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Date Printed: July 21, 2017: 12:38 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-81

Original Effective Date: 07/15/17

Reviewed: 06/14/17

Revised: 00/00/00

Subject: Valbenazine (Ingrezza)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  

 

           

DESCRIPTION:

Tardive dyskinesia is a drug-induced hyperkinetic movement disorder that is most commonly associated with the use of central dopamine receptor-blocking agents such as antipsychotics. Symptoms include involuntary movements of the face, trunk, and extremities and may persist after dose reduction or discontinuation. Approximately 20 to 30% of patients with chronic exposure to antipsychotics may develop tardive dyskinesia.

The Food and Drug Administration (FDA) approved valbenazine in April 2017 for the treatment of adults with tardive dyskinesia. Valbenazine is a reversible inhibitor of vesicular monamine transporter 2 (VMAT2) which regulates monamine uptake to the synaptic vesicle for storage and release resulting in the inhibition of dopamine release. The modulation of dopamine by VMAT2 inhibition is thought to improve movement-related disorders such as tardive dyskinesia.

In a randomized, double-blind, placebo-controlled trial, valbenazine 40 to 80 mg per day was evaluated in patients with moderate to severe tardive dyskinesia. Patients with schizophrenia, schizoaffective disorder or a mood disorder were included and permitted to continue medications for the management of psychiatric conditions if on a stable treatment regimen for at least 30 days. Patients with a risk of suicide or violent behavior or unstable psychiatric symptoms were excluded. The mean change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score (items 1 through 7) at week 6 was the primary efficacy endpoint. Valbenazine 80 mg significantly decreased dopamine receptor blocker-induced tardive dyskinesia severity compared with placebo at week 6, as measured by least-square mean difference from baseline on AIMS Dyskinesia Total score (-3.2 vs -0.1); however valbenazine 40 mg was not significantly different from placebo (-1.9 vs -0.1). Valbenazine 40 mg and 80 mg provided a significantly greater proportion of patients with at least a 50% reduction in AIMS score at week 6 as compared to placebo (23.8% and 40% vs 8.7%). The most common adverse reactions were somnolence, akathisia, and dry mouth.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

I. Initiation of valbenazine (Ingrezza) meets the definition of medical necessity when ALL of the following criteria are met:

1. Tardive dyskinesia

a. Member is diagnosed with tardive dyskinesia induced by an antipsychotic agent that has persisted for 3 months or more – documentation must be provided

b. Member’s tardive dyskinesia is moderate to severe (i.e., score of 3 or 4 on item 8 of the Abnormal Involuntary Movement Scale (AIMS)) – documentation must be provided

c. ONE of the following:

i. Member had an inadequate response to alternative approaches to alleviate symptoms of tardive dyskinesia (e.g., dose adjustment of the offending agent, discontinuation of the offending agent, switching to an alternative therapy) – documentation must be provided

ii. Antipsychotic therapy is unable to be adjusted to alleviate symptoms of tardive dyskinesia due to risk of destabilizing the member’s psychiatric condition– documentation must be provided

d. Member is diagnosed with schizophrenia, schizo-affective disorder, or a mood disorder

e. Member’s psychiatric status is stable

f. Member does not have a history of suicide or violent behavior

g. Member does not have congenital long QT syndrome or a history of arrhythmias associated with a prolonged QT interval

h. Member is not receiving concomitant monoamine oxidase inhibitor (MAOI) therapy (e.g., selegiline [Carbex], rasagiline [Azilect]), a strong CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampin), reserpine (Serpalan) or an additional VMAT2 inhibitor (e.g., deutetrabenazine, tetrabenazine).

i. Dose does not exceed 80 mg/day – dosage will be achieved using the fewest number of tablets per day

Approval duration: 3 months

II. Continuation of valbenazine (Ingrezza) meets the definition of medical necessity for the treatment of tardive dyskinesia in members meeting the following criteria:

1. Authorization/reauthorization has been previously approved by Florida Blue or another health plan in the past two years, OR the member has previously met all indication-specific initiation criteria

2. Member has demonstrated a beneficial response to valbenazine (i.e., improvement in AIMS score) – documentation must be provided

3. Dose does not exceed 80 mg/day – dosage will be achieved using the fewest number of tablets per day

Approval duration: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

Valbenazine is indicated for the treatment of adults with tardive dyskinesia. The initial dose is 40 mg once daily. After one week, increase the dose to the recommended dose of 80 mg once daily.

