Nucynta IR/ Nucynta ER (tapentadol immediate-release and extendedrelease)

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Nucynta Page: 1 of 7 Last Review Date: March 18, 2016 Nucynta Description Nucynta IR/ Nucynta ER (tapentadol immediate-release and extendedrelease) Background Nucynta IR and Nucynta ER are Schedule II controlled substances indicated for the management of moderate to severe pain in adults. Nucynta IR is specifically indicated to manage acute pain while Nucynta ER is indicated for both chronic pain and neuropathic pain associated with diabetic peripheral neuropathy (DPN)(1-2). The active ingredient, tapentadol, is a centrally-acting synthetic analgesic. Both possess a high potential for abuse and are 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: (1-2) Nucynta IR is an opioid analgesic indicated for the management of moderate to severe acute pain in adults. Nucynta ER is an opioid agonist indicated for the management of severe chronic pain in adults and neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Limitations of Use:

2 Subject: Nucynta Page: 2 of 7 Nucynta ER is not for use for the following: as an as-needed (prn) analgesic, for pain that is mild or not expected to persist for an extended period of time, for acute pain, for postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time (2). 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 (3). Nucynta IR and Nucynta ER have boxed warnings for the following (1-2): Respiratory depression is the chief hazard of opioid agonists, including Nucynta IR and Nucynta ER. 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 and Nucynta ER are essential. Nucynta IR and Nucynta ER are contraindicated in patients with respiratory depression and in patients with conditions that increase the risk of life-threatening 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. The safety and effectiveness of Nucynta IR and Nucynta ER in pediatric patients less than 18 years of age have not been established (1-2). Related policies Abstral, Actiq, Duragesic, Embeda, Fentanyl Powder, Fentora, Hysingla ER, Lazanda, Morphine drug class, Onsolis, Oxycodone, Subsys, Xartemis XR, Zohydro ER Policy

3 Subject: Nucynta Page: 3 of 7 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. Nucynta ER may be considered medically necessary in patients 18 years of age or older who require management of moderate or severe chronic pain and/or neuropathic pain associated with diabetic peripheral neuropathy (DPN) requiring management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Nucynta IR; Nucynta ER are 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 Age 18 years of age or older Diagnoses Nucynta IR Nucynta ER The patient must have the following: 1. Moderate to severe pain Patient must have ONE of the following: 1. Severe chronic pain 2. Neuropathic pain associated with diabetic peripheral neuropathy (DPN) a. Pain, severe enough to require daily, around-the clock long term opioid treatment.and the following: 1. Alternative treatment options have been ineffective, not tolerated or inadequate for controlling the pain a. These include non-opioid analgesic and immediate release opioids

4 Subject: Nucynta Page: 4 of 7 2. NO dual therapy with other long acting opioid analgesic(s) AND the following requirements for both IR and ER formulations: Answers to the following are for data collection only and are not used in the determination of the medical necessity. a. Care plan / agreement for opioid therapy has been established b. Patient has been advised of risks of chronic opioid therapy and has provided informed consent c. Patient is an appropriate candidate for chronic opioid therapy d. Prescriber will continue to monitor for signs of misuse, abuse and addiction during therapy Prior Approval Renewal Requirements Diagnoses Nucynta IR Patient must have the following: Nucynta ER 1. Moderate to severe pain Patient must have ONE of the following: 1. Severe chronic pain 2. Neuropathic pain associated with diabetic peripheral neuropathy (DPN) a. Pain, severe enough to require daily, around-the clock long term opioid treatment AND the following: NO dual therapy with other long acting opioid analgesic(s) Policy Guidelines Pre - PA Allowance Age 18 years of age or older

5 Subject: Nucynta Page: 5 of 7 Quantity Nucynta IR Nucynta ER 360 dosage units per 90 days 180 dosage units per 90 days Prior - Approval Limits Quantity Immediate Release Nucynta IR 50mg tablets dosage units per 90 days OR Nucynta IR 75mg tablets dosage units per 90 days OR Nucynta IR 100mg tablets dosage units per 90 days OR Maximum daily limit of any combination: 600mg OR Extended Release Nucynta ER 50mg tablets 900 tablets per 90 days OR Nucynta ER 100mg tablets 450 tablets per 90 days OR Nucynta ER 150mg tablets 270 tablets per 90 days OR Nucynta ER 200mg tablets 180 tablets per 90 days OR Nucynta ER 250mg tablets 180 tablets per 90 days OR Maximum daily limit of any combination: 500mg Prior Approval Renewal Limits Quantity Immediate Release Nucynta IR 50mg tablets dosage units per 90 days OR Nucynta IR 75mg tablets dosage units per 90 days OR Nucynta IR 100mg tablets dosage units per 90 days OR

6 Subject: Nucynta Page: 6 of 7 Maximum daily limit of any combination: 600mg OR Extended Release Nucynta ER 50mg tablets 900 tablets per 90 days OR Nucynta ER 100mg tablets 450 tablets per 90 days OR Nucynta ER 150mg tablets 270 tablets per 90 days OR Nucynta ER 200mg tablets 180 tablets per 90 days OR Nucynta ER 250mg tablets 180 tablets per 90 days OR Maximum daily limit of any combination: 500mg Rationale Summary Nucynta IR and Nucynta ER are schedule II controlled substances prescribed to treat moderate to severe, acute and chronic pain. Nucynta ER is also indicated for management of neuropathic pain associated with diabetic peripheral neuropathy (DPN). The safety and effectiveness of Nucynta IR and Nucynta ER in pediatric patients less than 18 years of age have not been established (1-2). Nucynta IR and Nucynta ER are contraindicated in patients with respiratory depression and in patients with conditions that increase the risk of life-threatening respiratory depression (1-2). To reduce the risk of respiratory depression, proper dosing and titration of Nucynta IR and Nucynta ER are 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 and Nucynta ER while maintaining optimal therapeutic outcomes. References 1. Nucynta IR [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; September Nucynta ER [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; April, 2014.

7 Subject: Nucynta Page: 7 of 7 3. Fidman B, Nogid A. Role of Tapentadol Immediate Release (Nucynta) in the Management of Moderate-to-Severe Pain. P&Te June 2010; 35(6): Policy History Date September 2014 April 2015 June 2015 March 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 Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on March 18, 2016 and is effective April 1, Deborah M. Smith, MD, MPH

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