Sunflower Health Plan Valbenazine (Ingrezza) Form

Valbenazine (Ingrezza®) is a vesicular monoamine transporter 2 (VMAT2) inhibitor. FDA Approved Indication(s) Ingrezza is indicated for the treatment of adults with tardive dyskinesia. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Ingrezza is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Tardive Dyskinesia (must meet all): 1. Diagnosis of TD secondary to a centrally acting dopamine receptor blocking agent (DRBA) (see Appendix F); 2. Prescribed by or in consultation with a psychiatrist or neurologist; 3. Age ≥ 18 years; 4. Ingrezza® is not prescribed concurrently with Austedo® or tetrabenazine; 5. Dose does not exceed both (a and b): a. 80 mg per day; b. 1 capsule per day. Approval duration: HIM – 6 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2): 1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: Page 1 of 7 CLINICAL POLICY Valbenazine CP.CPA.190 for commercial and HIM.PA.103 for health insurance marketplace; or 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace. II. Continued Therapy A. Tardive Dyskinesia (must meet all): 1. Currently Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B); 2. Member is responding positively to therapy as evidenced by a reduction since baseline in any one of Abnormal Involuntary Movement Scale (AIMS) items 1 through 9 (see Appendix G); 3. Ingrezza is not prescribed concurrently with Austedo or tetrabenazine; 4. If request is for a dose increase, new dose does not exceed both (a and b): a. 80 mg per day; b. 1 capsule per day. Approval duration: HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2): 1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.103 for health insurance marketplace; or 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace. Page 2 of 7 CLINICAL POLICY Valbenazine III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key AIMS: Abnormal Involuntary Movement Scale APA: American Psychiatry Association DRBA: dopamine receptor blocking agent Appendix B: Therapeutic Alternatives Not applicable DSM V: Diagnostic and Statistical Manual, Version 5 FDA: Food and Drug Administration TD: tardive dyskinesia VMAT2: vesicular monoamine transporter Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to valbenazine or any components of Ingrezza • Boxed warning(s): none reported Appendix D:General Information • Ingrezza should not be used concurrently with other VMAT2 inhibitors such as tetrabenazine or deutetrabenazine as this is considered duplicate therapy. • 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. • Tardive dyskinesia is a type of movement disorder that occurs secondary to therapy with centrally acting DRBAs (Appendix E). (DSM V) • Typical therapeutic drug classes containing DRBAs include first- and second-generation antipsychotics, antiemetics, and tri-cyclic antidepressants (Appendix F). (DSM V) • Other therapeutic drug classes containing agents that have been variously associated with movement disorders are listed below: (Waln 2013, Meyer 2014, Lerner 2015) o Antiarrhythmics o Antibiotics o Anticholinergics o Antidepressants o Antiepileptics o Antihistamines o Antimanics o Bronchodilators o Calcium channel blockers o Central nervous system stimulants o Dopamine agonists o Dopamine depleting agents o Dopaminergics o Glucocorticoids o Immunosuppressants o Mood stabilizers o Muscle relaxants o Oral contraceptives Page 3 of 7 Appendix E: Tardive Dyskinesia: DSM-V Definition Tardive Dyskinesia (ICD-9 333.85/ICD-10 G24.01) • 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. Appendix F: Centrally Acting Dopamine Receptor Blocking Agents (Neuroleptics) Pharmacologic Class Tri-cyclic antidepressants Amoxapine† First-generation (typical) antipsychotics Chlorpromazine Fluphenazine Perphenazine Thioridazine Thiothixene Trifluoperazine Haloperidol Phenothiazine Butryophenone Substituted benzamide Therapeutic Class Antiemetic agents Chlorpromazine Perphenazine Prochlorperazine Promethazine* Thiethylperazine Droperidol Haloperidol** Metoclopramide Trimethobenzamide Second-generation (atypical) antipsychotics Loxapine Dibenzazepine Diphenylbutylpiperidine Pimozide Pharmacologic Class Quinolone Dibenzazepine Piperazine Dibenzodiazephine Benzisoxazole Benzisothiazole Thienobenzodiazepine Pyrimidinone (DSM V, Meyer 2014, Smith 2010, Clinical Pharmacology, Lexicomp) *First generation H1 antagonist **Off-label use †A dibenzoxapine that shares properties with phenothiazines Aripiprazole, brexpiprazole Asenapine Cariprazine Clozapine, quetiapine Iloperidone Lurasidone, ziprasidone Olanzapine Paliperidone, risperidone Page 4 of 7 CLINICAL POLICY Valbenazine Appendix G: The Abnormal Involuntary Movement Scale (AIMS) • The AIMS is a clinician-rated 12-item assessment tool developed by the National Institute of Mental Health to evaluate severity of involuntary movements in multiple movement disorders including TD. The AIMS is commonly used in both research and clinical practice. • AIMS items 1-10 are rated on a 5-point scale (0 - none; 1 - minimal; 2 - mild; 3 - moderate; 4 - severe). Items 1-7 assess dyskinesia severity by body region (items 1-4 orofacial; items 5-7 extremity and trunk). Items 8-10 assess overall severity, incapacitation, and patient awareness respectively - item 8 uses the highest score of any one of items 1-7. Items 11 (dental) and 12 (dentures) are yes/no questions which help characterize lip, jaw, and tongue movements. • See Munetz 1988 for additional information about the AIMS. V. Dosage and Administration Indication Dosing Regimen TD 40 mg PO once daily; after a week, increase to the recommended dose of 80 mg. A dosage of 40 mg or 60 mg once daily may be considered depending on response and tolerability. Maximum Dose 80 mg/day VI. Product Availability Capsules: 40 mg, 60 mg, 80 mg VII.