Aubagio — Blue Cross Blue Shield of Kansas
Clinically Isolated Syndrome (CIS)
Preferred products
- teriflunomide
- Glatopa
- glatiramer
- fingolimod
- dimethyl fumarate
Initial criteria
- Patient age ≥ 18 years AND ALL of the following: (1) ONE of the following: (a) Tried and had an inadequate response to TWO preferred agents that are FDA labeled for the treatment of the requested indication (medical records required) OR (b) Intolerance or hypersensitivity to TWO preferred agents FDA labeled for the treatment of the requested indication OR (c) FDA labeled contraindication to ALL preferred agents FDA labeled for the treatment of the requested indication; (2) If requested agent is Tascenso ODT 0.5 mg, ONE of the following: (a) Tried and had inadequate response to generic fingolimod (medical records required) OR (b) Intolerance or hypersensitivity to generic fingolimod not expected to occur with the requested agent OR (c) FDA labeled contraindication to generic fingolimod not expected to occur with the requested agent OR (d) Support for use over generic fingolimod (e.g., swallowing difficulties).
- OR Patient has highly active MS disease activity (medical records including chart notes required) AND BOTH of the following: (1) ≥ 2 relapses in the previous year AND (2) ONE of the following: (a) ≥ 1 gadolinium enhancing lesion on MRI OR (b) Significant increase in T2 lesion load compared with previous MRI.
- OR Patient 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, prescriber has performed an electrocardiogram within 6 months prior to initiating treatment.
- If requested brand agent has an available generic equivalent (Aubagio/teriflunomide, Copaxone/Glatopa or glatiramer, Gilenya 0.5 mg/fingolimod, Tecfidera/dimethyl fumarate): ONE of the following (medical records required): (a) Intolerance or hypersensitivity to the generic equivalent not expected with brand OR (b) FDA labeled contraindication to the generic equivalent not expected with brand OR (c) Clinical support for use of brand over generic.
- Prescriber is a specialist in neurology or has consulted with a neurologist.
- ONE of the following: (a) Patient will NOT be using requested agent in combination with an additional disease modifying agent (DMA) for the requested indication OR (b) Patient will be using requested agent in combination with Mavenclad (cladribine) AND there is support for combination use (e.g., relapse between cycles of Mavenclad).
- Patient does NOT have any FDA labeled contraindications to the requested agent.
Reauthorization criteria
- Patient previously approved for the requested agent through the plan’s prior authorization process.
- If requested brand agent has an available generic equivalent (Aubagio/teriflunomide, Copaxone/Glatopa or glatiramer, Gilenya 0.5 mg/fingolimod, Tecfidera/dimethyl fumarate): ONE of the following (medical records required): (a) Intolerance or hypersensitivity to the generic equivalent not expected to occur with brand OR (b) FDA labeled contraindication to the generic equivalent not expected to occur with brand OR (c) Clinical support for use of brand over generic.
- Patient has had clinical benefit with the requested agent.
- Prescriber is a neurologist or has consulted with a neurologist.
- ONE of the following: (a) Patient will NOT be using requested agent in combination with another DMA for the requested indication OR (b) Patient will be using requested agent in combination with Mavenclad (cladribine) AND there is support for combination use (e.g., relapse between cycles of Mavenclad).
- Patient does NOT have any FDA labeled contraindications to the requested agent.
Approval duration
12 months