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Deutetrabenazine Drug and Biologic Coverage Policy Effective Date ............................................ 1/1/2021 Next Review Date… ..................................... 1/1/2022 Coverage Policy Number ............................... IP0079 Deutetrabenazine Table of Contents Related Coverage Resources Overview .............................................................. 1 Genetic Testing for Hereditary and Multifactorial Coverage Policy ................................................... 1 Conditions Reauthorization Criteria ....................................... 2 Authorization Duration ......................................... 2 Conditions Not Covered....................................... 2 Background .......................................................... 2 References .......................................................... 3 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Overview This policy supports medical necessity review for Austedo™ (deutetrabenazine). Coverage Policy Deutetrabenazine (Austedo) is medically necessary when the following are met: Individual has one of the following diagnoses: a. Documented diagnosis of Huntington's disease • Individual is 18 years of age or older • Confirmed by genetic testing (for example, an expanded HTT CAG repeat sequence of at least 36) • Presence of chorea • Prescribed by or in consultation with a neurologist Page 1 of 3 Coverage Policy Number: IP0079 b. Documented diagnosis of tardive dyskinesia • Individual is 18 years of age or older • Individual has a history of treatment with a dopamine receptor blocking agent (for example, antipsychotics, metoclopramide, prochlorperazine) • Prescribed by or in consultation with a neurologist or a psychiatrist When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to therapy. Note: Receipt of sample product does not satisfy any criteria requirements for coverage. Documentation: When documentation is required, the prescriber must provide written documentation supporting the trials of these other agents. Documentation may include, but is not limited to, chart notes, prescription claims records, and/or prescription receipts Reauthorization Criteria Austedo (deutetrabenazine) is considered medically necessary for continued use when initial criteria are met AND there is documentation of beneficial response. Authorization Duration Initial approval and reauthorization duration is 12 months unless otherwise stated. Conditions Not Covered Austedo (deutetrabenazine) is considered experimental, investigational or unproven for ANY other use. Background Overview Austedo reversibly depletes monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals.1 Austedo and its major circulating metabolites (α-dihydrotetrabenazine [HTBZ] and β-HTBZ) reversibly inhibit vesicular monoamine transporter type 2 (VMAT2), resulting in decreased uptake of monoamines (e.g., dopamine) into synaptic vesicles and depletion of monoamine stores. Austedo is indicated for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia in adults. Austedo has been evaluated for use in one small, Phase Ib study in adolescents with moderate-to-severe tics associated with Tourette syndrome.2 Tetrabenazine (Xenazine®, generics) is also a VMAT2 inhibitor indicated for the treatment of chorea associated with HD.3 Guidelines According to the American Academy of Neurology (AAN) guidelines on the treatment of chorea of Huntington’s disease (2012), if HD chorea requires treatment, clinicians should prescribe tetrabenazine (≤ 100 mg/day), amantadine (300 to 400 mg/day), or riluzole (200 mg/day) [Level B] for varying degrees of expected benefit.4 Austedo is not addressed in the guidelines. Safety Austedo is contraindicated in patients who are suicidal or in patients with untreated or inadequately treated depression in patients with Huntington’s disease.1 Austedo also has a Boxed Warning regarding depression and suicidality in patients with Huntington’s disease. Patients with Huntington’s disease are at increased risk for depression, and suicidal ideation or behaviors (suicidality), and Austedo may increase the risk for suicidality in patients with Huntington’s disease. When considering the use of Austedo, the risk of suicidality should be Page 2 of 3 Coverage Policy Number: IP0079 balanced against the need for treatment of chorea. All patients treated with Austedo should be observed for new or worsening depression or suicidality. If depression or suicidality does not resolve, consider discontinuing treatment with Austedo. References 1. Austedo® tablets [prescribing information]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; July 2019. 2. Jankovic J, Jimenez-Shahed J, Budman C, et al. Deutetrabenazine in tics associated with Tourette Syndrome. Tremor Other Hyperkinet Mov. 2016; 6:422. 3. Xenazine® tablets [prescribing information]. Deerfield, IL: Lundbeck; September 2017. 4. 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. “Cigna Companies” refers to operating subsidiaries of Cigna Corporation. All products and services are provided exclusively by or through such operating subsidiaries, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Cigna Behavioral Health, Inc., Cigna Health Management, Inc., QualCare, Inc., and HMO or service company subsidiaries of Cigna Health Corporation. The Cigna name, logo, and other Cigna marks are owned by Cigna Intellectual Property, Inc. © 2021 Cigna. Page 3 of 3 Coverage Policy Number: IP0079 .
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