Dose Adjustments

• The recommended dose for patients with moderate or severe hepatic impairment is 40 mg once daily.

• Use is not recommended for patients with severe renal impairment (CrCl < 30 ml/min).

• Consider dose reduction based on tolerability in known CYP2D6 poor metabolizers.

• Avoid use with monoamine oxidase inhibitors and strong CYP3A4 inducers.

• Reduce dose for use with strong CYP3A4 and CYP2D6 inhibitors.

Drug Availability

• 40 mg capsule

PRECAUTIONS:

Contraindications

• None

Precautions/Warnings

• Somnolence: May impair patient’s ability to drive or operate hazardous machinery.

• QT Prolongation: May cause an increase in QT interval. Avoid use in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J8499

Prescription drug, oral, non-chemotherapeutic, Not Otherwise Specified

ICD-10 Diagnoses Codes That Support Medical Necessity

G24.01

Drug-induced subacute dyskinesia

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the guideline creation.

DEFINITIONS:

None.

RELATED GUIDELINES:

09-J1000-07, Tetrabenazine (Xenazine) and Deutetrabenazine (Austedo)

OTHER:

Abnormal Involuntary Movement Scale (AIMS)

Movement Rating

0 = none, 1 = minimal, 2 = mild

3 = moderate, 4 = severe

I. Facial and Oral Movements

1. Muscles of Facial Expression (e.g., movements of forehead, eyebrows, periorbital area, cheeks; include frowning, blinking, smiling, grimacing)

0 1 2 3 4

2. Lips and Perioral Area (e.g., puckering, pouting, smacking)

0 1 2 3 4

3. Jaw (e.g., biting, clenching, chewing, mouth opening, lateral movement)

0 1 2 3 4

4. Tongue Rate only increases in movement both in and out of mouth, not inability to sustain movement

0 1 2 3 4

II. Extremity Movements

5. Upper (arms, wrists, hands, fingers) Include choreic movements (ie, rapid, objectively purposeless,irregular, spontaneous); athetoid movements (i.e., slow, irregular, complex, serpentine). Do not include tremor (ie, repetitive, regular, rhythmic).

0 1 2 3 4

6. Lower (legs, knees, ankles, toes) (e.g., lateral knee movement, foot tapping, heel dropping, foot squirming, inversion and eversion of foot)

0 1 2 3 4

III. Trunk Movements

7. Neck, shoulders, hips (e.g., rocking, twisting, squirming, pelvic gyrations)

0 1 2 3 4

IV. Global Judgement

8. Severity of abnormal movements overall

0 1 2 3 4

9. Incapacitation due to abnormal movements

0 1 2 3 4

10. Patient's awareness of abnormal movements (rate only patient's report)

0 1 2 3 4

V. Dental Status

11. Current problems with teeth and/or dentures?

Yes or No

12. Does patient usually wear dentures?

Yes or No

13. Endentia?

Yes or No

14. Do movements disappear with sleep?

Yes or No

REFERENCES:

  1. Bhidayasiri R, Fahn S, Weiner WJ et al. Evidence-based guideline: Treatment of tardive syndromes. Report of the guideline development subcommittee of the American Academy of Neurology. Neurology. 2013; 81 (5): 463-469.
  2. Center for Quality Assessment and Improvement in Mental Health (CQAIMH); 2017 [cited 2017-06-17] Available from http://www.cqaimh.org/pdf/tool_aims.pdf
  3. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 2017-05-24]. Available from: http://www.clinicalpharmacology.com/.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2017-05-24]. Available from: http://www.thomsonhc.com/.
  5. 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; 174: 476-484.
  6. Ingrezza [prescribing information]. Neurocrine Biosciences, Inc. San Diego, CA. April 2017.
  7. Obrien CF, Jimenez R, Jauser RA et al. NBI-98854, A selective monamine transport inhibitor for the treatment of tardive dyskinesia: a randomized, double-blind, placebo-controlled study. Movement Disorders. 2015; 30(12): 1681 – 1687.
  8. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2017 [cited 2017-05-24]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 06/14/17.

GUIDELINE UPDATE INFORMATION:

07/15/17

New Medical Coverage Guideline.

Date Printed: July 21, 2017: 12:38 AM