DOCSLIB.ORG

Vesicular Monoamine Transporter 2 Inhibitors for Tardive Dyskinesia: Effectiveness and Value

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Vesicular Monoamine Transporter 2 Inhibitors for Tardive Dyskinesia: Effectiveness and Value Vesicular Monoamine Transporter 2 Inhibitors for Tardive Dyskinesia: Effectiveness and Value Final Evidence Report December 22, 2017 Prepared for ©Institute for Clinical and Economic Review, 2017 ICER Staff/Consultants University of Illinois at Chicago College of Pharmacy Modeling Group* Steven J. Atlas, MD, MPH Surrey M Walton, PhD Director, Primary Care Research and Quality Associate Professor of Pharmacy Improvement Network Department of Pharmacy Systems, Outcomes, Massachusetts General Hospital and Policy University of Illinois at Chicago College of Foluso Agboola, MBBS, MPH Pharmacy Research Scientist Daniel R. Touchette, PharmD, MA, FCCP Institute for Clinical and Economic Review Associate Professor of Pharmacy and Takeda Professor of Medication Adherence Ifeoma Otuonye, MPH Department of Pharmacy Systems, Outcomes, Research Associate and Policy Institute for Clinical and Economic Review University of Illinois at Chicago College of Pharmacy Varun Kumar, MBBS, MPH, MSc Health Economist Katherine Harrigan, PharmD Institute for Clinical and Economic Review Research Fellow Department of Pharmacy Systems, Outcomes, Celia Segel, MPP and Policy Program Manager University of Illinois at Chicago College of Institute for Clinical and Economic Review Pharmacy Rick Chapman, PhD, MS Director of Health Economics Institute for Clinical and Economic Review Daniel A. Ollendorf, PhD Chief Scientific Officer *The role of the University of Illinois at Chicago (UIC) Institute for Clinical and Economic Review College of Pharmacy Modeling Group is limited to the development of the cost-effectiveness model, and the Steven D. Pearson, MD, MSc resulting ICER reports do not necessarily represent President the views of the UIC. Institute for Clinical and Economic Review DATE OF PUBLICATION: December 22, 2017 We would also like to thank Aqsa Mugal, Noah Mwandha, Molly Morgan, and Erin Lawler for their contributions to this report. ©Institute for Clinical and Economic Review, 2017 Page i Final Evidence Report: VMAT2 Inhibitors for Tardive Dyskinesia: Effectiveness and Value About ICER The Institute for Clinical and Economic Review (ICER) is an independent non-profit research organization that evaluates medical evidence and convenes public deliberative bodies to help stakeholders interpret and apply evidence to improve patient outcomes and control costs. The funding for this report comes from government grants and non-profit foundations, with the largest single funder being the Laura and John Arnold Foundation. No funding for this work comes from health insurers, pharmacy benefit managers, or life science companies. ICER receives approximately 15% of its overall revenue from these health industry organizations to run a separate Policy Forum program, with funding approximately equally split between insurers/PBMs and life science companies. For a complete list of funders and for more information on ICER's support, please visit http://www.icerreview.org/about/support/. Through all its work, ICER seeks to help create a future in which collaborative efforts to move evidence into action provide the foundation for a more effective, efficient, and just health care system. More information about ICER is available at http://www.icer-review.org About New England CEPAC The New England Comparative Effectiveness Public Advisory Council (New England CEPAC) – a core program of ICER – provides a public venue in which the evidence on the effectiveness and value of health care services can be discussed with the input of all stakeholders. New England CEPAC seeks to help patients, clinicians, insurers, and policymakers interpret and use evidence to improve the quality and value of health care. The New England CEPAC is an independent committee of medical evidence experts from across New England, with a mix of practicing clinicians, methodologists, and leaders in patient engagement and advocacy. All Council members meet strict conflict of interest guidelines and are convened to discuss the evidence summarized in ICER reports and vote on the comparative clinical effectiveness and value of medical interventions. More information about New England CEPAC is available at http://icer-review.org/programs/new-england-cepac/. ©Institute for Clinical and