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Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Narcotic Partial Agonists

Status Drug PR PR-QL PR-AL ST M EX‡
P buprenorphine sublingual X X      
P buprenorphine-naloxone sublingual tablet X X      
NP Suboxone®SL Film  (buprenorphine-naloxone sublingual film) X X      
FE Bunavail™  (buprenorphine/ naloxone buccal film) X X   X X
FE Suboxone®SL Tablet  (buprenorphine-naloxone sublingual tablet) X X     X
FE Zubsolv®  (buprenorphine-naloxone sublingual tablet) X X   X X


Policy:

  1. Precertification Criteria
  2. Under some plans, including plans that use an open or closed formulary, Bunavail, buprenorphine sublingual, buprenorphine-naloxone sublingual tablet, Suboxone SL tablet, Suboxone SL film, and Zubsolv are subject to precertification. If precertification requirements apply Aetna considers these medications to be medically necessary for those members who meet the following precertification criteria:

    For Bunavail, buprenorphine sublingual, buprenorphine-naloxone sublingual tablet, and Suboxone SL film

    For Initiation/ Renewals/ Discontinued-re-Initiation of therapy

    • A documented current diagnosis of opioid dependence
    • Prescriber provides verbal verification of patient’s current and ongoing enrollment in an outpatient drug addiction treatment program/ counseling* 

    For Suboxone SL tablet

    For Initiation/ Renewals/ Discontinued-re-Initiation of therapy

    • A documented current diagnosis of opioid dependence
    • Prescriber provides verbal verification of patient's current and ongoing enrollment in an outpatient drug addiction treatment program/ counseling*
    • A documented intolerance or allergy to the preferred generic equivalent alternative, buprenorphine-naloxone sublingual tablet

    For Zubsolv 

    For Initiation/Renewals/Discontinued-re-Initiation of therapy

    • A documented current diagnosis of opioid dependence
    • Prescriber provides verbal verification of patient's current and ongoing enrollment in an outpatient drug addiction treatment program/ counseling*
    • A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of the alternatives, buprenorphine-naloxone sublingual tablet AND Suboxone SL film

    According to the manufacturer Bunavail, buprenorphine sublingual, buprenorphine-naloxone sublingual tablet, Suboxone SL tablet, Suboxone SL film, and Zubsolv can be dosed up to a maximum daily dose at the interval as indicated in the table below. A quantity for these drugs will be considered medically necessary as indicated in the table below: 

    Drug Maximum Daily Dose Dosage Strength Quantity Limits
    Bunavail 12.6mg/ 2.1mg 2.1mg/ 0.3mg, 4.2mg/ 0.7mg, 6.3mg/ 1mg Up to 60 films in 30 days
    buprenorphine sl 8 mg day one; 16 mg day two / once daily 2 mg Up to 24 tablets in 30 days (for induction therapy)
    buprenorphine sl 8 mg day one; 16 mg day two / once daily 8 mg Up to 8 tablets in 30 days (for induction therapy)
    buprenorphine-naloxone sublingual tablet, Suboxone (sublingual film/tablet) 24/6 mg/once daily 2 mg/0.5 mg; 4 mg/1 mg; 8 mg/2 mg Up to 90 sublingual films/tablets in 30 days (for maintenance therapy)
    Suboxone (sublingual film/tablet) 24/6 mg/once daily 12 mg/3 mg Up to 60 films in 30 days
    Zubsolv 17.1 mg /4.2 mg 1.4 mg /0.36 mg; 5.7 mg /1.4 mg Up to 90 sublingual tablets in 30 days (for maintenance therapy)


    For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. A prior authorization will be granted for coverage of additional quantities of these drugs for those members who meet the following criteria:

    • For buprenorphine sl 
      • Member is pregnant or breastfeeding (Up to 120 tablets in 30 days)
    • For Suboxone or buprenorphine-naloxone sublingual tablet 2 mg/0.5mg
      • Member’s dose is being titrated by physician for 7 day induction therapy (max dose 12 mg/daily for total of 42 tablets/films in 7 days)
    • For Zubsolv 1.4 mg /0.36 mg
      • Member’s dose is being titrated by physician for 7 day induction therapy (max dose 8.4 mg/daily for total of 42 tablets/films in 7 days)
    • For buprenorphine sl
      • Member has a documented contraindication or intolerance or allergy to buprenorphine-naloxone sublingual tablet or Suboxone (Will allow up to 90 tablets per month for max length of approval of 6 months)


  3. Step Therapy Criteria
  4. Under some plans, including plans that use an open or closed formulary, Bunavail and Zubsolv is subject to step-therapy.  Aetna considers this medication to be medically necessary for those members who meet the following step-therapy criterion:

    For Bunavail

    • A documented trial of one month of the preferred alternative, buprenorphine-naloxone sublingual tablet

    For Zubsolv 

    • A documented trial of one month each of the preferred alternatives, buprenorphine-naloxone sublingual tablet AND Suboxone SL film

    If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member’s treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section II below.)

