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Vesicular Monoamine Transporter 2 (VMAT2) Inhibitors Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1152
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
10-01-2021 |
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Austedo® |
Treatment of adults with chorea associated with Huntington’s disease |
|
1 |
Austedo XR® |
Treatment of adults with chorea associated with Huntington’s disease |
|
8 |
Ingrezza® |
Treatment of adults with tardive dyskinesia |
|
2 |
Xenazine® |
Treatment of chorea associated with Huntington’s disease |
*generic available
|
3 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Huntington's Disease |
Huntington’s Disease (HD) is a hereditary neurodegenerative disorder caused by an expansion of a repeating cytosine-adenine-guanine (CAG) triplet series in the HTT (huntingtin) gene on chromosome 4. It is inherited in an autosomal dominant pattern with each child of an affected parent having a 50% chance of developing the disease. There is currently no cure or treatment which can halt, slow, or reverse the progression of the disease. The average length of survival after clinical diagnosis is typically 10-20 years.(6) |
Tardive dyskinesia |
Tardive syndromes are persistent abnormal involuntary movement disorders caused by sustained exposure to antipsychotic medication, the most common of which are tardive dyskinesia, tardive dystonia, and tardive akathisia. They begin later in treatment than acute dystonia, akathisia, or medication-induced parkinsonism and they persist and may even increase, despite reduction in dose or discontinuation of the antipsychotic medication. Tardive dyskinesia has been reported after exposure to any of the available antipsychotic medications. It occurs at a rate of approximately 4-8% per year in adult patients treated with first generation antipsychotics. Evaluation of the risk of tardive dyskinesia is complicated by the fact that dyskinetic movements may be observed with a reduction in antipsychotic medication dose. Fluctuations in symptoms are also common and may be influenced by factors such as psychosocial stressors. Regular assessment of patients for tardive syndromes through clinical examination or through the use of a structured evaluative tool, such as the Abnormal Involuntary Movement Scale (AIMS), can aid in identification, clarifying the likely etiology, monitoring, and determining the effects of medication changes or treatments for tardive dyskinesia. It should be noted that there is no specific score threshold that suggests a need for intervention, although ranges of scores are noted to correspond with mild, moderate, and severe symptoms. If no other contributing etiology is identified and moderate to severe or disabling tardive dyskinesia persists, treatment with a VMAT2 inhibitor is recommended. A change in antipsychotic therapy to a lower potency medication and particularly to clozapine may be associated with a reduction in tardive dyskinesia. The potential benefits of changing medication should be considered in light of the possibility of symptom recurrence.(7) |
Safety |
VMAT2 inhibitors (including Austedo/Austedo XR, Ingrezza, and Xenazine) have a boxed warning due to an increased risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Anyone considering the use of VMAT2 inhibitors (including Austedo/Austedo XR, Ingrezza, and Xenazine) must balance the risks of depression and suicidal ideation and behavior with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease.(1-3,8)
Ingrezza is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of Ingrezza. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.(2,5) Xenazine is contraindicated in patients:(3)
|
REFERENCES
Number |
Reference |
1 |
Austedo prescribing information. Teva Neuroscience, Inc. September 2023. |
2 |
Ingrezza prescribing information. Neurocrine Biosciences, Inc. August 2023. |
3 |
Xenazine Prescribing Information. Bausch Health Companies, Inc. November 2019. |
4 |
Bachoud-Lévi AC, Ferreira JJ, Massart R, et al. International Guidelines for the treatment of Huntington’s Disease. Frontiers in Neurology. 2019;10. doi:10.3389/fneur.2019.00710 |
5 |
Ingrezza Sprinkle prescribing information. Neurocrine Biosciences, Inc. April 2024. |
6 |
Nance MA, Paulsen JS, Rosenblatt A, Wheelock V. A Physician’s Guide to the Management of Huntington’s Disease (3rd edition). Huntington’s Disease Society of America. 2011. https://hdsa.org/wp-content/uploads/2015/03/PhysiciansGuide_3rd-Edition.pdf |
7 |
Keepers GA, Fochtmann LJ, Anzia JM, et al. The American Psychiatric Association Practice Guideline for the Treatment of Patients with Schizophrenia. American Journal of Psychiatry. 2020;177(9):868-872. doi:10.1176/appi.ajp.2020.177901 |
8 |
Austedo XR prescribing information. Teva Neuroscience, Inc. February 2023. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Austedo ; Austedo patient titration ; Austedo xr ; Austedo xr patient titrat |
deutetrabenazine tab ; deutetrabenazine tab er ; deutetrabenazine tab er titration pack ; deutetrabenazine tab titration pack |
12 & 18 & 24 & 30 MG ; 12 MG ; 18 MG ; 24 MG ; 30 MG ; 36 MG ; 42 MG ; 48 MG ; 6 & 12 & 24 MG ; 6 & 9 & 12 MG ; 6 MG ; 9 MG |
M ; N ; O ; Y |
N |
|
|
Xenazine |
tetrabenazine tab |
12.5 MG ; 25 MG |
M ; N ; O ; Y |
O ; Y |
|
|
Ingrezza |
valbenazine tosylate cap ; valbenazine tosylate cap therapy pack ; valbenazine tosylate capsule sprinkle |
40 & 80 MG ; 40 MG ; 60 MG ; 80 MG |
M ; N ; O ; Y |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Austedo |
