CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tetrabenazine Xenazine 2266 A Sgm P2024

Policy defines prior authorization and coverage criteria for tetrabenazine (Xenazine) for FDA-approved indication (chorea associated with Huntington's disease) and specified compendial uses (tic disorders, tardive dyskinesia, hemiballismus, chorea not associated with Huntington's). It details required documentation for initial requests and renewal/continuation durations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTetrabenazine Xenazine 2266 A Sgm P2024

Policy CodePolicy N/A

Change TypeClarified

Effective Date

Next Review Date

Key ActionFor initial requests, submit chart notes or medical record documentation of clinical manifestations or characteristic motor exam features plus confirmatory HTT CAG >=36 or positive family history for Huntington's disease as applicable.

SourceLink

POLICY UPDATE CHANGES

Policy lists covered FDA-approved indication and compendial uses with documentation and authorization durations.

5Covered Indications

6 moInitial Authorization

12 moContinuation Authorization

Coverage Summary & Covered Indications

Policy: Tetrabenazine (Xenazine) is covered with criteria for the FDA-approved indication and specified compendial uses. Initial authorizations are issued for 6 months; continuation/renewal authorizations may be granted for up to 12 months when benefit (stability or improvement) is documented.

Covered indications: Huntington's chorea (treatment of chorea associated with Huntington's disease), and compendial uses including tic disorders, tardive dyskinesia, hemiballismus, and chorea not associated with Huntington's disease.

Initial Therapy Criteria

Prior Authorization

Submit documentation for initial prior authorization

For initial prior authorization requests, submit chart notes or medical record documentation of the clinical manifestations. For chorea associated with Huntington’s disease, submit documentation of characteristic motor examination features plus confirmatory evidence: either laboratory results showing an expanded HTT CAG repeat sequence >= 36 or a positive family history for Huntington’s disease.

Chorea associated with Huntington’s disease
Chorea not associated with Huntington’s disease
Tic disorders
Tardive dyskinesia
Hemiballismus

Continuation Therapy Criteria

Prior Authorization

Duration limits for authorizations

Initial authorizations may be granted for 6 months for the listed indications. Continuation/renewal authorizations may be granted for up to 12 months when the member is experiencing benefit from therapy, demonstrated by disease stability or improvement. Be prepared to provide documentation of clinical benefit for continuation requests.

Document benefit (stability or improvement) to support continuation up to 12 months

Excluded / Not Medically Necessary Indications

Excluded/Not Medically Necessary Indications

Excluded/Not Medically Necessary Indications: All other indications not listed in Section I (FDA-approved and listed compendial uses) are considered experimental/investigational and not medically necessary

Provider Action Items and Documentation

Documentation Required

Assessment documentation for tardive dyskinesia

Document assessment of tardive dyskinesia using clinical examination findings or a structured evaluative tool. Acceptable tools include the Abnormal Involuntary Movement Scale (AIMS) or the Dyskinesia Identification System: Condensed User Scale (DISCUS). Include chart notes or medical record documentation of the clinical manifestations.

Use AIMS or DISCUS when available
Include clinical exam findings in chart notes

Prior Authorization

Submit documentation for initial prior authorization

For initial prior authorization, submit the required chart notes or medical record documentation of clinical manifestations. For chorea associated with Huntington’s disease, include characteristic motor exam findings plus confirmatory HTT testing (>= 36 CAG repeats) or a positive family history. Initial authorizations are 6 months; continuation may be up to 12 months with documentation of benefit (stability or improvement).

Affected indications: chorea (HD and non-HD), tic disorders, tardive dyskinesia, hemiballismus
Documentation of benefit required for continuation up to 12 months

For initial prior authorization for chorea associated with Huntington's disease, submit chart notes documenting characteristic motor examination features and confirmatory evidence: either laboratory results showing an expanded HTT CAG repeat sequence of >= 36 or a positive family history for Huntington's disease.

Clinical Evidence & References

Key references include the Xenazine and tetrabenazine package inserts, Micromedex, Lexicomp (AHFS DI), and selected literature and practice guidelines. References were accessed March 14, 2024. No clinical trial metrics are provided in this policy, so metric cards are not applicable.

Background and Definitions

Tetrabenazine (Xenazine) is indicated for the treatment of chorea associated with Huntington's disease and has compendial uses for tic disorders, tardive dyskinesia, hemiballismus, and chorea not associated with Huntington's disease.

Coverage is conditional on required documentation: initial requests must include chart notes or medical record documentation of clinical manifestations. For chorea associated with Huntington's disease, documentation must include characteristic motor examination features plus confirmatory HTT testing (CAG repeat ≥ 36) or a positive family history when applicable.

AIMS: Abnormal Involuntary Movement Scale.

DISCUS: Dyskinesia Identification System: Condensed User Scale.

Revision History

2024-03-14reference_updateLatest

Reference number 2266-A; package inserts and references accessed March 14, 2024. Policy lists covered FDA-approved indication and compendial uses with documentation and authorization durations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTetrabenazine Xenazine 2266 A Sgm P2024

Policy CodePolicy N/A

Change TypeClarified

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Tetrabenazine Xenazine 2266 A Sgm P2024

Coverage Summary & Covered Indications

Initial Therapy Criteria

Continuation Therapy Criteria

Excluded / Not Medically Necessary Indications

Provider Action Items and Documentation

Applicable Codes & Reference

Clinical Evidence & References

Background and Definitions

Revision History