Economic Review, 2017 Page ii Final Evidence Report: VMAT2 Inhibitors for Tardive Dyskinesia: Effectiveness and Value In the development of this report, ICER’s researchers consulted with several clinical experts, patients, manufacturers, and other stakeholders. The following clinical experts provided input that helped guide the ICER team as we shaped our scope and report. None of these individuals is responsible for the final contents of this report or should be assumed to support any part of this report, which is solely the work of the ICER team and its affiliated researchers. For a complete list of stakeholders from whom we requested input, please visit: https://icer-review.org/wp- content/uploads/2017/05/NECEPAC_TD_Stakeholder_List_05082017.pdf Expert Reviewers Robert Rosenheck, MD VA New England Mental Illness, Research, Education and Clinical Center VA Connecticut Health Care System Professor of Psychiatry, Epidemiology and Public Health, and the Child Study Center Yale Medical School Disclosure: No relevant conflicts of interest to disclose, defined as more than $10,000 in healthcare company stock or more than $5,000 in honoraria or consultancies during the previous year from health care manufacturers or insurers Cindy Specht Executive Vice President Depression and Bipolar Support Alliance (DBSA) Disclosure: No relevant conflicts of interest to disclose, defined as more than $10,000 in healthcare company stock or more than $5,000 in honoraria or consultancies during the previous year from health care manufacturers or insurers. Daniel Tarsy, MD Professor in Neurology Harvard Medical School Parkinson Disease & Movement Disorders Center Beth Israel Deaconess Medical Center Disclosure: No relevant conflicts of interest to disclose, defined as more than $10,000 in healthcare company stock or more than $5,000 in honoraria or consultancies during the previous year from health care manufacturers or insurers ©Institute for Clinical and Economic Review, 2017 Page iii Final Evidence Report: VMAT2 Inhibitors for Tardive Dyskinesia: Effectiveness and Value Table of Contents Executive Summary ............................................................................................................................ ES1 1. Background ........................................................................................................................................ 1 1.1 Introduction ................................................................................................................................. 1 2. The Topic in Context .......................................................................................................................... 5 2.1 How Common is Tardive Dyskinesia? .......................................................................................... 5 2.2 How is Tardive Dyskinesia Diagnosed? ........................................................................................ 6 2.3 Treatment Options for Tardive Dyskinesia .................................................................................. 6 2.4 Vesicular Monoamine Transporter 2 (VMAT2) Inhibitors ........................................................... 7 2.5 Insights Gained from Discussions with Patients and Patient Groups ........................................ 10 2.6 Definitions of Outcome Measures Used in Clinical Trials .......................................................... 13 3. Summary of Clinical Guidelines and Coverage Policies ................................................................... 15 4. Comparative Clinical Effectiveness .................................................................................................. 18 4.1 Overview .................................................................................................................................... 18 4.2 Methods ..................................................................................................................................... 19 4.3 Results ........................................................................................................................................ 21 5. Long-Term Cost-Effectiveness.......................................................................................................... 43 5.1 Overview .................................................................................................................................... 43 5.2 Cost-Effectiveness Model: Methods .......................................................................................... 