Subject: Austedo (deutetrabenazine) Original Effective Date: 3/8/2018. Policy Number: MCP-307. Revision Date(s):

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1 Subject: Austedo (deutetrabenazine) Original Effective Date: 3/8/2018 Policy Number: MCP-307 Revision Date(s): Review Date: 3/8/2018 MCPC Approval Date: 3/8/2018 DISCLAIMER This Molina Clinical Policy (MCP) is intended to facilitate the Utilization Management process. It expresses Molina's determination as to whether certain services or supplies are medically necessary, experimental, investigational, or cosmetic for purposes of determining appropriateness of payment. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Molina) for a particular member. The member's benefit plan determines coverage. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusion(s) or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the CMS website. The coverage directive(s) and criteria from an existing National Coverage Determination (NCD) or Local Coverage Determination (LCD) will supersede the contents of this MCP document and provide the directive for all Medicare members. SUMMARY OF EVIDENCE/POSITION This policy addresses the coverage of Austedo (deutetrabenazine) for the treatment of adult patients chorea associated with Huntington's disease (Huntington's Chorea) AND for the treatment of tardive dyskinesia when appropriate criteria are met. The intent of the Austedo (deutetrabenazine) policy is to ensure appropriate selection of patients for therapy based on product labeling, clinical guidelines, and clinical studies. This policy is intended to address coverage criteria that are appropriate for the majority of individuals/members with a particular disease, illness, or condition. Each member's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records. Huntington's Disease (HD) is a rare autosomal dominant neurodegenerative disorder characterized by progressive motor, cognitive, and psychiatric dysfunction. HD is caused by a mutation in the gene for a protein called huntingtin. The defect causes the cytosine, adenine, and guanine (CAG) building blocks of DNA to repeat many more times than is normal. Each child of a parent with HD has a chance of inheriting the HD gene. Symptoms of the disease, which gets progressively worse, include chorea (non-repetitive, non-periodic, involuntary jerking movements of face, trunk, or limbs often enhanced during voluntary movement), abnormal body postures, and changes in behavior, emotion, judgment, and cognition. Individuals with HD also develop impaired coordination, slurred speech, and difficulty feeding and swallowing. HD typically begins between ages 30 and 50. An earlier onset form called juvenile HD, occurs under age 20. Symptoms of juvenile HD differ somewhat from adult onset HD and include unsteadiness, rigidity, difficulty at school, and seizures. More than 30,000 Americans have HD. Annual incidence 0.38 per 100,000 and worldwide Dynamed 2018 service-based prevalence 2.71 per 100,000. Page 1 of 25

2 A genetic test, coupled with a complete medical history and neurological and laboratory tests, helps physicians diagnose HD. Diagnosis confirmed by DNA analysis finding 36 CAG trinucleotide repeats in HTT gene. Tardive dyskinesias (TDs) are involuntary movements of the tongue, lips, face, trunk, and extremities that occur in patients treated with long-term dopaminergic antagonist medications. Although TDs are associated with the use of neuroleptics, TDs apparently existed before the development of these agents. Patients with schizophrenia and other neuropsychiatric disorders are especially vulnerable to the development of TDs after exposure to conventional neuroleptics, anticholinergics, toxins, substances of abuse, and other agents. TDs are most common in patients with schizophrenia, schizoaffective disorder, or bipolar disorder who have been treated with antipsychotic medication for long periods, however TDs may occasionally occur in other patients as well, such as people with fetal alcohol syndrome, other developmental disabilities, and other brain disorders are vulnerable to the development of TDs, even after receiving only one dose of the causative agent (primarily antipsychotics but may include gastric motility agents and antiemetics such as metoclopramide and prochlorperazine). According to the manufacturer, the condition is estimated to affect at least 500,000 people in the United States. The exact mechanism of TD is unknown; however is theorized to be due to upregulation and increased sensitivity of dopamine receptors and alteration in central nervous system neurotransmitter activity in response to chronic antagonism from DRBAs which leads to dysregulation of the brainstem skeletomotor circuit. Movements are involuntary and repetitive and usually involve the orofacial area, but may affect movement in other areas as well. TD usually presents after 1-2 years of chronic exposure to a DRBA but may occur as early as 3 months (or 1 month in patients 60 years old) The risk of development of TD is related to both the dose and duration of exposure to DRBAs Reported in about 20%-50% of patients treated with DRBAs Typical (first generation) antipsychotics may be more likely to cause TD than atypical (second generation) antipsychotics Though there is currently no validated measure that reflects the impact of TD on a patient's quality of life, the Abnormal Involuntary Movement Scale (AIMS) has been used in clinical and research settings to assess the general severity of symptoms and the impact of treatment. (cited by ICER 2017) Deutetrabenazine is a selective inhibitor of vesicular monoamine transporter 2 (VMAT-2) that depletes dopamine in the CNS. Excess dopamine has been implicated in hyperkinetic movement disorders, and VMAT-2 inhibition has been associated with symptomatic relief. Deutetrabenazine is structurally similar to and has the same pharmacologic action as tetrabenazine, a well-established treatment for chorea associated with Huntington disease. Substitution of deuterium for hydrogen at key locations differentiates deutetrabenazines structure from tetrabenazine's chemical structure. Deutetrabenazine is a deuterated form of tetrabenazine (FDA approved for the treatment of chorea associated with Huntington s disease in 2008) and the first deuterated product approved by the FDA. Deuteration affects the metabolism and pharmacokinetics of the drug, such that for equivalent doses, exposure to the active metabolites of deutetrabenazine is approximately twice that of tetrabenazine, and the half-life is longer. Deutetrabenazine is similar to tetrabenazine in that it inhibits VMAT-2 action in the CNS, which helps deplete excess dopamine that may contribute to involuntary movements; however, deutetrabenazine contains deuterium molecules in place of hydrogen molecules at key locations, which slows metabolism to inactive compounds by CYP2D6, allowing for less frequent and lower dosing. The effect of selective incorporation of deuterium in place of hydrogen (i.e. deuteration) on the safety profile is unknown versus the safety profile of the parent compound, tetrabenazine. At the present time, no conclusive evidence demonstrating that deutetrabenazine (Austedo) is safer than tetrabenazine, as there are no head-to-head comparisons. Page 2 of 25

