omaveloxolone — Blue Cross Blue Shield of Texas

Initial criteria

• 1. BOTH of the following: A. The patient has a diagnosis of Friedreich ataxia (FA, FRDA) with genetic analysis confirming mutation in the frataxin (FXN) gene [chart notes required] AND B. If the patient has an FDA labeled indication, then ONE of the following: 1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR 2. There is support for using the requested agent for the patient’s age for the requested indication
• 2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist, geneticist, neurologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
• 3. The patient does NOT have any FDA labeled contraindications to the requested agent
• Alternative criteria for Ohio fully insured or HIM Shop (SG) members: 1. Member resides in Ohio AND 2. Plan is Fully Insured or HIM Shop (SG) AND BOTH of the following: A. The patient does NOT have any FDA labeled contraindications to the requested agent AND B. ONE of the following: 1. The patient has another FDA labeled indication for the requested agent and route of administration OR 2. The patient has another indication supported in compendia for the requested agent and route of administration OR 3. The prescriber has submitted TWO peer-reviewed journal articles supporting safety and efficacy (acceptable: randomized, double-blind, placebo-controlled clinical trials; unacceptable: case studies). Compendia accepted: DrugDex level 1, 2A, 2B; AHFS-DI; NCCN 1 or 2A; Clinical Pharmacology; LexiDrugs evidence level A.

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• 2. The patient has had clinical benefit with the requested agent
• 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist, geneticist, neurologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
• 4. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months