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Tecfidera — Blue Cross Blue Shield of Oklahoma

Clinically Isolated Syndrome (CIS)

Preferred products

  • teriflunomide
  • Glatopa
  • glatiramer
  • fingolimod
  • dimethyl fumarate

Initial criteria

  • Patient has ≥1 gadolinium enhancing lesion on MRI OR significant increase in T2 lesion load compared with previous MRI OR has been treated with at least 3 multiple sclerosis agents from different drug classes (documentation required)
  • If requested agent is Aubagio (teriflunomide): prescriber obtained transaminase and bilirubin levels within 6 months prior to initiating treatment
  • If requested agent is Gilenya or Tascenso ODT (fingolimod): prescriber performed an electrocardiogram within 6 months prior to initiating treatment
  • If patient has an FDA labeled indication: patient age is within FDA labeling OR there is support for use of the requested agent for the patient’s age
  • If requested agent is a brand product with a corresponding generic listed below, ONE of the following: A. patient currently stable on brand; OR B. intolerance or hypersensitivity to corresponding generic; OR C. FDA labeled contraindication to generic; OR D. generic discontinued due to lack of efficacy/adverse reaction; OR E. expected ineffectiveness, adherence barrier, or harm from generic; OR F. corresponding generic not in best interest of patient; OR G. patient tried another prescription drug in same class discontinued for lack of efficacy/adverse event; OR H. there is support for use of requested agent over generic
  • Prescriber is a specialist in neurology or has consulted a neurologist
  • ONE of the following: (A) patient will NOT use in combination with another disease-modifying agent for same indication OR (B) combination use only with Mavenclad when supported (e.g., relapse between cycles)
  • Patient does not have any FDA labeled contraindications to requested agent
  • Special approvals for BCBS MT fully insured or MT HIM members < age 18 years meeting evidence-based criteria OR for Ohio fully insured/HIM Shop members meeting compendia or literature support (two peer-reviewed articles or compendia levels approved)

Reauthorization criteria

  • Patient previously approved for requested agent through plan’s Prior Authorization process
  • If requested agent is brand product with corresponding generic, one of: A. currently stable on requested agent; OR B. intolerance or hypersensitivity to generic; OR C. labeled contraindication to generic; OR D. generic discontinued due to lack of efficacy/adverse event; OR E. expected ineffectiveness/adherence barrier/harm from generic; OR F. generic not in best interest of patient; OR G. tried another similar drug discontinued due to lack of efficacy/adverse event; OR H. support for use of requested agent over generic
  • Patient has had clinical benefit with requested agent
  • Prescriber is a specialist in neurology or has consulted a neurologist
  • Patient will not use requested agent in combination with another disease-modifying agent except possibly with Mavenclad supported by documentation
  • Patient does not have any FDA labeled contraindications to requested agent

Approval duration

12 months