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Prior Authorization Protocol
HYSINGLA ER, ZOHYDRO ERTM (hydrocodone bitartrate extended-release), MORPHABOND ER (morphine sulfate extended-release), XTAMPZA ER (oxycodone myristate)



NATL
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:
    • 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.
  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

    AND

    • Failure or clinically significant adverse effects to two of the following: controlled-release morphine sulfate (MS Contin), morphine sulfate sustained-release beads (Kadian), transdermal fentanyl patches, extended release oxymorphone, extended- release morphine sulfate (Avinza), or Oxycontin
  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 or as needed pain relief.
    • 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:
    • Zohydro ER and Hysingla ER are Schedule II controlled substance under the Controlled Substances Act. These products are single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone products. Zohydro ER and Hysingla ER will be part of the ER/ LA (Long-Acting) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS).
    • Zohydro ER and Hysingla ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Zohydro ER and Hysingla ER are not FDA approved for as-needed pain relief.
    • Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.
    • Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression. A single dose of Zohydro ER greater than 40 mg, Zohydro ER 50 mg capsules, or a total daily dose greater than 80 mg are only for patients in whom tolerance to an opioid of comparable potency is established. Daily doses of Hysingla ER greater than 80 mg are only for use in opioid tolerant patients.
    • Initial dose for Morphabond in patients as the first opioid analgesic or not opioid tolerant is 15 mg PO every 12 hours. Conversion from other oral morphine products by administering one-half of the patients 24-hour requirement as Morphabond on an every 12 hour schedule. Conversion from other opioids to Morphabond by using 15 mg every 12 hours and discontinuation of other opioids.
    • The tables below are only to be used for the conversion from current opioid therapy to Zohydro ER or Hysingla ER. The tables cannotbe used to convert fromZohydro ER or Hysingla ER to another opioid. Doing so will result in an overestimation of the dose of the new opioid and may result in fatal overdose.

    Conversion Factors to Zohydro ER (not equianalgesic doses)
    Prior Oral Opioid
    Oral Dose (mg)
    Approximate Oral
    Conversion Factor
    Hydrocodone
    10
    1
    Oxycodone
    10
    1
    Methadone
    10
    1
    Oxymorphone
    5
    2
    Hydromorphone
    3.75
    2.67
    Morphine
    15
    0.67
    Codeine
    100
    0.10


    Conversion Factors to Hysingla ER (not equianalgesic doses)
    Prior Oral Opioid
    Oral Dose (mg)
    Approximate Oral
    Conversion Factor
    Codeine
    133
    0.15
    Hydromorphone
    5
    4
    Methadone
    13.3
    1.5
    Morphine
    40
    0.5
    Oxycodone
    20
    1
    Oxymorphone
    10
    2
    Tramadol
    200
    0.1
    • The following table describes the equivalent amount of oxycodone HCl present in Xtampza ER compared to other oxycodone products.
    Oxycodone Hydrochloride
    Oxycodone base (XTAMPZA ER)
    10 mg
    9 mg
    15 mg
    13.5 mg
    20 mg
    18 mg
    30 mg
    27 mg
    40 mg
    36 mg
    • Patients receiving other oral oxycodone formulations, may be converted to Xtampza ER, using the same total daily dose of oxycodone, by administering one-half of the patient's total daily oral oxycodone dose as Xtampza ER every 12 hours with food. Because XTAMPZA ER is not bioequivalent to other oxycodone extended-release products, monitor patients for possible dosage adjustment.
    • There are no established conversion ratios for conversion from other opioids to Xtampza ER defined by clinical trials. Discontinue all other around-the-clock opioid drugs when Xtampza ER therapy is initiated. Initiate dosing using Xtampza ER 9 mg orally every 12 hours with food.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    morphine sulfate controlled-release tablet (MS ContinR)

    Opioid naive patients:
    15 mg PO Q12 hours
    Conversion to MS Contin:
    Dosing is individualized based on previous analgesic therapy.
    Administer at 1/2 the total daily requirement PO Q12 hours or
    1/3 the total daily requirement PO Q8 hours

    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 capsule
    (Kadian)

    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 Q24 hours or administer
    1/2 the patient's total daily requirement PO Q12 hours.

