Long-Acting Narcotic Analgesics Therapeutic Class Review (TCR)
Total Page:16
File Type:pdf, Size:1020Kb
Long-Acting Narcotic Analgesics Therapeutic Class Review (TCR) August 13, 2019 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]. August 2019 Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2019 Magellan Rx Management. All rights reserved. FDA-APPROVED INDICATIONS Drug Manufacturer Schedule Indication(s) buprenorphine Biodelivery CIII ▪ Management of pain severe enough to require (Belbuca™)1 Sciences daily, around-the-clock, long-term opioid treatment and for which alternative treatment buprenorphine generic, Purdue CIII options are inadequate (Butrans®)2 fentanyl transdermal generic, Janssen CII (Duragesic®)3 hydrocodone extended-release Purdue CII (Hysingla® ER)4 hydrocodone extended-release Pernix CII (Zohydro® ER)5 hydromorphone extended-release generic, CII (Exalgo®)6 Mallinckrodt methadone generic, West- CII ▪ Management of pain severe enough to require (Dolophine®, Diskets®, Ward/Hikma; daily, around-the-clock, long-term opioid Methadose™)7 Mallinckrodt treatment and for which alternative treatment options are inadequate; ▪ Detoxification and maintenance treatment of opioid addiction morphine sulfate controlled-release generic, Rhodes CII ▪ Management of pain severe enough to require (MS Contin®)8 daily, around-the-clock, long-term opioid morphine sulfate extended-release* Egalet/Zyla CII treatment and for which alternative treatment (Arymo ER™)9 options are inadequate morphine sulfate extended-release† generic, CII (Kadian®)10 Actavis/Allergan morphine sulfate extended-release Daiichi Sankyo CII (Morphabond™ ER)11 morphine sulfate extended-release Pfizer CII and naltrexone (Embeda®)12 oxycodone controlled-release generic‡, Purdue CII (Oxycontin®)13 oxycodone extended-release Collegium CII (Xtampza ER™)14 oxymorphone extended-release§15 generic CII tapentadol extended-release Depomed/ CII ▪ Management of pain severe enough to require (Nucynta® ER)16 Collegium daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate; ▪ Neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults severe enough to require daily, around-the-clock, long- term opioid treatment and for which alternative treatment options are inadequate Long-Acting Narcotic Analgesics – August 2019 Page 2 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2019 Magellan Rx Management. All rights reserved. 4 FDA-Approved Indications (continued) Drug Manufacturer Schedule Indication(s) tramadol extended-release generic, Vertical CIV ▪ Management of pain severe enough to require (Conzip®)17 daily, around-the-clock, long-term opioid treatment and for which alternative treatment tramadol extended-release¶ 18,19 generic CIV options are inadequate * Effective September 28, 2018, Egalet/Zyla announced that they are discontinuing the promotion and manufacture of Arymo ER.20 † Pfizer has discontinued manufacture of Avinza® non-abuse-deterrent extended-release morphine sulfate capsules. Generic products, approved with Avinza as the reference product, are still available. ‡ All generic products of Oxycontin are authorized generics. § In July 2017, Endo announced that they will voluntarily remove Opana® ER (oxymorphone ER) from the market in response to a request from the Food and Drug Administration (FDA) who determined that the product’s risks outweigh its benefits.21,22 Product may remain until supply is depleted. Although Opana ER had abuse-deterrent properties following its reformulation in 2012, it was not considered an abuse-deterrent formulation by the FDA. In addition, oxymorphone extended-release products were approved based on the original formulation of Opana ER (originally approved in 2006), which did not contain abuse-deterrent properties. ¶ Generics were approved as reference products to either Ryzolt® (previously manufactured by Purdue Pharma) or Ultram® ER (previously manufactured by Janssen). Ionsys®, a fentanyl iontophoretic transdermal system for pain management in hospitalized patients only, will not be addressed in this review. OVERVIEW Pain of multiple etiologies remains a substantial problem for many patients presenting in the clinical setting.23 Pain management must be individualized for each of these patients. There are many opioid analgesic products available, differing in specific opioid, dosage form, abuse-deterrent properties, and duration of action. In this review, the terms “narcotic” and “opioid” are used interchangeably. Data from 2012 demonstrated that approximately 11.2% of adults report daily pain, which is greatly misunderstood. Historically, data have suggested that pain may be undertreated, but newer estimates imply that opioid treatment for pain may be overutilized.24 An estimated 20% of patients who presented to outpatient providers with noncancer pain or pain-related diagnoses, whether acute or chronic, received an opioid prescription.25 Caregivers’ misconceptions regarding opiate doses, duration of analgesic effect, and fear of addiction may be responsible for the historical undertreatment of pain, and some of the historical increase in opioid use is thought to be related to prescribers worrying they are undertreating their patients’ pain.26,27 Unfortunately, approximately 70,237 people have died from overdoses related to opioid pain medications in the United States (US) in 2017.28 Likewise, drug related deaths have tripled from 1999 to 2015, and during 2015 alone 33,091 persons in the US died from opioid related overdoses.29 Opioid related overdose was higher among males (13.7%) in comparison to females (7.1%).30 In 2017, 17.4% of the US population received ≥ 1 opioid prescription. Annually from 2010, there has been a continued decreased in opioid prescribing.31 Likewise, per capita opioid prescriptions have subsequently decreased by 19.1% from 2006 to 2017. Regardless, persistent pain that is uncontrolled may have clinical, psychological, and social consequences; thus, it is critical to weigh the risks and benefits of opioid use and reevaluate patients routinely for appropriate dose, duration, and treatment choice, including both pharmacologic and nonpharmacologic modalities. Long-Acting Narcotic Analgesics – August 2019 Page 3 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2019 Magellan Rx Management. All rights reserved. 4 Different management techniques are utilized for acute and chronic pain. When properly used, long- acting opioids decrease administration frequency, decrease the incidence of adverse effects, and increase periods of consistent pain control. While definitions vary, chronic pain is generally defined as pain lasting > 3 months or past the time required for normal tissue healing. It has various etiologies, including injury, inflammation, and underlying medical conditions.32 Treatment Guidelines The World Health Organization’s (WHO) guidelines for cancer pain management, long recognized as the foundation of cancer pain relief, recommend a 3-stepped approach with consideration for the type of pain and response to therapy.33 Initial therapy should include non-opioid analgesics, such as non- steroidal anti-inflammatory drugs (NSAIDs). For mild to moderate pain, oral combinations of acetaminophen and NSAIDs with opioids are recommended. For moderate to severe pain, opioid analgesics are the treatment of choice. The American Pain Society does not distinguish amongst the available products in their 2009 clinical guidelines for the use of chronic opioid therapy for the treatment of chronic non-cancer pain.34 Titration of dose and frequency should be individualized to the patient’s response and experience of adverse effects. In 2016, the American Society of Clinical Oncology (ASCO) published guidelines for chronic pain management in adult cancer survivors.35 For pharmacologic treatment, systemic non-opioid analgesics and adjuvant analgesics are suggested for chronic pain and to improve function. They state that opioids may be used in those who do not respond to more conservative management.