Nucynta IR. Nucynta IR (tapentadol immediate-release) Description

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Nucynta IR Page: 1 of 9 Last Review Date: December 8, 2017 Nucynta IR Description Nucynta IR (tapentadol immediate-release) Background Nucynta IR is a Schedule II controlled substances indicated for the management of moderate to severe pain in adults. Nucynta IR is specifically indicated to manage acute pain. The active ingredient, tapentadol, is a centrally-acting synthetic analgesic. Nucynta IR possess a high potential for abuse and is subject to misuse, addiction, and criminal diversion in a manner similar to other opioid agonists. All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use (1). Regulatory Status FDA-approved indications: Nucynta IR is an opioid analgesic indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate (1). Limitations of Use: (1) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Oxycodone IR for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or non-opioid combination products): Have not been tolerated, or are not expected to be tolerated Have not provided adequate analgesia or are not expected to provide adequate analgesia

2 Subject: Nucynta IR Page: 2 of 9 Off Label Use: Nucynta immediate release is a centrally acting analgesic with established efficacy in acute pain, chronic pain, neuropathic pain, and pain with an inflammatory origin. Nucynta IR was as effective as oxycodone in managing chronic pain and was associated with a lower risk of GI adverse events (2). Nucynta IR have boxed warnings for the following (1): Respiratory depression is the chief hazard of opioid agonists, including Nucynta IR. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. To reduce the risk of respiratory depression, proper dosing and titration of Nucynta IR are essential. Nucynta IR are contraindicated in patients with respiratory depression and in patients with conditions that increase the risk of lifethreatening respiratory depression. All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Prolonged use of opioid agonists during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening. Patients should not consume alcohol or any products containing alcohol while taking. CDC guidelines find that concurrent use of benzodiazepines and opioids might put patients at greater risk for potentially fatal overdose. Three studies of fatal overdose deaths found evidence of concurrent benzodiazepine use in 31% 61% of decedents (3). CDC guidelines finds that given uncertain benefits and substantial risks that opioids should not be considered first-line or routine therapy for chronic pain (i.e., pain continuing or expected to continue longer than 3 months or past the time of normal tissue healing) outside of active cancer, palliative, and end-of-life care (3). The FDA warns that opioids can interact with antidepressants and migraine medicines to cause a serious central nervous system reaction called serotonin syndrome, in which high levels of the chemical serotonin build up in the brain and cause toxicity (see Appendix 1 for list of drugs) (4). The safety and effectiveness of Nucynta IR in pediatric patients less than 18 years of age have not been established (1).

3 Subject: Nucynta IR Page: 3 of 9 Related policies Abstral, Actiq, Butrans, Duragesic, Extended Release Opioid Drugs, Fentanyl Powder, Fentora, Lazanda, Meperidine, Methadone, Morphine IR, Onsolis, Oxycodone IR, Subsys, Tramadol Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Nucynta IR may be considered medically necessary in patients 18 years of age and older who require management of moderate to severe pain and if the conditions below are met. Nucynta IR is considered investigational in patients less than 18 years of age and for all other indications. Prior-Approval Requirements Prior authorization is not required if prescribed by an oncologist and/or the member has paid pharmacy claims for an oncology medication(s) in the past 6 months Age 18 years of age or older Diagnoses The patient must have ONE of the following: 1. Moderate to Severe Acute Pain (short term) a. Prescriber agrees to discontinue therapy after 30 days 2. Moderate to Severe Chronic Pain a. Prescriber agrees to assess the benefits of pain control (i.e. Care Plan signs of abuse, severity of pain) after 3 months of therapy AND ALL of the following: a. NO dual therapy with other immediate release opioid analgesic(s) b. Alternative treatment options have been ineffective, not tolerated or inadequate for controlling the pain i. These include non-opioid analgesic c. Prescriber agrees to assess patient for serotonin syndrome

4 Subject: Nucynta IR Page: 4 of 9 d. NO dual therapy with opioid addiction treatment or methadone e. NO dual therapy with an anti-anxiety benzodiazepine(s) i. Alprazolam (Xanax) ii. Clonazepam (Klonopin) iii. Diazepam (Valium) iv. Lorazepam (Ativan) v. Oxazepam (Serax) vi. Chlordiazepoxide (Librium) vii. Clorazepate dipotassium (Tranxene) Prior Approval Renewal Requirements Age 18 years of age or older Diagnosis Patient must have the following: Policy Guidelines Pre - PA Allowance 1. Moderate to Severe Chronic pain AND ALL of the following: a. NO dual therapy with other immediate release opioid analgesic(s) b. Prescriber agrees to assess the benefits of pain control (i.e. Care Plan signs of abuse, severity of pain) after 3 months of therapy c. Prescriber agrees to assess patient for serotonin syndrome d. NO dual therapy with opioid addiction treatment or methadone e. NO dual therapy with an anti-anxiety benzodiazepine(s) i. Alprazolam (Xanax) ii. Clonazepam (Klonopin) iii. Diazepam (Valium) iv. Lorazepam (Ativan) v. Oxazepam (Serax) vi. Chlordiazepoxide (Librium) vii. Clorazepate dipotassium (Tranxene) Age 18 years of age or older

