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Opioid Management - Commercial
Number: J-0672 Category: Prior Authorization
Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Commercial Plans (1., 2., or 3.)

 

  1. Rx Mgmt Performance = Deterrent/Patent Extenders
  2. Rx Mgmt Performance = Deterrent/Patent Extenders + Guideline
  3. Rx Mgmt Performance = MRXC = Yes

Region(s):

All
Delaware
New York
Pennsylvania
West Virginia

Additional Restriction(s):

None



Drugs Products

SHORT-ACTING OPIOID PRIOR AUTHORIZATION FORM

Shortacting opioid analgesics examples include:

  • Butalbital-APAP-Caffeine-Codeine
  • Butalbital/acetaminophen/caffeine/codeine
  • Butalbital/aspirin/caffeine/codeine
  • Codeine sulfate
  • Hydrocodone-Acetaminophen
  • Hydrocodone-Ibuprofen
  • Hydromorphone
  • Meperidine
  • Morphine sulfate IR tabs and solution
  • Nucynta (tapentadol)
  • Oxymorphone
  • Oxycodone
  • Oxycodone-Acetaminophen
  • Oxycodone-Aspirin
  • Oxycodone-Ibuprofen
  • Pentazocine-naloxone
  • Acetaminophen-Codeine #2
  • Tylenol with codeine #3
  • Tylenol With Codeine #4 Tablets
  • Tramadol
  • Tramadol HCl-Acetaminophen

 

EXTENDED RELEASE OPIOID PRIOR AUTHORIZATION FORM

Extended release opioids examples include:

  • Arymo ER (morphine sulfate extendedrelease)
  • ConZip (tramadol extended-release)
  • Duragesic Patch (fentanyl)
  • Embeda (morphine sulfate/naltrexoneextended-release)
  • Exalgo (hydromorphone extended-release)
  • Hysingla ER (hydrocodone bitartrate extended-release)
  • Kadian (morphine sulfate extended-release)
  • levorphanol
  • methadone
  • MorphaBond (morphine sulfate extended release)
  • Avinza (morphine sulfate ER)
  • MS Contin (morphine sulfate extended-release)
  • Nucynta ER (tapentadol extended-release)
  • Opana ER (oxymorphone extended-release)
  • OxyContin (oxycodone extended-release)
  • Targiniq ER (oxycodone ER/naloxone)
  • Troxyca ER (oxycodone /naltrexone hydrochloride extended-release)
  • Ultram ER (tramadol extended-release)
  • Vantrela ER (hydrocodone extended release)
  • Xtampza ER (oxycodone extended-release)
  • Zohydro ER (hydrocodone bitartrate extended-release)
FDA-Approved Indications:
  • For the treatment of moderate pain to moderately severe pain (short acting)
  • The management of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment (extended release)


Background:
  • Opioid pain medication use presents serious risks, including overdose and opioid use disorder. From 1999 to 2014, more than 165,000 persons died from overdose related to opioid pain medication in the United States (16). In the past decade, while the death rates for the top leading causes of death such as heart disease and cancer have decreased substantially, the death rate associated with opioid pain medication has increased markedly (17). Sales of opioid pain medication have increased in parallel with opioid-related overdose deaths (18). The Drug Abuse Warning Network estimated that >420,000 emergency department visits were related to the misuse or abuse of narcotic pain relievers in 2011, the most recent year for which data are available
  • The CDC’s Guideline for Prescribing Opioids recommends the following:
    • Opioids are not first-line or routine therapy for chronic pain
    • Establish and measure goals for pain and function
    • Discuss benefits and risks and availability of nonopioid therapies with patient
    • When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.
  • A Prescription Drug Monitoring Program (PDMP) is a statewide electronic database that tracks all controlled substance prescriptions. Authorized users can access prescription data such as medications dispensed and doses.
  • PDMPs improve patient safety by allowing clinicians to:
    • Identify patients who are obtaining opioids from multiple providers.
    • Calculate the total amount of opioids prescribed per day (in MME/day).
    • Identify patients who are being prescribed other substances that may increase risk of opioids—such as benzodiazepines.
  • CDC recommends checking at least once every 3 months and consider checking prior to every opioid prescription.
  • Morphine Equivalent Daily Dose (MEqD) is a patient’s cumulative dose of all opioids standardized to morphine equivalents.
    • Higher dosages of opioids are associated with higher risk of overdose and death—even relatively MEqD increase risk while higher dosages haven’t been shown to reduce pain over the long term. One randomized trial found no difference in pain or function between a more liberal opioid dose escalation strategy (with average final dosage 52 MEqD) and maintenance of current dosage (average final dosage 40 MEqD).
    • Calculating the total daily dose of opioids helps identify patients who may benefit from closer monitoring, reduction or tapering of opioids, prescribing of naloxone, or other measures to reduce risk of overdose.
      • The general algorithm used to determine the daily MED is as follows:
      • “# of Opioid Dosage units per day” is calculated as follows=  (Opioid claim quantity) ÷ (Opioid claim days’ supply)
      • “Oral MED Daily Dose per claim”=  (# Opioid Dosage Units per day) X (#mg Opioid per dosage unit) X (MED conversion factor)
      • Cumulative MED:  ∑ Oral MED daily dose per claim for all opiates received

