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Prior Authorization Protocol

OXYCONTINR (oxycodone controlled-release), morphine sulfate extended-release (AVINZAR), OPANA ERR (oxymorphone extended- release)

HNCA

Level III with PA for Qty > 3/day for OxyContinR or Level II with PA for Qty > 1/day for morphine sulfate extended-release (AvinzaR) or Level II with PA for Qty > 2/day for OPANA ER

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    Morphine sulfate extended-release (AvinzaR):
    • For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
    Opana ER:
    • For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
    Oxycontin:
    • Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
  2. Health Net Approved Indications and Usage Guidelines:
    • Chronic pain for which there is a documented, objective etiology
    AND
    • A treatment plan is required, including:
      • Diagnosis or conditions that are contributing to the pain
      • Pain intensity (scales or ratings)
      • Functional status (physical and psychosocial)
      • Patient's goal of therapy (level of pain acceptable and/or functional status)
      • Current analgesic (opioid and adjuvant) regimen
      • Current non-pharmacological treatment
      • Opioid-related side effects
      • Indications of medical misuse
      • Action plan if analgesic failure occurs
  3. Coverage is Not Authorized For:
    • Acute or intermittent pain
    • Immediate post-surgical pain
    • Use in patients who require opioid analgesia for a short period of time
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • Morphine sulfate extended-release (AvinzaR) (45 mg, 60 mg, 75 mg, 90 mg and 120 mg), KadianR (100 mg and 200 mg), MS ContinR (100 mg and 200 mg), OxyContinR (60 mg and 80 mg, a single dose greater than 40 mg or a total daily dose greater than 80mg) and DuragesicR are for use only in opioid tolerant patients. Opioid tolerant patients are those receiving, for one week or longer, at least 60 mg PO morphine/day, 25 mcg/hr transdermal fentanyl, 30 mg PO oxycodone/day, 8 mg PO hydromorphone/day, 25 mg PO oxymorphone/day or an equianalgesic dose of another opioid.
    • Morphine sulfate extended-release (AvinzaR), Kadian, MS Contin, Oxycontin, Opana ER, and Duragesic are not indicated as an as-needed (prn) analgesic.
    • Because it may be difficult to determine analgesic need using a controlled-release product, it is recommended to initiate therapy with immediate-release products. The table below may be useful in determining the appropriate dosing of a variety of analgesic options.

    EQUIANALGESIC OPIOID CHART
    Analgesic
    Parenteral IM, SC, IV (mg)
    Oral/Rectal/Patch (mg)
    Morphine*
    10
    30
    Codeine
    130
    200
    Fentanyl
    0.1  0.2
    25 mcg/hr (Patch)
    Hydromorphone
    1.5
    7.5
    Levorphanol
    2
    4
    Methadone
    10
    20
    Meperidine*
    75
    -
    Oxycodone
    -
    20
    Oxymorphone
    1
    10 (Rectal)

    *Adjust dose in renal impairment
    • Due to the potency of OxyContinR, it is recommended to use the conversion factor table when converting TO oral oxycodone to avoid overestimating the dose.
    • Conversion back FROM prior opioid divides by the conversion factor shown in the table below.

    Estimated conversion factor for converting prior opioid doses to oral oxycodone2
    (mg/day prior opioid x factor = mg/day oral oxycodone
    Prior Opioid
    Oral
    Parenteral
    Codeine
    0.15
    --
    Hydrocodone
    0.9
    --
    Hydromorphone
    4
    20
    Levorphanol
    7.55
    15
    Meperidine
    0.1
    0.4
    Methadone
    1.5
    3
    Morphine
    0.5
    1.5 - 3
    Oxycodone
    1
    --
    Oxymorphone
    2
    --

  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    morphine sulfate controlled-release tablet (MS ContinR)

    Conversion to MS ContinR:
    Dosing is individualized based on previous analgesic therapy.
    Administer at 1/2 the total daily requirement
    PO Q12H or 1/3 the total daily requirement PO Q8H

    The 100 mg and 200 mg tablets are reserved only for
    opioid-tolerant individuals who require morphine
    equivalent doses of 200 mg or more for the 100 mg tablet
    and 400 mg or more for the 200 mg tablet

    morphine sulfate sustained-release (KadianR)

    Opioid naive patients:
    10 mg or 20 mg PO,
    may adjust dosage at 20 mg increment QOD
    Conversion to KadianR:
    Dosing is individualized based on previous analgesic therapy.
    Administer patient`s total daily requirement PO Q24H or
    Q12H at 1/2 the estimated total daily requirement.

    Should not be given more frequently than every Q12H

    fentanyl transdermal system (DuragesicR)

    Dosing is individualized based on previous analgesic
    therapy. Initiate dose at one patch TD Q72H
    May increase following 3 days of therapy.
    Some patients may require dosing Q48H

    Doses > 25 mcg/hr patch are reserved
    for opioid-tolerant individuals

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    OxyContinR (oxycodone controlled-release abuse deterrent)

    One tablet PO BID;
    individualized dosing may require multiple
    tablets and TID dosing

    • 3 months initially for non-malignant pain. Duration of authorization to be determined for up to one year.
    • Treatment plan may be required for continued authorization.
    • 1 year for cancer patients
    morphine sulfate extended-release (AvinzaR)
    Initiate 30 mg PO QD. May titrate 30 mg/day every 4 days. Maximum dose is 1600 mg/day due to fumaric acid which can result in serious renal toxicity.
    • 3 months initially for non-malignant pain. Duration of authorization to be determined for up to one year.
    • Treatment plan may be required for continued authorization.
    • 1 year for cancer patients

    Opana ERR (extended-release oxymorphone crush resistant)

    One tablet PO BID; individualized dosing may require multiple tablets dosing
    • 3 months initially for non-malignant pain. Duration of authorization to be determined for up to one year.
    • Treatment plan may be required for continued authorization.
    • 1 year for cancer patients
  7. Product Availability:

    OxyContin tablet: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg
    morphine sulfate extended-release (AvinzaR) capsule: 30 mg, 45 mg, 60 mg, 75 mg, 90 mg, 120 mg
    Opana ER tablet: 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg

  8. References:
    1. AvinzaR [Prescribing Information] Bristol, TN: King Pharmaceuticals, Inc.; May 2014.
    2. OpanaERR [Prescribing Information] Chadds Ford, PA: Endo Pharmaceuticals, Inc, April 2014.
    3. OxyContinR [Prescribing Information] Stamford, CT: Purdue Pharma; April 2014.
    4. MS ContinR [Prescribing Information] Stamford, CT: Purdue Pharma; March 2009.
    5. KadianR [Prescribing Information] Morristown, NJ: Actavis; February 2010.
    6. DuragesicR [Prescribing Information] Raritan, NJ: PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.; April 2014.
    7. Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain 6th Edition; American Pain Society 2008.
    8. DRUGDEXR System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 24, 2015.
    9. American Hospital Formulary Service Drug Information. AHFSWeb site. Available at: http:// http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 24, 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.