5 Subject: Nucynta IR Page: 5 of 9 Quantity Medication / Strength Nucynta tablets Quantity Limit per 90 days 360 dosage units per 90 days OR Prior - Approval Limits Quantity Acute Pain Medication / Strength Nucynta tab 50mg Nucynta tab 75mg Nucynta tab 100mg Quantity Limit for 30 days 150 tablets for 30 days OR 150 tablets for 30 days OR 150 tablets for 30 days Duration 1 month Quantity Chronic Pain Medication / Strength Nucynta tab 50mg Nucynta tab 75mg Nucynta tab 100mg Quantity Limit per 90 days 720 tablets per 90 days OR 540 tablets per 90 days OR 540 tablets per 90 days Duration 6 months Prior Approval Renewal Limits Quantity Chronic Pain Medication / Strength Nucynta tab 50mg Nucynta tab 75mg Nucynta tab 100mg Quantity Limit per 90 days 720 tablets per 90 days OR 540 tablets per 90 days OR 540 tablets per 90 days

6 Subject: Nucynta IR Page: 6 of 9 Duration 6 months Rationale Summary Nucynta IR are schedule II controlled substances prescribed to treat moderate to severe, acute and chronic pain. The safety and effectiveness of Nucynta IR in pediatric patients less than 18 years of age have not been established. Nucynta IR is contraindicated in patients with respiratory depression and in patients with conditions that increase the risk of life-threatening respiratory depression. To reduce the risk of respiratory depression, proper dosing and titration of Nucynta IR is essential. All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use (1). Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Nucynta IR while maintaining optimal therapeutic outcomes. References 1. Nucynta IR [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; December Fidman B, Nogid A. Role of Tapentadol Immediate Release (Nucynta) in the Management of Moderate-to-Severe Pain. P&Te June 2010; 35(6): Dowell D, Haegerich T, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain. CDC Guidelines FDA Safety Release. FDA Drug Safety Communication: FDA warns about several safety issues with opioid pain medicines; requires label changes. March 22, Policy History Date September 2014 April 2015 June 2015 March 2016 Action New addition to PA Change to allow the Nucynta IR for moderate to severe pain and standard allowance to 90 days and adding renewal limits on the Nucynta IR Annual review and reference update Annual editorial review Addition of requirement: alternative treatment options have been ineffective, not tolerated or inadequate for controlling the pain Policy code changed from to

7 Subject: Nucynta IR Page: 7 of 9 September 2016 March 2017 June 2017 September 2017 January 2018 Annual review Addition of no dual therapy with other immediate release opioid analgesic(s); prescriber agrees to assess the benefits of pain control (i.e. Care Plan signs of abuse, severity of pain) after 3 months of therapy; prescriber agrees to assess patient for serotonin syndrome; no dual therapy with opioid addiction treatment; no dual therapy with any anti-anxiety benzodiazepines: alprazolam (Xanax), clonazepam (Klonopin), diazepam (Valium), lorazepam (Ativan), oxazepam (Serax), chlordiazepoxide (Librium), clorazepate dipotassium (Tranxene) Annual editorial review Addition of age limit to renewal criteria Addition of no dual therapy with methadone Annual review Annual editorial review and reference update Removal of Oxycontin and Oxycodone ER and the revision of the quantity limits Addition of the Acute Pain indication and quantity limits Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on December 8, 2017 and is effective on January 1, 2018.

8 Subject: Nucynta IR Page: 8 of 9 Appendix 1 - List of Serotonergic Medications Selective Serotonin Reuptake Inhibitors (SSRIs) paroxetine Paxil, Paxil CR, Pexeva, Brisdelle fluvoxamine Luvox, Luvox CR fluoxetine Prozac, Prozac Weekly, Sarafem, Selfemra, Symbyax sertraline Zoloft citalopram Celexa escitalopram Lexapro Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) venlafaxine Effexor XR desvenlafaxine Pristiq, Khedezla duloxetine Cymbalta milnacipran Savella Tricyclic Antidepressants (TCAs) amitriptyline No brand name currently marketed desipramine Norpramin clomipramine Anafranil imipramine Tofranil, Tofranil PM nortriptyline Pamelor, Aventyl protriptyline Vivactil doxepin Zonalon, Silenor trimipramine Surmontil Monoamine Oxidase Inhibitors (MAOIs) isocarboxazid Marplan phenelzine Nardil selegiline Emsam, Eldepryl, Zelapar tranylcypromine Parnate

9 Subject: Nucynta IR Page: 9 of 9 Other Psychiatric Medicines amoxapine No brand name currently marketed maprotiline No brand name currently marketed nefazodone No brand name currently marketed trazodone Oleptro buspirone No brand name currently marketed vilazodone Viibryd mirtazapine Remeron, Remeron Soltab lithium Lithobid Migraine Medicines almotriptan Axert frovatriptan Frova naratriptan Amerge rizatriptan Maxalt, Maxalt-MLT sumatriptan Imitrex, Imitrex Statdose, Alsuma, Sumavel Dosepro, Zecuity, Treximet zolmitriptan Zomig, Zomig-ZMT Antiemetics ondansetron granisetron dolasetron palonosetron Zofran, Zofran ODT, Zuplenz Kytril, Sancuso Anzemet Aloxi Other Serotonergic Medicines dextromethorphan linezolid cyclobenzaprine methylene blue St. John s wort tryptophan Bromfed-DM, Delsym, Mucinex DM, Nuedexta Zyvox Amrix

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