Embeda. Embeda (morphine sulfate and naltrexone hydrochloride) Description

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Embeda Page: 1 of 6 Last Review Date: March 18, 2016 Embeda Description Embeda (morphine sulfate and naltrexone hydrochloride) Background Embeda is an extended-release capsule consisting of morphine sulfate and naltrexone hydrochloride. Embeda is indicated for the management of moderate to severe pain when a continuous around-the-clock long term opioid analgesic is needed and for which alternative treatment options are inadequate. It is not approved for as-needed pain relief. Embeda capsules contain pellets of morphine sulfate, an opioid receptor agonist with a sequestered core of naltrexone hydrochloride, an opioid receptor antagonist (1). Regulatory Status FDA-approved indication: Embeda is indicated for the management of moderate to severe painto require daily, around the clock, long-term opioid treatment and for which alternative treatment options are inadequate (1). Limitations of use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Embeda for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Embeda is not indicated as an as-needed (prn) analgesic (1).

2 Subject: Embeda Page: 2 of 6 Embeda carries several boxed warnings regarding addiction, abuse, and misuse; lifethreatening respiratory depression; accidental exposure; neonatal opioid withdrawal syndrome; and interaction with alcohol (1). Embeda is contraindicated in patients who have significant respiratory depression, acute or severe bronchial asthma, and in patients who have or are suspected of having paralytic ileus and gastrointestinal obstruction (1). Care should be taken to use low initial doses of Embeda in patients who are not already opioidtolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications. Embeda 100 mg/4mg capsules are for use in opioid tolerant patients only (1). The safety and effectiveness of Embeda in pediatric patients below the age of 18 years have not been established (1). Related policies Abstral, Actiq, Duragesic, Fentanyl Powder, Fentora, Hysingla ER, Lazanda, Morphine Drug Class, Nucynta, Onsolis, Oxycodone, Subsys, Xartemis ER, Zohydro ER Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Embeda may be considered medically necessary in patients that are 18 years of age and older with moderate to severe pain when a continuous, around the-clock opioid analgesic is needed for an extended period of time, and alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain, these include non-opioid analgesic and immediate release opioids; no dual therapy with other long acting opioid analgesic(s); opioid naïve patient and opioid non-tolerant patient initiation therapy must start at 20mg once daily and for no less than 7 days before changing to a higher dose; opioid tolerant patient patients are considered opioid tolerant if they have been receiving, for one week or longer. Embeda is considered investigational in patients below 18 years of age and for all other indications.

3 Subject: Embeda Page: 3 of 6 Prior-Approval Requirements Prior authorization is not required if prescribed by an oncologist. Age 18 years of age or older Diagnosis Patient must have the following: Moderate to severe pain when a continuous, around the-clock long acting opioid analgesic is needed AND ALL of 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 2. NO dual therapy with other long acting opioid analgesic(s) AND ONE of the following: 1. Opioid naïve patient and opioid non-tolerant patient initiation therapy MUST start at 20/0.8 mg once or twice daily AND for no less than 7 days before changing to a higher dose. OR 2. Opioid tolerant patient patients are considered opioid tolerant if they have been receiving, for one week or longer, at least one of the following: a. 60 mg oral morphine per day b. 25 mcg transdermal fentanyl per hour c. 30 mg oral oxycodone per day d. 8 mg oral hydromorphone per day e. 25 mg oral oxymorphone per day f. Or an equianalgesic dose of another opioid AND ALL of the following requirements: Answers to the following are for data collection only and are not used in the determination of the medical necessity. 1. Care plan / agreement for opioid therapy has been established

4 Subject: Embeda Page: 4 of 6 2. Patient has been advised of risks of chronic opioid therapy and has provided informed consent 3. Patient is an appropriate candidate for chronic opioid therapy 4. Prescriber will continue to monitor for signs of severe respiratory depression, as well as misuse, abuse and addiction during therapy. Prior Approval Renewal Requirements Age 18 years of age or older Diagnosis Patient must have the following: Policy Guidelines 1. Pain moderate to severe enough to require continuous around-the clock long acting opioid treatment AND the following: 1. NO dual therapy with other long acting opioid analgesic(s) Pre - PA Allowance Quantity 180 capsules per 90 days Prior - Approval Limits Quantity Duration 6 months 20/0.8 mg 900 capsules per 90 days OR 30/1.2 mg 900 capsules per 90 days OR 50/2 mg 900 capsules per 90 days OR 60/2.4 mg 900 capsules per 90 days OR 80/3.2 mg 900 capsules per 90 days OR 100/4 mg 900 capsules per 90 days Maximum daily limit of any combination: 1200mg

5 Subject: Embeda Page: 5 of 6 Prior Approval Renewal Limits Quantity Duration Rationale 6 months 20/0.8 mg 900 capsules per 90 days OR 30/1.2 mg 900 capsules per 90 days OR 50/2 mg 900 capsules per 90 days OR 60/2.4 mg 900 capsules per 90 days OR 80/3.2 mg 900 capsules per 90 days OR 100/4 mg 900 capsules per 90 days Maximum daily limit of any combination: 1200mg Summary Embeda is an extended release oral formulation used in the treatment moderate to severe pain. It should not be used for as needed pain relief. The potential for developing substance abuse and addiction is extreme. Patients should be thoroughly assessed for their risk of developing severe respiratory depression, as well as substance abuse prior to being prescribed Embeda and should be routinely monitored for signs of misuse, abuse and addiction during therapy (1). Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Embeda while maintaining optimal therapeutic outcomes. References 1. Embeda [package insert]. Elizabeth, NJ: Actavis Elizabeth LLC; October, Policy History Date March 2015 June 2015 March 2016 Action New addition to PA Annual review Annual editorial review and reference update Addition of no dual therapy with other long acting opioid analgesic(s) in renewal section Policy number changed from to

6 Subject: Embeda Page: 6 of 6 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