3 The only known advantage of deutetrabenazine over tetrabenazine is the need for less frequent dosing (BID instead of TID) at the higher end of the dosing range. Patients who have had an inadequate response to tetrabenazine may switch to deutetrabenazine in search of better efficacy; however there is no basis that the two products differ with respect to efficacy; furthermore, an attempt to show superiority of deutetrabenazine to tetrabenazine would seem futile. [Center for Drug Evaluation and Research. April 3, NDA ] Considering the unknown impact on improved function or quality of life, deutetrabenazine (Austedo) may increase the risk of depression, suicidality, and possible disease worsening is a factor when determining the clinical need for the treatment of chorea. Therefore, the benefits of treatment should outweigh the risks, or an option for severe, disabling disease. In clinical trials, deutetrabenazine provided symptomatic relief in patients with Huntington chorea and tardive dyskinesia versus placebo. However, there are no studies comparing the efficacy or safety of deutetrabenazine (Austedo) to any other active treatment. There is no high-quality evidence and lack of head-to-head studies to supporting the safety and efficacy of deutetrabenazine (Austedo) over tetrabenazine. Clinical trials have shown minimal adverse drug reactions associated with deutetrabenazine, including psychiatric adverse events, although patients with untreated or undertreated depression were not included in the trials. CLINICAL PRACTICE GUIDELINES Chorea associated with Huntington Disease The American Academy of Neurology (2012) recommends tetrabenazine, amantadine, or riluzole if the chorea warrants treatment. [Reference: Evidence-based guideline: pharmacologic treatment of chorea in Huntington disease: report of the guideline development subcommittee of the AAN, 2012] Tardive Dyskinesias (TDs) Treatment recommendations have been developed by the American Psychiatric Association and the American Academy of Neurology (AAN 2013). ICER 2017 Avoiding long-term use of antipsychotic agents for conditions where evidence of benefit is lacking or other treatment options are available is preferred. Therapy for TD has primarily focused on decreasing and then stopping the offending agent, and switching to a different antipsychotic if such agents are still deemed necessary. It is often not possible to stop the antipsychotic immediately because TD symptoms can worsen upon withdrawal. Though patients with TD symptoms may improve with these changes, complete resolution of symptoms is rare, and long- lasting or ICER 2017 permanent symptoms can be seen, even in patients who successfully are taken off antipsychotics. Therefore, other treatments have been sought to decrease symptoms of patients with TD, and guideline recommendations may change with the availability of safer and more effective treatment options. The AAN published guidelines on the treatment of tardive syndromes in 2013, however valbenazine (Ingrezza) and deutetrabenazine (Austedo) have not been addressed in clinical practice guidelines. The 2013 AAN evidence-based guidelines for the treatment of TD did not make any level A (highest level of evidence for efficacy) treatment recommendations. Gingko biloba and clonazepam were recommended in the level B category. Based on AAN guidelines, tetrabenazine is possibly effective and may be considered in the treatment of patients with tardive dyskinesia (AAN 2013). CLASSIFICATION: Central Monoamine-Depleting Agent; Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor VMAT2 Inhibitors: Xenazine (tetrabenazine); Austedo (deutetrabenazine); Ingrezza (valbenazine) Page 3 of 25

4 FDA INDICATIONS CHOREA ASSOCIATED WITH HUNTINGTON S DISEASE Treatment of chorea associated with Huntington disease Orphan drug designation: Treatment of Huntington Disease The FDA previously granted Austedo (formerly known as SD-809) an Orphan Drug designation. TARDIVE DYSKINESIA Treatment of tardive dyskinesia in adults Available as: Oral Tablets: 6mg, 9mg, and 12 mg FDA Approved: Chorea associated with HD: April 3, 2017 Tardive dyskinesia: August 30, 2017 Black Box Warnings: Deutetrabenazine product labeling includes a boxed warning regarding an increased risk for depression and suicidality. Patients with Huntington disease are at increased risk for depression and suicidal ideation; deutetrabenazine and tetrabenazine may increase the risk. In clinical trials, depression was reported in 4% and suicidal ideation was reported in 2% of patients treated with deutetrabenazine; patients with uncontrolled depression were excluded from the trials. REMS: No REMS at the time of this writing Page 4 of 25

