Pharmacy Prior Authorization Criteria

Ingrezza (valbenazine)

Indications for Prior Authorization

Ingrezza (valbenazine)

• For diagnosis of Tardive Dyskinesia
  Indicated for the treatment of adults with tardive dyskinesia.

• For diagnosis of Chorea associated with Huntington's disease
  Indicated for the treatment of adults with chorea associated with Huntington’s disease

Criteria

Ingrezza

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)
For diagnosis of Tardive Dyskinesia

• Diagnosis of moderate to severe tardive dyskinesia [A]
AND
• One of the following [3, B]:
• Patient has persistent symptoms of tardive dyskinesia despite a trial of dose reduction, tapering, or discontinuation of the offending medication
OR
• Patient is not a candidate for a trial of dose reduction, tapering, or discontinuation of the offending medication
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist

Ingrezza

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Tardive Dyskinesia

• Patient demonstrates positive clinical response to therapy

Ingrezza

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)
For diagnosis of Chorea Associated with Huntington’s Disease

• Diagnosis of chorea in patients with Huntington's disease
AND
• Prescribed by or in consultation with a neurologist

Ingrezza

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Chorea Associated with Huntington’s Disease

• Patient demonstrates positive clinical response to therapy

P & T Revisions

2024-05-28, 2024-03-11, 2023-10-26, 2023-09-25, 2023-03-06, 2022-02-24, 2021-06-02, 2021-03-31, 2020-04-01, 2020-01-14

References

1. Ingrezza Prescribing Information. Neurocrine Biosciences, Inc. San Diego, CA. April 2024.
2. Hauser RA, Factor SA, Marder SR, et al. KINECT 3: A phase 3 randomized, double-blind, placebo-controlled trial of valbenazine for tardive dyskinesia. Am J Psychiatry. 2017 May 1;174(5):476-484.
3. Waln O, Jankovic J. An update on tardive dyskinesia: from phenomenology to treatment. Tremor Other Hyperkinet Mov (N Y) 2013 Jul 12;3. pii: tre-03-161-4138-1.
4. Per clinical consult with psychiatrist, June 9, 2017.

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End Notes

1. Patients were included in the pivotal randomized, double-blind, placebo-controlled trial of Ingrezza if they had moderate to severe tardive dyskinesia as determined by clinical observation (qualitative assessment). [1, 2]
2. Verified with consultant that dose reduction, tapering, or discontinuation of the offending medication is considered first-line treatment for tardive dyskinesia. [4]

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Revision History

• 2024-05-28: update guideline
• 2024-03-11: 2024 Annual Review
• 2023-10-26: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-09-25: New UM PA Criteria
• 2023-03-06: 2023 Annual Review
• 2022-02-24: 2022 Annual Review
• 2021-06-02: Added new product strength GPI.
• 2021-03-31: Annual review: Background updates.
• 2020-04-01: Annual review: reauthorization criteria update, background updates.
• 2020-01-14: Switch to Specialty.

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