PROBUPHINE (buprenorphine implant for subdermal administration)
OFFICE ADMINISTRATION
FDA Approved Indications:
- Maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet or generic equivalent)
Patients must meet the following criteria for the indications above:
- Patient is being treated for opioid dependence, AND
- Member is at least 16 years of age, AND
- Patient has acheived and sustained prolonged clinical stability (for at least 3 months without any need for supplemental dosing or adjustments) on low-to-moderate doses of a transmucosal buprenorphine-containing product (i.e., doses of no more than 8 mg per day of Subutex [buprenorphine sublingual {SL} tablets] or Suboxone [buprenorphine and naloxone SL tablets] equivalent or generic equivalent), AND
- Medical justification supports inability to continue to use oral (e.g., sublingual, buccal) formulations of buprenorphine, AND
- Does not exceed 4 implants per 6 months
For Reauthorization:
- Member is responding positively to therapy
- The member has not received an opiod analgesic since the last approval (or prescriber submits documentation that the use of an opioid since the last approval was due to a diagnosis of acute pain)
- Member has not previously received 2 sets of implants (one set is defined as four implants per arm)
Dosing:
- Four Probuphine implants are inserted subdermally in the upper arm for 6 months of treatment and are removed by the end of the sixth month
- Probuphine implants should not be used for additional treatment cycles after one insertion in each upper arm
- Probuphine implants must by inserted and removed by trained Healthcare Providers only
Approval:
- 6 months