  5. Medical Exception Criteria
  6. Suboxone SL tablet is currently listed on the Aetna Formulary Exclusions List.* Therefore, Suboxone SL tablet is excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Suboxone SL tablet to be medically necessary for those members who meet any of the following criteria:

    Bunavail and Zubsolv are currently listed on the Aetna Formulary Exclusions and Step-Therapy lists.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary or that require step-therapy criteria, unless a medical exception is granted. Aetna considers these medications to be medically necessary for those members who meet the criteria specified below:

    For Bunavail

    For Initiation/Renewals/Discontinued-re-Initiation of therapy

    • A documented current diagnosis of opioid dependence
    • Prescriber provides verbal verification of patient's current and ongoing enrollment in an outpatient drug addiction treatment program/ counseling*
    • A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of the preferred alternative, buprenorphine-naloxone sublingual tablet 

    For Suboxone SL tablet

    For Initiation /Renewals/Discontinued-re-Initiation of therapy

    • A documented current diagnosis of opioid dependence
    • Prescriber provides verbal verification of patient's current and ongoing enrollment in an outpatient drug addiction treatment program/ counseling*
    • A documented intolerance or allergy to the preferred generic equivalent alternative, buprenorphine-naloxone sublingual tablet

    For Zubsolv

    For Initiation/Renewals/Discontinued-re-Initiation of therapy

    • A documented current diagnosis of opioid dependence
    • Prescriber provides verbal verification of patient's current and ongoing enrollment in an outpatient drug addiction treatment program/ counseling*
    • A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of the preferred alternatives, buprenorphine-naloxone sublingual tablet AND Suboxone SL film

Special Notes:

*Note: The drug addiction treatment program should provide member ongoing counseling and/or behavioral health support.

Enrollment in a drug addiction treatment program/ counseling will be a "yes/ no" question.
If the member is enrolled (answer= yes), the approval will be 6 months
If the member is not enrolled (answer= no) AND prescriber provides verbal verification of patient’s agreed commitment to become enrolled in an acceptable drug addiction treatment program /counseling, the approval will be for 2 months
If after 2 months member does not enroll in a program, then all future requests will be denied until member enrolls in a program.

Aetna considers the following as acceptable programs:

Outpatient drug addiction treatment programs/ counseling
12- step programs focused on "drug" addiction such as Narcotics Anonymous (N.A.)
Other accepted programs can be found at this site;
http://findtreatment.samhsa.gov/TreatmentLocator/faces/quickSearch.jspx

*Note: Aetna considers the following as non-acceptable programs:

On-line programs such as Here to Help
12-step programs that are not focused on "drug" addiction (ex: Alcoholics Anonymous)

Note:  Medical literature does not support the concurrent use of opioids/Tramadol as part of opioid drug dependence treatment.  Abstinence of opioids/Tramadol is required both during and following therapy with Suboxone/ Subutex/ Zubsolv/ Bunavail/ buprenorphine, and will only be covered when determined to be medically necessary**.   Physicians can contact (855) 746-0013 with any information related to the medical necessity for opioid/Tramadol therapy.

**Medically necessary will be defined as:

  1. Short-term use during and following opioid dependence treatment:  for the treatment of acute pain related to surgery, dental procedure, or an emergency situation.
  2. Long-term use following opioid dependence treatment: for the treatment of chronic pain. In this case, 1) the member must be treated by a pain management specialist, 2) opioids will only be covered when prescribed by the treating pain specialist, and 3) the treating pain specialist is aware of past buprenorphine use for opioid dependence treatment in which an opioid dependence diagnosis (304.00) and enrollment in a drug addiction treatment program and/or counseling was confirmed.

Aetna will only allow approval for any one drug from the following group at one time: buprenorphine sublingual, Suboxone or Zubsolv.  All previous approvals will be terminated prior to entering an approval for a different  drug from this group.  The prescriber may switch back and forth between these drugs, however,  Aetna will only allow  access to only one drug at a time.

Where can I find out more information about buprenorphine treatment for opioid addiction?

In addition to http://buprenorphine.samhsa.gov/faq.html#A27 Web site, you can visit the FDA's buprenorphine pages at http://www.fda.gov/cder/drug/infopage/subutex_suboxone/default.htm, and the manufacturer's Web site at http://www.suboxone.com/.

Additionally, you can contact the SAMHSA Buprenorphine Information Center by telephone, toll-free at 1-866-BUP-CSAT (1-866-287-2728), or by e-mail at info@buprenorphine.samhsa.gov.

**FDA MedWatch:

http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm



Place of Service:

Outpatient

The above policy is based on the following references:

1. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
2. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
3. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
4. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
5. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
6. Jones HE, Martin PR, Heil SH, et al. Treatment of opioid-dependent pregnant women: Clinical and research issues. J Subst Abuse Treat. 2008;35:245-59.
7. Woody GE, Poole SA, Subramaniam G, et al. Extended vs. short-term Buprenorphine-naloxone for treatment of opioid-addicted youth. JAMA. 2008;300(17):2003-11.
8. Schottenfeld R, Chawarski MC, Mazlan M. Maintenance treatment with Buprenorphine and naltrexone for heroin dependence in Malaysia: a randomized, double-blind, placebo-controlled trial. Lancet. 2008;371:2192-9.
9. Brigham GS, Amass L, Winhusen T, et al. Using Buprenorphine short-term taper to facilitate early treatment engagement. J Subst Abuse Treat. 2007;32:349-56.
10. Donaher PA, Welsh C. Managing opioid addiction with Buprenorphine. Am Fam Physician. 2006;73:1573-8
11. Sung S and Conry JM. Role of Buprenorphine in the management of heroin addiction. Ann Pharmacother 2006;40:501-5.
12. Fiellin DA, Pantalon MV, Chawarski MC, et al. Counseling plus Buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med. 2006;355:365-74.
13. Amato L, Davoli M, Perucci CA, et al. An overview of systematic reviews of the effectiveness of opiate maintenance therapies: available evidence to inform clinical practice and research. J Subst Abuse Treat. 2005;28:321-9.
14. Fudala PJ, Bridge TP, Herbert S, et al, for the Buprenorphine/Naloxone Collaborative Study Group. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med. 2003;349(10):949-58.
15. http://www.deadiversion.usdoj.gov/drug_chem_info/tramadol.pdf

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

February 2, 2015
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