5 RECOMMENDATIONS/COVERAGE CRITERIA Austedo (deutetrabenazine) may be authorized for members who meet ALL of the following criteria [ALL] 1. Prescriber specialty [ONE] For Tardive Dyskinesia: Prescribed by, or in consultation with, a board-certified psychiatrist or neurologist. Submit consultation notes if applicable. NOTE: Consultation notes must be submitted for initial request and for continuation of treatment requests at least ONCE annually. Chorea associated with Huntington s Disease (HD): Prescribed by, or in consultation with, a boardcertified neurologist with expertise in HD. Submit consultation notes if applicable. NOTE: Consultation notes must be submitted for initial request and for continuation of treatment requests at least ONCE annually. 2. Diagnosis/Indication [ALL] Documentation of diagnosis required and may include clinical notes from the member s medical records including any relevant labs and/or tests, supporting the diagnosis [A OR B] A. TARDIVE DYSKINESIA [ALL] Diagnosis of schizophrenia, schizo-affective disorder, or a mood disorder for at least 3 months STABLE psychiatric status AND For member on maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorders: Stable medication doses and therapy required. Documentation required. Diagnosis of antipsychotic-induced moderate to severe tardive dyskinesia as indicated by a score of 3 or 4 on item 8 (severity of abnormal movement overall) of the Abnormal Involuntary Movement Scale (AIMS). Documentation required. --REFER to Appendix 1: Centrally-Acting Dopamine Receptor Blocking Agents (Neuroleptics) Informational Note: Drugs that most commonly cause TD are older antipsychotic agents such as haloperidol, chlorpromazine, and thioridazine; other drugs that may be associated with TD include antidepressants (amitriptyline, fluoxetine, phenelzine, sertraline, and trazodone), anti-parkinson s drugs (levodopa), epilepsy drugs (phenobarbital and phenytoin), and metoclopramide. Baseline evaluation of TD by an Abnormal Involuntary Movement Scale (AIMS) greater than or equal to 10. Documentation of the member s current AIMS score from items 1-7 (results range from 0 to 28, with higher scores indicating more severe involuntary movements) required. Austedo was approved based on two placebo-controlled trials involving 335 adult patients with TD. The primary endpoint was the AIMS assessment of TD severity. Page 5 of 25

6 B. CHOREA ASSOCIATED WITH HUNTINGTON S DISEASE [ALL] Diagnosis of chorea associated with Huntington s Disease confirmed by ONE (1) of the following: [ONE] Huntington Disease Mutation Analysis: indicating an expanded CAG repeat ( 36) in the huntington gene (HTT) (also known as HD gene). Documentation of laboratory result required. A positive family history of Huntington s Disease, with autosomal dominant inheritance pattern Clinical signs of Huntington s Disease. Submit documentation of clinical assessment indicating that the member has ONE (1) or more of the following clinical signs: [ONE OR MORE] neurologic manifestations, may include but not limited to: [ONE OR MORE] Warby, SC.GeneReviews. o changes in eye movements (saccades) o decreased coordination o minor involuntary movements o alteration in executive functioning o depressed or irritable mood o chorea consisting of non-repetitive jerking movements of limbs, face, or trunk fine motor voluntary movements may be impaired early in course of disease dystonia (such as torticollis) Baseline evaluation of Total Chorea Score ([using the Unified Huntington s Disease Rating Scale (UHDRS)]. Documentation required. MOLINA REVIEWER: Reauthorization requires positive response or demonstrated efficacy to therapy. Baseline score reviewed at Continuation of Therapy. Informational Note: Total Chorea Score (TCS), 1 of the items on the Unified Huntington s Disease Rating Scale (UHDRS; chorea is rated from 0 to 4 for 7 different parts of the body with lower scores representing less chorea; range, 0 to 28) 3. Age/Gender/Restrictions [ALL] 18 years of age or older Safety and efficacy of deutetrabenazine or tetrabenazine have not been established in pediatric patients; based on the age group affected by Huntington disease, deutetrabenazine is unlikely to be assessed in this population. No prior medical history of, or significant risk for: suicidal ideation, violent behavior, or unstable psychiatric symptoms. Documentation required. FOR members with Chorea associated with Huntington s Disease ONLY [ALL] For member with a history of depression and/or suicidal ideation only: An evaluation by a neurologist or behavioral health provider prior to starting therapy is required AND Agrees to receive care and follow-up assessment for psychiatric condition, from the Prescriber (neurologist) or behavioral health provider while on Austedo (deutetrabenazine) therapy. Documentation required. Page 6 of 25

7 4. Conventional Therapy/Concurrent Therapy/Other Requirements [ALL] FOR TARDIVE DYSKINESIA ONLY [ALL] Inadequate response, clinical intolerance, contraindication, or inappropriate for member s condition required for ALL of the following therapies. Documentation required: [ALL] Inadequate response is defined as failure to achieve and maintain improvement in TD symptoms after a compliant trial on the recommended dose for a sufficient period Prescriber has reduced the dose or discontinued medication(s) known to cause tardive dyskinesia [Refer to Appendix 1] OR Prescriber has switched from a first-generation to a second-generation antipsychotic [Refer to Appendix 1] OR Member is not a candidate for a trial of dose reduction, tapering, switching or discontinuation of the offending medication Additional pharmacologic interventions include the following: use of benzodiazepines, botulinum toxin injections, tetrabenazine, or anticholinergic drugs to control symptoms of TD, or paradoxically, resuming treatment with antipsychotic drugs in order to suppress TD (Tardive dyskinesia: Prevention and treatment. In: UpToDate). AND At least ONE (1) medication used to reduce tardive dyskinesia symptoms [i.e. benzodiazepines (clonazepam)] [Refer to Appendix 1] *Off-label use of various pharmacologic options encompasses the standard treatment approach for controlling symptoms of tardive dyskinesia severe enough to warrant treatment. AND tetrabenazine (Xenazine) at up to 100 mg/day [REFER TO MCP-075: Xenazine (tetrabenazine)] Page 7 of 25

