Bafiertam — Blue Cross Blue Shield of Montana

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 MS agents from different drug classes (medical records required)
• If requested agent is Aubagio (teriflunomide), prescriber has obtained transaminase and bilirubin levels within 6 months prior to initiating treatment
• If requested agent is Gilenya (fingolimod) or Tascenso ODT (fingolimod), prescriber has performed an electrocardiogram within 6 months prior to initiating treatment
• If patient has an FDA labeled indication, patient’s age is within FDA labeling for requested indication OR there is support for use for patient’s age for requested indication
• If the requested agent is a brand product with a corresponding generic (Aubagio-teriflunomide, Copaxone-Glatopa/glatiramer, Gilenya 0.5mg-fingolimod, Tecfidera/Bafiertam-dimethyl fumarate), then ONE of the following:
• • Patient currently treated and stable on requested agent (chart notes required) OR
• • Patient has intolerance or hypersensitivity to the corresponding generic not expected to occur with requested agent (chart notes required) OR
• • Patient has FDA labeled contraindication to corresponding generic not expected to occur with requested agent (chart notes required) OR
• • Corresponding generic discontinued due to lack of efficacy, diminished effect, or adverse event (chart notes required) OR
• • Corresponding generic expected to be ineffective, cause barrier to adherence, worsen comorbid condition, decrease functional ability, or cause harm (chart notes required) OR
• • Corresponding generic not in the best interest of patient based on medical necessity (chart notes required) OR
• • Patient has tried another drug in same class as corresponding generic and discontinued due to lack of efficacy or adverse event (chart notes required) OR
• • There is support for use of the requested agent over the generic
• Prescriber is a specialist (neurologist) or has consulted with one
• ONE of the following: patient will NOT use requested agent in combination with another disease modifying agent (DMA) OR patient will use requested agent in combination with Mavenclad (cladribine) AND there is support for such combination (e.g., relapse between cycles)
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Alternate approval: For BCBS MT Fully Insured or MT HIM members under age <18 years: (1) patient has no FDA contraindications, (2) indication supported by at least two major peer-reviewed journal articles, and (3) age bracket supported by literature (per infancy/childhood/adolescence definitions)
• Alternate approval: For Ohio Fully Insured or HIM Shop (SG) members: patient has no FDA labeled contraindications AND (1) patient has another FDA labeled indication OR (2) indication supported in compendia (non-oncology or oncology) OR (3) prescriber submitted two peer-reviewed journal articles supporting use as safe and effective

Reauthorization criteria

• Patient previously approved for requested agent through plan’s Prior Authorization process
• If requested agent is brand with corresponding generic (Aubagio-teriflunomide, Copaxone-Glatopa/glatiramer, Gilenya 0.5mg-fingolimod, Tecfidera/Bafiertam-dimethyl fumarate), then ONE of the following:
• • Patient currently treated and stable on requested agent (chart notes required) OR
• • Patient has intolerance or hypersensitivity to corresponding generic not expected with requested agent (chart notes required) OR
• • Patient has FDA labeled contraindication to corresponding generic not expected with requested agent (chart notes required) OR
• • Corresponding generic discontinued due to lack of efficacy, diminished effect, or adverse event (chart notes required) OR
• • Corresponding generic expected to be ineffective, cause adherence barriers, worsen comorbidities, decrease function, or cause harm (chart notes required) OR
• • Corresponding generic not in best interest of patient based on medical necessity (chart notes required) OR
• • Patient tried another drug in same class and discontinued due to lack of efficacy or adverse event (chart notes required) OR
• • There is support for use of requested agent over corresponding generic
• Patient has had clinical benefit with requested agent
• Prescriber is neurologist or consulted specialist
• ONE of the following: patient not using requested agent with additional DMA OR using with Mavenclad and there is supporting information for such combination (e.g., relapse between Mavenclad cycles)
• Patient does not have any FDA labeled contraindications to requested agent

Approval duration

12 months