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Nuplazid (Pimavanserin) Market Applicability Market GA KY MD NJ NY Applicable X NA X X X Nuplazid (pimavanserin) Override(s) Approval Duration Prior Authorization Initial Requests: 3 months Quantity Limit Maintenance Therapy Requests: 12 months Medications Quantity Limit Nuplazid (pimavanserin) May be subject to quantity limit APPROVAL CRITERIA Initial requests for Nuplazid (pimavanserin) may be approved if the following criteria are met: I. Documentation is provided that individual has a diagnosis of Parkinson’s disease (PD); AND II. Symptoms of psychosis developed after the PD diagnosis; AND III. Symptoms of psychosis include at least one of the following (Ravina, 2007): A. Visual hallucinations; OR B. Auditory hallucination; OR C. Delusions; AND IV. Symptoms have been present for at least one month; AND V. Documentation is provide that individual has experienced symptoms at least once weekly; AND VI. Psychiatric symptoms cannot be attributed to disorders such as schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features, or a general medical condition including delirium. Continuation of Nuplazid (pimavanserin) may be approved if the following criterion is met: I. Documentation is provided that individual has had a reduction in symptoms of psychosis compared to baseline. Requests for Nuplazid (pimavanserin) may not be approved for the following: I. Individual is using a medication known to prolong QT interval including Class 1A antiarrhythmics (such as procainamide, quinidine), Class 3 antiarrhythmics (such as amiodarone, sotalol), certain antipsychotic medications (such as ziprasidone, PAGE 1 of 2 04/23/2021 This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. CRX-ALL-0683-21 Market Applicability Market GA KY MD NJ NY Applicable X NA X X X chlorpromazine, thioridazine), certain antibiotics (such as gatifloxacin, moxifloxacin) and the medication cannot be discontinued; OR II. Individual has a history of cardiac arrhythmias or other circumstances that may increase the risk of torsade de pointes including symptomatic bradycardia, hypokalemina or hypomagnesimia, or the presence of congenital prolongation of the QT interval. Key References: 1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.: 2020. URL: http://www.clinicalpharmacology.com. Updated periodically. 2. DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health website. http://dailymed.nlm.nih.gov/dailymed/about.cfm. Accessed: December 30, 2020. 3. DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Updated periodically. 4. Lexi-Comp ONLINE™ with AHFS™, Hudson, Ohio: Lexi-Comp, Inc.; 2020; Updated periodically. 5. Food and Drug Administration (FDA). Nuplazid (pimavanserin). FDA Briefing Information for the March 29, 2016 Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvi soryCommittee/UCM492453.pdf Accessed: December 27, 2017. 6. Ravina B, Marder K, et al. Diagnostic criteria for psychosis in Parkinson’s disease: Report of an NINDS/NIMH work group. Mov Disord 2007; 22:1061-8. 7. Institute for Safe Medication Practices (ISMP). QuarterWatch™ (2017 Quarter 1 data): Safety Signals for two novel drugs, Nuplazid and Entresto. November 2, 2017. Available from: https://www.ismp.org/resources/quarterwatchtm-2017-quarter- 1-data-safety-signals-two-novel-drugs-nuplazid-and-entresto. Accessed December 31, 2018. 8. US Food & Drug Administration (FDA). Drug Safety and Availability. FDA analysis finds no new or unexpected safety risks associated with Nuplazid (pimavanserin), a medication to treat the hallucinations and delusions of Parkinson’s disease psychosis. September 20, 2018. Available from: https://www.fda.gov/Drugs/DrugSafety/ucm621160.htm. Accessed December 31, 2018. Federal and state laws or requirements, contract language, and Plan utilization management programs or polices may take precedence over the application of this clinical criteria. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan. PAGE 2 of 2 04/23/2021 This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. .
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