8 CHOREA ASSOCIATED WITH HUNTINGTON S DISEASE [ALL] Inadequate response, clinical intolerance, contraindication, or inappropriateness ALL of the following therapies. Documentation required: [ALL] Inadequate response is defined as failure to achieve and maintain improvement in TD symptoms after a compliant trial on the recommended dose for a sufficient period ONE (1) of the following medications or classes of medication, unless contraindicated or clinically significant adverse effects are experienced. Documentation required. [ONE] o Benzodiazepines o Amantadine o Antipsychotics Informational Note: Typical neuroleptics, atypical antipsychotics, benzodiazepines and anti-glutamatergic agents (amantadine) have been used off-label use in the treatment of chorea for many years. [The Cochrane database of systematic reviews. 2009] tetrabenazine (Xenazine) at up to 100 mg/day [REFER TO MCP-075: Xenazine (tetrabenazine)] Informational Note: There is no conclusive evidence demonstrating that deutetrabenazine (Austedo) is safer than tetrabenazine, as there are no head-to-head comparisons. Austedo (deutetrabenazine) is not prescribed with nor intended for use in combination with the following therapies: [ANY] Other VMAT2 Inhibitors: [ANY] o tetrabenazine (Xenazine) o Ingrezza (valbenazine) MAOI (monoamine oxidase inhibitors) [e.g., selegiline (Emsam), isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate)] Reserpine QTc-prolonging agents [e.g., antipsychotic agents (e.g., chlorpromazine, haloperidol), antibiotics (e.g., moxifloxacin), class IA and III antiarrhythmic agents] Informational Note: Deutetrabenazine is contraindicated in patients taking MAOIs (within 14 days), reserpine (within 20 days), or tetrabenazine Concurrent use with other VMAT2 inhibitors such as tetrabenazine or valbenazine is considered duplicate therapy. --Refer to Appendix 2 for VMAT2 Inhibitors and recommended dosages. Reserpine binds irreversibly to VMAT-2. Co-administration could result in major depletion of serotonin and norepinephrine. Co-administration may enhance the adverse/toxic effect of MAOIs. Deutetrabenazine is contraindicated in patients taking MAOIs and for a minimum of 14 days after discontinuing treatment with an MAOI. Co-administration with QTc-prolonging agents may increase the risk for life-threatening arrhythmia and/or torsades de pointes. Use of deutetrabenazine should be avoided in combination with drugs known to prolong QTc. Page 8 of 25

9 5. Contraindications/Exclusions/Discontinuations Authorization will not be granted if ANY of the following conditions apply [ANY] Non-FDA approved indications Hypersensitivity to valbenazine or any component of the formulation Younger than 18 years Serious untreated or undertreated psychiatric illness, such as depression A history of significant suicidal thoughts or behavior Arrhythmias associated with a prolonged QT interval NOTE: Members with congenital long QT syndrome or arrhythmias associated with prolonged QT interval, or members at risk of prolonged QT interval: An EKG may be required prior to therapy and before increasing the dosage. Peer-to-Peer and/or additional documentation may be requested at the discretion of the Pharmacy/Medical Director. Hepatic impairment NOTE: Members with a history of hepatic impairment, appropriate labs and/or additional documentation may be requested at the discretion of the Pharmacy/Medical Director. Concomitant therapy with ANY of the following will NOT be authorized: [ANY] Other VMAT2 inhibitors: Ingrezza (valbenazine) or tetrabenazine (Xenazine) MAOI (monoamine oxidase inhibitors) [e.g., selegiline (Emsam), isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate)] Reserpine QTc-prolonging agents [e.g., antipsychotic agents (e.g., chlorpromazine, haloperidol), antibiotics (e.g., moxifloxacin), class IA and III antiarrhythmic agents] 6. Labs/Reports/Documentation required [ALL] All documentation for determination of medical necessity must be submitted for review. Prescriber to submit documentation as indicated in the criteria above, including but not limited to chart notes, applicable lab values and/or tests, adverse outcomes, treatment failures, or any other additional clinical information or clinical notes from the member s medical records supporting the diagnosis. Letters of support and/or explanation are often useful, but are not sufficient documentation unless ALL specific information required by this MCP is included. NOTE: Additional documentation, rationale, and/or supporting evidence may be requested for review as deemed necessary or appropriate by Molina Medical/Pharmacy staff. Page 9 of 25

10 CONTINUATION OF THERAPY Austedo (deutetrabenazine) may be authorized for continuation of therapy if meet ALL of the following criteria are met: [ALL] 1. Initial Coverage Criteria [ALL] Member currently meets ALL initial coverage criteria Subsequent authorizations will require the Member to have an office visit and re-assessment for this condition annually to determine if continuation of treatment with requested medication is medically necessary. Chart notes or consultation notes (if applicable) must be submitted for initial request and for continuation of treatment requests at least ONCE annually. 2. Compliance [ALL] Adherence to therapy at least 85% of the time as verified by Prescriber and member s medication fill history (review Rx history for compliance), including: [ALL] Adherent to the prescribed medication regimen Tolerance to therapy No severe adverse reactions or drug toxicity NOTE: Therapy may be discontinued due to poor adherence upon recommendation of the Molina Medical Director when adherence < 85% has been demonstrated in at least two months during the course of therapy NOTE: History of non-compliance or non-adherence as verified by member s medication fill history or prescription drug profile may result in continuation of therapy request not being authorized. [MOLINA MEDICAL/PHARMACY REVIEWER TO VERIFY Page 10 of 25