43 5.3 Cost-Effectiveness Model: Results ............................................................................................. 52 5.4 Potential Budget Impact ............................................................................................................ 60 5.5 Value-Based Benchmark Prices .................................................................................................. 64 5.6 Summary and Comment ............................................................................................................ 65 6. Additional Considerations ................................................................................................................ 67 7. Summary of the Votes and Considerations
Load more

Recommended publications
  • (Xenazine); Deutetrabenazine (Austedo); Valbenazine
    tetrabenazine (Xenazine ®); deutetrabenazine (Austedo ™); valbenazine (Ingrezza ™) EOCCO POLICY Po licy Type: PA/SP Pharmacy Coverage Policy: EOCCO157 Description Tetrabenazine (Xenazine), deutetrabenazine (Austedo) and valbenazine (Ingrezza) are reversible vesicular monoamine transporter 2 (VMAT2) inhibitors that act by regulating monoamine uptake from the cytoplasm to the synaptic vesicle. Its mechanism of action in Tardive dyskinesia or chorea-reduction is unknown . Length of Authorization Initial (Tardive dyskinesia): Three months Initial (Chorea associated with Huntington’s disease): 12 months Renewal: 12 months Quantity limits Product Name Dosage Form Indication Quantity Limit 12.5 mg Chorea associated with 60 tablets/30 days 25 mg Huntington’s disease Chorea associated with tetrabenazine (Xenazine) Huntington’s disease, 25 mg genotyped extensive 120 tablets/30 days and intermediate metabolizers 12.5 mg Chorea associated with 60 tablets/30 days 25 mg Huntington’s disease Chorea associated with generic tetrabenazine Huntington’s disease, 25 mg genotyped extensive 120 tablets/30 days and intermediate metabolizers 6 mg Tardive dyskinesia in adults; Chorea 30 tablets/30 days deutetrabenazine (Austedo) 9 mg associated with 12 mg Huntington’s disease 120 tablets/30 days 40 mg 30 capsules/30 days; valbenazine (Ingrezza) Tardive Dyskinesia 80 mg 4-week Initiation Pack Initial Evaluation I. Tetrabenazine (Xenazine), deutetrabenazine (Austedo) and valbenazine (Ingrezza) may be considered medically necessary when the following criteria below are met: A. Member is 18 years of age or older; AND B. Medication is prescribed by, or in consultation with, a neurologist or psychiatrist; AND C. Medication will not be used in combination with another VMAT2 inhibitor [e.g. tetrabenazine (Xenazine), deutetrabenazine (Austedo) valbenazine (Ingrezza)], monoamine oxidase inhibitor (MAOI) [e.g.
    [Show full text]
  • New Zealand Data Sheet 1
    New Zealand Data Sheet 1. PRODUCT NAME Motetis 25 mg tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Motetis 25 mg tablets contains 25 mg of tetrabenazine. Excipient(s) with known effect Contains lactose monohydrate. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Yellow, round, flat tablet with a score line on one side. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Movement disorders associated with organic central nervous system conditions, such as Huntington's chorea, hemiballismus and senile chorea. Tetrabenazine is also indicated for the treatment of moderate to severe tardive dyskinesia, which is disabling and/or socially embarrassing. The condition should be persistent despite withdrawal of antipsychotic therapy, or in cases where withdrawal of antipsychotic medication is not a realistic option; also, where the condition persists despite reduction in dosage of antipsychotic medication or switching to atypical antipsychotic medication. 4.2. Dose and method of administration Dose Proper dosing of tetrabenazine involves careful titration of therapy to determine an individualised dose for each patient. When first prescribed, tetrabenazine therapy should be titrated slowly over several weeks to allow the identification of a dose for chronic use that reduces chorea and is well tolerated. Movement disorders Dosage and administration are variable and only a guide is given. An initial starting dose of 25 mg three times a day is recommended. This can be increased by 25 mg a day every three (3) or four (4) days until 200 mg per day is being given or the limit of tolerance, as dictated by unwanted effects, is reached, whichever is the lower dose.
