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Buprenorphine Implant for Treatment of Opioid Dependence

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 (

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 (

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 (

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.

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