Download Morphine Sulfate Hydromorphone Oxymorphone

Federal Employee Program®
1310 G Street, N.W.
Washington, D.C. 20005
202.942.1000
Fax 202.942.1125
5.70.33
Section:
Effective Date:
April 1, 2016
Subsection: Analgesics and Anesthetics
Original Policy Date:
September 12, 2014
Subject:
Page:
1 of 8
Prescription Drugs
Morphine Drug Class
Last Review Date:
March 18, 2016
Morphine Sulfate Hydromorphone Oxymorphone
Description
Avinza, Kadian, Morphabond, 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, Morphabond) 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).
5.70.33
Section:
Prescription Drugs
Effective Date:
April 1, 2016
Subsection: Analgesics and Anesthetics
Original Policy Date: September 12, 2014
Subject:
Page:
Morphine Drug Class
2 of 8
Morphine sulfate IR and ER (Avinza, MS Contin, Kadian, Morphabond) 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, Butrans Patch, 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.
5.70.33
Section:
Prescription Drugs
Effective Date:
April 1, 2016
Subsection: Analgesics and Anesthetics
Original Policy Date: September 12, 2014
Subject:
Page:
Morphine Drug Class
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;
alternative treatment options have been ineffective, not tolerated or inadequate for controlling
the pain, these include: non-opioid analgesics and immediate release analgesics; no dual
therapy with other long acting opioid analgesic(s).
Morphine sulfate and oxymorphone may be 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
18 years of age or older
Age
Diagnoses
Morphine Sulfate IR, Hydromorphone IR and Oxymorphone IR
Patient must have the following:
1. Moderate to severe pain
Morphine Sulfate ER, Hydromorphone ER and Oxymorphone ER
Patient must have the following:
1. Pain, severe enough to require daily, around-the–clock long term opioid
treatment
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 analgesics and immediate release
analgesics
2. NO dual therapy with other long acting opioid analgesic(s)
5.70.33
Section:
Prescription Drugs
Effective Date:
April 1, 2016
Subsection: Analgesics and Anesthetics
Original Policy Date: September 12, 2014
Subject:
Page:
Morphine Drug Class
4 of 8
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.
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
Diagnoses
Morphine Sulfate IR, Hydromorphone IR and Oxymorphone IR
Patient must have the following:
1. Moderate to severe pain
Morphine Sulfate ER, Hydromorphone ER and Oxymorphone ER
Patient must have the following:
1. Severe pain requiring a continuous, around-the-clock opioid analgesic
a. NO dual therapy with other long acting opioid analgesic(s)
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
5.70.33
Section:
Prescription Drugs
Effective Date:
April 1, 2016
Subsection: Analgesics and Anesthetics
Original Policy Date: September 12, 2014
Subject:
Page:
Morphine Drug Class
Dilaudid (hydromorphone) IR
5 of 8
540 tablets per 90 days
Extended-release Formulations
Avinza (morphine sulfate ER)
Kadian (morphine sulfate ER)
MS Contin (morphine sulfate ER)
Morphabond
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
900 tablets per 90 days OR
Morphine sulfate 15mg (IR)
Morphine sulfate 30mg (IR)
540 tablets per 90 days
Maximum daily limit of any combination: 180mg
900 tablets per 90 days OR
Opana 5mg (Oxymorphone) (IR)
720 tablets per 90 days OR
Opana 10mg (Oxymorphone) (IR)
Maximum daily limit of any combination: 80mg
900 tablets per 90 days OR
Dilaudid 2mg (Hydromorphone) (IR)
900 tablets per 90 days OR
Dilaudid 4mg (Hydromorphone) (IR)
810 tablets per 90 days OR
Dilaudid 8mg (Hydromorphone) (IR)
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)
1080 capsules per 90 days OR
1080 capsules per 90 days OR
1080 capsules per 90 days OR
5.70.33
Section:
Prescription Drugs
Effective Date:
April 1, 2016
Subsection: Analgesics and Anesthetics
Original Policy Date: September 12, 2014
Subject:
Page:
Morphine Drug Class
6 of 8
1080 capsules per 90 days OR
Avinza 75 mg (Morphine sulfate)
1080 capsules per 90 days OR
Avinza 90 mg (Morphine sulfate)
1080 capsules per 90 days OR
Avinza 120 mg (Morphine sulfate)
Maximum daily limit of any combination: 1600mg
900 tablets per 90 days OR
Exalgo 8mg (Hydromorphone)
900 tablets per 90 days OR
Exalgo 12mg (Hydromorphone)
720 tablets per 90 days OR
Exalgo 16mg (Hydromorphone)
360 tablets per 90 days OR
Exalgo 32mg (Hydromorphone)
Maximum daily limit of any combination: 128mg
900 capsules per 90 days OR
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)
Kadian 200mg (Morphine sulfate)
540 capsules per 90 days
Maximum daily limit of any combination: 1200mg
900 tablets per 90 days OR
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)
MS Contin 200mg (Morphine sulfate)
540 tablets per 90 days
Maximum daily limit of any combination: 1200mg
900 tablets per 90 days OR
Morphabond 15mg (Morphine sulfate)
900 tablets per 90 days OR
Morphabond 30mg (Morphine sulfate)
900 tablets per 90 days OR
Morphabond 60mg (Morphine sulfate)
Morphabond 100mg (Morphine sulfate)
900 tablets per 90 days
Maximum daily limit of any combination: 1200mg
Opana ER 5mg (Oxymorphone)
Opana ER 7.5mg (Oxymorphone)
Opana ER 10mg (Oxymorphone)
900 tablets per 90 days OR
900 tablets per 90 days OR
900 tablets per 90 days OR
5.70.33
Section:
Prescription Drugs
Effective Date:
April 1, 2016
Subsection: Analgesics and Anesthetics
Original Policy Date: September 12, 2014
Subject:
Page:
Morphine Drug Class
7 of 8
900 tablets per 90 days OR
Opana ER 15mg (Oxymorphone)
900 tablets per 90 days OR
Opana ER 20mg (Oxymorphone)
Opana ER 30mg (Oxymorphone)
540 tablets per 90 days
450 tablets per 90 days OR
Opana ER 40mg (Oxymorphone)
Maximum daily limit of any combination: 200mg
Duration
6 months
Prior – Approval Renewal Limits
Same as above
Rationale
Summary
Morphine sulfate IR and ER (Avinza, MS Contin, Kadian, Morphabond) 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. 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 (1-7).
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.; January 2012
5.70.33
Section:
Prescription Drugs
Effective Date:
April 1, 2016
Subsection: Analgesics and Anesthetics
Original Policy Date: September 12, 2014
Subject:
Page:
Morphine Drug Class
8 of 8
9. Morphabond [package insert]. Valley Cottage, NY: Inspirion Delivery Technologies LLC;
October 2015
Policy History
Date
Action
September 2014
Addition to PA
June 2015
Annual review
November 2015
March 2016
Addition of Morphabond
Annual editorial review and reference update
Addition of not used in combination with any other long acting opioids to
renewal section
Policy code changed from 5.02.33 to 5.70.33
Keywords
This policy was approved by the FEP® Pharmacy and Medical Policy Committee on
March 18, 2016 and is effective April 1, 2016.
Deborah M. Smith, MD, MPH