    [Show full text]
  • Tetrabenazine: the First Approved Drug for the Treatment of Chorea in US Patients with Huntington Disease
    Neuropsychiatric Disease and Treatment Dovepress open access to scientific and medical research Open Access Full Text Article REVIEW 7HWUDEHQD]LQHWKHÀUVWDSSURYHGGUXJ for the treatment of chorea in US patients with Huntington disease Samuel Frank Abstract: Huntington disease (HD) is a dominantly inherited progressive neurological disease Boston University School of Medicine, characterized by chorea, an involuntary brief movement that tends to flow between body regions. Boston, Massachusetts, USA HD is typically diagnosed based on clinical findings in the setting of a family history and may be confirmed with genetic testing. Predictive testing is available to those at risk, but only experienced clinicians should perform the counseling and testing. Multiple areas of the brain degenerate mainly involving the neurotransmitters dopamine, glutamate, and G-aminobutyric acid. Although pharmacotherapies theoretically target these neurotransmitters, few well-conducted trials for symptomatic or neuroprotective interventions yielded positive results. Tetrabenazine (TBZ) is a dopamine-depleting agent that may be one of the more effective agents for reducing chorea, although it has a risk of potentially serious adverse effects. Some newer antipsychotic agents, such as olanzapine and aripiprazole, may have adequate efficacy with a more favorable adverse-effect profile than older antipsychotic agents for treating chorea and psychosis. This review will address the epidemiology and diagnosis of HD as background for understanding potential pharmacological treatment options. Because TBZ is the only US Food and Drug Administration-approved medication in the United States for HD, the focus of this review will be on its pharmacology, efficacy, safety, and practical uses. There are no current treatments to change the course of HD, but education and symptomatic therapies can be effective tools for clinicians to use with patients and families affected by HD.
    [Show full text]
  • Clinical Study Protocol with Amendment 3 an Open-Label
    Clinical Study Protocol with Amendment 3 An Open-Label, Long Term Safety Study of SD-809 ER in Subjects with Chorea Associated with Huntington Disease Study SD-809-C-16 NCT01897896 Protocol with Amendment 3 Approval Date: 2 March 2015 &21),'(17,$/ 7KHIROORZLQJFRQWDLQVFRQILGHQWLDOSURSULHWDU\LQIRUPDWLRQZKLFKLVWKHSURSHUW\RI $XVSH[3KDUPDFHXWLFDOV,QF 35272&2/180%(56'& $123(1/$%(//21*7(506$)(7<678'<2)6'(5,1 68%-(&76:,7+&+25($$662&,$7(':,7+ +817,1*721',6($6( $OWHUQDWLYHVIRU5HGXFLQJ&KRUHDLQ+XQWLQJWRQ'LVHDVH $5&+' 0DUFK $PHQGPHQW 'HYHORSPHQW3KDVH Auspex Pharmaceuticals, Inc. Protocol SD-809-C-16 Huntington Study Group ARC-HD STUDY CONTACTS SPONSOR: Auspex Pharmaceuticals, Inc. 3333 N. Torrey Pines Court, Suite 400 La Jolla, CA 92037 USA Principal Investigator Co-Principal Investigator CLINICAL MONITOR Amendment 3 CONFIDENTIAL 2 Auspex Pharmaceuticals, Inc. Protocol SD-809-C-16 Huntington Study Group ARC-HD PROTOCOL SYNOPSIS PROTOCOL SD-809-C-16 TITLE An Open-Label, Long Term Safety Study of SD-809 ER in Subjects With Chorea Associated With Huntington Disease Running Title Alternatives for Reducing Chorea in HD (ARC-HD) PHASE 3 (Safety) INDICATION Treatment of chorea associated with Huntington disease NO. SITES Approximately 40 OBJECTIVES 1) Evaluate the safety and tolerability of titration and maintenance therapy with SD-809 ER 2) Evaluate the safety and tolerability of switching subjects from tetrabenazine to SD-809 ER 3) Evaluate the pharmacokinetics of tetrabenazine, SD-809 and their respective α- and β-HTBZ metabolites in subjects switching from tetrabenazine to SD-809 ER STUDY Approximately 116 male and female adult subjects with manifest Huntington disease POPULATION (HD) who are receiving approved doses of tetrabenazine for treatment of chorea (approx.
