Buprenorphine is a partial μ-opioid agonist used with or without naloxone, an opioid antagonist, via transmucosal delivery to treat patients with opioid dependence (or a moderate-to-severe opioid use disorder). Buprenorphine (Probuphine®) is an implant to provide sustained delivery of buprenorphine for up to six (6) months when four (4) rods are inserted subdermally. It is intended as a maintenance treatment for a selected subgroup of opioid-dependent patients who are clinically stable on a low dose of transmucosal buprenorphine (less than or equal to 8 mg/d).

Buprenorphine implants may be considered medically necessary for the treatment of opioid dependence when an individual is greater than or equal to 16 years of age and has met ALL of the following criteria:

• Diagnosed with opioid dependence; and
• Treated with a stable transmucosal buprenorphine dose (less than or equal to 8 mg/d of a sublingual Subutex or Suboxone tablet or its transmucosal buprenorphine product equivalent) for three (3) months or more without any need for supplemental dosing or adjustments; and
• Currently on a maintenance dose* of 8 mg per day or less of a sublingual Subutex or Suboxone tablet or its transmucosal buprenorphine product equivalent to achieve sustained prolonged clinical stability on transmucosal buprenorphine; and
• Buprenorphine implants are used as part of a comprehensive substance use disorder treatment program that includes
  • Counseling; and
  • Psychosocial support; and
• The treating physician must hold ALL the following:
  • Completed and certified in Probuphine Risk Evaluation and Mitigation Strategy (REMS) program to insert and remove the buprenorphine implants; and
  • Certification criteria in Drug Addiction Treatment Act (DATA) of 2000; and
  • Issued a Drug Enforcement Administration (DEA) Registration Number, indicating the provider is qualified under the DATA to prescribe buprenorphine implant.

* Food and Drug Administration indications specify that maintenance doses should not be tapered to a lower dose for the sole purpose of transitioning to buprenorphine implants.

Initial treatment  consist of inserting up to four (4) buprenorphine implants may be considered medically necessary for six (6) months. Implants must be removed at the end of the six (6) months following insertion.

If indicated, a second set of buprenorphine implants may be considered medically necessary and placed in the contralateral arm when the criteria above are met.  The second set of implants must be removed at the end of the second six (6) month treatment period.

Retreatment with buprenorphine implant after a prior 12-month treatment period is considered experimental/investigational and therefore, non-covered. Scientific evidence does not support the use of buprenorphine implant after a 12-month treatment period.

Individuals can be transitioned back to transmucosal buprenorphine-containing medications for continued treatment after 12 months as needed.

Buprenorphine implants are considered experimental/investigational and ,therefore, non-covered for all other indications. Scientific evidence does not support the use of buprenorphine implant for any other indication.

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.