Austedo XR — Blue Cross Blue Shield of Texas

Initial criteria

• ONE of the following: (A) The requested agent is Austedo/deutetrabenazine, Austedo XR/deutetrabenazine ER, or Ingrezza/valbenazine AND ONE of the following: (1) The patient has a diagnosis of tardive dyskinesia AND BOTH of the following: (A) ONE of the following: (1) The patient is NOT taking any medications known to cause tardive dyskinesia (dopamine receptor blocking agents) OR (2) The prescriber has reduced the dose or discontinued any medications known to cause tardive dyskinesia OR (3) A reduced dose or discontinuation of any medications known to cause tardive dyskinesia is not appropriate AND (B) The prescriber has evaluated the patient's tardive dyskinesia through clinical examination or through a structured evaluative tool (e.g., AIMS, DISCUS) OR (2) The patient has a diagnosis of chorea associated with Huntington’s disease OR (3) The patient has another FDA labeled indication for the requested agent and route of administration OR (4) The patient has another indication that is supported in compendia for the requested agent and route of administration) OR (B) The requested agent is Xenazine/tetrabenazine and ONE of the following: (1) The patient has a diagnosis of chorea associated with Huntington’s disease OR (2) The patient has another FDA labeled indication for the requested agent and route of administration OR (3) The patient has another indication that is supported in compendia for the requested agent and route of administration
• If the request is for one of the following brand agents with an available generic equivalent (Xenazine/tetrabenazine), then ONE of the following: (A) The patient has stage four advanced metastatic cancer and the requested agent is being used to treat the cancer or associated condition OR (B) The patient is currently stable on the requested agent OR (C) The patient has tried and had an inadequate response to the generic equivalent OR (D) The generic was discontinued due to lack of efficacy or an adverse event OR (E) The patient has intolerance or hypersensitivity to the generic equivalent OR (F) The patient has an FDA labeled contraindication to the generic equivalent OR (G) The generic equivalent is expected to be ineffective based on clinical characteristics OR (H) The generic equivalent is not in the best interest of the patient based on medical necessity OR (I) The patient has tried another prescription drug in the same pharmacologic class or with the same mechanism of action and it was discontinued due to lack of efficacy or adverse event OR (J) There is support for use of the requested brand agent over the generic equivalent AND (K) If the patient has an FDA labeled indication, the patient's age is within FDA labeling or there is support for use outside labeling AND (L) The prescriber is a specialist in the area (psychiatrist, neurologist) or has consulted one AND (M) The patient will NOT be using the requested agent in combination with another VMAT2 inhibitor for the same indication AND (N) The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• The prescriber is a specialist in the area of the patient’s diagnosis or has consulted with a specialist
• The patient has had clinical benefit with the requested agent
• If the request is for a brand agent with a generic equivalent (Xenazine/tetrabenazine), then ONE of the following: criteria A–N from initial section for brand vs. generic substitution

Approval duration

Tardive dyskinesia: 3 months (for non-BCBSIL plans); all other indications: 12 months; BCBSIL members: 12 months