Gilenya — Blue Cross Blue Shield of Texas

Preferred products

• Teriflunomide
• Glatopa
• Glatiramer
• Fingolimod 0.5 mg
• Dimethyl fumarate

Initial criteria

• Patient has greater than or equal to 1 gadolinium enhancing lesion on MRI OR patient has 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 (chart notes 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 (fingolimod) or Tascenso ODT (fingolimod), prescriber performed an electrocardiogram within 6 months prior to initiating treatment
• Patient has another FDA approved indication for the requested agent and route of administration
• Patient’s age is within FDA labeling for the requested indication OR there is support for use at the patient’s age for that indication
• If requested agent is a brand product with a corresponding generic (listed below), one of the following: patient is stable on the brand agent; intolerance or hypersensitivity to the generic; FDA labeled contraindication to the generic; generic discontinued due to lack of efficacy or adverse event; generic expected to be ineffective or cause barriers to adherence, comorbidity worsening, or functional impairment; generic not in best medical interest; patient tried another drug in same pharmacologic class and discontinued for inefficacy or adverse event; support for use of requested agent over generic (chart notes required)
• Prescriber is a specialist in the area of diagnosis (neurologist) or has consulted a specialist
• Patient will not use the agent in combination with an additional disease modifying agent (DMA) for the requested indication OR agent will be used in combination with Mavenclad (cladribine) and there is support for use with Mavenclad (e.g., relapse between cycles)
• Patient does not have FDA labeled contraindications to the requested agent
• For BCBS MT Fully Insured or MT HIM members under age <18 years: indication supported in two peer-reviewed journal articles showing safety and efficacy, and age bracket supported in two such articles; and patient has no FDA contraindications
• For plan members residing in Ohio meeting specified coverage (Fully Insured or HIM Shop (SG)): patient has no FDA labeled contraindications AND one of the following: another FDA labeled indication; another compendia-supported indication; or submission of two major peer-reviewed journal articles supporting proposed use as safe and effective

Reauthorization criteria

• Patient previously approved for requested agent through plan’s prior authorization process OR initial evaluation required
• If requested agent is a brand product with a corresponding generic (listed below), one of the following: patient stable on requested agent; intolerance or hypersensitivity to generic; FDA contraindication to generic; lack of efficacy/adverse event leading to discontinuation of generic; generic expected ineffective or harmful; generic not in patient’s best medical interest; trial of another drug in same class discontinued; support for use of brand over generic
• Patient has had clinical benefit with the requested agent
• Prescriber is a specialist (neurologist) or has consulted a specialist
• Patient will not use requested agent with another DMA OR will use it with Mavenclad with supporting evidence (e.g., relapse between cycles)
• Patient does not have FDA labeled contraindications to the requested agent

Approval duration

12 months