Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.02.33 Subject: Morphine Drug Class Page: 1 of 8 Last Review Date: June 19, 2015 Morphine Sulfate Hydromorphone Oxymorphone Description Avinza, Kadian, MS Contin (Morphine sulfate extended release), morphine sulfate immediate release, Exalgo (hydromorphone extended release), Dilaudid (hydromorphone), Opana (oxymorphone), Opana ER (oxymorphone extended release) Background Morphine sulfate IR and ER (Avinza, MS Contin, Kadian) and its derivatives hydromorphone (Exalgo, Dilaudid) and oxymorphone (Opana and Opana ER) are Schedule II narcotics prescribed to treat moderate to severe pain (1-7). Morphine produces both its therapeutic and adverse effects by interaction with one or more classes of specific opioid receptors located throughout the body. Morphine acts as a full agonist, binding with and activating opioid receptors at sites in brain and spinal cord (3). In addition to analgesia, the widely diverse effects of morphine include drowsiness, changes in mood, respiratory depression, decreased gastrointestinal motility, nausea, vomiting, and alterations of the endocrine and autonomic nervous system (1). Regulatory Status FDA-approved indications: Morphine sulfate, hydromorphone and oxymorphone are opioid agonists indicated for the relief of moderate to severe acute and chronic pain where an opioid is appropriate (1-9). Morphine sulfate extended-release (ER), hydromorphone (ER) and oxymorphone (ER) are opioid agonists indicated for the management of severe pain when a continuous, around-theclock opioid analgesic is needed for an extended period of time (1-9).
Subject: Morphine Drug Class Page: 2 of 8 Morphine sulfate IR and ER (Avinza, MS Contin, Kadian) and its derivatives hydromorphone (Exalgo, Dilaudid) and oxymorphone (Opana and Opana ER) have boxed warnings for the following (1-9): Respiratory depression is the chief hazard of opioid agonists, including morphine sulfate, which if not immediately recognized and treated, may lead to respiratory arrest and death. Risk is increased in patients receiving concurrent CNS depressants (including alcohol), patients with chronic obstructive pulmonary disease, orthostatic hypotension, increased intracranial pressure, biliary tract diseases, seizure disorders to reduce the risk of respiratory depression, proper dosing, titration, and monitoring are essential. 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. Morphine sulfate and oxymorphone are contraindicated in patients with paralytic ileus (1-9). Avoid use of Avinza in patients with other GI obstruction (1). The most common adverse reactions with Avinza include constipation, nausea, and somnolence (1). The safety and effectiveness of morphine sulfate in pediatric patients below the age of 18 have not been established (1-9). Related policies Abstral, Actiq, Duragesic, Embeda, Fentanyl Powder, Fentora, Hysingla ER, Lazanda, Nucynta, Onsolis, Oxycodone, Subsys, Tramadol, 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.
Subject: Morphine Drug Class Page: 3 of 8 Morphine sulfate, hydromorphone and oxymorphone may be considered medically necessary in patients that are 18 years of age and older with moderate to severe pain. Morphine sulfate (ER), hydromorphone (ER)and oxymorphone (ER) may be considered medically necessary in patient that are 18 years of age and older requiring management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine sulfate and oxymorphone may be considered investigational in patients that are under the age of 18 and patients that do not have moderate to severe acute or chronic pain. Prior-Approval Requirements Prior authorization is not required if prescribed by an oncologist Age Diagnoses 18 years of age or older Morphine Sulfate IR, Hydromorphone IR and Oxymorphone IR Patient must have the following: Moderate to severe pain Morphine Sulfate ER, Hydromorphone ER and Oxymorphone ER Patient must have ALL of the following: 1. Pain, severe enough to require daily, around-the clock long term opioid treatment 2. Alternative treatment options have been ineffective, not tolerated or inadequate for controlling the pain a. These include: non-opioid analgesics and immediate release analgesics AND the following: No dual therapy with other long acting opioid analgesic(s) AND the following requirements for both IR and ER formulations:
Subject: Morphine Drug Class Page: 4 of 8 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 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 misuse, abuse and addiction during therapy Prior Approval Renewal Requirements Age 18 years of age or older Diagnoses Morphine Sulfate IR, Hydromorphone IR and Oxymorphone IR Patient must have the following: Moderate to severe pain Morphine Sulfate ER, Hydromorphone ER and Oxymorphone ER Patient must have the following: Severe pain requiring a continuous, around-the-clock opioid analgesic Policy Guidelines Pre - PA Allowance Quantity Immediate-release Formulations Morphine sulfate (IR) Opana (oxymorphone) IR 360 tablets per 90 days, OR 360 tablets per 90 days, OR