    [Show full text]
  • Amnurite® Tablets
    Amnurite® Tablets Each Tablet Contains Amitriptyline – 10 / 25 mg Mecobalamin – 1500 mcg SR PHARMACEUTICAL INFORMATION – AMITRIPTYLINE Generic name: Amitriptyline Chemical name: 3-(10,11-dihydro-5H-dibenzo[a,d]cycloheptene-5-ylidene)-N,N-dimethyl propan - 1 - amine Molecular mass: 277.403 g/mol Structural formula: Empirical formula – C20 H23 N Storage and Stability: Store at room temperature (15°to 30°C) MECOBALAMIN Generic name: Methylcobalamin Molecular mass: 1344.40 g/mol Structural formula: Empirical formula – C63H91CoN13O14P PHARMACOKINETIC PROPERTIES – Amitriptyline Amitriptyline is well absorbed from the gastrointestinal tract with peak plasma concentrations occurring between 2 and 12 hours after administration. Bioavailability of the drug is between 30 and 60% due to extensive first pass metabolism of the drug in the liver. Amitriptyline is demethylated in the liver to its primary active metabolite, nortriptyline. Amitriptyline is over 90% protein bound. Its elimination half-life varies from 10 to 50 hours, with an average of 15 hours. Within 24 hours, approximately 25 to 50% of a dose of amitriptyline is excreted in the urine as inactive metabolites; small amounts are excreted in the bile. Routine serum drug concentration monitoring is not warranted but may be useful to assess compliance or suspected toxicity. Recommended therapeutic trough levels, i.e., the sum of both amitriptyline and its metabolite nortriptyline, vary widely and range from 250 to 900 nmol/L (60 to 250 ng/mL). Ideally, the trough level should be taken 12 hours following administration of the last dose. TCAs are thought to work by inhibiting reuptake of norepinephrine and serotonin in the CNS, which potentiates the neurotransmitters.
    [Show full text]
  • Medications to Be Avoided Or Used with Caution in Parkinson's Disease
    Medications To Be Avoided Or Used With Caution in Parkinson’s Disease This medication list is not intended to be complete and additional brand names may be found for each medication. Every patient is different and you may need to take one of these medications despite caution against it. Please discuss your particular situation with your physician and do not stop any medication that you are currently taking without first seeking advice from your physician. Most medications should be tapered off and not stopped suddenly. Although you may not be taking these medications at home, one of these medications may be introduced while hospitalized. If a hospitalization is planned, please have your neurologist contact your treating physician in the hospital to advise which medications should be avoided. Medications to be avoided or used with caution in combination with Selegiline HCL (Eldepryl®, Deprenyl®, Zelapar®), Rasagiline (Azilect®) and Safinamide (Xadago®) Medication Type Medication Name Brand Name Narcotics/Analgesics Meperidine Demerol® Tramadol Ultram® Methadone Dolophine® Propoxyphene Darvon® Antidepressants St. John’s Wort Several Brands Muscle Relaxants Cyclobenzaprine Flexeril® Cough Suppressants Dextromethorphan Robitussin® products, other brands — found as an ingredient in various cough and cold medications Decongestants/Stimulants Pseudoephedrine Sudafed® products, other Phenylephrine brands — found as an ingredient Ephedrine in various cold and allergy medications Other medications Linezolid (antibiotic) Zyvox® that inhibit Monoamine oxidase Phenelzine Nardil® Tranylcypromine Parnate® Isocarboxazid Marplan® Note: Additional medications are cautioned against in people taking Monoamine oxidase inhibitors (MAOI), including other opioids (beyond what is mentioned in the chart above), most classes of antidepressants and other stimulants (beyond what is mentioned in the chart above).
