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Austedo XR/deutetrabenazine ER — Blue Cross Blue Shield of Illinois

chorea associated with Huntington’s disease

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 medications known to cause tardive dyskinesia OR
  • 3. A dose reduction or discontinuation of such medications is not appropriate AND
  • B. The prescriber has evaluated the patient's tardive dyskinesia through clinical examination or 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 AND
  • If the request is for one of the following brand agents with an available generic equivalent (Xenazine/tetrabenazine), then ONE of the following:
  • A. BOTH of the following:
  • 1. ONE of the following:
  • A. The prescriber has stated or documented the patient has stage 4 advanced metastatic cancer and the requested agent is used to treat the cancer or an associated condition AND
  • 2. Use is consistent with best practices and FDA approval OR
  • B. The patient is currently being treated and stable on the requested agent OR
  • C. The patient has tried and had inadequate response to the generic equivalent OR
  • D. The generic equivalent was discontinued due to lack of efficacy or adverse event OR
  • E. The patient has an intolerance or hypersensitivity to the generic equivalent not expected to occur with the brand OR
  • F. The patient has an FDA labeled contraindication to the generic equivalent not expected with the brand OR
  • G. The generic equivalent is expected to be ineffective based on known clinical characteristics of the patient or drug; cause adherence issues; worsen comorbidity; decrease functional ability; or cause harm 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 drug in the same pharmacologic class or mechanism of action that 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, then ONE of the following:
  • A. The patient’s age is within FDA labeling for the requested indication OR
  • B. There is support for use of the agent for the patient's age for the requested indication AND
  • L. The prescriber is a specialist (e.g., psychiatrist, neurologist), or has consulted a specialist AND
  • M. The patient will NOT use the requested agent in combination with another VMAT2 inhibitor AND
  • N. The patient does NOT have any FDA labeled contraindications to the requested agent.

Reauthorization criteria

  • 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
  • 2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., psychiatrist, neurologist), or has consulted with one AND
  • 3. The patient has had clinical benefit with the requested agent AND
  • 4. If the request is for one of the following brand agents with an available generic equivalent (Xenazine/tetrabenazine), then ONE of the following:
  • A. BOTH of the following:
  • 1. ONE of the following:
  • A. The prescriber has stated that the patient has stage 4 advanced metastatic cancer and the requested agent is being used to treat the cancer OR
  • Other brand vs. generic equivalence exceptions as in the initial criteria may apply.

Approval duration

12 months (BCBSIL); 3 months for tardive dyskinesia and 12 months for other indications (non-BCBSIL)