11 3. Labs/Reports/Documentation required [ALL] Austedo (deutetrabenazine) therapy may be authorized when therapy has demonstrated efficacy as evidenced by disease stabilization or improvement in disease: [ALL] For TARDIVE DYSKINESIA Only: Disease stabilization or improvement in TD symptoms as documented by AIMS score (items 1-7): decrease from baseline by at least 2 points Informational Note: Compared with a change of -1.4 points in the placebo group, the least-squares mean AIMS score improved by -3.3 points in the deutetrabenazine 36 mg/day group, by -3.2 points in the 24 mg/day group, and by -2.1 points in the 12 mg/day group, with treatment differences of -1.9 points, -1.8 points, and -0.7 points, respectively, vs -1.4 points in the placebo group. For CHOREA ASSOCIATED WITH HUNTINGTON S DISEASE Only [ONE] Disease stabilization or improvement of Total Maximal Chorea Scores from baseline OR Disease stabilization or improvement in chorea or tardive dyskinesia symptoms from baseline STABLE psychiatric status AND ALL of the following as applicable to member. Documentation required [ALL APPLICABLE] For members on maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorders): Stable medication doses and therapy required. For members with a history of depression and/or suicidal thoughts or behaviors OR members with a current treatment for depression and/or suicidal thoughts or behaviors: [ALL] o Regular follow-up and recent evaluation for this condition by the Prescriber (neurologist or psychiatrist) or behavioral health provider is required. o Member is not experiencing suicidal thoughts or behaviors Austedo (deutetrabenazine) is not prescribed with nor intended for use in combination with the following therapies: [ANY] Other VMAT2 Inhibitors: [ANY] o tetrabenazine (Xenazine) o Ingrezza (valbenazine) MAOI (monoamine oxidase inhibitors) [e.g., selegiline (Emsam), isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate)] Reserpine QTc-prolonging agents [e.g., antipsychotic agents (e.g., chlorpromazine, haloperidol), antibiotics (e.g., moxifloxacin), class IA and III antiarrhythmic agents] Informational Note: Deutetrabenazine is contraindicated in patients taking MAOIs (within 14 days), reserpine (within 20 days), or tetrabenazine Concurrent use with other VMAT2 inhibitors such as tetrabenazine or valbenazine is considered duplicate therapy. Refer to Appendix 2 for VMAT2 Inhibitors and recommended dosages. Reserpine binds irreversibly to VMAT-2. Co-administration could result in major depletion of serotonin and norepinephrine. Co-administration may enhance the adverse/toxic effect of MAOIs. Deutetrabenazine is contraindicated in patients taking MAOIs and for a minimum of 14 days after discontinuing treatment with an MAOI. Co-administration with QTc-prolonging agents may increase the risk for life-threatening arrhythmia and/or torsades de pointes. Use of deutetrabenazine should be avoided in combination with drugs known to prolong QTc. Page 11 of 25

12 4. Discontinuation of Treatment [ANY] Discontinue treatment if ANY of the following conditions applies: [ANY] Intolerable adverse effects or drug toxicity Persistent and uncorrectable problems with adherence to treatment Poor response to treatment as evidenced by physical findings and/or clinical symptoms Contraindications/Exclusions/Discontinuations Non-FDA approved indications Hypersensitivity to valbenazine or any component of the formulation Younger than 18 years Serious untreated or undertreated psychiatric illness, such as depression A history of significant suicidal thoughts or behavior Arrhythmias associated with a prolonged QT interval NOTE: Members with congenital long QT syndrome or arrhythmias associated with prolonged QT interval, or members at risk of prolonged QT interval: An EKG may be required prior to therapy and before increasing the dosage. Peer-to-Peer and/or additional documentation may be requested at the discretion of the Pharmacy/Medical Director. Hepatic impairment NOTE: Members with a history of hepatic impairment, appropriate labs and/or additional documentation may be requested at the discretion of the Pharmacy/Medical Director. Concomitant therapy with ANY of the following will NOT be authorized: [ANY] Other VMAT2 inhibitors: Ingrezza (valbenazine) or tetrabenazine (Xenazine) MAOI (monoamine oxidase inhibitors) [e.g., selegiline (Emsam), isocarboxazid (Marplan), phenelzine(nardil), tranylcypromine (Parnate)] Reserpine QTc-prolonging agents [e.g., antipsychotic agents (e.g., chlorpromazine, haloperidol), antibiotics (e.g., moxifloxacin), class IA and III antiarrhythmic agents] 5. Labs/Reports/Documentation required [ALL] All documentation for determination of medical necessity must be submitted for review. Prescriber to submit documentation as indicated in the criteria above, including but not limited to chart notes, applicable lab values and/or tests, adverse outcomes, treatment failures, or any other additional clinical information or clinical notes from the member s medical records supporting the diagnosis. Letters of support and/or explanation are often useful, but are not sufficient documentation unless ALL specific information required by this MCP is included. NOTE: Additional documentation, rationale, and/or supporting evidence may be requested for review as deemed necessary or appropriate by Molina Medical/Pharmacy staff. Page 12 of 25

13 ADMINISTRATION, QUANTITY LIMITATIONS, AND AUTHORIZATION PERIOD Consult the manufacturer's labeling for more detailed information on dosage and administration of this drug, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and monitoring. 1. Recommended Dosage [ALL] Huntington s chorea: Dose of deutetrabenazine (Austedo) is determined individually for each patient based on reduction of chorea and tolerability. 6 mg once daily (in those not being switched from tetrabenazine), titrated at weekly intervals by 6 mg per day to a tolerated dose that reduces chorea (maximum dose, 48 mg/day) When switching from tetrabenazine, initiate deutetrabenazine 1 day after the last dose of tetrabenazine and use the following dosage conversion table: Current tetrabenazine daily dosage Initial deutetrabenazine dose 12.5 mg 6 mg once daily 25 mg 6 mg twice daily 37.5 mg 9 mg twice daily 50 mg 12 mg twice daily 62.5 mg 15 mg twice daily 75 mg 18 mg twice daily 87.5 mg 21 mg twice daily 100 mg 24 mg twice daily Tardive Dyskinesia 6 mg twice daily, titrated at weekly intervals by 6 mg per day to a tolerated dose that reduces dyskinesia (maximum dose, 48 mg/day) Administer total daily dosages of 12 mg in 2 divided doses; take with food; swallow whole Assess the QT interval before and after increasing total dosage above 24 mg/day Dosage of deutetrabenazine should be adjusted to no more than 18 mg as a maximum single dose and a maximum total daily dose of 36 mg in patients taking concomitant strong CYP2D6 inhibitors or CYP2D6 poor metabolizers Deutetrabenazine may be discontinued without tapering; if treatment is interrupted for > 1 week, treatment should be re-titrated when resumed; interruptions of < 1 week do not require retitration Page 13 of 25