    [Show full text]
  • Xenazine (Tetrabenazine) Policy Number: C3894A
    Prior Authorization Criteria Xenazine (tetrabenazine) Policy Number: C3894A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE 02/2019 02/2020 J CODE TYPE OF CRITERIA LAST P&T APPROVAL J8499 MCP MCP-075 PRODUCTS AFFECTED: Oral (tablets) DRUG CLASS: Central Monoamine-Depleting Agent; Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor ROUTE OF ADMINISTRATION: Oral PLACE OF SERVICE: Specialty Pharmacy AVAILABLE DOSAGE FORMS: Tablets: 12.5 mg, 25 mg FDA-APPROVED USES: Chorea associated with Huntington’s disease COMPENDIAL APPROVED OFF-LABELED USES: Tardive dyskinesia in adults, Tourette's syndrome (TS or Gilles de la Tourette's syndrome) COVERAGE CRITERIA: INITIAL AUTHORIZATION DIAGNOSIS: Chorea associated with Huntington’s Disease; Tardive Dyskinesia; Tourette's syndrome REQUIRED MEDICAL INFORMATION: A. CHOREA ASSOCIATED WITH HUNTINGTON’S DISEASE: 1. Diagnosis of Huntington’s disease with chorea symptoms confirmed by documentation of: (a) Huntington Disease Mutation Analysis: indicating an expanded CAG repeat (≥ 36) in the huntington gene (HTT) (also known as HD gene), OR (b)A positive family history of HD, with autosomal dominant inheritance pattern AND 2. Documented trial of at least one alternative treatment (typical neuroleptics, atypical antipsychotics, atypical antipsychotics, benzodiazepines, or amantadine) AND 3. STABLE psychiatric status: Member does not have risk for suicidal or violent behavior and does not have untreated or inadequately treated depression AND 4. If member has a history of depression and/or suicidal ideation: An evaluation by a neurologist or behavioral health provider prior to starting therapy is required AND member is counseled on receiving treatment and follow-up assessment for psychiatric condition from the Prescriber (neurologist) or behavioral health provider while on therapy.
    [Show full text]
  • Movement Disorders Therapeutic Class Review (TCR)
    Movement Disorders Therapeutic Class Review (TCR) April 3, 2020 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. Movement
    [Show full text]
  • Adasuve, INN-Loxapine
    13 December 2012 EMA/91055/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Adasuve International non-proprietary name: loxapine Procedure No. EMEA/H/C/002400 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E -mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged. Contents 1. Background information on the procedure .............................................. 8 1.1. Submission of the dossier .................................................................................... 8 Information on Paediatric requirements ....................................................................... 8 Information relating to orphan market exclusivity .......................................................... 8 Scientific Advice ....................................................................................................... 8 Licensing status ....................................................................................................... 8 1.2. Steps taken for the assessment of the product ....................................................... 9 2. Scientific discussion .............................................................................. 10 2.1. Introduction ...................................................................................................
    [Show full text]
  • ERX.SPA.140 Tetrabenazine (Xenazine)
    Clinical Policy: Tetrabenazine (Xenazine) Reference Number: ERX.SPA.140 Effective Date: 03.01.15 Last Review Date: 05.21 Line of Business: Commercial, Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Tetrabenazine (Xenazine®) is a vesicular monoamine transporter 2 (VMAT) inhibitor. FDA Approved Indication(s) Xenazine is indicated for the treatment of chorea associated with Huntington’s disease. 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. Health plan approved formularies should be reviewed for all coverage determinations. Requirements to use preferred alternative agents apply only when such requirements align with the health plan approved formulary. It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Xenazine is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Chorea Associated with Huntington Disease (must meet all): 1. Diagnosis of chorea associated with Huntington disease; 2. Prescribed by or in consultation with a neurologist; 3. Age ≥ 18 years; 4. Targeted mutation analysis demonstrates a cytosine-adenine-guanine (CAG) trinucleotide expansion of ≥ 36 repeats in the huntingtin (HTT) gene; 5. Evidence of chorea is supported by a Unified Huntington Disease Rating Scale (UHDRS) score ranging from 1 to 4 on any one of chorea items 1 through 7 (see Appendix D); 6. Tetrabenazine is not prescribed concurrently with Austedo® or Ingrezza®; 7. Dose does not exceed 50 mg per day (100 mg per day if genotype testing confirms extensive or intermediate CYP2D6 metabolizer status).