    Should not be given more frequently than Q12 hours

    fentanyl transdermal system (Duragesic)

    Dosing is individualized based on previous analgesic therapy.
    Initiate dose at one patch TD Q72 hours.
    May increase following 3 days of therapy.
    Some patients may require dosing Q48 hours

    Reserved for opioid-tolerant individuals

    oxymorphone extended release
    (Opana ER)

    One tablet PO twice daily;
    individualized dosing may require multiple tablets dosing

    Patients who are not opioid-experienced being initiated on chronic around-the-clock
    opioid therapy be started with Opana ER 5 mg Q12 hours

    morphine sulfate extended-release (AvinzaR)

    Opioid naive patients:
    30 mg PO Q24 hours, with dosage adjustments of not > 30 mg every 4 days
    Conversion to morphine sulfate extended-release:
    Dosing is individualized based on previous analgesic therapy
    Administer patient's total daily morphine requirement PO Q24 hours
    1600 mg/day
    Should not be given more frequently than Q24 hours

    OxyContin
    (oxycodone)

    One tablet PO twice daily;
    individualized dosing may require multiple
    tablets and three times daily dosing

    One tablet PO twice daily;
    individualized dosing may require multiple
    tablets and three times daily dosing

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

    Zohydro ERTM

    For opioid-naive and opioid non-tolerant patients, initiate with 10 mg PO Q12 hours.

    Increase the dose of Zohydro ER in increments of 10 mg Q12 hours every 3 to 7 days as needed to achieve adequate analgesia.

    Individualize treatment; titrate to effective and tolerable dose.
    • 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

    Hysingla ER

    For opioid-naive and opioid non-tolerant patients, initiate with 20 mg PO Q24 hours.
    Increase the dose of Hysingla ER in increments of 10 mg to 20 mg every 3 to 5 days as needed to achieve adequate analgesia.

    Individualize treatment; titrate to effective and tolerable dose.

    • 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

    Morphabond ER
    (morphine sulfate)

    For opioid-naive and opioid non-tolerant patients, initiate with 15 mg PO Q12 hours.

    Increase the dose to achieve adequate analgesia every 1 to 2 days.

    Individualize treatment; titrate to effective and tolerable dose.

    •  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

    Xtampza ER

    For opioid-naove and opioid non-tolerant patients, initiate with 9 mg PO Q12 hours. Limit daily dose to a maximum of 288 mg per day.

    •  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:
    Zohydro ER: Extended-release capsules: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg and 50 mg
    Hysingla ER: Extended-release tablets: 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg, and 120 mg
    Morphabond extended-release tablets: 15 mg, 30 mg, 60 mg, 100 mg
    Xtampza ER: Extended-release capsules: 9 mg, 13.5 mg, 18 mg, 27 mg, 36 mg
  8. References:
    1. Zohydro ER [prescribing information]. Pernix Ireland Pain Limited, Morristown, NJ, January 2016.
    2. Hysingla [prescribing information]. Purdue Pharma L.P., Stamford, CT. November 2014.
    3. Chronic Pain. American Chronic Pain Association. Accessed June 7, 2016.
    Available at: http://theacpa.org/conditionDetail.aspx?id=74.
    4. Farrell, SE. Acetaminophen Toxicity. Medscape. Accessed June 7, 2016. Available at: http://emedicine.medscape.com/article/820200-overview.
    5. Morphabond ER [prescribing information]. Inspirion Delivery Technologies LLC, Valley Cottage, NY; October 2015.
    6. Xtampza ER [prescribing information]. Patheon Pharmaceuticals, Cincinnati, OH, April 2016.
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.