14 2. Authorization Limit [ALL] Quantity limit: [ALL] Maximum dosage: 48 mg/day 2 tablets per day CYP2D6 poor metabolizers or co-administration with strong CYP2D6 inhibitors: 36 mg/day or 18 mg/dose [AS APPLICABLE[ Dispensing limit: Only a 1-month supply may be dispensed at a time Duration authorization: [ALL] Initial: 3 months Continuation: 6 months Continuation of treatment: Re-authorization is required every 6 months to determine effectiveness of therapy and continued need based on documented positive clinical response. Subsequent renewals will be authorized upon verification of marked clinical improvement demonstrated by objective improvement in these selected markers. Refer to Continuation of Therapy section. 3. Route of Administration [ALL] Austedo (deutetrabenazine) is considered a self-administered medication Austedo (deutetrabenazine) is deemed 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 will not be authorized. If member meets all criteria and approval for therapy is granted, medication will be dispensed by a specialty pharmacy vendor at the discretion of Molina Healthcare. Self-administered medications may not be dispensed for self-administration and billed through the medical benefit by a provider. These agents must be dispensed through a participating pharmacy. Page 14 of 25

15 COVERAGE EXCLUSIONS This policy addresses the coverage of Austedo (deutetrabenazine) for the treatment of adult patients chorea associated with Huntington's disease (Huntington's Chorea) AND for the treatment of tardive dyskinesia when appropriate criteria are met. All other uses of Austedo (deutetrabenazine) that are not an FDA-approved indication or not included in the Coverage Criteria section of this policy are considered not medically necessary. This is subject to change based on research and medical literature, or at the discretion of Molina Healthcare. *Pharmaceutical samples: The use of pharmaceutical samples (from the prescriber or manufacturer assistance program) will not be considered when evaluating the medical condition, prior prescription history, or as continuation of therapy. *FDA-approved indication does not, in itself, dictate coverage. Molina Clinical Policy may not recommend coverage for all FDA-approved indications. Please review this Policy in its entirety for indications covered by Molina Healthcare. Page 15 of 25

16 SUMMARY OF EVIDENCE/POSITION TARDIVE DYSKINESIA Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV) According to the Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV), TD develops during exposure to a DRBA for 3 months (or one month in patients 60 years of age) or within four weeks of withdrawal from an oral medication (or within eight weeks of withdrawal from a depot medication). The disorder should persist for at least one month after discontinuation of an offending drug to qualify as TD (Waln and Jankovic 2013). DSM-V Definition of Tardive Dyskinesia Diagnostic and statistical manual of mental disorders, 5th Ed. American Psychiatric Association. Tardive dyskinesia is a type of movement disorder that occurs secondary to therapy with centrally acting DRBAs (Appendix 1) Medication-induced movement disorders, including tardive dyskinesia, are organized in the DSM-V as follows: neuroleptic-induced parkinsonism/other medication-induced parkinsonism, neuroleptic malignant syndrome, medication-induced acute dystonia, medication-induced acute akathisia, tardive dyskinesia, tardive dystonia/tardive akathisia, medication-induced postural tremor, other medication-induced movement disorder, antidepressant discontinuation syndrome, and other adverse effects of medication. Involuntary athetoid or choreiform movements (lasting at least a few weeks) generally of the tongue, lower face and jaw, and extremities (but sometimes involving the pharyngeal, diaphragmatic, or trunk muscles) developing in association with the use of a neuroleptic medication for at least a few months. Symptoms may develop after a shorter period of medication use in older persons. In some patients, movements of this type may appear after discontinuation, or after change or reduction in dosage, of neuroleptic medications, in which case the condition is called neuroleptic withdrawal emergent dyskinesia. Because withdrawal emergent dyskinesia is usually time limited, lasting less than 4-8 weeks, dyskinesia that persists beyond this window is considered to be tardive dyskinesia. ASSESSING TARDIVE DYSKINESIA (TD) has been complicated by the use of different research criteria and rating scales. We studied concordance between two commonly used scales, the Abnormal Involuntary Movement Scale (AIMS) and Extrapyramidal Symptom Rating Scale (ESRS), to study interscale concordance and criteria to define TD. Abnormal Involuntary Movement Scale (AIMS) The most widely used instrument is the Abnormal Involuntary Movement Scale (AIMS) developed by the Psychopharmacology Research Branch of the National Institute of Mental Health (see the image below). Because the AIMS can be readily administered in a few minutes, it is recommended in patients receiving treatment with substances that may cause TD. Administer the AIMS at baseline before the institution of pharmacotherapy to document any movements present, then at least every 3 months thereafter during the course of treatment. The AIMS is a 12-item scale; items 1 to 7 assess the severity of involuntary movements across body regions and these items were used in this study. Each of the 7 items was scored on a 0 to 4 scale, rated as: 0=no dyskinesia; 1=low amplitude, present during some but not most of the exam; 2=low amplitude and present during most of the exam (or moderate amplitude and present during some of the exam); 3=moderate amplitude and present during most of exam; or 4=maximal amplitude and present during most of exam. The AIMS dyskinesia total score (sum of items 1 to 7) could range from 0 to 28, with a decrease in score indicating improvement. Page 16 of 25

