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Prior Authorization Protocol
DURAGESICR (fentanyl transdermal system); NUCYNTAR ER (tapentadol extended-release);
OPANA ER
R (oxymorphone extended-release); OXYCONTINR (oxycodone controlled-release)

HNMC
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:

    DuragesicR

    • For the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

    Opana ERR

    • 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.
    OxycontinR
    • Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
    NucyntaR 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.
    • For the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults 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:
    • Failure or clinically significant adverse effects to ONE formulary controlled-release product: controlled-release morphine sulfate, morphine sulfate beads sustained-release, or sustained-release morphine sulfate

    AND

    • Diagnosis of cancer pain
    OR
    • End-stage medical conditions accompanied by significant pain
    OR
      • Chronic pain for which there is a documented, objective etiology
    AND
        • Documentation that the patient is being managed under a pain medication contract signed and dated within the year
    OR
        • Patient resides in a Long Term Care (LTC) Facility
  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:
    • 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 80 mg) 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.
    • Avinza, 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 CHART7
    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 Kadian:
    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 Q12H

    Morphine sulfate beads sustained-release (AvinzaR)

    Opioid naive patients:
    30 mg PO Q24H, with dosage adjustments of not > 30 mg every 4 days
    Conversion to Avinza:
    Dosing is individualized based on previous analgesic therapy.
    Administer patient's total daily morphine requirement PO Q24H
    1600 mg/day
    Should not be given more frequently than Q24H
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Oxycontin

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

    Cancer pain:
    Length of benefit

    End-stage medical conditions accompanied by significant pain:
    Length of benefit

    LTC resident:
    Length of benefit

    All other diagnoses:
    Initial Authorization
    Up to 1 year

    Re-authorization
    A new pain medication contract is required every year. Up to 1 year.

    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
    Cancer pain:
    Length of benefit

    End-stage medical conditions accompanied by significant pain:

    Length of benefit

    LTC resident:
    Length of benefit

    All other diagnoses:
    Initial Authorization
    Up to 1 year

    Re-authorization
    A new pain medication contract is required every year. Up to 1 year.

    Opana ER

    One tablet PO BID; individualized dosing may require multiple tablets dosing
    Cancer pain:
    Length of benefit

    End-stage medical conditions accompanied by significant pain:

    Length of benefit

    LTC resident:
    Length of benefit

    All other diagnoses:
    Initial Authorization
    Up to 1 year

    Re-authorization
    A new pain medication contract is required every year. Up to 1 year.

    Nucynta ER

    The starting dose in patients currently not taking
    opioid analgesics is 50 mg PO BID (approximately Q12H). Individually
    titrate the dose within the therapeutic
    range of 100 mg to 250 mg BID.
    Cancer pain:
    Length of benefit
    End-stage medical conditions
    accompanied by significant pain:
    Length of benefit

    LTC resident:
    Length of benefit

    All other diagnoses:
    Initial Authorization
    Up to 1 year

    Re-authorization:
    A new pain medication contract is
    required every year. Up to 1 year.
  7. Product Availability:
    Nucynta ER tablet: 50 mg, 100 mg, 150 mg, 200 mg, 250 mg
    Opana ER tablet: 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg
    Oxycontin tablet: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg
    Duragesic patch: 12 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, 100 mcg/hr; available under generic name only: 37.5mcg, 62.5 mcg, 87.5 mcg/hr.
  8. References:
    1. NucyntaR ER [Prescribing Information] Gurabo, PR, Janssen Ortho, LLC; April 2014.
    2. AvinzaR [Prescribing Information] Bristol, TN: King Pharmaceuticals, Inc.; May 2014.
    3. Opana ERR [Prescribing Information] Chadds Ford, PA: Endo Pharmaceuticals, Inc.,April 2014.
    4. OxyContinR [Prescribing Information] Stamford, CT: Purdue Pharma; April 2014.
    5. MS ContinR [Prescribing Information] Stamford, CT: Purdue Pharma; April 2014.
    6. KadianR [Prescribing Information] Morristown, NJ: Actavis; February 2010.
    7. DuragesicR [Prescribing Information] Titusville, NJ: PriCara, Janssen Pharmaceuticals, Inc April 2014.
    8. DRUGDEXRSystem [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.