VMAT2 Inhibitors - NC Standard

Restricted Product(s)

Restriction applies to brand and generic products

• Austedo® (deutetrabenazine) 
• Austedo® XR (deutetrabenazine ER) 
• Austedo® XR Titration Kit (deutetrabenazine ER) 
• Ingrezza® (valbenazine) 
• Ingrezza Sprinkle ® (valbenazine) 
• Xenazine® (tetrabenazine)

FDA Approved Use

• Austedo, Austedo XR, Austedo XR Titration Kit 
  • For the treatment of chorea associated with Huntington’s disease. 
  • For the treatment of tardive dyskinesia in adults. 
• Ingrezza, Ingrezza Sprinkle 
  • For the treatment of adults with tardive dyskinesia. 
  • For the treatment of adults with chorea associated with Huntington’s disease. 
• Xenazine 
  • For the treatment of chorea associated with Huntington’s disease.

Criteria for Approval of Restricted Product(s)

Initial Coverage Criteria

1. Patients with history of depression or suicidal ideation are being treated and/or stable; AND 
2. If the request is for Austedo, Austedo XR, Austedo XR Titration Kit, Xenazine, or generic tetrabenazine: 
   1. The patient is not receiving a monoamine oxidase inhibitor (ex. Marplan® (isocarboxazid), Nardil® (phenelzine), and Parnate® (tranylcypromine)); AND 
   2. The patient is not receiving reserpine or the patient’s reserpine will be discontinued at least 20 days before starting the requested medication therapy; AND 
   3. The dose of the requested medication does not exceed 48 mg daily of Austedo/Austeo XR or 100 mg of Xenazine; AND 
3. The patient has a diagnosis of Huntington’s disease and is experiencing signs and symptoms of chorea; AND
   1. The requested medication is being prescribed by or in consultation with a neurologist; OR
4. The patient has a diagnosis of tardive dyskinesia; AND 
   1. The requested medication is Austedo, Austedo XR, Ingrezza or Ingrezza Sprinkle; AND 
   2. The patient is 18 years of age or older; AND 
   3. The prescriber has reduced the dose or discontinued any medications known to cause tardive dyskinesia such as dopamine receptor antagonists (ex. antipsychotics, metoclopramide); OR 
      1. If the patient is not a candidate for a trial of dose reduction or discontinuation of a medications known to cause tardive dyskinesia, the prescriber has provided clinical rationale (medical record documentation required); AND 
   4. The patient has been stable on any psychiatric and or/neurologic medications without titration for 30 days prior to the start of the requested medication; AND 
   5. The prescriber has evaluated the patient with the Abnormal Involuntary Movement Scale (AIMS) to assess baseline disturbances in movement; AND 
5. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND 
6. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies. 

Duration of Approval: 90 days (3 months)

Continuation Coverage Criteria

1. The patient has been previously approved with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND 
2. The patient has a diagnosis of Huntington’s disease; AND 
   1. The patient’s signs and symptoms of chorea associated with Huntington’s disease must be decreased from baseline [medical record documentation of improvement is required]; OR 
3. The patient has demonstrated and maintained a reduction in score on the Abnormal Involuntary Movement Scale (AIMS) from their baseline Tardive dyskinesia assessment [medical record documentation of improvement is required]; AND 
4. The patient must not show signs of worsening depression.

Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed). 

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

July 2024: Criteria update: Added new to market Austedo XR 18 mg and Austedo XR Titration Kit 12 & 18 & 24 & 30 mg to quantity limit chart.

June 2024: Criteria update: Added new to market Austedo XR 30 mg, 36 mg, 42 mg, and 48 mg to quantity limit chart.

May 2024: Criteria update: Added Ingrezza Sprinkle to the policy and updated quantity limit chart.

October 2023: Criteria update: Formatting updates.

September 2023: Criteria change: Added new indication of chorea associated with Huntington’s disease for Ingrezza to the criteria.

July 2023: Criteria update: Added Austedo XR Titration Kit to the policy.

May 2023: Criteria update: Added Austedo XR to the policy. Criteria review and formatting changes.

Feb 2022: Criteria update: Removed step through generic tetrabenazine for Austedo and Xanazine for Huntington’s disease initial and continuation coverage criteria. Updated tardive dyskinesia criteria for initial coverage.

Oct 2021: Criteria update: Added step through generic tetrabenazine for Austedo and Xenazine requests on continuation for Huntington’s disease.

May 2021: Criteria update: Added Ingrezza 60mg capsules to the policy. Decreased Ingrezza 40mg QL to 1 capsule/day.

April 2021: Criteria change: Combine Ingrezza policy to create VMAT2 Inhibitors NC Standard. Require t/f generic tetrabenazine for diagnosis of HD. Apply quantity limits to Austedo and Xenazine.

Oct 2017: Removed a neurology consult as a requirement for tardive dyskinesia

Sep 2017: Added new indication of tardive dyskinesia for Austedo to policy; removed liver function from criteria

Apr 2017: New to market Austedo added to criteria

Jan 2016: Original utilization management criteria issued