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Prior Authorization Protocol
SUBUTEXR (buprenorphine), BUNAVAIL, SUBOXONER, ZUBSOLVR (buprenorphine plus naloxone)


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:
    • SubutexR: Treatment of opioid dependence and is preferred for induction
    • SuboxoneR: Treatment of opioid dependence
    • ZubsolvR: Treatment of opioid dependence. Prescription use of this product is limited under the Drug Addiction Treatment Act.
    • Bunavail: For the maintenance treatment of opioid dependence
  2. Health Net Approved Indications and Usage Guidelines:
    • Patient is not using concurrent opioid medications (including tramadol)

    AND

    • Subutex may be approved for:
      • Induction treatment of opioid dependence
      • Maintenance treatment for pregnant patients
      • Maintenance treatment for patients with documented hypersensitivity to naloxone

    OR

    • Bunavail, Suboxone, or Zubsolv: Treatment of opioid dependence

    REAUTHORIZATION REQUESTS (treatment of opioid dependence):

    • Confirmation of abstinence from opioid medications (including tramadol) by state Prescription Drug Monitoring programs (PDMPs) databases

    AND

    • Documentation of a treatment plan OR taper strategy is required
  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:
    • The Drug Addiction Treatment Act of 2000 (DATA 2000), limits office-based use of Suboxone and Subutex to physicians who meet special training criteria and can provide appropriate services.
    • Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of Zubsolv in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.
    • Pharmacists who seek information to verify whether or not physicians have valid waivers can check:
    OR
      • 1-866-BUP-CSAT
    OR
    • Subutex contains only buprenorphine and is intended for use at the beginning of treatment for drug abuse. SuboxoneR contains both buprenorphine and the opiate antagonist naloxone and is intended to be the formulation used in maintenance treatment of opiate addiction.
    • The difference in bioavailability of Zubsolv compared to Suboxone tablet requires a different tablet strength to be given to the patient. One Zubsolv 5.7/1.4 mg sublingual tablet provides equivalent buprenorphine exposure to one Suboxone 8/2 mg sublingual tablet.
    • Because of the potential for naloxone to precipitate withdrawal in both mother and fetus, pregnant women who are deemed to be appropriate candidates for buprenorphine treatment should be inducted and maintained on buprenorphine monotherapy (SubutexR).
    • Tramadol is a centrally-acting synthetic opioid analgesic. Concomitant use of buprenorphine with tramadol increases the risk of serotonin syndrome, CNS depression, and respiratory depression.
    • Prescription Drug Monitoring programs (PDMPs) are databases of all controlled substance prescriptions dispensed in a particular state. PDMP databases should be used to confirm opioid abstinence. The California PDMP, known as CURES (Controlled Substance Utilization Review and Evaluation System) encourages judicious prescribing including use of the CURES system before prescribing controlled substances. For more information visit http://oag.ca.gov/cures or http://www.deadiversion.usdoj.gov/faq/rx_monitor.htm
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Methadone (DolophineR)

    30 mg PO QD; titrate to maintenance dose of 40 - 120 mg/day

    40 - 120 mg/day

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

    SubutexR (buprenorphine) Sublingual Tablet

    Induction dose:
    Day 1: 8 mg SL, Day 2 and beyond: 16 mg SL QD
    Usual maintenance dose:
    12-16 mg SL QD
    Dosing range:
    4-24 mg

    Non-pregnant patients: One month initial authorization

    Patients are encouraged to switch to Suboxone unless intolerant to naloxone.

    Reauthorization is approved every 6 months based on written documentation of no concurrent opioid use and intolerance to naloxone portion of Suboxone and a treatment plan/taper strategy.
    Approval beyond 24 months will require documentation that continued treatment is medically necessary.

    Pregnant or breast feeding patients:
    Initial treatment:
    3 months,
    Reauthorization is approved every 6 months based on written documentation of no concurrent opioid use and intolerance to naloxone portion of Suboxone and a treatment plan/taper strategy. Approval beyond 24 months will require documentation that continued treatment is medically necessary.

    SuboxoneR (buprenorphine/naloxone) Sublingual Film and Tablet

    For patients dependent on short-acting opioid products who are in opioid withdrawal
    On Day 1, administer up to 8 mg/ 2 mg Suboxone sublingual film (in divided doses).
    On Day 2, administer up to 16 mg/4 mg of Suboxone sublingual film as a single dose.
    For patients dependent on methadone or long-acting opioid products,
    induction onto sublingual buprenorphine monotherapy is recommended on Days 1 and 2 of treatment.