Subject: Morphine Drug Class Page: 5 of 8 Dilaudid (hydromorphone) IR 540 tablets per 90 days Extended-release Formulations Avinza (morphine sulfate ER) Kadian (morphine sulfate ER) MS Contin (morphine sulfate ER) Exalgo (hydromorphone ER) Opana (oxymorphone) ER 360 tablets per 90 days, OR 180 tablets per 90 days, OR 270 tablets per 90 days Prior - Approval Limits Quantity Immediate-release Formulations Morphine sulfate 15mg (IR) 900 tablets per 90 days OR Morphine sulfate 30mg (IR) 540 tablets per 90 days Maximum daily limit of any combination: 180mg Opana 5mg (Oxymorphone) (IR) 900 tablets per 90 days OR Opana 10mg (Oxymorphone) (IR) 720 tablets per 90 days OR Maximum daily limit of any combination: 80mg Dilaudid 2mg (Hydromorphone) (IR) 900 tablets per 90 days OR Dilaudid 4mg (Hydromorphone) (IR) 900 tablets per 90 days OR Dilaudid 8mg (Hydromorphone) (IR) 810 tablets per 90 days OR Maximum daily limit of any combination: 72mg OR Extended-release Formulations Avinza 30 mg (Morphine sulfate) Avinza 45 mg (Morphine sulfate) Avinza 60 mg (Morphine sulfate) Avinza 75 mg (Morphine sulfate) 1080 capsules per 90 days OR 1080 capsules per 90 days OR 1080 capsules per 90 days OR 1080 capsules per 90 days OR
Subject: Morphine Drug Class Page: 6 of 8 Avinza 90 mg (Morphine sulfate) 1080 capsules per 90 days OR Avinza 120 mg (Morphine sulfate) 1080 capsules per 90 days OR Maximum daily limit of any combination: 1600mg Exalgo 8mg (Hydromorphone) 900 tablets per 90 days OR Exalgo 12mg (Hydromorphone) 900 tablets per 90 days OR Exalgo 16mg (Hydromorphone) 720 tablets per 90 days OR Exalgo 32mg (Hydromorphone) 360 tablets per 90 days OR Maximum daily limit of any combination: 128mg Kadian 10mg (Morphine sulfate) 900 capsules per 90 days OR Kadian 20mg (Morphine sulfate) 900 capsules per 90 days OR Kadian 30mg (Morphine sulfate) 900 capsules per 90 days OR Kadian 40mg (Morphine sulfate) 900 capsules per 90 days OR Kadian 50mg (Morphine sulfate) 900 capsules per 90 days OR Kadian 60mg (Morphine sulfate) 900 capsules per 90 days OR Kadian 80mg (Morphine sulfate) 900 capsules per 90 days OR Kadian 100mg (Morphine sulfate) 900 capsules per 90 days OR Kadian 200mg (Morphine sulfate) 540 capsules per 90 days Maximum daily limit of any combination: 1200mg MS Contin 15mg (Morphine sulfate) 900 tablets per 90 days OR MS Contin 30mg (Morphine sulfate) 900 tablets per 90 days OR MS Contin 60mg (Morphine sulfate) 900 tablets per 90 days OR MS Contin 100mg (Morphine sulfate) 900 tablets per 90 days OR MS Contin 200mg (Morphine sulfate) 540 tablets per 90 days Maximum daily limit of any combination: 1200mg Opana ER 5mg (Oxymorphone) 900 tablets per 90 days OR Opana ER 7.5mg (Oxymorphone) 900 tablets per 90 days OR Opana ER 10mg (Oxymorphone) 900 tablets per 90 days OR Opana ER 15mg (Oxymorphone) 900 tablets per 90 days OR Opana ER 20mg (Oxymorphone) 900 tablets per 90 days OR Opana ER 30mg (Oxymorphone) 540 tablets per 90 days Opana ER 40mg (Oxymorphone) 450 tablets per 90 days OR Maximum daily limit of any combination: 200mg Duration 6 months
Subject: Morphine Drug Class Page: 7 of 8 Prior Approval Renewal Limits Same as above Rationale Summary Morphine sulfate IR and ER (Avinza, MS Contin, Kadian) and its derivatives hydromorphone (Exalgo, Dilaudid) and oxymorphone (Opana and Opana ER) are Schedule II narcotics prescribed to treat moderate to severe pain (1-7). In addition to analgesia, the widely diverse effects of morphine include drowsiness, changes in mood, respiratory depression, decreased gastrointestinal motility, nausea, vomiting, and alterations of the endocrine and autonomic nervous system (1). 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. Prior approval is required to ensure the safe, clinically appropriate and cost effective use of morphine sulfate IR/ER, hydromorphone IR/ER and oxymorphone IR/ER while maintaining optimal therapeutic outcomes. References 1. Avinza [package insert]. Bristol, TN: King Pharmaceuticals; April 2014 2. Dilaudid [package insert]. Whippany, NJ: Halo Pharmaceutical, Inc.; June 2013 3. Exalgo [package insert]. Hazelwood, MO: Mallinckrodt Brand Pharmaceuticals, Inc.; April 2014 4. MS Contin [package insert]. Stamford, CT: Purdue Pharma L.P.; April 2014 5. Kadian [package insert]. Morristown, NJ: Actavis Elizabeth LLC; April 2014 6. Opana [package insert]. Malvern, PA: Endo Pharmaceuticals; April 2014 7. Opana ER [package insert]. Chadds Ford, PA: Endo Pharmaceuticals; April 2014 8. Morphine sulfate [package insert]. Columbus, OH: Roxane Laboratories, Inc.; July 2010 Policy History Date September 2014 Action Addition to PA
Subject: Morphine Drug Class Page: 8 of 8 June 2015 Annual review Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on June 19, 2015 and is effective July 1, 2015. Deborah M. Smith, MD, MPH