Prior Auth Protocol

FDA Approved Indications:

For the 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

Health Net Approved Indications and Usage Guidelines:

Diagnosis of opioid dependence

AND

Currently on a maintenance dose of 8 mg/day or less of Subutex or Suboxone sublingual tablet or its transmucosal buprenorphine product equivalent (patients should not be tapered down to a lower dose for the sole purpose of transitioning to Probuphine) for 3 months or longer without any need for supplemental dosing or adjustments

AND

Age 16 years and older

AND

For reauthorization requests: Patient has not had prior implants inserted in the contralateral arm

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

Black-Box Warning: Implant migration, protrusion, expulsion, and nerve damage has been associated with implant insertion and removal.
Reasons to discontinue: Patients treated with Probuphine with concomitant CYP3A4 inducers or inhibitors, or who have symptoms of overmedication or withdrawal, should have Probuphine implants removed and patients should be transitioned back to a formulation of buprenorphine that permits dose adjustments. Discontinue Probuphine if serotonin syndrome is suspected.
The effect of scarring and fibrosis on safety and effectiveness of Probuphine in previously-implanted sites has not been studied. Probuphine implants should not be used for additional treatment cycles after one insertion in each upper arm.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
buprenorphine (Belbuca, Butrans)	Day 1: 8 mg sublingually daily Day 2: 12-16 mg sublingually daily Maintenance: 16 mg daily (12 mg may be effective for some patients)	16 mg/day
methadone (Dolophine, Methadose)	Initial: single 20-30 mg oral dose, additional 5-10 mg dose may be provided if withdrawal symptoms reappear after 2-4 hours (Max: 40 mg on Day 1) Maintenance: 80-120 mg PO QD	120 mg/day
naltrexone (ReVia)	Day 1: 25 mg PO QD Maintenance: 50 mg PO QD or 50 mg PO QD on weekdays with 100 mg dose on Saturday or 100 mg PO QOD or 150 mg PO every 3 days	50 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Probuphine Implant Kit	Each dose consists of four Probuphine implants inserted subdermally in the inner side of the upper arm. Each implant contains 74.2 mg of buprenorphine (equivalent to 80 mg of buprenorphine hydrochloride). Implants should be removed no later than 6 months after the date of insertion.	6 months Reauthorization criteria: Patient has not had prior implants inserted in the contralateral arm.

Product Availability:

Probuphine Implant Kit (includes four individually packaged, sterile implants and one individually packaged sterile disposable applicator). Each implant is 26 mm in length and 2.5 mm in diameter and contains 74.2 mg of buprenorphine (equivalent to 80 mg of buprenorphine hydrochloride).

References:

1. Probuphine. Prescribing Information. Braeburn Pharmaceuticals. https://braeburnpharmaceuticals.com/wp-content/uploads/2016/05/probuphine-full-prescribing-information.pdf. Published May 2016. Accessed October 5, 2016.

Interim Guidelines; Final Review and Approval by the P&T Committee Pending