Sublocade™
Drug - Sublocade™ (buprenorphine solution) [Indivior Inc.]
April 2019
Therapeutic Area - Opiate Dependence Treatments
Initial approval criteria
Provider must:
- Be certified to treat addictions under the Drug Addiction Treatment Act of 2000 (DATA 2000) waiver and provide an X-DEA number AND
- Provide written attestation of a comprehensive treatment plan between provider and patient AND
- Provide written attestation of a comprehensive review of patient’s medications and education provided to patient about risks of concomitant use of benzodiazepines, sedatives, opioid analgesics, alcohol or other CNS depressants, if applicable
- Provide written attestation that concomitant psychosocial support has been recommended AND
- Have complied with all aspects of the REMS program AND
Patient must:
- Be 18 years old or older AND
- Meet diagnosis of DSM-5 criteria for moderate or severe opioid use disorder AND
- Have initiated treatment and had at least 7 days of therapy on a transmucosal buprenorphine-containing product delivering the equivalent of 8 mg to 24 mg of buprenorphine daily with control of cravings and withdrawal symptoms AND
- Discontinue therapy with transmucosal buprenorphine upon initiation of Sublocade AND
- NOT have pre‐existing moderate to severe hepatic impairment OR
- NOT have a history of Long QT Syndrome OR
- NOT have concurrent Class IA antiarrhythmic medications (e.g., quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone, dofetilide), or other medications that prolong the QT interval AND
- Have 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
- NOT be receiving methadone AND
- NOT be receiving other long-acting products for the treatment of opioid abuse disorder (e.g. – buprenorphine [Probuphine®] implant, naltrexone [Vivitrol®], etc.)
Initial approval is for 3 months
Renewal criteria
Provider must:
- Be certified to treat addictions under the Drug Addiction Treatment Act of 2000 (DATA 2000) waiver and provide an X-DEA number AND
- Provide written attestation of a comprehensive treatment plan between provider and patient AND
- Provide written attestation of a comprehensive review of patient’s medications and education provided to patient about risks of concomitant use of benzodiazepines, sedatives, opioid analgesics, alcohol or other CNS depressants, if applicable
- Provide written attestation that concomitant psychosocial support has been recommended AND
- Have complied with all aspects of the REMS program AND
Patient must:
- Have 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
- NOT be on concurrent long-acting naltrexone, buprenorphine-containing or methadone product AND
- NOT have moderate or severe hepatic impairment AND
- NOT have adrenal insufficiency AND
- NOT have evidence of tampering or attempts to remove the depot at the injection site AND
- NOT be receiving other long acting-products for the treatment of opioid abuse disorder (e.g. – buprenorphine [Probuphine] implant, naltrexone [Vivitrol])
Renewal approval is for 6 months
Quantity limits
Billing
Sublocade is not covered through the MHCP fee-for-service pharmacy benefit and must be submitted as a medical claim.
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411