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Prior Authorization Protocol
ACTIQR, FENTORAR, (oral transmucosal fentanyl citrate [OTFC]),
ABSTRAL
R (fentanyl sublingual), LAZANDATM (fentanyl nasal spray), SUBSYSTM (fentanyl sublingual spray)

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:
    • The management of breakthrough cancer pain in patients ( >16 years old for Actiq and >18 years old for Fentora, Lazanda, Subsys and Abstral) with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of cancer
    AND
    • Member is on fentanyl transdermal patches
    AND
    • For Abstral, Fentora, Lazanda and Subsys requests: Failure or clinically significant adverse effects to generic fentanyl citrate oral transmucosal lozenge (Actiq)
  3. Coverage is Not Authorized For:
    • 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:
    • Because of the potential risk for misuse, abuse, and overdose, the fentanyl sublingual and transmucosal products listed below are only available through restricted distribution programs. Under the transmucosal immediate release fentanyl risk evaluation and mitigation strategy (TIRF REMS) program, only prescribers, pharmacies, and patients registered with TIRF REMS are able to prescribe, dispense, and receive these products. Additional information is available at: www.tirfremsaccess.com/TirfUISplashWeb/index.html
    • These products are not interchangeable and must not be used in opioid non-tolerant patients because life-threatening hypoventilation could occur at any dose in patients not taking chronic opiates. Substantial differences exist in the pharmacokinetic profiles of these drugs that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of these products may result in fatal overdose.
    • Patients considered opioid tolerant are those who are taking around the clock medicine consisting of at least 60 mg morphine/day, at least 25 mcg transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.
    • Fentanyl absorption with different formulations of transmucosal delivery systems can be substantially different. When Abstral is prescribed, patients should not be converted on a mcg per mcg basis from any other oral transucocal fentanyl product. Patients beginning treatment with Abstral must begin with titration from 100 mcg dose. Patients switching from Actiq to Fentora should be initiated as shown:
    Actiq dose (mcg)
    Fentora dose (mcg)
    200
    100
    400
    100
    600
    200
    800
    200
    1200
    400
    1600
    400
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Morphine sulfate immediate release

    10 mg - 30 mg PO Q 4 H PRN
    Individualize dosage based on extent of pre-existing opioid tolerance

    Varies

    Oxycodone immediate release

    5 mg - 15 mg PO Q 4 to 6 H PRN
    Individualize dosage based on extent of pre-existing opioid tolerance

    Varies

    Hydromorphone

    2 mg - 4 mg PO Q 3 to 4 H PRN
    Individualize dosage based on extent of pre-existing opioid tolerance

    Varies

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

    Actiq

    Initiate dosing with 200 mcg PO and if breakthrough episode is not relieved in 30 minutes, patients may take only 1 additional dose using the same strength and must wait at least 4 hours before taking another dose.
    Individually titrate to a dose that provides adequate analgesia using single dosage unit per breakthrough cancer pain episode and minimizes side effects.
    Initial prescription recommendation for maximum of 6 units; no more than 4 doses per day; separate by at least 4 hours.

    Length of benefit

    Fentora

    Initiate dosing with 100 mcg PO and if breakthrough episode is not relieved in 30 minutes, patients may take only 1 additional dose using the same strength and must wait at least 4 hours before taking another dose.

    Length of benefit

    Abstral

    Begin titration of all patients with an initial dose of Abstral of 100 mcg SL.
    Due to differences in the pharmacokinetic properties and individual variability, even patients switching from other fentanyl containing products to Abstral must start with the 100 mcg dose.
    Abstral is not equivalent on a mcg per mcg basis with all other fentanyl products, therefore, do not switch patients on a mcg per mcg basis from any other fentanyl product.
    The safety and efficacy of doses higher than 800 mcg have not been evaluated.

    Length of benefit

    Lazanda

    Initial dose of Lazanda for all patients is 100 mcg.
    Individually titrate to an effective dose, from 100 mcg to 200 mcg to 400 mcg, and up to a maximum of 800 mcg, that provides adequate analgesia with tolerable side effects.
    Dose is a single spray into one nostril or a single spray into each nostril (2 sprays).
    Maximum dose is a single spray into one nostril or single spray into each nostril per episode; no more than four doses per 24 hours.
    Wait at least 2 hours before treating another episode of breakthrough pain with Lazanda.

    Length of benefit

    Subsys

    Initial dose of Subsys
    100 mcg

    Individually titrate to a tolerable dose that provides adequate analgesia using a single Subsys dose per breakthrough cancer pain episode. No more than two doses can be taken per breakthrough pain episode.
    Wait at least 4 hours before treating another episode of breakthrough pain with Subsys.
    Limit consumption to four or fewer doses per day once successful dose is found.

    Length of benefit

  7. Product Availability:
    • Actiq (oral transmucosal fentanyl): available as 200 mcg, 400 mcg, 600 mcg, 800 mcg,1200 mcg and 1600 mcg lozenges. 30 lozenges per package.
    • Fentora (fentanyl buccal tablet): available as 100 mcg, 200 mcg, 400 mcg, 600 mcg, and 800 mcg buccal tablets. Package of 7 blister cards containing 4 tablets in each card.
    • Abstral (fentanyl sublingual tablet); available in 100 mcg, 200 mcg, 300 mcg, 400 mcg (12 or 32 tablets per package), 600 mcg, and 800 mcg (32 tablets per package) sublingual tablets.
    • Lazanda (metered dose nasal spray): available as 100 mcg or 400 mcg per spray. Each bottle contains 8 sprays.
    • Subsys single spray units of 100 mcg, 200 mcg, 400 mcg, 600 mcg, and 800 mcg per spray
  8. References:
    1. Actiq [Prescribing Information]. Salt Lake City, UT: Cephalon, Inc; June 2012.
    2. Aronoff GM, Brennan MJ, Pritchard DD, Ginsberg B. Evidence-based oral transmucosal fentanyl citrate (OTFC) dosing guidelines. Pain Medicine. 2005,6(4):305-14.
    3. Fentora [Prescribing Information]. Salt Lake City, UT: Cephalon, Inc; February 2013.
    4. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 26, 2013.
    5. Abstral [Prescribing Information]. Bedminster, NJ: ProStrakken. June 2012.
    6. Lazanda [Prescribing Information] Bedminster, New Jersey; Arcjimedes Pharmaceuticals; June 2012.
    7. Subsys [Prescribing Information] Phoenix, AZ; Insys Therapeutics, August 2012.
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.