Medication Assisted Therapy (Buprenorphine) – NC Standard

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90-day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed); OR
5. If the request is for buprenorphine (Subutex) and over the induction quantity (15 tablets for 5 days);
   1. The patient has a contraindication or intolerance to naloxone or naltrexone and requires use of buprenorphine only [medical record documentation required]; OR
   2. The patient is pregnant or breastfeeding a child [medical record documentation required]

Duration of Approval: 365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

The ASAM National Practice Guideline for the Treatment of Opioid Use Disorder: 2020 Focused Update. J Addict Med. 2020 Mar/Apr;14(2SSuppl 1):1-91.

Policy Implementation/Update Information:

March 2025: Criteria change: removed maximum dose restriction from quantity limit criteria.

December 2024: Criteria change: Removed obsolete product, Bunavail. Policy is now QL only. Increased QL for Suboxone (buprenorphinenaloxone hcl sl film) 8mg/2mg to 3 films per day. Updated QL Exception criteria for buprenorphine (Subutex) to allow contraindication or intolerance to naloxone or naltrexone.

Nov 2020: Criteria update: Annual Criteria Review. Formatting updates, no change to policy.

Oct 2019: Criteria update: Added generic Subuxone to the unrestricted section and clarified generic Suboxone in criteria points. Brand Suboxone restricted on Essential formulary.

Feb 2019: Removed ‘excludes medication intolerance’ to Subutex criteria point

Feb 2019: Removed prior authorization for Zubsolv and updated Zubsolv quantity limits for 2.9mg, 5.7mg, & 8.6mg; combined Enh/Es & NR criteria together.

Historical policy changes prior to 2019 can be obtained from BCBSNC Corporate Pharmacy