Buprenorphine subdermal implants may be considered medically necessary when all four of the following criteria have been met:
The individual has been diagnosed with opioid dependence; and
The individual has been treated with a stable transmucosal buprenorphine dose (≤8 mg/d of a sublingual Subutex or Suboxone tablet or its transmucosal buprenorphine product equivalent) for 3 months or more without any need for supplemental dosing or adjustments; and
The individual is currently on a maintenance dosea 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.
a U.S. 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 (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf).
Buprenorphine implants are considered investigational for all other indications, including but not limited to:
When the medically necessary criteria above have not been met;
For new entrants to treatment;
For individuals who have not achieved and sustained prolonged clinical stability while being maintained on buprenorphine 8 mg or less per day of a Subutex or Suboxone sublingual tablet or generic equivalent;
For individuals not enrolled in a comprehensive substance use disorder treatment program;
Treatment for longer than 12 months.
Individuals can be transitioned back to transmucosal buprenorphine-containing medications for continued treatment after 12 months as needed. Retreatment with buprenorphine implant after a prior 12-month treatment period is considered investigational and not medically necessary under all circumstances.
The prescribing information also provides guidance on acceptable doses of transmucosal buprenorphine that demonstrating stable maintenance dosing (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf):
Buprenorphine (Subutex) sublingual tablet (generic equivalent) 8 mg or less per day;
Buprenorphine and naloxone (Suboxone) sublingual tablet (generic equivalent) 8 mg/2 mg or less per day;
Buprenorphine and naloxone (Bunavail) buccal film 4.2 mg/0.7 mg or less per day;
Buprenorphine and naloxone (Zubsolv) sublingual tablets 5.7 mg/1.4 mg or less per day.
Additionally, the prescribing information includes the following factors in determining clinical stability and suitability for Probuphine treatment (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf):
Period free from illicit opioid drug use;
Stability of living environment;
Participation in a structured activity/job;
Consistent participation in recommended behavioral therapy/peer support program;
Consistent compliance with clinic visit requirements;
Minimal to no desire or need to use illicit opioids;
Period without episodes of hospitalizations (addiction or mental health issues), emergency room visits, or crisis interventions;
Social support system.
