INGREZZA (valbenazine)

INGREZZA (valbenazine)

Self-Administration – oral (capsule)

Diagnosis considered for coverage:

• Chorea associated with Huntington's disease (HD): Treatment of chorea associated with Huntington's disease in adults.
• Tardive dyskinesia (TD): Treatment of tardive dyskinesia in adults.

Coverage Criteria:

For diagnosis of chorea associated with Huntington's disease (HD):

• Diagnosis of chorea associated with Huntington’s disease; AND
• Prescribed by or in consultation with a neurologist.

For diagnosis of tardive dyskinesia (TD):

• Diagnosis of tardive dyskinesia (TD); AND
• TD disease severity is considered moderate or severe; AND
• One of the following:
  • Patient has persistent symptoms of tardive dyskinesia despite a trial of dose reduction, tapering, or discontinuation of the offending medication
  • 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 a psychiatrist or a neurologist.

Reauthorization Criteria:

For diagnosis of chorea associated with Huntington's disease (HD) OR tardive dyskinesia (TD):

• Documentation of positive clinical response to therapy

Tardive Dyskinesia:

• Documentation that the member's TD symtpoms have improved due to Ingrezza use as evidenced by AIMS score (items 1-7) showing reduction of score from baseline, AND
• The member is not at a significant risk for suicidal or violent behaviro and does not have unstable psychiatric symptoms.

Dosing:

Chorea (assoc. w/ HD):

• The initial dosage is 40 mg once daily.
• Increase the dose in 20 mg increments every two weeks to the recommended dosage of 80 mg once daily.
  • 40 mg or 60 mg once daily may be considered depending on response and tolerability.

TD:

• The initial dosage is 40 mg once daily.
• After one week, increase the dose to the recommended dosage of 80 mg once daily.
  • 40 mg or 60 mg once daily may be considered depending on response and tolerability.

Coverage Duration:

• Initial: 3 months
• Reauthorization: 1 year

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• INGREZZA can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease.
• Consultation with a specialist ensures the requirement for proper diagnosing and quantifying an adequate chorea score (total maximal chorea score of greater than or equal to 10 (moderate to severe chorea) from the subscale of the Unified Huntington’s Disease Rating Scale (UHDRS).
• 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).
• Dose reduction, tapering, or discontinuation of the offending medication is considered first-line treatment for TD.

Policy Updates:

• 07/16/2019 – Criteria review; no changes
• 11/14/2023 – For TD: Remove quantitative diagnosis requirements, remove cautionary exclusion requirements, remove prerequisite drug requirements. For chorea a/w HD: Added criteria for new FDA approved indication. (P&T, 11/14/2023)

References:

1. Ingrezza Prescribing Information. Neurocrine Biosciences, Inc. San Diego, CA. August 2023.
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. Stimming EF, Claassen DO, Kayson E, Goldstein J, Mehanna R, Zhang H, Liang GS, Haubenberger D, Adams J, Beck C, Chen C. Safety and efficacy of valbenazine for the treatment of chorea associated with Huntington's disease (KINECT-HD): a phase 3, randomised, double-blind, placebo-controlled trial. The Lancet Neurology. 2023 Jun 1;22(6):494-504.