17 Extrapyramidal Symptom Rating Scale (ESRS) The Extrapyramidal Symptom Rating Scale (ESRS) was developed to assess four types of drug-induced movement disorders (DIMD): Parkinsonism, akathisia, dystonia, and TD. Comprehensive ESRS definitions and basic instructions are given. Factor analysis provided six ESRS factors: 1) hypokinetic Parkinsonism; 2) orofacial dyskinesia; 3) trunk/limb dyskinesia; 4) akathisia; 5) tremor; and 6) tardive dystonia. Two pivotal studies found high inter-rater reliability correlations in both antipsychotic-induced movement disorders and idiopathic Parkinson disease. For inter-rater reliability and certification of raters, >or=80% of item ratings of the complete scale should be +/-1 point of expert ratings and >or=70% of ratings on individual items of each ESRS subscale should be +/-1 point of expert ratings. During a cross-scale comparison, AIMS and ESRS were found to have a 96% (359/374) agreement between TD-defined cases by DSM-IV TD criteria. Two recent international studies using the ESRS included over 3000 patients worldwide and showed an incidence of TD ranging from 10.2% (2000) to 12% (1998). ESRS specificity was investigated through two different approaches, path analyses and ANCOVA PANSS factors changes, which found that ESRS measurement of drug-induced EPS is valid and discriminative from psychiatric symptoms. (Gharabawi GM et al PMID: DOI: /j.schres ) PIVOTAL TRIALS HUNTINGTON S CHOREA Austedo (deutetrabenazine) versus placebo First Time Use of SD-809 in Huntington Disease (FIRST-HD) The evidence for efficacy for deutetrabenazine (Austedo) in Huntington s disease was established in a single, randomized, placebo-controlled trial in 90 adults. The efficacy of deutetrabenazine was evaluated in a randomized, double-blind, placebo-controlled, multicenter trial. The primary endpoint was the Total Chorea Score (TCS), 1 of the items on the Unified Huntington s Disease Rating Scale (UHDRS; chorea is rated from 0 to 4 for 7 different parts of the body with lower scores representing less chorea; range, 0 to 28). This trial enrolled 90 adults diagnosed with Huntington s disease and a baseline chorea score of 8 or higher. Subjects were ambulatory at enrollment and were randomized to receive deutetrabenazine (n=45) or placebo (n=45) in a double-blind fashion at over 30 treatment sites. The duration of treatment was 12 weeks, including an 8-week dose titration period and a 4-week maintenance period, followed by a 1-week washout. Deutetrabenazine or placebo was started at 6 mg per day and titrated upward, at weekly intervals, in 6 mg increments until satisfactory treatment of chorea was achieved, intolerable side effects occurred, or until a maximal dose of 48 mg per day was reached. The mean dose after titration was 40 mg per day. Results A total of 87 patients (mean age, 53.7 years; 40 women [44.4%]) completed the study. Deutetrabenazine (Austedo) reduced the maximal chorea score by a mean of 4.4 points compared to a reduction of 1.9 for placebo treated patients following twelve weeks of treatment. The treatment difference between deutetrabenazine (Austedo) and placebo was 2.5 points. Treatment success, as measured by the Patient Global Impression of Change (PGIC) and the Clinical Global Impression of Change (CGIC), occurred in 51% and 42% of those treated with deutetrabenazine, respectively, compared with 20% and 13% with placebo, respectively (p=0.02 for both measures versus placebo). A statistically significant difference was also found in the mean 36-Item Short Form physical functioning subscale score (SF-36) (p=0.03) but not in the Berg Balance Test (p=0.14). The treatment difference in this trial was considered statistically significant; however, the minimal clinically important difference for the change in maximal chorea score is not clearly established. It is unknown if the change in score observed in this study improves function or quality of life in patients with Huntington s disease. Page 17 of 25

18 Adverse Reactions In 2 phase 3 clinical trials, the most common adverse reaction was somnolence (11.1% and 13.8%) [Reference: ARM-TD Fernandez HH, 2017]. Other adverse reactions included dry mouth (9%), diarrhea (9%), irritability (7%), insomnia (7%), fatigue (7%), falls (4%), dizziness (4%), and depression or agitated depression (4%). [Reference: Effect of deutetrabenazine on chorea among patients with Huntington disease: a randomized clinical trial, 2016] Unlike phase 3 trials for tetrabenazine, clinical trials evaluating use of deutetrabenazine in Huntington disease and tardive dyskinesia reported a low and insignificant incidence of psychiatric adverse reactions compared to placebo. It is unknown whether the substitution of deuterium molecules results in fewer psychiatric adverse effects. TARDIVE DYSKINESIA Austedo was approved based on two placebo-controlled trials involving 335 adult patients with TD. The primary endpoint was the Abnormal Involuntary Movement Scale (AIMS) for the assessment of TD severity. Austedo (deutetrabenazine) versus placebo Addressing Involuntary Movements in Tardive Dyskinesia (AIM-TD) AIM-TD is a 12-week, Phase III, randomized, double-blind, placebo-controlled study that evaluated the efficacy, safety, and tolerability of fixed-dose regimens (12 mg/day, 24 mg/day, and 36 mg/day) of deutetrabenazine for the treatment of moderate severe TD (n=222). Ambulatory adults with TD caused by dopamine receptor antagonists use for at least 3 months (or 1 month in those 60 years) were randomized 1:1:1:1 to 12 mg deutetrabenazine, 24 mg deutetrabenazine, 36 mg deutetrabenazine, or placebo. The 12-week treatment period consisted of a 4-week dose escalation period and an 8-week maintenance period, which was then followed by a 1-week washout. At baseline, the population was 21 to 81 years old (mean, 57 years), 48% male, and 79% Caucasian. The primary endpoint was improvement in TD, as measured by a change from baseline in TD symptoms using the first 7 measures on the Abnormal Involuntary Movement Scale (AIMS; range, 0 to 28 with higher scores indicated greater severity). At 12 weeks, the least squares mean change from baseline in AIMS was -3.3 (standard error [SE], 0.42), -3.2 (SE, 0.45), and -2.1 (0.42) with deutetrabenazine 36 mg/day, 24 mg/day, and 12 mg/day compared to -1.4 (SE, 0.41) with placebo (12 mg difference, -0.7 [95% CI, to 0.42]; 24 mg difference, -1.8 [95% CI, -3 to ]; 36 mg difference, -1.9 [95% CI, to -0.79). Only the 36 mg/day dosing demonstrated superiority over placebo when adjusting for multiplicity. Comments: Deutetrabenazine 24 mg/day and 36 mg/day provided a significant reduction in tardive dyskinesia, with favorable safety and tolerability. These findings suggest that dosing regimens could be individualized and tailored for patients on the basis of dyskinesia control and tolerability. ClinicalTrials.gov. Identifier NCT AIM-TD Available from: Page 18 of 25