    [Show full text]
  • Xenazine® (Tetrabenazine) Treatment Form
    Xenazine® (tetrabenazine) Treatment Form Step 1: Patient Information Name: (First) (Middle) (Last) Sex: ❑ Male ❑ Female DOB: Address: City: State: Zip Code: Phone: Cell Phone: Best Time to Call: E-mail: Preferred Contact Person: Phone: Cell Phone: Ship to: (If different from above) ❑ Skilled Nursing Facility ❑ Hospital ❑ Other Facility Name: (if applicable) Address: City: State: Zip Code: Phone: Contact Person: Special Shipping Instructions: Step 2: Patient Insurance—complete the information below OR include copies of insurance cards Primary Insurance Name of Medical Plan: Phone: Relationship to Cardholder: ❑ Self ❑ Spouse ❑ Child ❑ Other: Cardholder Name: Plan Number: Group Number: ID Number: Secondary Insurance Cardholder Name: Plan Number: Group Number: ID Number: Employer: Phone: Prescription Insurance Name of Prescription Plan: Phone: Rx BIN: Rx PCN: Rx ID #: Group #: Step 3: Patient Authorization for Use and Disclosure of Personal Health Information I authorize my healthcare providers (including pharmacy providers) and health plans to disclose my personal health information related to this prescription form or my use or potential use of XENAZINE, including my personal contact information on this form (collectively, my “Information”), to the patient support program called the XENAZINE Information Center (the “Program”) so that the Program may use and disclose the Information in order to: (1) establish my benefit eligibility; (2) communicate with my healthcare providers and health plans about my benefit and coverage status and my medical
    [Show full text]
  • List of Formulary Drug Removals
    July 2021 Formulary Drug Removals Below is a list of medicines by drug class that have been removed from your plan’s formulary. If you continue using one of the drugs listed below and identified as a Formulary Drug Removal, you may be required to pay the full cost. If you are currently using one of the formulary drug removals, ask your doctor to choose one of the generic or brand formulary options listed below. Category Formulary Drug Formulary Options Drug Class Removals Acromegaly SANDOSTATIN LAR SOMATULINE DEPOT SIGNIFOR LAR SOMAVERT Allergies dexchlorpheniramine levocetirizine Antihistamines Diphen Elixir RyClora CARBINOXAMINE TABLET 6 MG Allergies BECONASE AQ flunisolide spray, fluticasone spray, mometasone spray, DYMISTA Nasal Steroids / Combinations OMNARIS QNASL ZETONNA Anticonvulsants topiramate ext-rel capsule carbamazepine, carbamazepine ext-rel, clobazam, divalproex sodium, (generics for QUDEXY XR only) divalproex sodium ext-rel, gabapentin, lamotrigine, lamotrigine ext-rel, levetiracetam, levetiracetam ext-rel, oxcarbazepine, phenobarbital, phenytoin, phenytoin sodium extended, primidone, rufinamide, tiagabine, topiramate, valproic acid, zonisamide, FYCOMPA, OXTELLAR XR, TROKENDI XR, VIMPAT, XCOPRI BANZEL SUSPENSION clobazam, lamotrigine, rufinamide, topiramate, TROKENDI XR ONFI SABRIL vigabatrin ZONEGRAN carbamazepine, carbamazepine ext-rel, divalproex sodium, divalproex sodium ext-rel, gabapentin, lamotrigine, lamotrigine ext-rel, levetiracetam, levetiracetam ext-rel, oxcarbazepine, phenobarbital, phenytoin, phenytoin sodium
    [Show full text]