Aubagio — Blue Cross Blue Shield of Illinois
other FDA approved indications
Preferred products
- teriflunomide
- Glatopa
- glatiramer
- fingolimod
- dimethyl fumarate
Initial criteria
- Patient meets diagnostic criteria as described (e.g., MRI findings or treatment history per earlier section) AND has been treated with at least 3 MS agents from different classes if applicable
- If requested agent is Aubagio (teriflunomide), prescriber has obtained transaminase and bilirubin levels within 6 months prior to initiation
- If requested agent is Gilenya (fingolimod) or Tascenso ODT (fingolimod), prescriber has performed an electrocardiogram within 6 months prior to initiation
- For agents with a corresponding generic (Aubagio/teriflunomide, Copaxone/Glatopa or glatiramer, Gilenya 0.5 mg/fingolimod, Tecfidera or Bafiertam/dimethyl fumarate), ONE of the following applies: (A) Patient currently treated and stable on requested agent; OR (B) Patient has intolerance or hypersensitivity to corresponding generic not expected with requested agent; OR (C) Patient has FDA labeled contraindication to the generic not expected with requested agent; OR (D) Generic discontinued due to lack of efficacy or adverse event; OR (E) Generic expected to be ineffective or inappropriate due to clinical characteristics or adherence barriers; OR (F) Generic not in patient’s best interest based on medical necessity; OR (G) Patient has tried another agent in same class discontinued due to lack of efficacy/adverse event; OR (H) Support exists for use of requested agent over generic
- Prescriber is a specialist in the area of diagnosis (e.g., neurologist) or has consulted with such specialist
- ONE of the following combination therapy rules apply: (A) Patient will not use requested agent with another DMA for same indication; OR (B) Patient will use requested agent in combination with Mavenclad (cladribine) AND there is support for combination use (e.g., relapse between Mavenclad cycles)
- Patient does not have FDA labeled contraindications to requested agent
- For BCBS MT Fully Insured or HIM members under age 18 years: all of the following must apply – no contraindications, indication supported by ≥2 peer‑reviewed journal articles as generally safe/effective, and age group supported in ≥2 such articles
- For plan members residing in Ohio who are Fully Insured or HIM Shop (SG): all of the following must apply – no contraindications, and patient has either an FDA‑labeled or compendia‑supported indication, or ≥2 peer‑reviewed journal articles demonstrating safety/effectiveness; acceptable compendia per listed criteria
Reauthorization criteria
- Patient was previously approved for requested agent through plan’s PA process
- For brand product with corresponding generic, ONE of: currently stable on requested agent; has intolerance or contraindication to generic; generic ineffective or caused adverse event; generic not in patient’s best interest; patient tried same‑class drug discontinued for lack of efficacy/adverse event; support for requested agent over generic
- Patient has had clinical benefit with the requested agent
- Prescriber is a specialist or has consulted a specialist
- Combination use rules same as for initial approval (not used with another DMA unless with Mavenclad supported)
- Patient has no FDA labeled contraindications
Approval duration
12 months