19 Aim to Reduce Movements in Tardive Dyskinesia (ARM-TD) A 12-week multicenter, randomized, double-blind, placebo-controlled trial assessed the efficacy and safety of deutetrabenazine for the treatment of TD (n=113). Ambulatory adults with TD caused by dopamine receptor antagonist use for at least 3 months (or 1 month in those 60 years) were randomized to flexible-dose deutetrabenazine or placebo. Deutetrabenazine doses were started at 12 mg per day with increases allowed in 6 mg increments (maximum 48 mg/day) at 1-week intervals until satisfactory control of dyskinesia was achieved or until intolerable side effects occurred. The 12- week treatment period consisted of a 6-week dose titration period and a 6-week maintenance period, which was then followed by a 1-week washout. At baseline, the population was 25 to 75 years old (mean, 55 years), 48% male, and 70% Caucasian. The mean dose of deutetrabenazine after treatment was 38.3 mg/day. The primary endpoint was improvement in TD, as measured by a change from baseline in TD symptoms using the first 7 measures on the AIMS tool. At 12 weeks, the least squares mean change from baseline in AIMS was -3 (SE, 0.45) with deutetrabenazine and -1.6 (SE, 0.46) with placebo (difference, -1.4; 95% CI, -2.6 to -0.2; p=0.019). ClinicalTrials.gov. Identifier NCT , ARM-TD Available from: CLINICAL PRACTICE GUIDELINES NOTE: Deutetrabenazine (Austedo) and valbenazine (Ingrezza) have not been addressed in clinical practice guidelines as of this writing in January 2018 TARDIVE DYSKINESIA AMERICAN ACADEMY OF NEUROLOGY (AAN) Evidence-Based Guideline: Treatment of Tardive Syndromes: Report of the Guideline Development Subcommittee of the American Academy of Neurology (Bhidayasiri et al 2013) The AAN guidelines were originally published in 2013 and reaffirmed by the AAN on July 16, 2016 AAN guideline states that treatments for tardive dyskinesia caused by prolonged use of dopamine receptor blocking agents include amantadine, clonazepam, ginkgo biloba extract, or tetrabenazine; switching from a first-generation antipsychotic to a second-generation antipsychotic may lower the risk of tardive dyskinesia. The AAN does not provide any Level A recommendations for the treatment of tardive syndromes; however, it does list ginkgo biloba extract and clonazepam as Level B recommendations. Level A recommendations (recommendation must be done; high confidence in the evidence with high benefit and low risk) None Level B recommendations (recommendation should be done based on benefit/risk profile) Ginkgo biloba extract (EGb-761) for schizophrenia only Clonazepam, for short-term use Level C recommendations (recommendation may or might be done; lowest recommendation level considered useful within the scope of practice) Amantadine for short-term use Tetrabenazine Level U (available evidence is insufficient to support or refute efficacy of an intervention) Withdrawal of DRBAs Switching from typical to atypical antipsychotics Acetazolamide plus thiamine Typical antipsychotics Atypical antipsychotics Page 19 of 25

20 Electroconvulsive therapy Reserpine or α-methyldopa Bromocriptine Anticholinergic agents (other than galantamine) Biperiden discontinuation Antioxidants (vitamin E, vitamin B6, melatonin, selegiline, yi-gan san) Baclofen Levetiracetam Nifedipine Buspirone Botulinum toxin Pallidal deep-brain stimulation Potential interventions assessed included discontinuing dopamine receptor antagonists, switching from first generation to second generation antipsychotics, pharmacological medications, chemodenervation with botulinum toxin (BoNT), and surgical therapy, such as pallidal deep brain stimulation (DBS). Data were insufficient to support or refute TD treatment by discontinuation of a dopamine receptor antagonist, switching from first generation to second generation antipsychotics, botulinum toxin, or pallidal deep brain stimulation (DBS) therapies. Data are insufficient to support or refute the use of acetazolamide, anticholinergic drugs, baclofen, bromocriptine, buspirone, levetiracetam, nifedipine, selegiline, and vitamin B 6. Diltiazem probably does not reduce tardive dyskinesia and should not be considered as treatment. Galantamine is possibly ineffective. HAYES At the time of this writing in January 2018, a Hayes Directory report addressing the management of Tardive Dyskinesia and Huntington Disease is not available. Page 20 of 25

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