Deutetrabenazine Tab 12 MG |
12 MG |
120 |
Tablets |
30 |
DAYS |
|
|
|
Austedo |
Deutetrabenazine Tab 6 MG |
6 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Austedo |
Deutetrabenazine Tab 9 MG |
9 MG |
120 |
Tablets |
30 |
DAYS |
|
|
|
Austedo xr |
deutetrabenazine tab er |
6 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Austedo xr |
deutetrabenazine tab er |
12 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Austedo xr |
deutetrabenazine tab er |
18 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Austedo xr |
deutetrabenazine tab er |
24 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Austedo xr |
deutetrabenazine tab er |
30 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Austedo xr |
deutetrabenazine tab er |
36 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Austedo xr |
deutetrabenazine tab er |
42 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Austedo xr |
deutetrabenazine tab er |
48 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Austedo xr patient titrat |
deutetrabenazine tab er titration pack |
6 & 12 & 24 MG |
42 |
Tablets |
180 |
DAYS |
|
|
|
Austedo xr patient titrat |
deutetrabenazine tab er titration pack |
12 & 18 & 24 & 30 MG |
1 |
Pack |
180 |
DAYS |
|
|
|
Ingrezza |
Valbenazine Tosylate Cap |
60 MG |
30 |
Capsules |
30 |
DAYS |
|
|
|
Ingrezza |
Valbenazine Tosylate Cap 40 MG (Base Equiv) |
40 MG |
30 |
Capsules |
30 |
DAYS |
|
|
|
Ingrezza |
Valbenazine Tosylate Cap 80 MG (Base Equiv) |
80 MG |
30 |
Capsules |
30 |
DAYS |
|
|
|
Ingrezza |
Valbenazine Tosylate Cap Therapy Pack 40 MG (7) & 80 MG (21) |
40 & 80 MG |
28 |
Capsules |
180 |
DAYS |
|
|
|
Ingrezza |
valbenazine tosylate capsule sprinkle |
40 MG |
30 |
Capsules |
30 |
DAYS |
|
|
|
Ingrezza |
valbenazine tosylate capsule sprinkle |
60 MG |
30 |
Capsules |
30 |
DAYS |
|
|
|
Ingrezza |
valbenazine tosylate capsule sprinkle |
80 MG |
30 |
Capsules |
30 |
DAYS |
|
|
|
Xenazine |
Tetrabenazine Tab 12.5 MG |
12.5 MG |
240 |
Tablets |
30 |
DAYS |
|
|
|
Xenazine |
Tetrabenazine Tab 25 MG |
25 MG |
120 |
Tablets |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Austedo ; Austedo patient titration ; Austedo xr ; Austedo xr patient titrat |
deutetrabenazine tab ; deutetrabenazine tab er ; deutetrabenazine tab er titration pack ; deutetrabenazine tab titration pack |
12 & 18 & 24 & 30 MG ; 12 MG ; 18 MG ; 24 MG ; 30 MG ; 36 MG ; 42 MG ; 48 MG ; 6 & 12 & 24 MG ; 6 & 9 & 12 MG ; 6 MG ; 9 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ingrezza |
valbenazine tosylate cap ; valbenazine tosylate cap therapy pack ; valbenazine tosylate capsule sprinkle |
40 & 80 MG ; 40 MG ; 60 MG ; 80 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Xenazine |
tetrabenazine tab |
12.5 MG ; 25 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Austedo |
Deutetrabenazine Tab 12 MG |
12 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Austedo |
Deutetrabenazine Tab 6 MG |
6 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Austedo |
Deutetrabenazine Tab 9 MG |
9 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Austedo xr |
deutetrabenazine tab er |
18 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Austedo xr |
deutetrabenazine tab er |
48 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Austedo xr |
deutetrabenazine tab er |
42 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Austedo xr |
deutetrabenazine tab er |
36 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Austedo xr |
deutetrabenazine tab er |
30 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Austedo xr |
deutetrabenazine tab er |
24 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Austedo xr |
deutetrabenazine tab er |
6 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Austedo xr |
deutetrabenazine tab er |
12 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Austedo xr patient titrat |
deutetrabenazine tab er titration pack |
12 & 18 & 24 & 30 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Austedo xr patient titrat |
deutetrabenazine tab er titration pack |
6 & 12 & 24 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ingrezza |
Valbenazine Tosylate Cap |
60 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ingrezza |
Valbenazine Tosylate Cap 40 MG (Base Equiv) |
40 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ingrezza |
Valbenazine Tosylate Cap 80 MG (Base Equiv) |
80 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ingrezza |
Valbenazine Tosylate Cap Therapy Pack 40 MG (7) & 80 MG (21) |
40 & 80 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ingrezza |
valbenazine tosylate capsule sprinkle |
80 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ingrezza |
valbenazine tosylate capsule sprinkle |
60 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ingrezza |
valbenazine tosylate capsule sprinkle |
40 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Xenazine |
Tetrabenazine Tab 12.5 MG |
12.5 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Xenazine |
Tetrabenazine Tab 25 MG |
25 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||||||||
PA |
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence Length of Approval: Tardive dyskinesia - 3 months, all other indications - 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL with PA |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 12 months |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
ALBP _ Commercial _ CSReg _ VMAT2_Inhibitors_PAQL _ProgSum_ 10-01-2024 _
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