®, Lemtrada®], fingolimod [Gilenya®], etc)

Additional Information:

• Contraindications
  • Severe hepatic impairment
  • Pregnant women and females of reproductive potential not using effective contraception. Aubagio may cause fetal harm
  • Patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients
  • Coadministration with leflunomide
• Black Box Warnings for: hepatotoxicity and embryofetal toxicity
• Additional warnings for: procedure for accelerated elimination of teriflunomide, bone marrow effects/immunosuppression potential/infections, hypersensitivity reactions, serious skin reactions, drug reaction with eosinophilia and systemic symptoms (DRESS), peripheral neuropathy, increased blood pressure, respiratory effects, concomitant use with immunosuppressive or immunomodulating therapies
• Prior to starting Aubagio assess the following: transaminase and bilirubin levels and complete blood cell count (CBC) within 6 months before the initiation of treatment, screen patients for latent tuberculosis infection with a tuberculin skin test or blood test for mycobacterium tuberculosis infection, exclude pregnancy prior to initiation of treatment with Aubagio in females of reproductive potential, and check blood pressure
• Pregnancy: contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm based on animal data
• Lactation: Because of the potential for adverse reactions in a breastfed infant from Aubagio, women should not breastfeed during treatment with Aubagio
• Aubagio is detected in human semen. Men wishing to father a child should discontinue use of Aubagio and either undergo an accelerated elimination procedure or wait until verification that the plasma teriflunomide concentration is less than 0.02 mg/L (0.02 mcg/mL)
• Safety and effectiveness in pediatric patients have not been established

Review History:

• 11/27/12- Original review
• 11/7/19- Annual review, no changes
• 11/17/20- Class review, criteria updated
• 6/1/2024 (policy effective date)- RRT for MS Agents, updated SSE (P&T 5/20/2024) (P&T Meeting May)

References: 

• Aubagio [package insert]. Cambridge (MA): Genzyme Corporation; 2020.
• OptumRX Therapeutic Class Overview – Multiple Sclerosis Agents.  Publication Date:  June 22, 2020.
• Aubagio. IBM Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed April 15, 2024. http://www.micromedexsolutions.com.