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    Probuphine®

    Drug - Probuphine® (buprenorphine) [Braeburn Pharmaceuticals]

    April 2019

    Therapeutic area - Opioid Dependence - Medication Assisted Therapy (MAT)

    Initial approval criteria

    • Patient is 16 years of age or older AND
    • Patient has diagnosis of opiate abuse/dependence AND
    • Prescriber is certified to treat addictions under the Drug Addiction Treatment Act of 2000 (DATA 2000) waiver and provide an X-DEA number AND
    • Patient is compliant with addiction counseling and psychosocial support AND
    • Patient does not have prior hypersensitivity reaction to buprenorphine AND
    • Patient has been taking a buprenorphine-containing transmucosal product for at least the prior 6 months based on pharmacy fill history AND
    • Buprenorphine-containing transmucosal product has been stable for the past 3 months and does NOT exceed the following:
      • 8 mg/day of Suboxone or Subutex equivalent OR
      • 5.7 mg/day of Zubsolv OR
      • 4.2 mg/day Bunavail AND
    • Patient is NOT pregnant (women of childbearing age have a negative pregnancy test dated within prior 30 days) AND
    • A urine drug screen, including buprenorphine, within the past 30 days of prior authorization submission is provided (if negative for buprenorphine or positive for other opioids, the provider must provide an explanation) AND
    • Patient is not prescribed concurrent opioid medication without explanation other than buprenorphine transmucosal product, and buprenorphine transmucosal product will be discontinued upon insertion of implant AND
    • Patient does not have “as needed” prescription for buprenorphine-containing products AND
    • Patient has NOT used the implant twice previously (if received once previously, must be for opposite arm) AND
    • Patient has not had any episodes of hospitalizations (addiction or mental health), emergency room visits, or crisis intervention in the past 90 days related to opioid dependence AND
    • Patient reports minimal to no desire or need to use illicit opioids AND
    • Patient does NOT have moderate to severe hepatic impairment (Child-Pugh B or C)
    • Patient must NOT be receiving methadone AND
    • Patient must NOT be receiving other long-acting products for the treatment of opioid abuse disorder (e.g. – buprenorphine [Sublocade®], naltrexone [Vivitrol®], etc.)
    • Initial approval is for 6 months

    Renewal criteria

    • Prescriber is certified to treat addictions under the Drug Addiction Treatment Act of 2000 (DATA 2000) waiver and provide an X-DEA number AND
    • Patient is compliant with addiction counseling and psychosocial support AND
    • Patient does not have prior hypersensitivity reaction to buprenorphine or implant AND
    • Patient is NOT pregnant (women of childbearing age have a negative pregnancy test dated within prior 30 days)
    • A urine drug screen, including buprenorphine, within the past 30 days of prior authorization submission is provided (if negative for buprenorphine or positive for other opioids, the provider must provide an explanation) AND
    • Patient is not prescribed concurrent opioid medication without explanation (including routine use of buprenorphine transmucosal products in addition to implant) AND
    • Patient has demonstrated efficacy on prior buprenorphine implant AND
    • Patient has been compliant with clinic visit requirement plan established by provider for first implant AND
    • Patient has NOT used the implant more than once previously and insertion site is the opposite arm of prior implant AND
    • There was no indication of patient tampering with insertion site/implant AND
    • Patient has not had any episodes of hospitalizations (addiction or mental health), emergency room visits, or crisis intervention in the past 90 days related to opioid dependence AND
    • Patient reports minimal to no desire or need to use illicit opioids AND
    • Patient does NOT have moderate to severe hepatic impairment (Child-Pugh B or C)
    • Renewal approval is for 6 months

    Quantity limits

    • 1 implant kit on one arm for the first 6 months
    • 1 implant kit on the other arm for the second 6 months
    • No additional quantity will be approved beyond 2 implant kits

    Billing for Probuphine

    Probuphine must be billed as a medical claim.

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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