MEqD Information

MEqD Conversion Factors



Approval Criteria

Short‐acting opioid analgesics

 

When a benefit, short‐acting opioid analgesics for greater than 7 days’ supply per fill and greater than 14 days’ supply per 30 days may be approved for the following: (A or B or C):

A.    Documentation of pain associated with (1 or 2 or 3):

1.     Active cancer treatment or cancer not in remission (provide diagnosis)

2.     Hospice program, end-of-life care, or palliative care

3.     Sickle cell anemia

B.    Individual is currently utilizing opioid therapy on a consistent basis for chronic pain (Individuals currently receiving opioids on a consistent basis is defined as prescribed use for 90 out of the past 110 days)

C.    Documentation being used for the treatment of severe pain and all the following criteria (1,2 and 3)

1.     Non-opioid therapies (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen) have provided an inadequate response or are inappropriate according to the prescribing physician; AND

2.     The patient’s history of controlled substance prescriptions has been checked using the state prescription drug monitoring program (PDMP) according to the prescribing physician; AND

3.     Documentation the member, or parent/guardian, has been educated on the potential adverse effects of opioid analgesics, including the risk of misuse, abuse, and addiction.

 

Extended release opioids

When a benefit, extended release opioid may be approved for the following: (A or B):

A.    Documentation of pain associated with (1 or 2 or 3):

1.     Active cancer treatment or cancer not in remission (provide diagnosis)

2.     Hospice program, end-of-life care, or palliative care

3.     Sickle cell anemia

B.    Documentation of all the following (1,2,3, 4 and 5)

1.     Pain is severe enough to require daily, around-the-clock, long-term opioid treatment

2.     Patient is not opioid naïve;

3.     At least one of the following therapies have been evaluated

a.     Non-opioid therapies (e.g., non-opioid medications [e.g., nonsteroidal anti-inflammatory drugs {NSAIDs}, tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors {SNRIs}, anticonvulsants]

b.    Exercise therapy

c.     Physical therapy

d.    Weight loss

e.     Cognitive behavioral therapy

4.     The patient’s history of controlled substance prescriptions has been checked using the state prescription drug monitoring program (PDMP), according to the prescribing physician

5.     Documentation the member, or parent/guardian, has been educated on the potential adverse effects of opioid analgesics, including the risk of misuse, abuse, and addiction.

 

Morphine Equivalent Daily Dose (MEqD)

When a benefit, cumulative opioids that exceeded 90 MEqD be approved for the following: (A. or B)

A.    Documentation of pain associated with (1 or 2 or 3):

1.     Active cancer treatment or cancer not in remission (provide diagnosis)

2.     Hospice program, end-of-life care, or palliative care

3.     Sickle cell anemia

B.    The prescriber states based on the patient’s clinical circumstances that the amount of opioid prescribed is warranted in order to adequately manage the patient’s pain

 



Limitations of Coverage

I.      Coverage of opioids for disease states outside of their FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions.



Authorization Duration
  • Commercial Plans: If approved, up to a 6 month authorization may be granted base on patient treatment plan for Short‐acting opioid analgesics and extended release opioids.
  • Commercial Plans: If approved, up to a 12 month authorization may be granted base on patient treatment plan for Morphine Equivalent Daily Dose


Automatic Approval Criteria
None


Version: J-0672-002
Effective Date Begin: 02/01/2019
Effective End Begin: 03/10/2018
Original Date: 11/08/2017
Review Date: 01/31/2019


References:

  1. Dowell, Deborah, Tamara M. Haegerich, and Roger Chou. "CDC guideline for prescribing opioids for chronic pain—United States, 2016." Jama 315.15 (2016): 1624-1645.

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Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.



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