    Usual maintenance dose
    16/4 mg SL buprenorphine/naloxone QD
    Dosing range
    4/1 mg to 24/6 mg SL buprenorphine/naloxone QD
    Initial treatment:
    3 months,
    Reauthorization is approved every 6 months based on written documentation of no concurrent opioid use and a treatment plan/taper strategy.
    Approval beyond 24 months will require documentation that continued treatment is medically necessary.

    ZubsolvR (buprenorphine/naloxone)

    For patients dependent on short-acting opioid products who are in opioid withdrawal; on Day 1, administer up to 5.7 mg/1.4 mg in divided doses.
    On day 2 administer up to a total dose of 11.4 mg/2.9 mg as a single dose.
    For patients dependent on methadone or long-acting opioid products, induction onto sublingual buprenorphine monotherapy is recommended on Days 1 and 2 of treatment.
    Usual Maintenance Dose:
    11.4 mg/2.9 mg SL QD
    Initial treatment:
    3 months

    Reauthorization is approved every 6 months based on written documentation of no concurrent opioid use and a treatment plan/taper strategy.
    Approval beyond 24 months will require documentation that continued treatment is medically necessary.

    BunavailR (buprenorphine/naloxone)

    The recommended daily dose for maintenance is 8.4 mg/1.4 mg
    Initial treatment:
    3 months

    Reauthorization is approved every 6 months based on written documentation of no concurrent opioid use and a treatment plan/taper strategy.
    Approval beyond 24 months will require documentation that continued treatment is medically necessary.
  7. Product Availability:
    Subutex Sublingual Tablet: 2 mg, 8 mg
    Suboxone Tablet: 2 mg/0.5 mg, 8 mg/2 mg
    Suboxone Sublingual Film: 2 mg/0.5 mg, 4 mg/1 mg; 8 mg/2 mg; 12 mg/3 mg
    Zubsolv Sublingual mucoadhesive tablet: buprenorphine/naloxone - 1.4 mg/ 0.36 mg; 2.9 mg/0.71 mg; 5.7 mg/1.4 mg; 8.6 mg/2.1 mg; 11.4 mg/2.9 mg
    Bunavail buccal film: 2.1 mg buprenorphine/0.3 mg naloxone; 4.2 mg buprenorphine/0.7 mg naloxone; 6.3 mg buprenorphine/1 mg naloxone.
  8. References:
    1. Subutex-Suboxone [prescribing information]. Columbus, Ohio:Roxane Labratories, INC,February 2015.
    2. SuboxoneSublingual Film [prescribing information]. Hull, UK: Reckitt Benckiser Pharmaceuticals, April 2014.
    3. Zubsolv [prescribing information]. Chadds Ford, PA: Orexo Pharmaceuticals, August 2015.
    4. The Management of Substance Use Disorders Working Group. VHA/DoD Clinical practice guideline for the management of substance use disorders. v. 2.0 Available at http://www.healthquality.va.gov/sud/sud_full_601f.pdf Accessed June 20, 2013.
    5. Johnson RE, Jaffe JH, Fundala PJ. A controlled trial of buprenorphine treatment for opioid dependence. JAMA. 1992;267(20):2750-2755.
    6. Ling W, Charuvastra C, Collins JF, et al. Buprenorphine maintenance treatment of opiate dependence: a multicenter, randomized clinical trial. Addiction.1998;93(4):475-486.
    7. Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHS Publication No. (SMA) 04-3939. Rockville, Md: Substance Abuse and Mental Health Services Administration; 2004. Available at: http://buprenorphine.samhsa.gov/Bup_Guidelines. Accessed June 20, 2013.
    8. Mattick RP, Ali R, White J, O'Brien S, Wolk S, Danz C. Buprenorphine versus methadone maintenance therapy: a randomised double-blind with 405 opioid-dependent patients. Addiction. 2003;98:441-452.
    9. Micromedex R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 20, 2013.
    10. Clinical Pharmacology Web site. Available at: http://www.clinicalpharmacology-ip.com/default.aspx. Accessed June 24, 2014.
    11. SubutexR. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 20, 2013.
    12. SuboxoneR. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 20, 2013.
    13. Bunavail [prescribing information]. Raleigh, NC: BioDelivery Sciences, June 2014.
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.